Abnoba Viscum
Abnoba Viscum
Abnoba Viscum
for use
ABNOBA GmbH
Hohenzollernstrae 16 Information for Healthcare Professionals
75177 Pforzheim | Germany
Phone +49(0)7231-315050
Fax +49(0)7231-358714
eMail: [email protected]
www.abnoba.de
overview
How to reach optimal dosage
and long-term therapy
overview
Start of treatment
and how to reach optimal dosage (detailed description, page 22)
Reactions 1 3 (above) will regularly reappear. If reactions are too strong or severe, please follow the
recommendations of how to proceed in case of too high dosage or overdosage (see opposite).
Either: If well-tolerated and the intensity of reactions 1 3 subside again, and if the patients general
condition is good, dosage can again be increased to the next higher strength:
Long-term therapy
Once the individual optimal dosage has been reached, from Week 6
onwards the following process is often followed:
abnobaVISCUM 2 mg, 1 ml (= 1 ampoule) Week 6
Maintain s.c. inj. 3 x per week, continue with this strength as long-term therapy. onwards
Injections s.c. are maintained at 3 x per week for up to 2 years.
Thus the individual optimal dosage for long-term therapy has been reached. Then 2 x per week for 1 further year.
Breast Cancer
Ovarian Carcinoma
Gynaecological Tumours Mali or Abietis Uterine Carcinoma
Cervial Carcinoma
Sarcoma / Osteosarcoma
Fraxini or Abietis
Bone and Soft Tissue Tumours Soft Tissue Sarcoma
Carcinoid
Endocrinous Tumours Abietis or Amygdali Thyroid Carcinoma
Leukaemia
Paediatric Tumours
Fraxini or Abietis Lymphoma
Solid and Haematological Tumours Neuroblastoma
* The second preparation is used in the case that no reactions according 1-3 appear.
Known primary tumour Fraxini or the preparation recommended for the primary tumour
Introduction 9
Treatment advice
Our specialists can be consulted
regarding treatment with abnobaVISCUM
Please contact us at:
Phone +49 (0)7231 - 31 50 50 Fax: +49 (0)7231 - 35 87 14
E-mail: [email protected]
Introduction
abnobaVISCUM mistletoe preparations were first used in 1971. The
experience gained in clinical and private practice since provides the
basis of the following recommendations for administering the treat-
ment.
abnobaVISCUM is used in supportive, adjuvant and palliative tumour
therapy programs as well as in post-operative treatment of tumour
disease. As it is an anthroposophical mistletoe preparation, the
costs are refundable within the context of a cancer treatment plan
(in Germany).
Abietis fir
Aceris maple
Amygdali almond
Betulae birch
Crataegi hawthorn
Fraxini ash
Mali apple
Pini pine
Quercus oak
9
abnobaVISCUM: 0.02 mg to 20 mg strengths
Solution for subcutaneous injection. Each concentration is available
in packages of 8, 21 and 48 ampoules.
1 ml of injection solution contains:
Pressed juice from the mistletoe plant of the particular host tree,
produced from mg mistletoe
10
Old and new designations
In 2006 the designations of abnobaVISCUM mistletoe preparations
were simplified by omitting the dilution step 2 to 30 (see following table).
New designation Old designation
(type e.g. Mali) 20 mg -2 20 mg
(type e.g. Mali) 2 mg -3 2 mg
(type e.g. Mali) 0.2 mg -4 0.2 mg
(type e.g. Mali) 0.02 mg -5 0.02 mg
(type e.g. Mali) D6 -6 D6
(type e.g. Mali) D10 -10 D10
(type e.g. Mali) D20 -20 D20
(type e.g. Mali) D30 -30 D30
11
Production and quality control of abnobaVISCUM
Harvest
abnobaVISCUM is produced using summer and winter harvests.
The mistletoe plant is distinguished by a series of characteristics
which can be described in terms of time-related and space-related
biological development processes. In this way the unique features of
the mistletoe can be understood in relation to other plants within its
species and a rationale for harvesting the mistletoe becomes appa-
rent. These specific features can also be observed in the mistletoes
spectrum of substances which is subject to seasonal variations. For
this reason, mistletoe is harvested in summer and winter, at times
that are predefined in accordance with the particular characteristics
of biological development. Plant materials are apportioned and
deep-frozen in fluid nitrogen at the harvest site and then stored until
the extraction process. This provides for microbiological stability
and prevents oxidation.
