Insulin Lispro Sanofi Epar Product Information - en PDF

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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This medicinal product is subject to additional monitoring. This will allow quick identification of
new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1. NAME OF THE MEDICINAL PRODUCT
Insulin lispro Sanofi 100 units/ml solution for injection in vial

Insulin lispro Sanofi 100 units/ml solution for injection in cartridge
Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 100 units (equivalent to 3.5 mg) insulin lispro*.

Each vial contains 10 ml equivalent to 1,000 units insulin lispro.

Each cartridge contains 3 ml equivalent to 300 units insulin lispro.
Each pre-filled pen contains 3 ml equivalent to 300 units insulin lispro.
Each pre-filled pen delivers 1-80 units in steps of 1 unit.
* produced in E.coli by recombinant DNA technology
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Insulin lispro Sanofi 100 units /ml solution for injection in vial
Solution for injection (injection).
Insulin lispro Sanofi 100 units /ml solution for injection in cartridge
Solution for injection (injection).
Insulin lispro Sanofi 100 units /ml solution for injection in a pre-filled pen
Solution for injection (injection) SoloStar.
Clear, colourless, aqueous solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance
of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of
diabetes mellitus.
4.2 Posology and method of administration
Posology
The dosage should be determined by the physician, according to the requirement of the patient.
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Insulin lispro may be given shortly before meals. When necessary insulin lispro can be given soon
after meals.
Insulin lispro Sanofi takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given
subcutaneously as compared with regular insulin. This rapid onset of activity allows an Insulin lispro
Sanofi injection (or, in the case of administration by continuous subcutaneous infusion, an Insulin
lispro Sanofi bolus) to be given very close to mealtime. The time course of action of any insulin may
vary considerably in different individuals or at different times in the same individual. The faster onset
of action compared to soluble human insulin is maintained regardless of injection site. As with all
insulin preparations, the duration of action of Insulin lispro Sanofi is dependent on dose, site of
injection, blood supply, temperature, and physical activity.
Insulin lispro Sanofi can be used in conjunction with a longer-acting insulin or oral sulphonylurea
medicinal products, on the advice of a physician.
Insulin lispro Sanofi (insulin lispro 100 units/ml) and another insulin lispro medicinal product
(200 units/ml) in a pre-filled pen
Insulin lispro in a pre-filled pen is available in two strengths. For both, the needed dose is dialled in
units.
The number of units is shown in the dose window of the pen regardless of strength and no dose
conversion should be done when transferring a patient to a new strength or to another insulin lispro
pre-filled pen with a different dose step.
Special populations
Renal impairment
Insulin requirements may be reduced in the presence of renal impairment.
Hepatic impairment
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for
gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic
impairment, an increase in insulin resistance may lead to increased insulin requirements.
Paediatric population
Insulin lispro Sanofi can be used in adolescents and children (see section 5.1).
Method of administration
Insulin lispro Sanofi solution for injection should be given by subcutaneous injection or by continuous
subcutaneous infusion pump (see section 4.2) and may, although not recommended, also be given by
intramuscular injection.
If necessary, Insulin lispro Sanofi may also be administered intravenously, for example; for the control
of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.
Insulin lispro Sanofi 100 units/ml solution for injection in a cartridge

Insulin lispro Sanofi 100 units/ml in cartridges is only suitable for subcutaneous injections from a
reusable pen. If administration by syringe, intravenous injection or infusion pump is necessary, a vial
should be used (see section 4.4). For further details on handling, see section 6.6.
Insulin lispro Sanofi 100 units/ml in pre-filled pen is only suitable for subcutaneous injections. If
administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used
(see section 4.4).
Subcutaneous administration of Insulin lispro Sanofi

Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen. Use of
injection sites should be rotated so that the same site is not used more than approximately once a
month.
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When administered subcutaneously care should be taken when injecting Insulin lispro Sanofi to ensure
that a blood vessel has not been entered. After injection, the site of injection should not be massaged.
Patients must be educated to use the proper injection techniques.
Use of Insulin lispro Sanofi in an insulin infusion pump

Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing
insulin lispro, the manufacturer’s instructions should be studied to ascertain the suitability or otherwise
for the particular pump. Read and follow the instructions that accompany the infusion pump. Use the
correct reservoir and catheter for the pump. The infusion set (tubing and cannula) should be changed in
accordance with the instructions in the product information supplied with the infusion set. In the event
of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or
severe low blood glucose levels occur, notify your health care professional and consider the need to
reduce or stop your insulin infusion. A pump malfunction or obstruction of the infusion set can result
in a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions
in the product literature and if appropriate, notify your health care professional. When used with an
insulin infusion pump, Insulin lispro Sanofi should not be mixed with any other insulin.
Intravenous administration of Insulin lispro Sanofi

Intravenous injection of insulin lispro should be carried out following normal clinical practice for
intravenous injections, for example by an intravenous bolus or by an infusion system. Frequent
monitoring of the blood glucose levels is required.
Infusion systems at concentrations from 0.1 units/ml to 1.0 units/ml insulin lispro in 0.9% sodium
chloride or 5% dextrose are stable at room temperature for 48 hours. It is recommended that the
system is primed before starting the infusion to the patient.
4.3 Contraindications
Hypersensitivity to insulin lispro or to any of the excipients listed in section 6.1.
Hypoglycaemia.
4.4 Special warnings and precautions for use
Traceability
It is recommended that health care professionals record the brand name (“Insulin lispro Sanofi”) and
Lot number (included on the outer cartons and labels of each vial, cartridge and pre-filled pen) and
provide this information when reporting any side effects.
Transferring a patient to another type or brand of insulin

Transferring a patient to another type or brand of insulin should be done under strict medical
supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, etc.), species
(animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA versus
animal-source insulin) may result in the need for a change in dosage. For fast-acting insulins, any
patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the
whole day, particularly nocturnal/fasting glucose control.
Hypoglycaemia or hyperglycaemia
Conditions which may make the early warning symptoms of hypoglycaemia different or less
pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or
medications such as beta-blockers.
A few patients who have experienced hypoglycaemic reactions after transfer from animal-source
insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less
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pronounced or different from those experienced with their previous insulin. Uncorrected
hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
The use of dosages which are inadequate or discontinuation of treatment, especially in

insulin-dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which
are potentially lethal.
Insulin requirements and dosage adjustment

Insulin requirements may be increased during illness or emotional disturbances.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or
change their usual diet. Exercise taken immediately after a meal may increase the risk of
hypoglycaemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if
hypoglycaemia occurs, it may occur earlier after an injection when compared with soluble human
insulin.
Combination of Insulin lispro Sanofi with pioglitazone

Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin,
especially in patients with risk factors for development of cardiac heart failure. This should be kept in
mind, if treatment with the combination of pioglitazone and Insulin lispro Sanofi is considered. If the
combination is used, patients should be observed for signs and symptoms of heart failure, weight gain
and oedema. Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs.
Avoidance of medication errors when using Insulin lispro Sanofi

Patients must be instructed to always check the insulin label before each injection to avoid accidental
mix-ups between Insulin lispro Sanofi and other insulin products.
Insulin lispro Sanofi 100 units/mL solution in a pre-filled pen

Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the
requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who
are blind or have poor vision must be instructed to always get help/assistance from another person who
has good vision and is trained in using the insulin device.
Instructions for use and handling

The shorter-acting Insulin lispro Sanofi should be drawn into the syringe first, to prevent
contamination of the vial by the longer-acting insulin. Mixing of the insulins ahead of time or just
before the injection should be on advice of the physician. However, a consistent routine must be
followed.
For further details on handling, see section 6.6.

