EMA - Pandemrix® (Vaccin A H1N1 - GSK)

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1. NAME OF THE MEDICINAL PRODUCT
Pandemrix suspension and emulsion for emulsion for injection.

Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
After mixing, 1 dose (0.5 ml) contains:
Split influenza virus, inactivated, containing antigen* equivalent to:
A/California/7/2009 (H1N1)v-like strain (X-179A) 3.75 micrograms**

*
propagated in eggs
**
haemagglutinin
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and
polysorbate 80 (4.86 milligrams)
The suspension and emulsion, once mixed, form a multidose vaccine in a vial. See section 6.5 for the
number of doses per vial.
Excipients: the vaccine contains 5 micrograms thiomersal
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Suspension and emulsion for emulsion for injection.

The suspension is a colourless light opalescent liquid.
The emulsion is a whitish homogeneous liquid.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Prophylaxis of influenza in an officially declared pandemic situation (see sections 4.2 and 5.1).
Pandemic influenza vaccine should be used in accordance with Official Guidance.
4.2 Posology and method of administration
This pandemic influenza vaccine has been authorised based on data obtained with a version containing
H5N1 antigen supplemented with data obtained with a vaccine containing H1N1 antigen. The Clinical
Particulars section will be updated in accordance with emerging additional data.
There is currently very limited clinical experience with Pandemrix (H1N1) (see section 5.1) in healthy
adults aged 18-60 years and no clinical experience in the elderly, in children or in adolescents. The
decision to use Pandemrix (H1N1) in each age group defined below should take into account the
extent of the clinical data available with a version of the vaccine containing H5N1 antigen and the
disease characteristics of the current influenza pandemic.
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The dose recommendations are based on:
• safety and immunogenicity data available on the administration of AS03-adjuvanted vaccine
containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days to adults,
including the elderly, and on the administration of the adult dose and half of the adult dose at 0
and 21 days to children aged from 3-9 years
• very limited immunogenicity data obtained three weeks after administration of a single dose of
Pandemrix (H1N1) to healthy adults aged 18-60 years.
See sections 4.8 and 5.1.
Posology
Adults aged 18-60 years:

One dose of 0.5 ml at an elected date.
A second dose of vaccine should preferably be given. There should be an interval of at least three
weeks between the first and second dose.
However, preliminary immunogenicity data obtained at three weeks after administration of Pandemrix
(H1N1) to a limited number of healthy adults aged 18-60 years suggest that a single dose may be
sufficient in this age group. See section 5.1.
Elderly (>60 years)

One dose of 0.5 ml at an elected date.
A second dose of vaccine should be given after an interval of at least three weeks. See section 5.1.
Children and adolescents aged 10-17 years

If vaccination is considered to be necessary, consideration may be given to dosing in accordance with
the recommendations for adults. However, the choice of dose for this age group should take into
account the available data on safety and immunogenicity in adults and in children aged from 3-9 years.
Children aged 3-9 years

If vaccination is considered to be necessary, the available data suggest that administration of 0.25 ml
of vaccine (i.e. half of the adult dose) at an elected date and a second dose administered at least three
weeks later may be sufficient.
There are very limited safety and immunogenicity data available on the administration of AS03-
adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) and on
administration of half a dose of the same vaccine (i.e. 1.875 µg HA and half the amount of AS03
adjuvant in 0.25 ml ) at 0 and 21 days in this age group.
Children aged from 6 months to 3 years

If vaccination is considered to be necessary, consideration may be given to dosing in accordance with
the recommendation in children aged 3-9 years. See sections 4.8 and 5.1.
Children aged less than 6 months

Vaccination is not currently recommended in this age group.
For further information, see sections 4.4, 4.8 and 5.1.
It is recommended that subjects who receive a first dose of Pandemrix, complete the vaccination
course with Pandemrix (see section 4.4).
Method of administration
Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or
anterolateral thigh (depending on the muscle mass).
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4.3 Contraindications
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues
(egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of
this vaccine. If vaccination is considered to be necessary, facilities for resuscitation should be
immediately available in case of need.
See section 4.4 for Special warnings and special precautions for use.
4.4 Special warnings and precautions for use
Caution is needed when administering this vaccine to persons with a known hypersensitivity (other
than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to
residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium
deoxycholate).
As with all injectable vaccines, appropriate medical treatment and supervision should always be
readily available in case of a rare anaphylactic event following the administration of the vaccine.
If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile
illness or acute infection.
Pandemrix should under no circumstances be administered intravascularly.

There are no data with Pandemix using the subcutaneous route. Therefore, healthcare providers need
to assess the benefits and potential risks of administering the vaccine in individuals with
thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless
the potential benefit outweighs the risk of bleedings.
There are no data on administration of AS03-adjuvanted vaccines before or following other types of
influenza vaccines intended for pre-pandemic or pandemic use.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
A protective immune response may not be elicited in all vaccinees (see section 5.1).
There is very limited experience in children between 3 and 9 years of age and no experience in
children less than 3 years of age or in children and adolescents between 10 and 17 years. See sections
4.2, 4.8 and 5.1.
There are no safety, immunogenicity or efficacy data to support interchangeability of Pandemrix with
other H1N1 pandemic vaccines.
4.5 Interaction with other medicinal products and other forms of interaction
There are no data on co-administration of Pandemrix with other vaccines.