Extraction
The active ingredient in abnobaVISCUM is produced by means of
the two-step procedure described in the Deutsche Homopathische
Arzneibuch (HAB) [German Homeopathic Pharmacopoeia]. The
summer and winter harvests are treated separately according to
a patented pressing procedure under protective atmosphere. The
extraction is carried out using a ascorbate phosphate buffer solu-
tion so that 75% of plant materials are retained in the solution. This
ensures that the mistletoe extract contains a high yield of all main
ingredients (e.g. mistletoe lectins, viscotoxins). abnobaVISCUM 20
mg and 2 mg strengths have typically a yellow-green colour. This is
due to the special extraction that retains additional fat-related sub-
stances, the so-called membrane lipids in the extract, in the form
of tiny bubbles called liposomes. These liposomes are formed from
12
the cell membranes occurring naturally in plants and contain green
mistletoe plant pigment. Numerous immunological effects have been
reported for mistletoe liposomes, and they probably explain why ab-
nobaVISCUM is well-tolerated.
Quality assurance
Manufacture of abnobaVISCUM and quality control procedures are
carried out according to legal regulations and in strict adherence
to international standards and rules of good manufacturing prac-
tice, i.e. the GMP guidelines. These regulations are applied and
continually updated according to the most current knowledge and
technology. A series of substances have been detected in mistletoe
preparations that contribute to the overall effect of the remedies
(active substances such as mistletoe lectins, viscotoxins, polysac-
charides, liposomes, triterpenoids, amongst many others). These
are not defined individual substances but rather substance groups.
The contribution of each substance group to the overall medicinal
preparation depends on its interactions with other constituents, i.e.
secondary substances, as well as on galenic features (liposomes).
Therefore the pharmaceutical quality of abnobaVISCUM is ensured
by means of process standardization, i.e. fixing of harvest times, for-
mulas, production processes and specifications, and employment of
validated control methods.
13
Controls carried out during production and at the end of the entire
manufacturing process show that the mistletoe preparations are of
consistent quality.
The substance composition of each type (i.e. host tree) of mistletoe
preparation is different. For example, the total lectin content of ab-
nobaVISCUM Fraxini is 50 times higher on average than the same
extraction strength of abnobaVISCUM Pini. See Figure 1 and 2.
12000
10000
8000
6000
4000
2000
0
Amygdali
Quercus
Crataegi
Betulae
Abietis
Fraxini
Aceris
Mali
Pini
Type
14
Viscotoxin content in abnobaVISCUM [g/ml]
100
90
80
70
60
50
40
30
20
10
0
Amygdali
Quercus
Crataegi
Betulae
Abietis
Fraxini
Aceris
Mali
Pini
Type
15
Specific features of abnobaVISCUM
abnobaVISCUM differs from other mistletoe preparations in the
following ways:
Processing of liposomes
The natural liposomes contained in the extract explain why
abnobaVISCUM is well-tolerated as a medicament and its high
bio-availability.
16
17
Recommendations
for use
Therapeutic indications
Relapse prophylaxis following tumour surgery.
Treatment of malignant and benign tumour disease.
Treatment of malignant disease of the haematopoietic organs.
Treatment of defined pre-cancerous conditions.
Contraindications
In the case of acute infections or diseases accompanied by fever
(body temperature above 38 C), mistletoe treatment must be dis-
continued until the fever or infection subside.
abnobaVISCUM should not be administered if there is any known
hypersensitivity to mistletoe preparations.
18
Side effects
The following symptoms appear in almost all patients taking the
correct individual dosage:
Skin, cutaneous Injection site inflammation up to 5 cm
appendages: in diameter mostly appears 8 -12 hours
after the injection; rarely after 24 hours
19
Recommendations
for use
The general symptoms described here do not indicate intolerance
of the medication but rather that the dosage is effective. However, if
these symptoms do not subside during the course of the day follo-
wing the injection, or if the patient is unable to tolerate the symptoms,
the dosage should be reduced to the next lowest strength. The next
injection should only be given after the symptoms have subsided.