Insulin lispro Sanofi 100 units/ml in cartridges is only suitable for subcutaneous injections from a
should be used.
The Insulin lispro Sanofi cartridges should only be used with the following pens:
- JuniorSTAR which delivers Insulin lispro Sanofi in 0.5 unit dose increments
- Tactipen, AllStar and AllStar PRO which all deliver Insulin lispro Sanofi in 1 unit dose
increments.
These cartridges should not be used with any other reusable pen as the dosing accuracy has only been
established with the listed pens (see section 4.2 and 6.6).
Not all of these pens may be marketed in each country.
To prevent the possible transmission of disease, each cartridge must be used by one patient only, even
if the needle on the delivery device is changed.
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Insulin lispro Sanofi 100 units/ml in a pre-filled pen is only suitable for subcutaneous injections. If
administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used.
To prevent the possible transmission of disease, each pen must be used by one patient only, even if the
needle is changed.
Excipients
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially
“sodium-free”.
4.5 Interaction with other medicinal products and other forms of interaction
Insulin requirements may be increased by medicinal products with hyperglycaemic activity, such as
oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta2 stimulants (such as
ritodrine, salbutamol, terbutaline).
Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic
activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics,
certain antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors), certain
angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers,
beta-blockers, octreotide or alcohol.
The physician should be consulted when using other medicinal products in addition to Insulin lispro
Sanofi (see section 4.4).
4.6 Fertility, pregnancy and lactation
Pregnancy
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on
pregnancy or on the health of the foetus/new-born.
It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes)

patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase
during the second and third trimesters. Patients with diabetes should be advised to inform their doctor
if they are pregnant or are contemplating pregnancy. Careful monitoring of glucose control, as well as
general health, is essential in pregnant patients with diabetes.
Breast-feeding
Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both.
Fertility
Insulin lispro did not induce fertility impairment in animal studies (see section 5.3).
4.7 Effects on ability to drive and use machines
The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may
constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using
machines).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is
particularly important in those who have reduced or absent awareness of the warning signs of
hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be
considered in these circumstances.
4.8 Undesirable effects
Summary of the safety profile
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Hypoglycaemia is the most frequent adverse reaction of insulin therapy that a patient with diabetes
may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No
specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin
dose and other factors e.g. a patient`s level of diet and exercise.
Tabulated list of adverse reactions

The following related adverse reactions from clinical investigations are listed below by system organ
class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10;
uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000) and not known:
cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
MedDRA system organ classes Common Uncommon Rare

Immune system disorders
Local allergy X
Systemic allergy X
Skin and subcutaneous tissue disorders
Lipodystrophy X
Description of selected adverse reactions

Local allergy
Local allergy in patients is common. Redness, swelling, and itching can occur at the site of insulin
injection. This condition usually resolves in a few days to a few weeks. In some instances, this
condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or
poor injection technique.
Systemic allergy
Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin. It may
cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast
pulse, or sweating. Severe cases of generalised allergy may be life-threatening.
Lipodystrophy
Lipodystrophy at the injection site is uncommon.
Oedema
Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic
control is improved by intensified insulin therapy.
Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V.
4.9 Overdose
Insulins have no specific overdose definitions because serum glucose concentrations are a result of
complex interactions between insulin levels, glucose availability and other metabolic processes.
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy
expenditure.
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and
vomiting.
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or
saccharated products.
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Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or
subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers
sufficiently. Patients who fail to respond to glucagon must be given glucose solution intravenously.
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.

However, glucose solution must be given intravenously if glucagon is not available or if the patient
fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered.
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur
after apparent clinical recovery.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting,
ATC code: A10AB04
Insulin lispro Sanofi is a biosimilar medicinal product. Detailed information is available on the website
of the European Medicines Agency http://www.ema.europa.eu
The primary activity of insulin lispro is the regulation of glucose metabolism.
In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues.
Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and
amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein
catabolism and amino acid output.
Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given
closer to a meal (within zero to 15 minutes of the meal) when compared to regular insulin (30 to
45 minutes before). Insulin lispro takes effect rapidly and has a shorter duration of activity (2 to
5 hours) when compared to regular insulin.
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial
hyperglycaemia with insulin lispro compared to soluble human insulin.
As with all insulin preparations, the time course of insulin lispro action may vary in different
individuals or at different times in the same individual and is dependent on dose, site of injection,
blood supply, temperature and physical activity. The typical activity profile following subcutaneous
injection is illustrated below.
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Insulin lispro
Regular human insulin
The above representation reflects the relative amount of glucose over time required to maintain the
subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of
these insulins on glucose metabolism over time.
Clinical trials have been performed in children (61 patients aged 2 to 11) and children and adolescents
(481 patients aged 9 to 19 years), comparing insulin lispro to human soluble insulin. The
pharmacodynamic profile of insulin lispro in children is similar to that seen in adults.
When used in subcutaneous infusion pumps, treatment with insulin lispro has been shown to result in
lower glycosylated haemoglobin levels compared to soluble insulin. In a double-blind, crossover
study, the reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 percentage
points with insulin lispro, compared to 0.03 percentage points for soluble insulin (p = 0.004).
In patients with type 2 diabetes on maximum doses of sulphonyl urea agents, studies have shown that
the addition of insulin lispro significantly reduces HbA1c compared to sulphonyl urea alone. The
reduction of HbA1c would also be expected with other insulin products e.g. soluble or isophane
insulins.
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number of
episodes of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin. In some
studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime
hypoglycaemia.
The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment.
Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a
glucose clamp procedure, were maintained over a wide range of renal function.
Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more
rapid and of a shorter duration.
5.2 Pharmacokinetic properties
The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak
blood levels 30 to 70 minutes following subcutaneous injection. When considering the clinical
relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as
discussed in section 5.1).
Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients
with renal impairment. In patients with type 2 diabetes over a wide range of renal function the
pharmacokinetic differences between insulin lispro and soluble human insulin were generally
maintained and shown to be independent of renal function. Insulin lispro maintains more rapid
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absorption and elimination when compared to soluble human insulin in patients with hepatic
impairment.
5.3 Preclinical safety data
In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro
behaved in a manner that closely resembled human insulin. Studies also demonstrate that the
dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin. Acute,
one month and twelve month toxicology studies produced no significant toxicity findings.
Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Metacresol
Glycerol
Disodium hydrogen phosphate heptahydrate
Zinc oxide
Water for injections
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment).
6.2 Incompatibilities
The medicinal product should not be mixed with insulins produced by other manufacturers or with
animal insulin preparations.