However, if co-administration with another vaccine is considered, immunisation should be carried out
on separate limbs. It should be noted that the adverse reactions may be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant

treatment.
Following influenza vaccination, false-positive serology test results may be obtained by the ELISA
method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially,
HTLV-1. In such cases, the Western blot method is negative. These transitory false-positive results
may be due to IgM production in response to the vaccine.
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4.6 Pregnancy and lactation
There are currently no data available on the use of Pandemrix in pregnancy. Data from pregnant
women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest
malformations or fetal or neonatal toxicity.
Animal studies with Pandemrix do not indicate reproductive toxicity (see section 5.3).
The use of Pandemrix may be considered during pregnancy if this is thought to be necessary, taking
into account official recommendations.
Pandemrix may be used in lactacting women.
4.7 Effects on ability to drive and use machines
Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive
or use machines.
4.8 Undesirable effects
• Clinical trials
Adverse reactions from clinical trials with the mock-up vaccine are listed here below (see section 5.1
for more information on mock-up vaccines).
Adults
Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 5,000
subjects 18 years old and above who received formulations containing A/Vietnam/1194/2004 (H5N1)
strain with at least 3.75 microgram HA/AS03.
Adverse reactions reported are listed according to the following frequency:
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)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and lymphatic system disorders

Common: lymphadenopathy
Psychiatric disorders
Uncommon: insomnia
Nervous system disorders

Very common: headache
Uncommon: paraesthesia, somnolence, dizziness
Gastrointestinal disorders
Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Skin and subcutaneous tissue disorders

Common: ecchymosis at the injection site, sweating increased
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Uncommon: pruritus, rash
Musculoskeletal and connective tissue disorders

Very common: arthralgia, myalgia
General disorders and administration site conditions

Very common: induration, swelling, pain and redness at the injection site, fever, fatigue
Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus)
Uncommon: malaise
Children aged 3-9 years
A clinical study evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received
either a full or a half dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from
A/Vietnam/1194/2004 (H5N1).
The per-dose frequency of adverse reactions observed in the groups of children who received a full
dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1)
was higher than that observed in the groups of children who received half of the dose, except for
redness in the 6-9 years of age group. The per-dose frequency of the following adverse reactions was
as follows:
Adverse reactions 3-5 years 6-9 years

Half dose Full dose Half dose Full dose
Induration 9.9% 18.6% 12.0% 12.2%
Pain 48.5% 62.9% 68.0% 73.5%
Redness 10.9% 19.6% 13.0% 6.1%
Swelling 11.9% 24.7% 14.0% 20.4%
Fever (>38°C) 2.0% 6.2% 2.0% 10.2%
Fever (>39°C)
- per-dose 2.0% 5.2% 0% 7.1%
frequency
- per-subject 3.9% 10.2% 0% 14.3%
frequency
Drowsiness 7.9% 13.4% NA NA
Irritability 7.9% 18.6% NA NA
Loss of appetite 6.9% 16.5% NA NA
Shivering 1.0% 12.4% 4.0% 14.3%
NA=not available
• Post-marketing surveillance
From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse
reactions have been reported:
Uncommon:
Generalised skin reactions including urticaria
Rare:
Neuralgia, convulsions, transient thrombocytopenia.
Allergic reactions, in rare cases leading to shock, have been reported.
Very rare:
Vasculitis with transient renal involvement.
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
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This medicinal product contains thiomersal (an organomercuric compound) as a preservative and
therefore, it is possible that sensitisation reactions may occur (see section 4.4).
4.9 Overdose
No case of overdose has been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
This medicinal product has been authorised under “Exceptional Circumstances”. The European
Medicines Agency (EMEA) will regularly review any new information which may become available
and this SPC will be updated as necessary.
This section describes the clinical experience with the mock-up vaccines following a two-dose
administration and with Pandemrix (H1N1) after a single dose in healthy adults aged 18-60 years.
Mock-up vaccines contain influenza antigens that are different from those in the currently circulating
influenza viruses. These antigens can be considered as “novel” antigens and simulate a situation where
the target population for vaccination is immunologically naïve. Data obtained with the mock-up
vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical
immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the
pandemic vaccines.
Clinical studies have evaluated the immunogenicity of different formulations of AS03-adjuvanted and
non-adjuvanted vaccines (A/H5N1) in subjects aged 3-9 years, 18-60 years and >60 years following a
0, 21 day schedule. The majority of these subjects had no detectable anti-haemagglutinin (anti-HA)
antibody to the H5N1 strains tested before vaccination.
Immune response to Pandemrix (H1N1) in adults aged 18-60 years
In a clinical study that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg
HA derived from A/California/7/2009 (H1N1)v-like in healthy subjects aged 18-60 years the anti-HA
antibody responses were as follows:
anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like

21 days after 1st dose
Total enrolled subjects Seronegative subjects prior to

N=61 vaccination
[95% CI] N=40
[95% CI]
Seroprotection rate1 100% 100%
[94.1;100] [91.2;100]
Seroconversion rate2 96.7% 100%

[88.7;99.6] [91.2;100]
Seroconversion 43.3 56.7
factor3 [31.8;59.0] [39.9;80.5]
1
seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
2
seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have
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a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-
fold increase in titre;
3
seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-
vaccination GMT.
Immune response against A/Vietnam/1194/2004 (H5N1):
Adults aged 18-60 years
In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg
HA derived from A/Vietnam/1194/2004 the anti-HA antibody responses were as follows:
anti-HA antibody Immune response to A/Vietnam/1194/2004

