abnobaVISCUM® Summary of Product Characteristics > 의학

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abnobaVISCUM® Summary of Product Characteristics

(all products)

1 Name of the medicinal product

abnobaVISCUM Abietis D 6

abnobaVISCUM Abietis D 10

abnobaVISCUM Abietis D 20

abnobaVISCUM Abietis D 30

Liquid dilution for injection

Active substance:

Viscum album Abietis ex herba recente col.

D 6/D 10/D 20/D 30

abnobaVISCUM Abietis 20 mg

abnobaVISCUM Abietis 2 mg

abnobaVISCUM Abietis 0.2 mg

abnobaVISCUM Abietis 0.02 mg

Solution for injection

Active substance:

Extract of fresh fir mistletoe herb

abnobaVISCUM Aceris D 6

abnobaVISCUM Aceris D 10

abnobaVISCUM Aceris D 20

abnobaVISCUM Aceris D 30

Liquid dilution for injection

Active substance:

Viscum album Aceris ex herba recente col.

D 6/D 10/D 20/D 30

abnobaVISCUM Aceris 20 mg

abnobaVISCUM Aceris 2 mg

abnobaVISCUM Aceris 0.2 mg

abnobaVISCUM Aceris 0.02 mg

Solution for injection

Active substance:

Extract of fresh maple mistletoe herb

abnobaVISCUM Amygdali D 6

abnobaVISCUM Amygdali D 10

abnobaVISCUM Amygdali D 20

abnobaVISCUM Amygdali D 30

Liquid dilution for injection

Active substance:

Viscum album Amygdali ex herba recente col.

D 6/D 10/D 20/D 30

abnobaVISCUM Amygdali 20 mg

abnobaVISCUM Amygdali 2 mg

abnobaVISCUM Amygdali 0.2 mg

abnobaVISCUM Amygdali 0.02 mg

Solution for injection

Active substance:

Extract of fresh almond mistletoe herb

abnobaVISCUM Betulae D 6

abnobaVISCUM Betulae D 10

abnobaVISCUM Betulae D 20

abnobaVISCUM Betulae D 30

Liquid dilution for injection

Active substance:

Viscum album Betulae ex herba recente col.

D 6/D 10/D 20/D 30

abnobaVISCUM Betulae 20 mg

abnobaVISCUM Betulae 2 mg

abnobaVISCUM Betulae 0.2 mg

abnobaVISCUM Betulae 0.02 mg

Solution for injection

Active substance:

Extract of fresh birch mistletoe herb

abnobaVISCUM Crataegi D 6

abnobaVISCUM Crataegi D 10

abnobaVISCUM Crataegi D 20

abnobaVISCUM Crataegi D 30

Liquid dilution for injection

Active substance:

Viscum album Crataegi ex herba recente col.

D 6/D 10/D 20/D 30

abnobaVISCUM Crataegi 20 mg

abnobaVISCUM Crataegi 2 mg

abnobaVISCUM Crataegi 0.2 mg

abnobaVISCUM Crataegi 0.02 mg

Solution for injection

Active substance:

Extract of fresh hawthorn mistletoe herb

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim

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abnobaVISCUM Fraxini D 6

abnobaVISCUM Fraxini D 10

abnobaVISCUM Fraxini D 20

abnobaVISCUM Fraxini D 30

Liquid dilution for injection

Active substance:

Viscum album Fraxini ex herba recente col.

D 6/D 10/D 20/D 30

abnobaVISCUM Fraxini 20 mg

abnobaVISCUM Fraxini 2 mg

abnobaVISCUM Fraxini 0.2 mg

abnobaVISCUM Fraxini 0.02 mg

Solution for injection

Active substance:

Extract of fresh ash mistletoe herb

abnobaVISCUM Mali D 6

abnobaVISCUM Mali D 10

abnobaVISCUM Mali D 20

abnobaVISCUM Mali D 30

Liquid dilution for injection

Active substance:

Viscum album Mali ex herba recente col.

D 6/D 10/D 20/D 30

abnobaVISCUM Mali 20 mg

abnobaVISCUM Mali 2 mg

abnobaVISCUM Mali 0.2 mg

abnobaVISCUM Mali 0.02 mg

Solution for injection

Active substance:

Extract of fresh apple mistletoe herb

abnobaVISCUM Pini D 6

abnobaVISCUM Pini D 10

abnobaVISCUM Pini D 20

abnobaVISCUM Pini D 30

Liquid dilution for injection

Active substance:

Viscum album Pini ex herba recente col.