This medicinal product must not be mixed with other medicinal products except those mentioned in
section 6.6.
6.3 Shelf life
Before first use

3 years.
After first use

Dispose of after 4 weeks.
6.4 Special precautions for storage

Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
After first use

Store below 30°C. Do not refrigerate.

Keep the cartridge in the outer carton in order to protect from light.
After first use
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Store below 30°C and protect from direct heat and light. Do not refrigerate.
The pen with the inserted cartridge should not be stored with the needle attached.
Keep the pre-filled pen in the outer carton in order to protect from light.
After first use

Store below 30°C. Do not refrigerate.
The pre-filled pen should not be stored with the needle attached.
The pen cap must be put back on the pen after each injection in order to protect from light.
6.5 Nature and contents of container

Type I colourless glass vial with a flanged cap (aluminium) with a sealing disk (chlorobutyl rubber)
and a tear-off cap (polypropylene) containing 10 ml of solution.
Pack sizes: 1 or 5 vials.
Not all packs sizes may be marketed.

Type 1 colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap
(aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber). Each cartridge contains
3 ml of solution.
Pack sizes: 5 or 10 cartridges
Not all packs sizes may be marketed.
Type 1 colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap
(aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber) sealed in a disposable
pen injector (SoloStar). Each pre-filled pen contains 3 ml of solution.
Pack sizes: 1, 3, 5 or 10 pre-filled pens.
Not all pack sizes may be marketed.
Needles are not included in the pack.
6.6 Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.

The vial is to be used in conjunction with an appropriate syringe (100 units markings).
Preparing a dose
Inspect the Insulin lispro Sanofi solution. It should be clear and colourless. Do not use the medicinal
product if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
If the therapeutic regimen requires the injection of basal insulin and Insulin lispro Sanofi at the same
time, the two can be mixed in the syringe. If mixing insulins, see section “Mixing Insulin lispro Sanofi
with longer-acting human insulins” below and section 6.2.
1. Wash your hands.
2. If using a new vial, flip off the plastic protective cap, but do not remove the stopper.
3. Draw air into the syringe equal to the prescribed Insulin lispro Sanofi dose. Wipe the top of the vial
with an alcohol swab. Put the needle through the rubber top of the Insulin lispro Sanofi vial and inject
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the air into the vial.
4. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand.
5. Making sure the tip of the needle is in the Insulin lispro Sanofi;withdraw the correct dose into the
syringe.
6. Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount
of Insulin lispro Sanofi in it. If bubbles are present, hold the syringe straight up and tap its side until
the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.
7. Remove the needle from the vial and lay the syringe down so that the needle does not touch
anything.
Mixing Insulin lispro Sanofi with longer-acting human insulins (see section 6.2)
1. Insulin lispro Sanofi should be mixed with longer-acting human insulins only on the advice of a
doctor. Insulin in vials must not be mixed with insulin in cartridges.
2. Draw air into the syringe equal to the amount of longer-acting insulin being taken. Insert the needle
into the longer-acting insulin vial and inject the air. Withdraw the needle.
3. Now inject air into the Insulin lispro Sanofi vial in the same manner, but do not withdraw the
needle.
4. Turn the vial and syringe upside down.
5. Making sure the tip of the needle is in the Insulin lispro Sanofi, withdraw the correct dose of Insulin
lispro Sanofi into the syringe.
6. Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount
of Insulin lispro Sanofi in it. If bubbles are present, hold the syringe straight up and tap its side until
the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.
7. Remove the needle from the vial of Insulin lispro Sanofi and insert it into the vial of the longer-
acting insulin. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand and
shake gently. Making sure the tip of the needle is in the insulin; withdraw the dose of longer-acting
insulin.
8. Withdraw the needle and lay the syringe down so that the needle does not touch anything.
Injecting a dose
1. Choose a site for injection.
2. Clean the skin as instructed.
3. Stabilise the skin by spreading it or pinching up a large area. Insert the needle and inject as
instructed.
4. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub
the area.
5. Dispose of the syringe and needle safely.
6. Use of the injection sites should be rotated so that the same is not used more than approximately
once a month.
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Insulin lispro Sanofi 100 units/ml in a cartridge is only suitable for subcutaneous injections from a
should be used. To prevent the possible transmission of disease, each cartridge must be used by one
patient only, even if the needle on the delivery device is changed.
Insulin lispro Sanofi cartridges are to be used with JuniorSTAR, Tactipen, AllStar or AllStar PRO
pens as recommended in the user manual (see section 4.2 and 4.4).
Preparing a dose
Inspect the Insulin lispro Sanofi solution. It should be clear and colourless. Do not use the medicinal
product if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.
The following is a general description. The manufacturer’s instructions with each individual pen must
be followed for loading the cartridge, attaching the needle and administering the insulin injection
Injecting a dose
1. Wash your hands.
2. Choose a site for injection.
3. Clean the skin as instructed.
4. Remove outer needle cap.
5. Stabilise the skin by spreading it or pinching up a large area. Insert the needle as instructed.
6. Press the knob.
7. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub
the area.
8. Using the outer needle cap, unscrew the needle and dispose of it safely.
9. Use of injection sites should be rotated so that the same site is not used more than approximately
once a month.
Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen (SoloStar)
Insulin lispro Sanofi 100 units/ml in a pre-filled pen is only suitable for subcutaneous injections. If
administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used.
To prevent the possible transmission of disease, each pen must be used by one patient only, even if the
needle is changed.
Inspect the Insulin lispro Sanofi solution. It should be clear and colourless. Do not use it if it appears
cloudy, thickened, or slightly coloured or if solid particles are visible.
Before using the pre-filled pen, the user manual included in the package leaflet must be read carefully.
The pre-filled pen has to be used as recommended in the user manual.
7. MARKETING AUTHORISATION HOLDER
sanofi-aventis groupe
54 rue La Boétie
F - 75008 Paris
France
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8. MARKETING AUTHORISATION NUMBER(S)
EU/1/17/1203/001-008
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19 july 2017
10. DATE OF REVISION OF THE TEXT
Detailed information on this medicinal product is available on the website of the European Medicines
Agency http://www.ema.europa.eu.
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ANNEX II
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE

SUBSTANCE AND MANUFACTURERS RESPONSIBLE
FOR BATCH RELEASE
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY

AND USE
C. OTHER CONDITIONS AND REQUIREMENTS OF THE

MARKETING AUTHORISATION
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
PRODUCT
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A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer of the biological active substance
Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50
Industriepark Höchst
65926 Frankfurt am Main
Germany
Name and address of the manufacturers responsible for batch release
Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50
Industriepark Höchst
65926 Frankfurt am Main
Germany
Sanofi-Aventis Private Co. Ltd.,

Budapest Logistics and Distribution Platform
Bdg. DC5, Campona utca 1.,
Budapest, 1225, Hungary
The printed package leaflet of the medicinal product must state the name and address of the
manufacturer responsible for the release of the concerned batch.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING

AUTHORISATION
 Periodic safety update reports
The requirements for submission of periodic safety update reports for this medicinal product are set
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive
2001/83/EC and any subsequent updates published on the European medicines web-portal.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND

EFFECTIVE USE OF THE MEDICINAL PRODUCT
 Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the
agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent
updates of the RMP.
An updated RMP should be submitted:

 At the request of the European Medicines Agency;
 Whenever the risk management system is modified, especially as the result of new information
being received that may lead to a significant change to the benefit/risk profile or as the result of
an important (pharmacovigilance or risk minimisation) milestone being reached.
16
ANNEX III
LABELLING AND PACKAGE LEAFLET
17
A. LABELLING
18
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON (10 ml vial)

Insulin lispro
2. STATEMENT OF ACTIVE SUBSTANCE(S)
One ml solution contains 100 units (equivalent to 3.5 mg) insulin lispro.
Each vial contains 10 ml equivalent to 1,000 units insulin lispro.
3. LIST OF EXCIPIENTS
Excipients: metacresol, glycerol, zinc oxide, disodium hydrogen phosphate heptahydrate, hydrochloric
acid and sodium hydroxide (for pH adjustment), water for injections
4. PHARMACEUTICAL FORM AND CONTENTS
Solution for injection

1 x 10 ml
5 x 10 ml
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.