0, 21 days schedule 0, 6 months schedule
21 days after 21 days after 21 days after 7 days after 21 days after
1st dose 2nd dose 1st dose 2nd dose 2nd dose
N=925 N=924 N=55 N=47 N=48
1
Seroprotection rate 44.5% 94.3% 38.2% 89.4% 89.6%
Seroconversion rate2 42.5% 93.7% 38.2% 89.4% 89.6%
Seroconversion factor3 4.1 39.8 3.1 38.2 54.2
1
2
3
vaccination GMT.
After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum
neutralising antibody titres and 98-100% had a titre of at least 1:80.
Follow up of 50 subjects who had received two doses of AS03-adjuvanted vaccine containing 3.75 µg
HA derived from A/Vietnam/1194/2004 at 0 and 21 days showed that 84% were seroprotected (HI
titre ≥1:40) at day 42 compared with 54% at day 180. A 4-fold increase in serum neutralising antibody
titres from day 0 was observed in 85.7% at day 42 and 72% at day 180.
Elderly (>60 years)
In another clinical study, 152 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and
> 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing
3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days. At day 42, the anti-HA
antibody responses were as follows:
anti-HA Immune response to A/Vietnam/1194/2004 (D42)

antibody
61 to 70 years 71 to 80 years >80 years
Single Double Single Double Single Double
dose dose dose dose dose dose
N=91 N=92 N=48 N=43 N=13 N=10
Seroprotection 84.6% 97.8% 87.5% 93.0% 61.5% 90.0%
rate1
Seroconversion 74.7% 90.2% 77.1% 93.0% 38.5% 50.0%
2
rate
Seroconversion 11.8 26.5 13.7 22.4 3.8 7.7
factor3
1
8
2
3
vaccination GMT.
Although an adequate immune response was achieved at day 42 following two administrations of a
single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004
(H5N1), a higher response was observed following two administrations of a double dose of vaccine.
Very limited data in seronegative subjects >80 years of age (N=5) showed that no subject achieved
seroprotection following two administrations of a single dose of AS03-adjuvanted vaccine containing
3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1). However, following two administrations of
a double dose of vaccine, the seroprotection rate at day 42 was 75%.
The day 180 seroprotection rates in subjects aged >60 years were 52.9% for those who had received
two single doses and 69.5% for those who had received two doubles doses at day 0 and day 21.
In addition, 44.8% and 56.1% of subjects in respective dose groups had a 4-fold increase in serum
neutralising antibody titres from day 0 to day 42 and 96.6% and 100% of subjects had a titre of at least
1:80 at day 42.
Children aged 3 to 9 years
In another clinical study, children aged 3 to 5 and 6 to 9 years old received two doses of either a full
(0.5 ml) or a half dose (0.25 ml) of AS03-adjuvanted vaccine containing 3.75 µg HA derived from
A/Vietnam/1194/2004 (H5N1) at 0 and 21 days. At day 42 and six months after the second dose, the
anti-HA antibody responses were as follows:
anti-HA Immune response to A/Vietnam/1194/2004

antibody
3 to 5 years 6 to 9 years
Day 42 Day 180 Day 42 Day 180
Half Full Half Full Half Full Half Full
dose dose dose dose dose dose dose dose
N=49 N=44 N=50 N=29 N=43 N=43 N=44 N=41
Seroprotection 95.9% 100% 56.0% 82.8% 100% 100% 63.6% 78%
rate1
Seroconversion 95.9% 100% 56.0% 82.8% 100% 100% 61.0% 78%
rate2
Seroconversion 78.5 191.3 5.9 16 108.1 176.7 6.1 12.3
factor3
1
2
3
vaccination GMT.
The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
At day 42, the neutralising antibody responses were as follows:
Serum neutralising Immune response to A/Vietnam/1194/2004

antibody
21 days after 2nd dose
9
Half dose Full dose Half dose Full dose
N=47 N=42 N=42 N=42
GMT1 1044.4 4578.3 1155.1 3032.5
Seroconversion rate2 95.6% 97.4% 100% 100%
≥1:803 100% 100% 100% 100%
1
Geometric Mean Titre
2
4-fold increase in serum neutralising antibody titre
3
% of subjects reaching a serum neutralising antibody titre of at least 1:80
Immune response against A/Indonesia/05/2005 (H5N1)
In a clinical study in which two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived
from A/Indonesia/05/2005 were administered on days 0 and 21 to 140 subjects aged 18-60 years, the
anti-HA antibody responses were as follows:
anti-HA antibody Immune response to A/Indonesia/05/2005

Day 21 Day 42 Day 180
N=140 N=140 N=138
Seroprotection rate1 45.7% 96.4% 49.3%
2
Seroconversion rate 45.7% 96.4% 48.6%
Seroconversion factor3 4.7 95.3 5.2
1
2
3
vaccination GMT.
A 4-fold increase in serum neutralising antibody titres was observed in 79.2% of subjects twenty-one
days after the first dose, 95.8% twenty-one days after the second dose and 87.5% six months after the
second dose.
In a second study, 49 subjects aged 18-60 years received two doses of AS03-adjuvanted vaccine
containing 3.75 µg HA derived from A/Indonesia/05/2005 on days 0 and 21. At day 42, the anti-HA
antibody seroconversion rate was 98%, all subjects were seroprotected and the seroconversion factor
was 88.6. In addition, all subjects had neutralising antibody titres of at least 1:80.
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived

from A/Vietnam/1194/2004 (H5N1):
Adults aged 18-60 years
Anti-HA responses against A/Indonesia/5/2005 following administration of AS03-adjuvanted vaccine

containing 3.75 µg HA derived from A/Vietnam/1194/2004 were as follows:
anti-HA antibody A/Indonesia/5/2005