A fever persisting for more than three days cannot be caused by a
mistletoe injection and other causes should be investigated.
20
Use of abnobaVISCUM in patients with impaired renal
or hepatic function
No restrictions for use. Long-term clinical experience provides no
evidence for restricting administration of abnobaVISCUM to patients
with limited kidney and liver function.
Pediatric use
abnobaVISCUM can be used in paediatric medicine. Extensive expe-
rience in this area shows no evidence of contraindications for child-
ren below the age of 12 years. Insufficient knowledge is available on
administration to infants and toddlers under the age of 3 years.
21
Recommendations
for use
Dosage
abnobaVISCUM treatment starts at a low dosage which is slowly
increased over time.
Increases in dosage and the frequency of administration are adju-
sted according to the individual patients responsiveness to the pre-
parations. In this way dosage is gradually increased until the optimal
dosage (individual dosage) is achieved.
Start of treatment
It is recommended that treatment starts with 1 ml (1 ampule) of
0.02 mg strength, injected 3 times per week. The treatment scheme
provided (inside front cover) for increasing dosage is based on ex-
tensive clinical experience gained over many years. The reactions
described in the section Individual dosage can be expected to
arise frequently.
If no reaction or a very minor reaction is observed after 8 injections
of 0.02 mg strength, dosage can be increased to 0.2 mg strength,
3 injections per week.
After a further 8 injections, if no reaction or a very minor reaction
is observed, the dosage should be increased to 2 mg strength,
3 injections per week.
If the reactions described in points (a) to (d) below are achieved at
any stage, the dosage should be maintained until the reaction is
no longer observed.
22
Individual dosage
The optimal individual dosage is reached when at least one of the
following reactions is observed:
a) Injection site inflammation
An injection site inflammation mostly arises at the injection site
within 8 to 12 hours; rarely only after 24 hours. This localized
inflammatory skin reaction should be a maximum of 5 cm in dia-
meter. It subsides within the next two to three days and becomes
weaker during the course of treatment.
b) Body temperature response
Three types of body temperature response can be observed:
Immediate response: Temperature increases during the course of
the first 12 hours after the injection.
Rhythmical response: The normal physiological temperature
difference of 0.5 C between morning and evening is recovered
(page 37).
Late reaction: During the course of the treatment the average
body temperature level increases (page 37).
Temperature readings are taken rectally or orally. The first reading
should be taken in the morning before getting out of bed, before
700h if possible; the second reading in the afternoon between
1400h and 18 00h following a 30 minutes rest. The temperature
readings should always be taken at the same time each day. The
second reading should be taken at the point when the individual
temperature is normally at its maximum. Experience has shown
that the body temperature response (immediate response) disap-
pears after several months of continual treatment with the same
dosage concentration.
c) Immunological response
Stimulation of the specific and non-specific immune system. A
positive immune system response can be shown by means of
changes in the leukocytes, particularly through maturation and
23
Recommendations
for use
activation of lymphocytes and increase in eosinophiles.
An improvement of the cellular immune status can be observed
through identifying lymphocyte sub-populations as well as by the
number and activation of NK-cells.
These observable pharmacodynamic effects are dependent on
the dosage strength at the start of treatment and change during
the course of treatment. After 3 to 9 weeks, antibodies mostly
IgG-type against mistletoe proteins (mistletoe lectins, viscoto-
xins) begin to appear.
d) Changes in general condition
Once the body temperature response subsides there is often an
improvement in the patients general physical and psychological
condition. The patient often experiences increased sense of initia-
tive, and in some cases pain reduction and appetite increase. It is
possible to consider reducing the dosage of analgesics that have
otherwise been necessary up to that point.
24
the injection, or if the symptoms become intolerable for the patient,
the concentration or dosage should be reduced.
If the transition from one concentration to the next highest concen-
tration results in an overshooting reaction, then the next administra-
tion of the new strength should only be half an ampule.*
If the patient already has strong reactions to 0.02 mg strength then D6
strength should be used. In cases of a strong reaction to D6 strength,
then only one third of an ampule should be used; alternatively a diffe-
rent type (host tree) of abnobaVISCUM should be selected.
* The contents of ampoules that have already been broken open should be
disposed of and not used for a later injection.