Subcutaneous and intravenous use
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Before first use:

Store in a refrigerator.
19
Do not freeze.
After first use:

Store below 30°C.
Do not refrigerate.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
54 rue La Boétie
F - 75008 Paris
France
EU/1/17/1203/007 1 vial
EU/1/17/1203/008 5 vials.
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Insulin lispro Sanofi 100
17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
20
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
PC:
SN:
NN:
21
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LABEL (10 ml vial)
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Insulin lispro Sanofi 100 units/ml injection

Insulin lispro
SC/IV
2. METHOD OF ADMINISTRATION
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
10 ml
6. OTHER
22
OUTER CARTON (cartridge)

Insulin lispro
Each cartridge contains 3 ml equivalent to 300 units insulin lispro.
Solution for injection

5 x 3 ml
10 x 3 ml
The cartridges are to be used only with the pens: Tactipen, AllStar, AllStar PRO, JuniorSTAR.
Not all of these pens may be marketed in your country.

Subcutaneous use

For single patient use only.
8. EXPIRY DATE
EXP
23
Before first use:

Do not freeze.
After first use:

Store below 30°C.
Do not refrigerate.

APPROPRIATE
54 rue La Boétie
F - 75008 Paris
France
EU/1/17/1203/001 5 cartridges
EU/1/17/1203/002 10 cartridges.
13. BATCH NUMBER
Lot
Insulin lispro Sanofi 100
24
PC:
SN:
NN:
25
LABEL (cartridge)
Insulin lispro Sanofi 100 units/ml injection in cartridge

Insulin lispro
SC
Use specific pens.
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
3 ml
6. OTHER
26
OUTER CARTON (3 ml pre-filled pen)
Insulin lispro
Each pre-filled pen contains 3 ml equivalent to 300 units insulin lispro.
Solution for injection SoloStar

1 pen of 3 ml
3 pens of 3 ml
5 pens of 3 ml
10 pens of 3 ml

Subcutaneous use
Open here

Always use a new needle for each injection.

For single patient use only.
8. EXPIRY DATE
EXP
27
Before first use:

Do not freeze.
After first use:

Store below 30°C.
Do not refrigerate.
Put the pen cap back on the pen after each injection in order to protect from light.

APPROPRIATE
54 rue La Boétie
F - 75008 Paris
France
EU/1/17/1203/003 1 pen.
EU/1/17/1203/004 3 pens.
EU/1/17/1203/005 5 pens.
EU/1/17/1203/006 10 pens.
13. BATCH NUMBER
Lot
Insulin lispro 100 SoloStar
28
PC:
SN:
NN:
29
PEN LABEL (Pre-filled pen)
Insulin lispro Sanofi 100 units/ml injection

Insulin lispro
SC
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
3 ml
6. OTHER
SoloStar
30
B. PACKAGE LEAFLET
31
Package leaflet: information for the user

Insulin lispro
This medicine is subject to additional monitoring. This will allow quick identification of new
safety information. You can help by reporting any side effects you may get. See the end of section 4
for how to report side effects.
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Insulin lispro Sanofi is and what it is used for

2. What you need to know before you use Insulin lispro Sanofi
3. How to use Insulin lispro Sanofi
4. Possible side effects
5. How to store Insulin lispro Sanofi
6. Contents of the pack and other information
Insulin lispro Sanofi is used to treat diabetes. It works more quickly than normal human insulin
because the insulin molecule has been changed slightly.
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your
blood. Insulin lispro Sanofi is a substitute for your own insulin and is used to control glucose in the
long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You
should normally use Insulin lispro Sanofi within 15 minutes of a meal.
Your doctor may tell you to use Insulin lispro Sanofi as well as a longer-acting insulin. Each kind of
insulin comes with another patient information leaflet to tell you about it. Do not change your insulin
unless your doctor tells you to. Be very careful if you do change insulin.
Insulin lispro Sanofi is suitable for use in adults and children.
Do not use Insulin lispro Sanofi

- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to
deal with mild hypoglycaemia (see section 3: If you use more Insulin lispro Sanofi than you
need).
- if you are allergic to insulin lispro or to any of the other ingredients of this medicine (listed in
section 6).
32
Warnings and precautions
Record the brand name (“Insulin lispro Sanofi”) and Lot number (included on the outer cartons and
labels of each vial, cartridge and pre-filled pen) of the product you are using and provide this
information when reporting any side effects.
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel
the warning symptoms when your blood sugar is falling too low. Warning signs are listed later
in this leaflet. You must think carefully about when to have your meals, how often to exercise
and how much to do. You must also keep a close watch on your blood sugar levels by testing
your blood glucose often.
 A few people who have had hypoglycaemia after switching from animal insulin to human
insulin have reported that the early warning symptoms were less obvious or different. If you
often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.
 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes
nurse
- Have you recently become ill?
- Do you have trouble with your kidneys or liver?
- Are you exercising more than usual?
 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.
The time difference between countries may mean that you have to have your injections and
meals at different times from when you are at home.
 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke
who were treated with pioglitazone and insulin experienced the development of heart failure.
Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual
shortness of breath or rapid increase in weight or localised swelling (oedema).
Other medicines and Insulin lispro Sanofi

Your insulin needs may change if you are taking
• the contraceptive pill,
• steroids,
• thyroid hormone replacement therapy,
• oral hypoglycaemics,
• acetyl salicylic acid,
• sulpha antibiotics,
• octreotide,
• “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),
• beta-blockers, or
• some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
• danazol,
• some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and
• angiotensin II receptor blockers.
Tell your doctor if you are taking, have recently taken or might take any other medicines (see also
section “Warnings and precautions”).
Insulin lispro Sanofi with alcohol

Your blood sugar levels may change if you drink alcohol. Therefore the amount of insulin needed may
change.
Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.The amount of insulin you need usually falls during
the first three months of pregnancy and increases for the remaining six months.
If you are breast-feeding, you may need to alter your insulin intake or diet.
Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this
33
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving
a car or using machines). You should contact your doctor about the advisability of driving if you have:
 frequent episodes of hypoglycaemia
 reduced or absent warning signs of hypoglycaemia
Important information about some of the ingredients of Insulin lispro Sanofi