D 6/D 10/D 20/D 30

abnobaVISCUM Pini 20 mg

abnobaVISCUM Pini 2 mg

abnobaVISCUM Pini 0.2 mg

abnobaVISCUM Pini 0.02 mg

Solution for injection

Active substance:

Extract of fresh pine mistletoe herb

abnobaVISCUM Quercus D 6

abnobaVISCUM Quercus D 10

abnobaVISCUM Quercus D 20

abnobaVISCUM Quercus D 30

Liquid dilution for injection

Active substance:

Viscum album Quercus ex herba recente col.

D 6/D 10/D 20/D 30

abnobaVISCUM Quercus 20 mg

abnobaVISCUM Quercus 2 mg

abnobaVISCUM Quercus 0.2 mg

abnobaVISCUM Quercus 0.02 mg

Solution for injection

Active substance:

Extract of fresh oak mistletoe herb

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim

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2 Qualitative and quantitative composition

Name of the medicinal

product

1 ampoule of 1 ml contains

Active substance:

abnobaVISCUM Abietis

D 6/D 10/D 20/D 30

Viscum album Abietis ex herba recente col. Dil.

D 6/D 10/D 20/D 30 (GHP [German Homeopathic

Pharmacopoeia], V. 32) 1 ml

abnobaVISCUM Abietis

20 mg/2 mg/0.2 mg/

0.02 mg

Extract of fresh fir mistletoe herb

(plant to extract = 1:50) 1 ml/0.1 ml/0.01 ml/0.001 ml

Extractant:

Sodium monohydrogen phosphate 2 H2O, ascorbic acid, water

for injection (2.03 : 0.34 : 97.63)

abnobaVISCUM Aceris

D 6/D 10/D 20/D 30

Viscum album Aceris ex herba recente col. Dil.

D 6/D 10/D 20/D 30 (GHP [German Homeopathic

Pharmacopoeia], V. 32) 1ml

abnobaVISCUM Aceris

20 mg/2 mg/0.2 mg/

0.02 mg

Extract of fresh maple mistletoe herb

(plant to extract = 1:50) 1 ml/0.1 ml/0.01 ml/0.001 ml

Extractant:

Sodium monohydrogen phosphate 2 H2O, ascorbic acid, water

for injection (2.03 : 0.34 : 97.63)

abnobaVISCUM Amygdali

D 6/D 10/D 20/D 30

Viscum album Amygdali ex herba recente col. Dil.

D 6/D 10/D 20/D 30 (GHP [German Homeopathic

Pharmacopoeia], V. 32) 1ml

abnobaVISCUM Amygdali

20 mg/2 mg/0.2 mg/

0.02 mg

Extract of fresh almond mistletoe herb

(plant to extract = 1:50) 1 ml/0.1 ml/0.01 ml/0.001 ml

Extractant:

Sodium monoihydrogen phosphate 2 H2O, ascorbic acid, water

for injection (2.03 : 0.34 : 97.63)

abnobaVISCUM Betulae

D 6/D 10/D 20/D 30

Viscum album Betulae ex herba recente col. Dil.

D 6/D 10/D 20/D 30 (GHP [German Homeopathic

Pharmacopoeia], V. 32) 1ml

abnobaVISCUM Betulae

20 mg/2 mg/0.2 mg/

0.02 mg

Extract of fresh birch mistletoe herb

(plant to extract = 1:50) 1 ml/0.1 ml/0.01 ml/0.001 ml

Extractant:

Sodium monohydrogen phosphate 2 H2O, ascorbic acid, water

for injection (2.03 : 0.34 : 97.63)

abnobaVISCUM Crataegi

D 6/D 10/D 20/D 30

Viscum album Crataegi ex herba recente col. Dil.

D 6/D 10/D 20/D 30 (GHP [German Homeopathic

Pharmacopoeia], V. 32) 1ml

abnobaVISCUM Crataegi

20 mg/2 mg/0.2 mg/

0.02 mg

Extract of fresh hawthorn mistletoe herb

(plant to extract = 1:50) 1 ml/0.1 ml/0.01 ml/0.001 ml

Extractant:

Sodium monohydrogen phosphate 2 H2O, ascorbic acid, water

for injection (2.03 : 0.34 : 97.63)

abnobaVISCUM Fraxini

D 6/D 10/D 20/D 30

Viscum album Fraxini ex herba recente col. Dil.

D 6/D 10/D 20/D 30 (GHP [German Homeopathic

Pharmacopoeia], V. 32) 1ml

abnobaVISCUM Fraxini

20 mg/2 mg/0.2 mg/

0.02 mg

Extract of fresh ash mistletoe herb

(plant to extract = 1:50) 1 ml/0.1 ml/0.01 ml/0.001 ml

Extractant:

Sodium monohydrogen phosphate 2 H2O, ascorbic acid, water

for injection (2.03 : 0.34 : 97.63)

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim

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abnobaVISCUM Mali

D 6/D 10/D 20/D 30

Viscum album Mali ex herba recente col. Dil.