25
Recommendations
for use
Overdosage
Increasing dosage in steps of more than one strength should be
avoided. The procedure for determining the optimal individual
dosage must be complied with.
A too-rapid increase in dosage, e.g. by skipping the next
strength to the following one can lead to allergoid reactions
requiring emergency medical treatment (see page 39). As the
allergoid reaction is related to dosage (and not to an allergy as
such), treatment can be continued at a decreased dosage when
the symptoms have subsided.
26
Mistletoe therapy can be continued behond the 7th year, for example
as a prophylaxis against tumour recurrence.
Treatment-free intervals
After a treatment-free interval lasting longer than 4 weeks, the
patient should always begin injecting again with 0.02 mg strength
following the process described in the section on Individual do-
sage (page 23)
Intravenous Infusion
abnobaVISCUM D6 D30 strength can be administered intrave-
nously in special cases. Dosage and frequency depend on the phy-
sical condition of the patient and are determined individually.
The appropriate dosage of abnobaVISCUM combined with 250 ml
27
Recommendations
for use
saline solution is administered by intravenous infusion. The infusion
should be administered over a period of at least 30 minutes. (This
only applies to D6 to D30 preparations. Higher strength Off
label use infusions should be administered over a period of at
least 120 to 150 minutes). If an allergoid reaction appears during
the infusion, administration must be discontinued immediately. If the
symptoms do not subside, emergency medical treatment must be
given (see page 39).
28
abnobaVISCUM in combination with other therapies
The patients reaction to abnobaVISCUM injections can change
during the course of radiation therapy, chemotherapy and following
surgery. In rare cases it may be essential to re-establish the optimal
individual dosage, starting injections with 0.02 mg strength once
again (see page 22).
Surgery
Surgical interventions and anaesthetic drugs can have an immu-
nosuppressive effect. Therefore it is recommended that abnoba-
VISCUM is given as an immunmodulatory medicine pre-operatively
if possible, even if there is only a short period of time before the
operation. The pre-operative treatment should start with 0.02mg
strength, 3 times per week. The mistletoe injections should be
continued after the operation and until the wound has healed.
Chemotherapy
Treatment with abnobaVISCUM can reduce side effects of chemo-
therapy. Negative interactions between abnobaVISCUM treatment
and simultaneous chemotherapy are not known. Clinical research
has shown that quality of life improves when chemotherapy is
accompanied by treatment with mistletoe preparations. When
chemotherapy and mistletoe treatment are given simultaneously it
is unlikely that mistletoe will have an immunomodulatory effect, i.e.
that it will stimulate the immune system, because the immunosup-
pressive effect of chemotherapy is normally too strong. The main
aim of mistletoe treatment in this case is to improve tolerance of
chemotherapy and thus reduce side effects and improve quality of
life. Dosage is determined according to the guidelines on page 22.
If mistletoe treatment is started for the first time during chemothe-
rapy, dosage should begin at a low level and should be increased
very gradually and carefully over time.
29
Recommendations
for use
Radiation therapy
abnobaVISCUM can be administered during radiation therapy,
although the areas of the body and skin that have been treated
should be strictly avoided as injection sites. In some cases it can
become necessary to reduce dosage because of changes in the
patients reactions (especially where there is a tendency to in-
flammatory reactions).
Hormone treatment
abnobaVISCUM can also be administered simultaneously with
hormone treatment. Any changes in the patients reactions to the
mistletoe preparations, however, should be taken into account.
Ampoules:
Indications for handling, storage and transport
abnobaVISCUM preparations have been protected from oxidation
under the strictest conditions during the entire manufacturing pro-
cess. For this reason, injections must be given immediately after
breaking open the ampoules; the contents of opened ampules can-
not be used at a later time.
Ampoules containing brown-coloured liquid may not be used as
this indicates that the preparation has been exposed to oxygen and
spoiled. abnobaVISCUM 20 mg to 0.02 mg strengths must be stored
in the refrigerator (2 to 13 C). The ampoules may not be frozen. If
ampoules are transported, e.g. from the pharmacy to the patients
home, continual cooling at the abovementioned temperatures is not
necessary. However, extreme temperatures such as frost or heat
(over 25 C) should be avoided.