This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially “sodium-free”.
Always check the pack and the vial label for the name and type of the insulin when you get it
from your pharmacy. Make sure you get the Insulin lispro Sanofi that your doctor has told you
to use.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not
sure.
Dosage
 You should normally inject Insulin lispro Sanofi within 15 minutes of a meal. If you need to,
you can inject soon after a meal. But your doctor will have told you exactly how much to use,
when to use it, and how often. These instructions are only for you. Follow them exactly and visit
your diabetes clinic regularly.
 If you change the type of insulin you use (for example from a human or animal insulin to an
Insulin lispro Sanofi product), you may have to use more or less than before. This might just be
for the first injection or it may be a gradual change over several weeks or months.
 Inject Insulin lispro Sanofi under the skin (subcutaneous use or “SC”). You should only inject it
into a muscle if your doctor has told you to.
Preparing Insulin lispro Sanofi

 Insulin lispro Sanofi is already dissolved in water, so you do not need to mix it. But you must
use it only if it looks like water. It must be clear, have no colour and no solid pieces in it. Check
each time you inject yourself.
Injecting Insulin lispro Sanofi

 First wash your hands.
 Before you make an injection, clean your skin as you have been instructed. Clean the rubber
stopper on the vial, but do not remove the stopper.
 Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of
Insulin lispro Sanofi you want. Your doctor or clinic will tell you how to do this. Do not share
your needles and syringes.
 Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection,
leave the needle in the skin for five seconds to make sure you have injected the whole dose. Do
not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the
last injection and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t
matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Insulin
lispro Sanofi injection will still work quicker than soluble human insulin.
 Your doctor will tell you if you have to mix Insulin lispro Sanofi with one of the human insulins.
For example if you do need to inject a mixture, draw the Insulin lispro Sanofi into the syringe
before the long acting insulin. Inject the liquid as soon as you have mixed it. Do the same thing
every time.
 You should not normally mix Insulin lispro Sanofi with one of the mixtures of human insulins.
You should never mix Insulin lispro Sanofi with insulins produced by other manufacturers or
animal insulins.
 You must not administer Insulin lispro Sanofi by the intravenous route (IV). Inject Insulin lispro
Sanofi as your physician or nurse has taught you. Only your physician can administer Insulin
34
lispro Sanofi by the intravenous route. He will only do this under special circumstances such as
surgery or if you are ill and your glucose levels are too high.
Using Insulin lispro Sanofi in an infusion pump

 Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before
infusing insulin lispro, the manufacturer’s instructions should be studied to ascertain the
suitability or otherwise for the particular pump. Read and follow the instructions in the product
literature supplied with the infusion pump.
 Be sure to use the correct reservoir and catheter for your pump.
 Changing of the infusion set (tubing and needle) must be done according to the instructions in
the product information supplied with the infusion set.
 In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is
resolved. If repeated or severe low blood glucose levels occur, notify your doctor or clinic and
consider the need to reduce or stop your insulin infusion.
 A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels.
If an interruption to insulin flow is suspected, follow the instructions in the product literature and
if appropriate, notify your doctor or clinic.
 When used with an insulin infusion pump, Insulin lispro Sanofi should not be mixed with any
other insulin.
If you use more Insulin lispro Sanofi than you should

If you use more Insulin lispro Sanofi than you need, a low blood sugar may occur. Check your blood
sugar. If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary
drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This
will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.
If you forget to use Insulin lispro Sanofi

If you use less Insulin lispro Sanofi than you need, a high blood sugar may occur. Check your blood
sugar.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be
very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids
(dehydration), unconsciousness, coma or even death (see Hypoglycaemia and Hyperglycaemia and
diabetic ketoacidosis in section 4 “Possible Side Effects”).
Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

 Always keep spare syringes and a spare vial of Insulin lispro Sanofi
 Always carry something to show you are diabetic.
 Always carry sugar with you.
If you stop using Insulin lispro Sanofi

If you use less Insulin lispro Sanofi than you need, a high blood sugar may occur. Do not change your
insulin unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
35
Systemic allergy is rare (may affect up to 1 in 1,000 people). The symptoms are as follows:
 rash over the whole body  blood pressure dropping
 difficulty in breathing  heart beating fast
 wheezing  sweating
If you think you are having this sort of insulin allergy with Insulin lispro Sanofi, tell your doctor at
once.
Local allergy is common (may affect up to 1 in 10 people). Some people get redness, swelling or
itching around the area of the insulin injection. This usually clears up in anything from a few days to a
few weeks. If this happens to you, tell your doctor.
Lipodystrophy (thickening or pitting of the skin) is uncommon (may affect up to 1 in 100 people). If
you notice your skin thickening or pitting at the injection site, tell your doctor.
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of
insulin therapy or during a change in therapy to improve control of your blood glucose.
Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of
this medicine.
Common problems of diabetes
Hypoglycaemia
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:
 you inject too much Insulin lispro Sanofi or other insulin;
 you miss or delay meals or change your diet;
 you exercise or work too hard just before or after a meal;
 you have an infection or illness (especially diarrhoea or vomiting);
 there is a change in your need for insulin; or
 you have trouble with your kidneys or liver which gets worse.
Alcohol and some medicines can affect your blood sugar levels (see section 2).
The first symptoms of low blood sugar usually come on quickly and include the following:
 tiredness  rapid heartbeat
 nervousness or shakiness  feeling sick
 headache  cold sweat
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a
car, in which you or others would be put at risk by hypoglycaemia.
Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.
Hyperglycaemia can be brought about by:
 not using your Insulin lispro Sanofi or other insulin;
 using less insulin than your doctor tells you to;
 eating a lot more than your diet allows; or
 fever, infection or emotional stress.
36
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many
hours or days. The symptoms include the following:
 feeling sleepy  no appetite
 flushed face  fruity smell on the breath
 thirst  feeling or being sick
Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.
Illness
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even
when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick
rules’, and tell your doctor.
Keep out of the reach and sight of children.
Do not use Insulin lispro Sanofi after the expiry date which is stated on the label and the carton. The
expiry date refers to the last day of that month.
Before the first use store your medicine in a refrigerator (2°C – 8°C). Do not freeze.
Keep your vial in use at room temperature (below 30°C) and dispose of after 4 weeks. Do not store the
vial in a refrigerator. Keep the vial in the outer carton in order to protect from light.
Do not use Insulin lispro Sanofi if it is coloured or it has solid pieces in it. You must use it only if it
looks like water. Check this each time you inject yourself.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
What Insulin lispro Sanofi contains