D 6/D 10/D 20/D 30 (GHP [German Homeopathic

Pharmacopoeia], V. 32) 1ml

abnobaVISCUM Mali

20 mg/2 mg/0.2 mg/

0.02 mg

Extract of fresh apple mistletoe herb

(plant to extract = 1:50) 1 ml/0.1 ml/0.01 ml/0.001 ml

Extractant:

Sodium monohydrogen phosphate 2 H2O, ascorbic acid, water

for injection (2.03 : 0.34 : 97.63)

abnobaVISCUM Pini

D 6/D 10/D 20/D 30

Viscum album Pini ex herba recente col. Dil.

D 6/D 10/D 20/D 30 (GHP [German Homeopathic

Pharmacopoeia], V. 32) 1ml

abnobaVISCUM Pini

20 mg/2 mg/0.2 mg/

0.02 mg

Extract of fresh pine mistletoe herb

(plant to extract = 1:50) 1 ml/0.1 ml/0.01 ml/0.001 ml

Extractant:

Sodium monohydrogen phosphate 2 H2O, ascorbic acid, water

for injection (2.03 : 0.34 : 97.63)

abnobaVISCUM Quercus

D 6/D 10/D 20/D 30

Viscum album Quercus ex herba recente col. Dil.

D 6/D 10/D 20/D 30 (GHP [German Homeopathic

Pharmacopoeia], V. 32) 1ml

abnobaVISCUM Quercus

20 mg/2 mg/0.2 mg/

0.02 mg

Extract of fresh oak mistletoe herb

(plant to extract = 1:50) 1 ml/0.1 ml/0.01 ml/0.001 ml

Extractant:

Sodium monohydrogen phosphate 2 H2O, ascorbic acid, water

for injection (2.03 : 0.34 : 97.63)

For the strengths 20 mg/2 mg/0.2 mg/0.02 mg:

The strength in mg indicates the quantity of fresh plant material used for the manufacture of 1

ampoule of abnobaVISCUM from the respective host tree.

Example: “abnobaVISCUM Abietis 20 mg” contains an extract of 20 mg fresh fir mistletoe herb

in one ampoule.

For a full list of excipients, see section 6.1.

3 Pharmaceutical form

Strengths of 20 mg/2 mg/0.2 mg/0.02 mg:

Solution for injection

Potency levels D 6/D 10/D 20/D 30:

Liquid dilution for injection

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim

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4 Clinical particulars

4.1 Therapeutic indications

Therapeutic indications according to the anthroposophical understanding of man and nature.

These include, in adults, stimulation of the forming and integrative forces for the elimination

and re-assimilation of growth processes which have become independent, e.g.:

- in malignant tumor diseases, also with accompanying disorders of the hematopoietic

organs

- as prophylaxis against relapse following tumor surgery

- in defined precancerous conditions

- in benign tumor diseases

4.2 Posology, method and duration of administration

Initiation phase

Posology and frequency of use (for all abnobaVISCUM preparations)

Unless otherwise prescribed, the usual dosage is 1 ml solution for injection of the given

strength or potency level. Treatment should be initiated with the 0.02 mg strength (for the

strengths 0.02 mg, 0.2 mg, 2 mg, 20 mg and potency level D 6) three times weekly. Then the

dose is gradually increased until the optimal dose is achieved.

The potency levels D 10 - D 30 are to be used according to individual diagnosis.

The optimal concentration or dose must be individually determined. According to current

knowledge, it is important to watch for the following reactions, which may occur individually or

in combination.

a) Change in the subjective sense of well-being

On the day of injection, possible fatigue, shivering, general malaise, headache and transient

dizziness are not signs of intolerance; moreover, these signs indicate an effective (and

possibly excessive) dosing. However, if such symptoms have not subsided by the following

day or exceed a tolerable level, the strength or dose should be reduced.

An improvement in general state of health (increase in appetite and body weight, normalization

of sleep, sensation of warmth and performance) and mental state (improvement in mood,

increase in courage to face life and ability to show initiative) as well as alleviation of pain

conditions show that dosing is in a therapeutically optimal range.

b) Temperature response

Temperature reactions occur in the form of an above-average increase in body temperature

several hours after injection, restoration of the physiological morning/evening differential of at

least 0.5°C, or an increase in mean body temperature during the course of treatment.