0, 21 days schedule 0, 6 months schedule
21 days after 2nd dose 7 days after 2nd dose 21 days after 2nd dose
N = 924 N = 47 N = 48
1
Seroprotection rate 50.2% 74.5% 83.3%
Seroconversion rate2 50.2% 74.5% 83.3%
Seroconversion factor3 4.9 12.9 18.5
1
2
10
3
vaccination GMT.
A 4-fold increase in serum neutralising antibodyagainst A/Indonesia/5/2005 was achieved in >90% of

subjects after two doses regardless of the schedule. After two doses administered 6 months apart all
subjects had a titre of at least 1:80.
In a different study in 50 subjects the anti-HA antibody seroprotection rates 21 days after the second
dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were
20% against A/Indonesia/5/2005, 35% against A/Anhui/01/2005 and 60% against
A/Turkey/Turkey/1/2005.
Elderly (>60 years)
In 152 subjects aged > 60 years the anti-HA antibody seroprotection and seroconversion rates against
A/Indonesia/5/2005 at day 42 after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA
derived from A/Vietnam/1194/2004 were 23% and the seroconversion factor was 2.7. Neutralising
antibody titres of at least 1:40 or at least 1:80 were achieved in 87% and 67%, respectively, of the 87
subjects tested.
Children aged 3 to 9 years
In the subjects aged 3 to 5 and 6 to 9 years old who received two doses of either a full or a half dose of
AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1), the
anti-HA antibody responses at day 42 (N=179) and six months after the second dose (N=164) were as
follows:
anti-HA Immune response to A/Indonesia/5/2005

antibody
Day 42 Day 180 Day 42 Day 180
Half Full Half Full Half Full Half Full
dose dose dose dose dose dose dose dose
N=49 N=44 N=50 N=29 N=43 N=43 N=44 N=41
Seroprotection 71.4% 95.5% 6.0% 69.0% 74.4% 79.1% 4.5% 61.0%
rate1
Seroconversion 71.4% 95.5% 6.0% 69.0% 74.4% 79.1% 2.4% 61.0%
rate2
Seroconversion 10.7 33.6 1.4 8.5 12.2 18.5 1.2 7.4
factor3
1
2
3
vaccination GMT.
Furthermore, in the group of children that received a half dose of vaccine, the rate of subjects with a
titre of neutralising antibodies above 1:80 remained high up to 12 months after the first dose: in the 3-
5 years old group, 97.8% at day 42, 89.6% at month 6 and 87.2% at month 12 and in the 6-9 years old
group, 97.6% at day 42, 90.0% at month 6 and 82.9% at month 12.
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One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005
administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from
A/Vietnam/1194/2004.
In a clinical study, subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing
3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had
received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from
A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively. The anti-HA responses were as
follows:
anti-HA antibody Against A/Vietnam 21 days after Against A/Indonesia 21 days after
boosting with A/Vietnam boosting with A/Indonesia
N=46 N=49
After one After two After one After two
priming dose priming doses priming dose priming doses
Seroprotection rate1 89.6% 91.3% 98.1% 93.9%
Booster 87.5% 82.6% 98.1% 91.8%
seroconversion rate2
Booster factor3 29.2 11.5 55.3 45.6
1
2
booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and
have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4-
3
booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT.
Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the
seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine
containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against
A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from
A/Indonesia/05/2005. All subjects achieved a neutralising antibody titre of at least 1:80 against each of
the two strains regardless of the HA type in the vaccine and the previous number of doses.
In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine
containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two
doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004
administered on day 0 and day 21. The seroprotection rate against A/Indonesia 21 days after booster
vaccination was 92% and 69.2% at day 180.
Information from non-clinical studies:
The ability to induce protection against homologous and heterologous vaccine strains was assessed
non-clinically using ferret challenge models.
In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03
adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14). Doses of 15,
5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15,
7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment. Control
groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA)
or phosphate buffered saline solution. Ferrets were vaccinated on days 0 and 21 and challenged by the
intra-tracheal route on day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous
H5N1/A/Indonesia/5/05. Of the animals receiving adjuvanted vaccine, 87% and 96% were protected
against the lethal homologous or heterologous challenge, respectively. Viral shedding into the upper
respiratory tract was also reduced in vaccinated animals relative to controls, suggesting a reduced risk
of viral transmission. In the unadjuvanted control group, as well as in the adjuvant control group, all
animals died or had to be euthanized as they were moribund, three to four days after the start of
challenge.
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5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Non-clinical data obtained with the mock-up vaccine using a H5N1 vaccine strain reveal no special
hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose
toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the
lactation period).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Suspension vial:
Polysorbate 80
Octoxynol 10
Thiomersal
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Magnesium chloride (MgCl2)
Water for injections
Emulsion vial:
For adjuvants, see section 2.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
6.3 Shelf-life
2 years.
After mixing, the vaccine should be used within 24 hours. Chemical and physical in-use stability has
been demonstrated for 24 hours at 25°C.
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C).

Do not freeze.
Store in the original package in order to protect from light.
6.5 Nature and contents of container
One pack containing:

13
- one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
- two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to
10 doses of vaccine (5 ml).
6.6 Special precautions for disposal and other handling
Pandemrix consists of two containers:

Suspension: multidose vial containing the antigen,
Emulsion: multidose vial containing the adjuvant.
Prior to administration, the two components should be mixed.
Instructions for mixing and administration of the vaccine:
1. Before mixing the two components, the emulsion and suspension should be shaken and
inspected visually for any foreign particulate matter and/or abnormal physical appearance. In
the event of either being observed, discard the vaccine.
2. The vaccine is mixed by withdrawing the contents of the vial containing the emulsion by means
of a syringe and by adding it to the vial containing the suspension.
3. After the addition of the emulsion to the suspension, the mixture should be well shaken. The
mixed vaccine is a whitish emulsion. In the event of other variation being observed, discard the
vaccine.
4. The volume of the Pandemrix vial after mixing is 5 ml. The vaccine should be administered in
accordance with the recommended posology (see section 4.2).
5. The vial should be shaken prior to each administration.
6. Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a syringe for
injection and administered intramuscularly. The vaccine should be allowed to reach room
temperature before use.
7. After mixing, use the vaccine within 24 hours and do not store above 25°C.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89
B-1330 Rixensart, Belgium
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/08/452/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20/05/2008
10. DATE OF REVISION OF THE TEXT
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA) http://www.emea.europa.eu/.
14
ANNEX II
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE

SUBSTANCE AND MANUFACTURING AUTHORISATION
HOLDER RESPONSIBLE FOR BATCH RELEASE
B. CONDITIONS OF THE MARKETING AUTHORISATION
C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE

MARKETING AUTHORISATION HOLDER
15
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) of the biological active substance
GlaxoSmithKline Biologicals
Branch of SmithKline Beecham Pharma GmbH & Co. KG
Zirkustraße 40, D-01069 Dresden
Germany
Name and address of the manufacturer(s) responsible for batch release
GlaxoSmithKline Biologicals S.A.