 The active substance is insulin lispro. One ml of the solution contains 100 units (equivalent to
3.5 mg) of insulin lispro. Each vial contains 10 ml of solution for injection, equivalent to
1,000 units.
 The other ingredients are: metacresol, glycerol, disodium hydrogen phosphate heptahydrate, zinc
oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to
adjust the acidity.
What Insulin lispro Sanofi looks like and contents of the pack
Insulin lispro Sanofi, solution for injection in a vial is a clear, colourless, aqueous solution
Each vial contains 10 ml.
The Insulin lispro Sanofi in a vial comes in a pack of 1 vial or 5 vials. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

sanofi-aventis groupe, 54 rue La Boétie, F - 75008 Paris, France
Manufacturer:
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
37
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.
België/Belgique/Belgien Lietuva
Sanofi Belgium UAB « SANOFI-AVENTIS LIETUVA »
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 2755224
България Luxembourg/Luxemburg
SANOFI BULGARIA EOOD Sanofi Belgium
Тел.: +359 (0)2 970 53 00 Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
Česká republika Magyarország

sanofi-aventis, s.r.o. SANOFI-AVENTIS Zrt.,
Tel: +420 233 086 111 Tel.: +36 1 505 0050
Danmark Malta
Sanofi A/S Sanofi Malta Ltd.
Tlf: +45 45 16 70 00 Tel: +356 21493022
Deutschland Nederland
Sanofi-Aventis Deutschland GmbH sanofi-aventis Netherlands B.V.
Tel.: 0800 52 52 010 Tel: +31 20 245 4000
Tel. aus dem Ausland: +49 69 305 21 131
Eesti Norge
sanofi-aventis Estonia OÜ sanofi-aventis Norge AS
Tel: +372 627 34 88 Tlf: +47 67 10 71 00
Ελλάδα Österreich
sanofi-aventis AEBE sanofi-aventis GmbH
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0
España Polska
sanofi-aventis, S.A. sanofi-aventis Sp. z o.o.
Tel: +34 93 485 94 00 Tel.: +48 22 280 00 00
France Portugal
sanofi-aventis France Sanofi - Produtos Farmacêuticos, Lda
Tél: 0 800 222 555 Tel: +351 21 35 89 400
Appel depuis l’étranger : +33 1 57 63 23 23
Hrvatska România
sanofi-aventis Croatia d.o.o. Sanofi Romania SRL
Tel: +385 1 600 34 00 Tel: +40 (0) 21 317 31 36
Ireland Slovenija
sanofi-aventis Ireland Ltd. T/A SANOFI sanofi-aventis d.o.o.
Tel: +353 (0) 1 403 56 00 Tel: +386 1 560 48 00
Ísland Slovenská republika

Vistor hf. sanofi-aventis Pharma Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 33 100 100
38
Italia Suomi/Finland
Sanofi S.p.A. Sanofi Oy
Tel: 800 13 12 12 (domande di tipo tecnico) Puh/Tel: +358 (0) 201 200 300
800.536389 (altre domande)
Κύπρος Sverige
sanofi-aventis Cyprus Ltd. Sanofi AB
Τηλ: +357 22 871600 Tel: +46 (0)8 634 50 00
Latvija United Kingdom

sanofi-aventis Latvia SIA Sanofi
Tel: +371 67 33 24 51 Tel: +44 (0) 845 372 7101
This leaflet was last revised in
Other source of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu/
39

Insulin lispro


need).
section 6).

Insulin lispro Sanofi in cartridges is only suitable for injecting just under the skin using a reusable pen
(see also section 3). Speak to your doctor if you need to inject your insulin by another method.
40
nurse
- Are you exercising more than usual?
 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.
The time difference between countries may mean that you have to have your injections and
meals at different times from when you are at home.

• steroids,
• octreotide,
• danazol,
Tell your doctor if you are taking, have recently taken or might take any other medicines. (see also

change.

your doctor for advice before taking this medicine.The amount of insulin you need usually falls during
41

The 3 ml cartridge is only for use in 3 ml pens. It is not for use in 1.5 ml pens.
Always check the pack and the label cartridge for the name and type of the insulin when you get
it from your pharmacy. Make sure you get the Insulin lispro Sanofi that your doctor has told
you to use.
sure. To prevent the possible transmission of disease, each cartridge must be used by you only, even if
the needle on the delivery device is changed.
Dosage

Getting the pen ready to use

 First wash your hands. Disinfect the rubber membrane of the cartridge.
 The 3 ml cartridge only fits the 3 ml pen. Insulin lispro Sanofi in cartridges is only suitable for
injecting just under the skin using a reusable pen. Speak to your doctor if you need to inject your
insulin by another method. To ensure you get the accurate dose, the Insulin lispro Sanofi
cartridges are to be used only with the following pens:
- JuniorSTAR which delivers doses in steps of 0.5 units
- Tactipen, AllStar and AllStar PRO which deliver doses in steps of 1 unit.
Not all of these pens may be marketed in your country.
 Follow the instructions that come with the pen. The manufacturer’s instructions for using the
pen must be followed carefully for loading the cartridge, attaching the needle, and administering
the insulin injection.
 Always perform a safety test before each injection.

 Before you make an injection, clean your skin as you have been instructed. Inject under the skin,
as you were taught. Do not inject directly into a vein. After your injection, leave the needle in
the skin for ten seconds to make sure you have injected the whole dose. Do not rub the area you
have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and
42
that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which injection
site you use, either upper arm, thigh, buttock or abdomen, your Insulin lispro Sanofi injection
will still work quicker than soluble human insulin.
After injecting
 As soon as you have done the injection, take the needle off the pen using the outer needle cap.
Do not share your needles. Do not share your pen. Replace the cap on your pen. Leave the
cartridge in the pen.
Further injections Always use a new sterile needle for each injection. Always perform a safety test
before each injection.
Do not mix any other insulin in an Insulin lispro Sanofi cartridge. Once the cartridge is empty,
do not use it again.


sugar.

 Always keep spare syringes and a spare vial of Insulin lispro Sanofi, or a spare pen and
cartridges, in case you lose your pen or cartridges or they get damaged.

43
once.

this medicine.
Hypoglycaemia

44
Illness
Do not use Insulin lispro Sanofi after the expiry date which is stated on the label and the carton. The
expiry date refers to the last day of that month.
Before the first use store your Insulin lispro Sanofi in a refrigerator (2°C – 8°C). Do not freeze. Keep
the cartridge in the outer carton in order to protect from light.
Keep your cartridge in use at room temperature (below 30°C) and dispose of after 4 weeks. Do not put
it near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen
with the inserted cartridge should not be stored with the needle attached.
Do not use Insulin lispro Sanofi, if it is coloured or it has solid pieces in it. You must use it only if it
looks like water. Check this each time you inject yourself.

 The active substance is insulin lispro. One ml of the solution contains 100 units (equivalent to
3.5 mg) of insulin lispro. Each cartridge contains 3 ml of solution for injection, equivalent to
300 units.
adjust the acidity.
Insulin lispro Sanofi, solution for injection is a clear, colourless, aqueous solution.
Each cartridge contains 3 ml.
The Insulin lispro Sanofi cartridges come in a pack of 5 or 10 cartridges. Not all pack sizes may be
marketed.