There are no particular storage recommendations for abnoba-
VISCUM D6 to D30 strengths. These ampoules do not have to be
kept in the refrigerator, although they should not be stored or trans-
ported at temperatures above 25 C.
30
Preclinical investigations
Pharmacology and toxicology studies were carried out for abnoba-
VISCUM Fraxini 20 mg in 2002, in accordance with the GLP. As this
particular type of preparation (host tree) and strength contains the
highest content of pharmacologically effective substances, e.g. mist-
letoe lectins and viscotoxins, it was considered to be representative
of all the other preparations for the purposes of these studies.
The following pharmacological safety studies using animals were
carried out for abnobaVISCUM Fraxini 20 mg:
Effect on breathing and cardiovascular system.
Effect on water and electrolyte metabolism.
Effect on the central nervous system.
An effect on these secondary pharmacological parameters was only
observed once the clinical human dosage was increased by more
than 50 times.
The following toxicity studies were carried out:
Acute toxicity following subcutaneous and intravenous ad-
ministration.
Embryotoxicity following repeated subcutaneous administra-
tion.
Studies on acute toxicity indicated that there is a wide spectrum for
clinical administration to the human being, both for intravenous and
subcutaneous administration. The embryotoxicity studies showed
no teratogenic effect.
The mutagenicity (genotoxicity) of abnobaVISCUM was tested in-
vitro (Ames assay and structural chromosomal aberrations test for
human lymphocytes) and in-vivo (micronucleus test). The studies
gave no indication of mutagenic potential.
The toxological studies gave no indication of carcinogenic potential.
Studies concerning local tolerance of anobaVISCUM in intrapleural
applications showed excellent intrapleural tolerance.
31
Recommendations
for use
Thus pre-clinical data obtained through standard safety studies of
acute toxicity, reproduction toxicity and genotoxicity show no par-
ticular danger for the human being. Both pre-clinical and clinical
pharmacokinetic studies show good biological availability of typical
mistletoe substances (e.g. mistletoe lectins, viscotoxins) following
subcutaneous injection. Hence, within the context of the abovemen-
tioned embryotoxicity study, viscotoxins were found in rat serum.
Once sufficiently sensitive analytical tools became available for mist-
letoe lectins, an analysis of the serum of test subjects and patients
showed that mistletoe lectins were also systemically available follo-
wing subcutaneous administration of abnobaVISCUM.
Pharmaceutical information
Incompatibilities: Not known.
32
Type of container abnobaVISCUM is available in break
and content: able glass ampoules, each containing
1ml of injection solution.
The 20 mg und 2 mg strengths are yel-
low-green in colour. All other strengths
are colourless.
33
Expert Information*
1 Name of the medicinal product 20 mg: 15 mg pressed juice from 20
mg mistletoe herb of the respective
abnobaVISCUM
host tree
differentiated according to the mist-
2mg: 1.5mg pressed juice from 2.0mg
letoe host trees: (Abietis) fir, (Aceris)
mistletoe herb of the respective host
maple, (Amygdali) almond, (Betulae)
tree
birch, (Crataegi) hawthorn, (Fraxini)
ash, (Mali) apple, (Pini) pine and 0.2 mg: 0.15 mg pressed juice from 0.2
(Quercus) oak, in the concentrations mg mistletoe herb of the respective
20 mg, 2 mg, 0.2 mg, 0.02 mg, D6, host tree
D10, D20, D30, complete name e.g.:
abnobaVISCUM Abietis 20 mg or 0.02 mg: 0.015 mg pressed juice from
abnobaVISCUM Abietis D6. 0.02 mg mistletoe herb of the respec-
tive host tree
Active substance:
a) Pressed juice from mistletoe herb b) For the concentrations D6, D10, D20
from the respective host tree (20 mg and D30 the following applies:
0.02 mg), 1 ampoule of 1 ml liquid dilution for
and injection contains in
b) Viscum album of the respective host D6: Viscum album of the respective
tree ex herba recente col. D6, D10, host tree ex herba recente col.
D20, D30. D6: 1 ml
D10: Viscum album of the respective
2 Prescription status/Legal category host tree ex herba recente col.
D10: 1 ml
Pharmacy-only medicine
D20: Viscum album of the respective
3 Composition of the medicinal pro- host tree ex herba recente col.
duct D20: 1 ml
D30: Viscum album of the respective
3.1 Substance or indication group
host tree ex herba recente col.