89, rue de l'Institut
B-1330 Rixensart
Belgium
B. CONDITIONS OF THE MARKETING AUTHORISATION
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON

THE MARKETING AUTHORISATION HOLDER
Medicinal product subject to medical prescription.
Pandemrix can only be marketed when there is an official WHO/EU declaration of an influenza
pandemic, on the condition that the Marketing Authorisation Holder for Pandemrix takes due account
of the officially declared pandemic strain.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND

EFFECTIVE USE OF THE MEDICINAL PRODUCT
• The MAH shall agree with Member States to measures facilitating the identification and
traceability of the A/H1N1 pandemic vaccine administered to each patient, in order to minimise
medication errors and aid patients and health care professionals to report adverse reactions. This
may include the provision by the MAH of stickers with invented name and batch number with
each pack of the vaccine.
• The MAH shall agree with Member States on mechanisms allowing patients and health care
professionals to have continuous access to updated information regarding Pandemrix.
• The MAH shall agree with Member Sates on the provision of a targeted communication to
healthcare professionals which should address the following:
• The correct way to prepare the vaccine prior to administration.
• Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse
reactions, unexpected severe adverse reactions, adverse events of special interest (AESI).
• The minimal data elements to be transmitted in individual case safety reports in order to
facilitate the evaluation and the identification of the vaccine administered to each subject,
including the invented name, the vaccine manufacturer and the batch number.
• If a specific notification system has been put in place, how to report adverse reactions.
16
• OTHER CONDITIONS
Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official
batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, as described in version 3.4 (dated 4
September 2009) presented in Module 1.8.1 of the marketing authorisation application, is in place and
functioning before the product is placed on the market and for as long as the marketed product remains
in use.
PSUR submission during the influenza pandemic:
During a pandemic situation, the frequency of submission of periodic safety update reports specified
in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a
pandemic vaccine for which high levels of exposure are expected within a short period of time. Such
situation requires rapid notification of safety information that may have the greatest implications for
benefit-risk balance in a pandemic. Prompt analysis of cumulative safety information, in light of the
extent of exposure, will be crucial for regulatory decisions and protection of the population to be
vaccinated. The MAH shall submit on a monthly basis a simplified periodic safety update report with
the timelines, format and content as defined in the CHMP Recommendations for the
Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing
Authorisation Application for a Pandemic Influenza Vaccine (EMEA/359381/2009) and any
subsequent update.
Risk Management Plan

The MAH commits to performing the studies and additional pharmacovigilance activities detailed in
the Pharmacovigilance Plan, as agreed in version RMPv2 (dated September 2009) of the Risk
Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and
any subsequent updates of the RMP agreed by the CHMP.
C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING

AUTHORISATION HOLDER
The Marketing Authorisation Holder shall complete the following programme of studies within the
specified time frame, the results of which shall form the basis of the continuous reassessment of the
benefit/risk profile.
Clinical The MAH commits to provide abridged

reports for the following studies performed in
adults:
Safety and Immunogenicity data:
Study D-Pan H1N1-021 06 November 2009
The MAH commits to provide the D21

neutralising antibodies data from study D-Pan 04 December 2009
H1N1-021
Study D-Pan H1N1-007
-post dose 2 04 December 2009
17
-post dose 1 06 November 2009
-post dose 2 05 February 2010

- post dose 1 04 December 2009
- post dose 2 05 February 2010

- post dose 1 06 November 2009
- post dose 2 05 February 2010
Study D-Pan H1N1-022 09 April 2010
Study D-Pan H1N1-017 05 March 2010
Clinical The MAH commits to provide abridged

reports for the following studies performed in
children:
Safety and Immunogenicity data:

- post dose 1 (half dose data) 06 November 2009
- post dose 2 (half dose data) 08 January 2010
- post dose 1 (full dose data) 04 December 2009
- post dose 2 (full dose data) 08 January 2010
- post dose 2 (full and half dose cleaned data) 05 March 2010

-post dose 1 04 December 2009
-post dose 2 05 March 2010
Study D-Pan H1N1-023 05 March 2010
Study D-Pan H1N1-012 09 July 2010
Clinical The MAH commits to provide the results of Results of study to be provided within
the effectiveness study. two weeks of availability.
Pharmacovigilance The MAH will conduct a prospective cohort Interim and final results will be
safety study in at least 9,000 patients, in submitted in accordance with the
different age groups, including protocol.
immunocompromised subjects, in accordance
with the protocol submitted with the Risk
Management Plan. Observed-to-Expected
analyses will be performed.
Pharmacovigilance The MAH commits to provide the details of Details to be submitted within one
the design and to provide the results of amonth of Commission Decision
study in a pregnancy registry. granting the Variation. Results to be
provided in the simplified PSUR.
Pharmacovigilance The MAH commits to establish the Agree with EMEA on design of
mechanism to promptly investigate issues additional studies for emerging benefit-
affecting the benefit-risk balance of the risk evaluation within 1 month of the
vaccine. Commission Decision granting the
Variation.
18
ANNEX III
LABELLING AND PACKAGE LEAFLET
19
A. LABELLING
20
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS
OF EMULSION
Pandemrix suspension and emulsion for emulsion for injection.

Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
2. STATEMENT OF ACTIVE SUBSTANCE(S)
After mixing, 1 dose (0.5 ml) contains:
Split influenza virus inactivated, containing antigen equivalent to:
3.75 micrograms*
A/California/7/2009 (H1N1)v-like strain (X-179A)
AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80

*
haemagglutinin
3. LIST OF EXCIPIENTS
Polysorbate 80
Octoxynol 10
Thiomersal
Magnesium chloride (MgCl2)
4. PHARMACEUTICAL FORM AND CONTENTS
Suspension and emulsion for emulsion for injection
50 vials: suspension (antigen)

50 vials: emulsion (adjuvant)
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to
10 doses of 0.5 ml vaccine
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use
Shake before use
Read the package leaflet before use
21
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
Suspension and emulsion to be mixed before administration
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Store in a refrigerator
Do not freeze
Store in the original package in order to protect from light
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Dispose of in accordance with local regulations
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Rue de l’Institut 89
B-1330 Rixensart, Belgium
EU/1/08/452/001
13. BATCH NUMBER
Lot:
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
22
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
23
PACK OF 50 VIALS OF SUSPENSION (ANTIGEN)
Suspension for emulsion for injection for Pandemrix

Split influenza virus, inactivated, containing antigen* equivalent to
3.75 micrograms haemagglutinin/dose

*Antigen: A/California/7/2009 (H1N1)v-like strain (X-179A)
Excipients:
Polysorbate 80
Octoxynol 10
Thiomersal
Sodium chloride
Disodium hydrogen phosphate
Potassium dihydrogen phosphate
Potassium chloride
Magnesium chloride
Antigen suspension for injection

50 vials: suspension
2.5 ml per vial.
After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Intramuscular use
Shake before use

24
Suspension to be exclusively mixed with adjuvant emulsion before administration
8. EXPIRY DATE
EXP
Do not freeze

APPROPRIATE
GSK Biologicals, Rixensart - Belgium
EU/1/08/452/001
13. BATCH NUMBER
Lot:
25
PACK OF 25 VIALS OF EMULSION (ADJUVANT)
Emulsion for emulsion for injection for Pandemrix
Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86

milligrams) and polysorbate 80 (4.86 milligrams)
Excipients:
Sodium chloride
Disodium hydrogen phosphate
Potassium dihydrogen phosphate
Potassium chloride
Adjuvant emulsion for injection

25 vials: emulsion
2.5 ml
Intramuscular use
Shake before use

Emulsion to be exclusively mixed with antigen suspension before administration
8. EXPIRY DATE
EXP
26
Do not freeze

APPROPRIATE
GSK Biologicals, Rixensart - Belgium
EU/1/08/452/001
13. BATCH NUMBER
Lot:
27
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
SUSPENSION VIAL
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Antigen suspension for Pandemrix

Pandemic influenza vaccine
A/California/7/2009 (H1N1)v-like strain (X-179A)
I.M.
2. METHOD OF ADMINISTRATION
Mix with adjuvant emulsion before use
3. EXPIRY DATE
EXP
After mixing: Use within 24 hours and do not store above 25°C.
Date and time of mixing:
4. BATCH NUMBER
Lot
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
2.5 ml
After mixing with adjuvant emulsion: 10 doses of 0.5 ml
6. OTHER
Storage (2ºC-8ºC), do not freeze, protect from light
28
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
EMULSION VIAL
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Adjuvant emulsion for Pandemrix

I.M.
2. METHOD OF ADMINISTRATION
Mix into Antigen suspension before use
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
2.5 ml
6. OTHER
Storage (2ºC-8ºC), do not freeze, protect from light
29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pandemrix suspension and emulsion for emulsion for injection

For the most up-to-date information please consult the website of the European Medicines
Agency (EMEA): http://www.emea.europa.eu/.
Read all of this leaflet carefully before you receive this vaccine .
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.
In this leaflet:
1. What Pandemrix is and what it is used for
2. Before you receive Pandemrix
3. How Pandemrix is given
4. Possible side effects
5. How to store Pandemrix
6. Further information
1. What Pandemrix is and what it is used for
Pandemrix is a vaccine to prevent pandemic influenza (flu).
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around
the world. The symptoms of pandemic flu are similar to those of ordinary flu but may be more severe.
When a person is given the vaccine, the immune system (the body’s natural defence system) will
produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can
cause flu.
2. Before you receive Pandemrix
You should not receive Pandemrix:
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of
Pandemrix (these are listed at the end of the leaflet) or to any of the substances that may be
present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde,
gentamicin sulphate (antibiotic) or sodium deoxycholate. Signs of an allergic reaction may
include itchy skin rash, shortness of breath and swelling of the face or tongue. However, in a
pandemic situation, it may be appropriate for you to have the vaccine provided that appropriate
medical treatment is immediately available in case of an allergic reaction.
If you are not sure, talk to your doctor or nurse before having this vaccine.
Take special care with Pandemrix:
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any
ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin,
formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate. (see section 6.
Further information).
31
• if you have a severe infection with a high temperature (over 38°C). If this applies to you then
your vaccination will usually be postponed until you are feeling better. A minor infection such
as a cold should not be a problem, but your doctor or nurse will advise whether you could still
be vaccinated with Pandemrix,
• if you are having a blood test to look for evidence of infection with certain viruses. In the first
few weeks after vaccination with Pandemrix the results of these tests may not be correct. Tell
the doctor requesting these tests that you have recently been given Pandemrix.
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended,
or may need to be delayed.
Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription or have recently been given any other vaccine.
There is no information on administration of the vaccine Pandemrix with other vaccines. However,
if this cannot be avoided, the vaccines should be injected into separate limbs. In such cases, you
should be aware that the side effects may be more intense.
Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant. You should
discuss with your doctor whether you should receive Pandemrix.
The vaccine may be used during breast-feeding.
Driving and using machines

Some effects mentioned under section 4. “Possible side effects” may affect the ability to drive or use
machines.
Important information about some of the ingredients of Pandemrix