Manufacturer:
45
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 2755224

Tel: +420 233 086 111 Tel.: +36 1 505 0050
Danmark Malta
Tlf: +45 45 16 70 00 Tel: +356 21493022
Tel.: 0800 52 52 010 Tel: +31 20 245 4000
Eesti Norge
Tel: +372 627 34 88 Tlf: +47 67 10 71 00
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0
España Polska
Tel: +34 93 485 94 00 Tel.: +48 22 280 00 00
France Portugal
Tél: 0 800 222 555 Tel: +351 21 35 89 400
Hrvatska România
Tel: +385 1 600 34 00 Tel: +40 (0) 21 317 31 36
Ireland Slovenija
Tel: +353 (0) 1 403 56 00 Tel: +386 1 560 48 00

Sími: +354 535 7000 Tel: +421 2 33 100 100
46
Τηλ: +357 22 871600 Tel: +46 (0)8 634 50 00

Tel: +371 67 33 24 51 Tel: +44 (0) 845 372 7101

47
Insulin lispro
Each pre-filled pen delivers 1-80 units in steps of 1 unit.

Insulin lispro Sanofi SoloStar is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml)
of insulin lispro. One Insulin lispro Sanofi pre-filled pen contains multiple doses of insulin. The
Insulin lispro Sanofi pre-filled pen dials 1 unit at a time. The number of units are displayed in the
dose window, always check this before your injection. You can give from 1 to 80 units in a single
injection. If your dose is more than 80 units, you will need to give yourself more than one
injection.

48
need).
section 6).

Insulin lispro Sanofi in pre-filled pen is only suitable for injecting just under the skin (see also
section 3). Speak to your doctor if you need to inject your insulin by another method.
nurse
 - Are you exercising more than usual? You should also tell your doctor, pharmacist or diabetes
nurse if you are planning to go abroad. The time difference between countries may mean that
you have to have your injections and meals at different times from when you are at home.
 This pen is not recommended for use by the blind or visually impaired without the help of
someone trained to use the pen.

• steroids,
• octreotide,
• danazol,
Tell your doctor if you are taking, have recently taken or might take any other medicines. (see also
49
change.

your doctor for advice before taking this medicine. The amount of insulin you need usually falls during


Always check the pack and the label of the pre-filled pen for the name and type of the insulin
when you get it from your pharmacy. Make sure you get the Insulin lispro Sanofi that your
doctor has told you to use.
sure. To prevent the possible transmission of disease, each pen must be used by you only, even if the
needle is changed.
Dosage

Getting the SoloStar pre-filled pen ready to use (Please see user manual)
 Insulin lispro Sanofi in pre-filled pen is only suitable for injecting just under the skin. Speak to
your doctor if you need to inject your insulin by another method.
 First wash your hands.
 Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions
carefully. Here are some reminders.
 Use a clean needle. (Needles are not included).
 Always perform a safety test before each injection.
50
 Before you make an injection, clean your skin as you have been instructed. Inject under the skin,
as you were taught. Do not inject directly into a vein. After your injection, leave the needle in
the skin for ten seconds to make sure you have injected the whole dose. Do not rub the area you
have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and
that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which injection
site you use, either upper arm, thigh, buttock or abdomen, your Insulin lispro Sanofi injection
will still work quicker than soluble human insulin.
After injecting
 As soon as you have done the injection, unscrew the needle from the pre-filled pen using the
outer needle cap. Do not share your needles. Do not share your pen. Replace the cap on your
pen.
Further injections
 Every time you use a pre-filled pen you must use a new needle. Always perform a safety test
before each injection. You can see roughly how many units of insulin are left by looking at
where the plunger is on the insulin scale.
 Do not mix any other insulin in your pre-filled pen. Once the pre-filled pen is empty, do not use
it again. Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do
this.


sugar.

 Always keep spare syringes and a spare vial of Insulin lispro Sanofi, or a spare pen and
cartridges, in case you lose your SoloStar pre-filled pen or it gets damaged.


51
once.

this medicine.
Hypoglycaemia

52
Illness
Do not use Insulin lispro Sanofi in a pre-filled pen after the expiry date which is stated on the label and
the carton. The expiry date refers to the last day of that month.
Before the first use store your medicine pre-filled pen in a refrigerator (2°C – 8°C). Do not freeze.
Keep your Insulin lispro Sanofi pre-filled pen in use at room temperature (below 30°C) and dispose of
after 4 weeks. Do not keep the pre-filled pen that you are using in the fridge. The pre-filled pen should
not be stored with the needle attached. Always keep the cap on the pre-filled pen when you are not
using it in order to protect from light.
Do not use Insulin lispro Sanofi pre-filled pen if the solution is coloured or it has solid pieces in it.
You must use it only if it looks like water. Check this each time you inject yourself.

 The active substance is insulin lispro. Each ml of the solution contains 100 units (equivalent to
3.5 mg) of insulin lispro. Each pre-filled pen contains 3 ml of solution for injection, equivalent
to 300 units.
adjust the acidity.
Insulin lispro Sanofi, solution for injection is a clear, colourless, aqueous solution.
Each pre-filled pen contains 3 ml.
The Insulin lispro Sanofi in a pre-filled pen (SoloStar) comes in a pack of 1, 3, 5 or 10 pre-filled pens.
Not all pack sizes may be marketed.
The Insulin lispro Sanofi in your pre-filled pen is the same as the Insulin lispro Sanofi, which comes in
separate Insulin lispro Sanofi cartridges. The pre-filled pen simply has a built in cartridge. When the
pre-filled pen is empty you cannot use it again.
53
Manufacturer:
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 2755224

Tel: +420 233 086 111 Tel.: +36 1 505 0050
Danmark Malta
Tlf: +45 45 16 70 00 Tel: +356 21493022
Tel.: 0800 52 52 010 Tel: +31 20 245 4000
Eesti Norge
Tel: +372 627 34 88 Tlf: +47 67 10 71 00
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0
España Polska
Tel: +34 93 485 94 00 Tel.: +48 22 280 00 00
France Portugal
Tél: 0 800 222 555 Tel: +351 21 35 89 400
Hrvatska România
Tel: +385 1 600 34 00 Tel: +40 (0) 21 317 31 36
Ireland Slovenija
Tel: +353 (0) 1 403 56 00 Tel: +386 1 560 48 00
54
Sími: +354 535 7000 Tel: +421 2 33 100 100
Τηλ: +357 22 871600 Tel: +46 (0)8 634 50 00

Tel: +371 67 33 24 51 Tel: +44 (0) 845 372 7101

55
Insulin lispro Sanofi solution for injection in a pre-filled pen (SoloStar)
INSTRUCTIONS FOR USE
Read this first
Important information
Never share your pen – it is only for you.

Never use your pen if it is damaged or if you are not sure that it is working properly.
Always perform a safety test
Always carry a spare pen and spare needles in case they got lost or stop working.
Never re-use needles. If you do you might not get your dose (underdosing) or get too much
(overdosing) as the needle could block.
Learn to inject
 Talk with your doctor, pharmacist or nurse about how to inject, before using your pen.
 Ask for help if you have problems handling the pen, for example if you have problems with your
sight.
 This pen is not recommended for use by the blind or visually impaired without the help of
someone trained to use the pen.
 Read all of these instructions before using your pen. If you do not follow all of these instructions,
you may get too much or too little insulin.
Need help?
If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or
call sanofi-aventis number on the front of this leaflet.
Extra items you will need:
 a new sterile needle (see STEP 2).

 a puncture resistant container for used needles and pens (see Throwing your pen away).
Get to know your pen
Cartridge holder Insulin name Dose window Dose pointer
Dose selector
Rubber Insulin
Pen cap seal scale Plunger Injection button
* You will not see the plunger until you have injected a few doses.
STEP 1: Check your pen
Take a new pen out of the fridge at least 1 hour before you inject. Cold insulin is more painful to
inject.
56
A Check the name and expiration date on the label of your pen.
 Make sure you have the correct insulin. This is especially important if you have other
injector pens.
 Never use your pen after the expiration date.
B Pull off the pen cap.
C Check that the insulin is clear.