Anthroposophical medicinal product D30: 1 ml
35
is then carefully increased until the made in the afternoon between 2 p.m.
optimal dose is reached. The dosage and 6 p.m. after the patient has been
should always be established on an lying down for half an hour. The tem-
individual basis in accordance with perature should always be taken at the
patient response. same time of day. The second measu-
rement should preferably be taken at
Determining the individual dose
the time of the individual maximum
The individual dose is that at which temperature.
the patient shows at least one of the
If it necessary to determine the indivi-
following responses:
dual maximum temperature then the
temperature should be taken regularly
a) Change in subjective condition
over the course of one day. It should be
Improvement in general condition and measured every two hours between 7
psychological state, increased initia- a.m. and 9 p.m. after the patient has
tive and possibly pain relief indicate been lying down.
that the chosen regimen is within the
Three types of temperature response
effective dose range. Any tiredness,
are observed:
shivering, general malaise, headache
and transient dizziness on the day of 1. Immediate response: a single rise in
injection are not signs of intolerance temperature after the injection.
but show that the dosage administe-
red was effective, possibly too high. 2. Rhythmical response: restitution
If these symptoms have not subsided of the physiological morning/evening
on the day after the injection or if they temperature dif ference of at least
become intolerable, the concentration 0.5C (Fig. 1).
and/or the dose should be reduced. 3. Delayed response: in the course of
treatment the mean temperature in-
b) Local inflammatory response creases. In such cases the subfebrile
range must also be monitored (Fig. 2).
This should not be more than 5 cm in
diameter. In some patients only one temperature
response is observed. However, in
c) Temperature response most cases combinations of the three
types of response can be observed.
Since the desirable temperature re-
sponses during therapy are impor-
d) Immunological response
tant for evaluating the course of treat-
ment the patient should be instructed For example, increased leukocytes
to keep a basal temperature graph. (above all the absolute lymphocyte
Please note the following: and/or eosinophil count). Improvement
of the cellular immune status in the
The temperature should be measured
Multitest Mrieux or by counting the
rectally or orally. The first measure-
lymphocyte subpopulations.
ment should be made in the morning
before rising, preferably before 7 a.m. The individual dose may already be re-
The second measurement should be ached at a concentration of 0.02 mg.
36
39
37
without treatment
36
Example for temperature response Fig. 1: Rhythmical response
39
37
without treatment
36
Example for temperature response Fig. 2: Late response
37
be brought into a rhythm using weaker must be injected immediately after
concentrations. For example, if the opening the ampoule. Any opened
individual dose is with concentration ampoules must be discarded imme-
2 mg, then concentration 2 mg can diately.
be administered on Mondays, and the
Site:
concentration 0.2 mg on Wednesdays
Wherever possible inject near to the
and Fridays.
tumour or metastases, a different in-
If the patients response situation jection site should preferably be cho-
changes during the course of treat- sen at every administration (various
ment, the individual dose must also be sites in the abdomen, thigh or up-
reassessed. In addition to the patients per arm). Injections into inflamed skin
general condition and local and tem- areas (e.g., local response) or irradia-
perature responses, immunological tion fields should be avoided. Strictly
parameters can also be used to assess observe subcutaneous injection tech-
responsiveness. nique.
During radiotherapy or chemotherapy Time:
and after surgery, the patients indi- Whenever possible the injections
vidual response may change and the should be given in the morning du-
dose may have to be readjusted. ring the temperature increase phase.