This vaccine contains thiomersal as a preservative and it is possible that you may experience an
allergic reaction. Tell your doctor if you have any known allergies.
This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium
(39 mg) per dose, i.e. essentially sodium- and potassium-free.
3. How Pandemrix is given
Your doctor or nurse will administer the vaccine in accordance with official recommendations.
The vaccine will be injected into a muscle (usually in the upper arm).
Adults, including the elderly

A dose (0.5 ml) of the vaccine will be given.
A second dose of 0.5 ml vaccine may be given after an interval of at least three weeks.
Children and adolescents 10-17 years of age

If it is considered that you need to be vaccinated, you may receive two doses of 0.5 ml vaccine given
at least three weeks apart.
Children 3-9 years of age

If it is considered that your child needs to be vaccinated, he/she may receive one dose of 0.25 ml
vaccine and a second dose of 0.25 ml at least three weeks later.
32
Children aged from 6 months to 3 years of age
If it is considered that your child needs to be vaccinated, he/she may receive one dose of 0.25 ml
vaccine and a second dose of 0.25 ml at least three weeks later.
Children aged less than 6 months of age

Vaccination is currently not recommended in this age group.
When Pandemrix is given for the first dose, it is recommended that Pandemrix (and not another
vaccine against H1N1) be given for the complete vaccination course.
4. Possible side effects
Like all medicines, Pandemrix can cause side effects, although not everybody gets them.
Allergic reactions may occur following vaccination, in rare cases leading to shock. Doctors are aware
of this possibility and have emergency treatment available for use in such cases.
In the clinical studies with a similar vaccine, most side effects were mild in nature and short term. The
side-effects are generally similar to those related to the seasonal flu vaccine.
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)

Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
The side effects listed below have occurred with Pandemrix in clinical studies in adults, including the
elderly and in children aged from 3-9 years::
Very common:
• Headache
• Tiredness
• Pain, redness, swelling or a hard lump at the injection site
• Fever
• Aching muscles, joint pain
Common:
• Warmth, itching or bruising at the injection site
• Increased sweating, shivering, flu-like symptoms
• Swollen glands in the neck, armpit or groin
Uncommon:
• Tingling or numbness of the hands or feet
• Sleepiness
• Dizziness
• Diarrhoea, vomiting, stomach pain, feeling sick
• Itching, rash
• Generally feeling unwell
• Sleeplessness
In children aged 3-9 years fever occurred more often when the adult dose (0.5 ml of vaccine) was
given compared to administration of half the adult dose (0.25 ml of vaccine). Also fever occurred
more often in children aged 6-9 years compared to the children aged 3-5 years.
33
These side effects usually disappear within 1-2 days without treatment. If they persist, CONSULT
YOUR DOCTOR.
The side effects listed below have occurred in the days or weeks after vaccination with vaccines given
routinely every year to prevent flu. These side effects may occur with Pandemrix.
Uncommon
• Generalised skin reactions including urticaria (hives)
Rare
• Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may
lead to shock. Doctors are aware of this possibility and have emergency treatment available for
use in such cases.
• Fits
• Severe stabbing or throbbing pain along one or more nerves
• Low blood platelet count which can result in bleeding or bruising
Very rare
• Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney
problems)
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system),
neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
If any of these side effects occur, please tell your doctor or nurse immediately.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor.
5. How to store Pandemrix
Before the vaccine is mixed:

Do not use the suspension and the emulsion after the expiry date which is stated on the carton. The
expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).

Store in the original package in order to protect from light.
Do not freeze.
After the vaccine is mixed:

After mixing, use the vaccine within 24 hours and do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Pandemrix contains
• Active substance:
Split influenza virus, inactivated, containing antigen* equivalent to:
34
A/California/7/2009 (H1N1)v-like strain (X-179A) 3.75 micrograms** per 0.5 ml dose
*
propagated in eggs
**
expressed in microgram haemagglutinin
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
• Adjuvant:
The vaccine contains an ‘adjuvant’ AS03 to stimulate a better response. This adjuvant contains
squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86
milligrams).
• Other ingredients:
The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium
hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium
chloride, water for injections
What Pandemrix looks like and contents of the pack
Suspension and emulsion for emulsion for injection.

The suspension is a colourless light opalescent liquid.
The emulsion is a whitish homogeneous liquid.
Prior to administration, the two components should be mixed. The mixed vaccine is a whitish
emulsion.
One pack of Pandemrix consists of:

• one pack containing 50 vials of 2.5 ml suspension (antigen)
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant)
Marketing Authorisation Holder and Manufacturer

Rue de l’Institut 89
B-1330 Rixensart
Belgium
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien Luxembourg/Luxemburg
GlaxoSmithKline s.a./n.v. GlaxoSmithKline s.a./n.v.
Tél/Tel: + 32 2 656 21 11 Tél/Tel: + 32 2 656 21 11
България Magyarország
ГлаксоСмитКлайн ЕООД GlaxoSmithKline Kft.
Тел.: + 359 2 953 10 34 Tel.: + 36-1-2255300
Česká republika Malta