 Do not use the pen if the insulin looks cloudy, coloured or contains particles.
STEP 2: Attach a new needle
Always use a new sterile needle for each injection. This helps stop blocked needles, contamination
and infection.
Only use needles that are compatible for use with Insulin lispro Sanofi (e.g. needles from BD,
Ypsomed, Artsana or Owen Mumford).
A Take a new needle and peel off the protective seal.
57
B Keep the needle straight and screw it onto the pen until fixed. Do not overtighten.
C Pull off the outer needle cap. Keep this for later.
D Pull off the inner needle cap and throw away.
Handling needles
 Take care when handling needles – this is to prevent needle injury and cross-infection.
STEP 3: Do a safety test
Always do a safety test before each injection – this is to:

 check your pen and the needle are working properly.
 make sure that you get the correct insulin dose.
58
A Select 2 units by turning the dose selector until the dose pointer is at the 2 mark.
B Press the injection button all the way in.

 When insulin comes out of the needle tip, your pen is working correctly.
If no insulin appears:
 You may need to repeat this step up to 3 times before seeing insulin.
 If no insulin comes out after the third time, the needle may be blocked. If this happens:
- change the needle (see STEP 6 and STEP 2),
- then repeat the safety test (STEP 3).
 Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen.
 Never use a syringe to remove insulin from your pen.
If you see air bubbles

 You may see air bubbles in the insulin. This is normal, they will not harm you.
STEP 4: Select the dose
Never select a dose or press the injection button without a needle attached. This may damage your
pen.
59
A Make sure a needle is attached and the dose is set to ‘0’.
B Turn the dose selector until the dose pointer lines up with your dose.
 If you turn past your dose, you can turn back down.
 If there are not enough units left in your pen for your dose, the dose selector will stop at the
number of units left.
 If you cannot select your full prescribed dose, use a new pen or inject the remaining units and
use a new pen to complete your dose.
How to read the dose window
Even numbers are shown in line with the dose pointer:
20 units selected
Odd numbers are shown as a line between even numbers:
21 units selected
Units of insulin in your pen

 Your pen contains a total of 300 units of insulin. You can select doses from 1 to 80 units in
steps of 1 unit. Each pen contains more than one dose.
 You can see roughly how many units of insulin are left by looking at where the plunger is on
the insulin scale.
60
STEP 5: Inject your dose
If you find it hard to press the injection button in, do not force it as this may break your pen. See
the section below for help.
A Choose a place to inject as shown in the picture
Upper arms
Stomach
Buttocks
Thighs
B Push the needle into your skin as shown by your doctor, pharmacist or nurse.
 Do not touch the injection button yet
C Place your thumb on the injection button. Then press all the way in and hold.
 Do not press at an angle – your thumb could block the dose selector from turning.
61
D Keep the injection button held in and when you see "0" in the dose window, slowly count to
10.
This will make sure you get your full dose.
E After holding and slowly counting to 10, release the injection button. Then remove the needle
from your skin.
If you find it hard to press the button in:

 Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3).
 If you still find it hard to press in, get a new pen.
 Never use a syringe to remove insulin from your pen.
STEP 6: Remove the needle
Take care when handling needles – this is to prevent needle injury and cross-infection.
Never put the inner needle cap back on.
A Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.
 To reduce the risk of accidental needle injury, never replace the inner needle cap.
 If your injection is given by another person, or if you are giving an injection to another
person, special caution must be taken by this person when removing and disposing of the
needle.
 Follow recommended safety measures for removal and disposal of needles (contact your
doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and
transmission of infectious diseases.
62
B Throw away the used needle in a puncture resistant container, or as told by your pharmacist
or local authority.
C Put the pen cap back on.

 Do not put the pen back in the fridge.
Use by
 Only use your pen for up to 28 days after its first use.
How to store your pen
Before first use

 Keep new pens in a fridge, at 2°C to 8°C.
 Do not freeze.
After first use

 Keep your pen at room temperature, below 30°C.
 Never put your pen back in the fridge.
 Never store your pen with the needle attached.
 Store your pen with the pen cap on.
How to care for your pen
Handle your pen with care

 Do not drop your pen or knock it against hard surfaces.
 If you think that your pen may be damaged, do not try to repair it, use a new one.
Protect your pen from dust and dirt

 You can clean the outside of your pen by wiping it with a damp cloth (water only). Do not
soak, wash or lubricate your pen – this may damage it.
Throwing your pen away

 Remove the needle before throwing your pen away.
 Throw away your used pen as told by your pharmacist or local authority.
63

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Insulin lispro Sanofi 100 units/ml solution for injection in vial

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Insulin lispro Sanofi 100 units/ml solution for injection in vial

Insulin lispro Sanofi 100 units/ml solution for injection in cartridge

* produced in E.coli by recombinant DNA technology

For the full list of excipients, see section 6.1.

Clear, colourless, aqueous solution.

4.1 Therapeutic indications

4.2 Posology and method of administration

Insulin lispro Sanofi 100 units/ml solution for injection in a cartridge

Subcutaneous administration of Insulin lispro Sanofi

Use of Insulin lispro Sanofi in an insulin infusion pump

Intravenous administration of Insulin lispro Sanofi

Hypersensitivity to insulin lispro or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Transferring a patient to another type or brand of insulin

The use of dosages which are inadequate or discontinuation of treatment, especially in

Insulin requirements and dosage adjustment

Combination of Insulin lispro Sanofi with pioglitazone

Avoidance of medication errors when using Insulin lispro Sanofi

Insulin lispro Sanofi 100 units/mL solution in a pre-filled pen

Instructions for use and handling

Insulin lispro Sanofi 100 units/ml solution for injection in cartridge

4.6 Fertility, pregnancy and lactation

It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes)

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

Summary of the safety profile

Tabulated list of adverse reactions

MedDRA system organ classes Common Uncommon Rare

Description of selected adverse reactions

Reporting of suspected adverse reactions

If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.

5.1 Pharmacodynamic properties

The primary activity of insulin lispro is the regulation of glucose metabolism.

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

6.1 List of excipients

Insulin lispro Sanofi 100 units/ml solution for injection in vial

6.3 Shelf life

Before first use

After first use

6.4 Special precautions for storage

Insulin lispro Sanofi 100 units/ml solution for injection in vial

After first use

Insulin lispro Sanofi 100 units/ml solution for injection in cartridge

After first use

After first use

6.5 Nature and contents of container

Insulin lispro Sanofi 100 units/ml solution for injection in vial

Insulin lispro Sanofi 100 units/ml solution for injection in cartridge

6.6 Special precautions for disposal and other handling

Insulin lispro Sanofi 100 units/ml solution for injection in vial

1. Wash your hands.

4. Turn the vial and syringe upside down.

2. Clean the skin as instructed.