Patients are recommended to rest af-
After any breaks lasting more than 4
terwards.
weeks the initial dose should be halved
when resuming therapy. Duration:
There is basically no limit to the du-
Posology in impaired renal function
ration of treatment. It will be decided
As described above. There are no re- upon by the clinician, based upon the
strictions on use. risk of tumour recurrence, the individual
findings, and the patients condition. If
11 Method and duration of adminis- the patients condition is stable, a dose
tration reduction to two ampoules a week can
be made after two years. After three
Method: years, treatment breaks of four weeks
Subcutaneous injection can be made after each eight weeks
In special cases the required dose therapy. After each treatment break
of concentrations D6 to D30 can be therapy must be started with the in-
mixed with a solution for infusion (phy- duction therapy as given in the dosage
siological saline or 5% glucose so- instructions. After seven years if the
lution) and administered by slow i.v. course remains unsuspicious therapy
infusion. The infusion of 250 ml should with abnobaVISCUM may be discon-
last for at least 30 minutes. In the case tinued. During times of psychological
of malignant effusions the infusion may and physical stress, particularly with
be given directly into the affected body intercurrent viral illness, patients re-
cavity after the required puncture. quire closer monitoring. It is essential
Since the preparations are produced to continue treatment during holidays
under strict oxidation protection they or while travelling.
38
Emergency Measures
39
15 Shelf life
Concentrations 20 mg, 2 mg, 0.2 mg
and 0.02 mg: The preparations have
a shelf life of three years when stored
between 2C and 13C. The prepara-
tion should be used immediately after
opening the ampoule.
Concentrations D6, D10, D20 and D30:
The preparations have a shelf life of
five years when stored normally. The
preparation should be used immedia-
tely after opening the ampoule.
40
41
Selected literature for further reading
Eisenbraun J., Huber R., Krz M., Schad F., Scheer R.: Quality of life in
breast cancer patients during chemotherapy and concurrent therapy with
a mistletoe-extract of the apple tree, Phytomedicine 14 SVII 35, Elsevier-
Verlag Mnchen (2007) Abstract
Klein R., Claen K., Fischer S., Errenst M., Scheffler A., Stein G.M., Scheer
R. und H.B. von Laue: Induction of Antibodies to Viscotoxins A1, A2,
A3, and B in Tumour Patients During Therapy with an Aqueous Mistletoe
Extract, European Journal of Medical Research 7, 359 - 367 (2002)
Klein, R., Franz M., Wacker R., Claen K., Scheer R., von Laue H.B., Stoeva S.,
Voelter W.: Demonstration of Antibodies to the Chitin-Binding Mistletoe
Lectin (CBML) in Tumor Patients before and during Therapy with an
Aqueous Mistletoe. Extract, European Journal of Medical Research 9, 316-
322 (2004)
Krz M., Schad F., Matthes B., Pickartz H., Girke M.: Blut- und
Gewebseosinophilie, Mistellektin-Antikrper und Lebensqualitt bei
einer Mammakarzinom-Patientin unter intratumoraler und subkutaner
Misteltherapie, Forsch Komplementrmed Klass Naturheilkd 9, 160-167
(2002) English Summary
Mabed M., El-Helw L., Shamaa S.: Phase II study of viscum fraxini-2 in
patients with advanced hepatocellular carcinoma, British Journal of Cancer
90 (1), 65-69 (2004)
42
Society for Gastrointestinal Endoscopy, April 2000, Gastoenterology 118,
No. 4, Suppl. 2, P221 (2000) Abstract
Scheer R., Bauer R., Becker H., Berg P.A., Fintelmann V. (Hrsg.): Die Mistel
in der Tumortherapie Grundlagenforschung und Klinik, KVC Verlag,
Essen, 2001. English Summaries
Scheer R., Bauer R., Becker H., Fintelmann V., Kemper F.H., Schilcher H.
(Hrsg.): Fortschritte in der Misteltherapie. Aktueller Stand der Forschung
und klinischer Anwendung, KVC Verlag, Essen, 2005. English Summaries
Scheer R., Alban S., Becker H., Holzgrabe U., Kemper F.H., Kreis W., Matthes
H., Schilcher H. (Hrsg.): Die Mistel in der Tumortherapie 2. Aktueller Stand
der Forschung und klinische Anwendung, KVC Verlag, Essen, 2009. English
Summaries
Kienle G.S., Kiene H.: Die Mistel in der Onkologie Fakten und konzep-
tionelle Grundlagen. Schattauer Verlag, Stuttgart, New York, 2003. German
Language
Websites:
www.abnoba.de English language available
www.mistel-therapie.de (www.mistel-therapie.de/mistletoe.html)
43
Selected literature for further reading
For Patients
Our patient brochure is also available in Dutch, German, Spanish
and Turkish.
44
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improvement of this brochure.
45
Recommendations
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