GlaxoSmithKline s.r.o. GlaxoSmithKline Malta
Tel: + 420 2 22 00 11 11 Tel: + 356 21 238131
[email protected]
Danmark Nederland
GlaxoSmithKline Pharma A/S GlaxoSmithKline BV
Tlf: + 45 36 35 91 00 Tel: + 31 (0)30 69 38 100
35
[email protected] [email protected]
Deutschland Norge
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline AS
Tel: + 49 (0)89 360448701 Tlf: + 47 22 70 20 00
Eesti Österreich
GlaxoSmithKline Eesti OÜ GlaxoSmithKline Pharma GmbH.
Tel: +372 667 6900 Tel: + 43 1 970 75-0
Ελλάδα Polska
GlaxoSmithKline A.E.B.E GSK Commercial Sp. z o.o.
Tηλ: + 30 210 68 82 100 Tel.: + 48 (22) 576 9000
España Portugal
GlaxoSmithKline, S.A. GlaxoSmithKline, Produtos Farmacêuticos, Lda.
Tel: + 34 902 202 700 Tel: + 351 21 412 95 00
France România
Laboratoire GlaxoSmithKline GlaxoSmithKline (GSK) SRL
Tél: + 33 (0) 800 00 12 12 Tel: + 40 (0)21 3028 208
[email protected]
Ireland Slovenija
GlaxoSmithKline (Ireland) Ltd GlaxoSmithKline d.o.o.
Tel: + 353 (0)1 4955000 Tel: + 386 (0) 1 280 25 00
[email protected]
Ísland Slovenská republika

GlaxoSmithKline ehf. GlaxoSmithKline Slovakia s.r.o.
Sími: +354-530 3700 Tel: + 421 (0)2 48 26 11 11
[email protected]
Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel:+ 39 04 59 21 81 11 Puh/Tel: + 358 10 30 30 30
[email protected]
Κύπρος Sverige
GlaxoSmithKline Cyprus Ltd GlaxoSmithKline AB
Τηλ: + 357 22 39 70 00 Tel: + 46 (0)8 638 93 00
[email protected]
Latvija United Kingdom

GlaxoSmithKline Latvia SIA GlaxoSmithKline UK
Tel: + 371 67312687 Tel: + 44 (0)808 100 9997
Lietuva
GlaxoSmithKline Lietuva UAB
Tel. +370 5 264 90 00
[email protected]
This leaflet was last approved in {MM/YYYY}.

36
Pandemrix has been authorised under “Exceptional Circumstances”.
The European Medicines Agency (EMEA) will regularly review any new information on the medicine
and this package leaflet will be updated as necessary.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web
site: http://www.emea.europa.eu/
---------------------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only:
Pandemrix consists of two containers:

Suspension: multidose vial containing the antigen,
Emulsion: multidose vial containing the adjuvant.
Prior to administration, the two components should be mixed.
Instructions for mixing and administration of the vaccine:
1. Before mixing the two components, the emulsion and suspension should be shaken and
inspected visually for any foreign particulate matter and/or abnormal physical appearance. In
the event of either being observed, discard the vaccine.
2. The vaccine is mixed by withdrawing the contents of the vial containing the emulsion
(adjuvant) by means of a syringe and by adding it to the vial containing the suspension
(antigen).
3. After the addition of the emulsion to the suspension, the mixture should be well shaken. The
mixed vaccine is a whitish emulsion. In the event of other variation being observed, discard the
vaccine.
4. The volume of the Pandemrix vial after mixing is 5 ml. The vaccine should be administered in
accordance with the recommended posology (see section 3 “How Pandemrix is given”).
5. The vial should be shaken prior to each administration.
6. Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a syringe for
injection and administered intramuscularly. The vaccine should be allowed to reach room
temperature before use.
7. After mixing, use the vaccine within 24 hours and do not store above 25°C.
The vaccine should not be administered intravascularly.
Any unused product or waste material should be disposed of in accordance with local requirements.
37

EMA - Pandemrix® (Vaccin A H1N1 - GSK)

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EMA - Pandemrix® (Vaccin A H1N1 - GSK)

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EMA - Pandemrix® (Vaccin A H1N1 - GSK)

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

Pandemrix suspension and emulsion for emulsion for injection.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

After mixing, 1 dose (0.5 ml) contains:

Split influenza virus, inactivated, containing antigen* equivalent to:

A/California/7/2009 (H1N1)v-like strain (X-179A) 3.75 micrograms**

Excipients: the vaccine contains 5 micrograms thiomersal

For a full list of excipients see section 6.1.

Suspension and emulsion for emulsion for injection.

4.1 Therapeutic indications

Pandemic influenza vaccine should be used in accordance with Official Guidance.

4.2 Posology and method of administration

See sections 4.8 and 5.1.

Adults aged 18-60 years:

Elderly (>60 years)

Children and adolescents aged 10-17 years

Children aged 3-9 years

Children aged from 6 months to 3 years

Children aged less than 6 months

For further information, see sections 4.4, 4.8 and 5.1.

4.4 Special warnings and precautions for use

Pandemrix should under no circumstances be administered intravascularly.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

There are no data on co-administration of Pandemrix with other vaccines.

The immunological response may be diminished if the patient is undergoing immunosuppressant

Pandemrix may be used in lactacting women.

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

Adverse reactions reported are listed according to the following frequency:

Very common (≥1/10)

Blood and lymphatic system disorders

Nervous system disorders

Skin and subcutaneous tissue disorders

Musculoskeletal and connective tissue disorders

General disorders and administration site conditions

Children aged 3-9 years

Adverse reactions 3-5 years 6-9 years

No case of overdose has been reported.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.

Immune response to Pandemrix (H1N1) in adults aged 18-60 years

anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like

Total enrolled subjects Seronegative subjects prior to

Seroconversion rate2 96.7% 100%

Immune response against A/Vietnam/1194/2004 (H5N1):

Adults aged 18-60 years

anti-HA antibody Immune response to A/Vietnam/1194/2004

Elderly (>60 years)

anti-HA Immune response to A/Vietnam/1194/2004 (D42)

Children aged 3 to 9 years

anti-HA Immune response to A/Vietnam/1194/2004

At day 42, the neutralising antibody responses were as follows:

Serum neutralising Immune response to A/Vietnam/1194/2004

Immune response against A/Indonesia/05/2005 (H5N1)

anti-HA antibody Immune response to A/Indonesia/05/2005

Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived

Adults aged 18-60 years

Anti-HA responses against A/Indonesia/5/2005 following administration of AS03-adjuvanted vaccine