In contrast, in the case of tumor fever, attempts should be made to restore a normal core

temperature rhythm by using lower strengths.

c) Immunological response

e.g. an increase in leukocytes (in particular in absolute lymphocyte and eosinophil counts); an

improvement of the cellular immune status in the recall antigen test or by determining

lymphocyte sub-populations.

d) Local inflammatory response

Local inflammatory reaction at the injection site with a maximal diameter of up to 5 cm.

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim

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Maintenance phase

Unless otherwise prescribed:

Individual doses can already be obtained with the 0.02 mg formulation. Otherwise, the dose

should be increased in increments to 0.2 mg, 2 mg or 20 mg, given in each case as 2 - 3

injections a week.

As excessive responses are known to occur when switching to higher-strength concentrations,

it is advisable to initially administer only half an ampoule of the next higher concentration. If the

response is already too excessive with the 0.02 mg formulation, patients should be switched to

the D6 formulation. If this should also provoke an excessive response, only 1/3 of potency level

D 6 should be used. Alternatively, the patient should be switched to the D10 formulation or to

abnobaVISCUM obtained from a different host tree. In the above-mentioned cases, the use of

0.5 ml or 0.3 ml abnobaVISCUM with the aid of a scaled 1 ml syringe is recommended.

During radiotherapy, chemotherapy or hormone therapy or after surgery, the individual

responsiveness of the patients may change and make a dose adjustment necessary.

With the optimal individual concentration or dose determined in this manner, treatment is

continued.

To prevent habituation effects, a rhythmic application in the following forms may be applied:

- alternation between lower concentrations or doses in the form of increasing and

possibly also decreasing dosages or

- a new rhythm of the injection intervals.

At intervals of 3 - 6 months, the dosage should be reviewed as regards patient reaction and

tumor behavior.

Frequency of application

Unless otherwise prescribed: subcutaneous injection 2 - 3 x weekly.

Posology in cases of impaired renal function

There is insufficient data for concrete dosage recommendations in cases of impaired renal

function. General experience up to this point shows no requirement for a dose adjustment.

Mode of application

Subcutaneous injection: if possible, into an area near the primary or secondary tumor

(metastasis). Otherwise, it is advisable to alternate injection sites between each dose (e.g.

abdominal skin, upper arm or thigh). Do not inject into inflamed skin areas or irradiated areas.

The strict procedure for subcutaneous injection should be followed.

As a precaution, it is recommended that abnobaVISCUM is not to be drawn up in a syringe with

other medicinal products (see also section 6.2 Incompatibilities).

Ampoules must be injected immediately after opening. Opened ampoules must not be saved

for a later injection.

For potency levels D 10, D 20 and D30 only:

For potency levels D 10, D 20 and D 30, the required dosage may, in special cases, be mixed

with a solution for infusion (physiological saline solution or 5% glucose solution) and

administered as a slow i.v. infusion. For 250 ml, the duration of infusion should be at least 90

minutes. Dosage and frequency are based on the patient’s current physical constitution and

are individually determined by the doctor.

Duration of use

The treating physician decides on the duration of use.

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim

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In principle, there is no limit to the duration of use, which is decided by the doctor based on the

individual risk of relapse and the patient's condition or findings. It should last for several years,

usually with intermittent pauses of increasing length.

4.3 Contraindications

- known hypersensitivity to mistletoe preparations

- acute inflammatory or highly febrile diseases: treatment should be interrupted until the

signs of inflammation subside

- chronic granulomatous diseases and florid autoimmune diseases and those treated

with immunosuppressive therapy

- hyperthyroidism with tachycardia

4.4 Special warnings and precautions for use

Excessive dose increases (by two orders of magnitude) may cause allergoid reactions

requiring emergency treatment. As allergoid reactions are dose-dependent, the therapy can be

continued with a reduced dose after the symptoms have subsided.

After each therapeutic pause lasting longer than 4 weeks, the individual dosage must always

be redetermined by starting with the 0.02 mg concentration.

Primary brain and spinal tumors or intracranial metastases with the risk of an increase in

intracranial pressure: In this case, the preparations should only be administered according to

strict determination of the indication and under close clinical control.

The ampoule should be briefly warmed in the hand as the formation of cold agglutinins after i.v.

injection have been described for mistletoe solutions for injection which were not at body

temperature.

4.5 Interactions with other medicinal products and other forms of interaction

There are no investigations available on interactions with other immune modulating

substances (e.g., thymus extracts). When administering relevant preparations at close

intervals, careful dosage and monitoring of appropriate immune parameters is recommended.

4.6 Pregnancy and lactation

There are no clinical data available on pregnant women exposed to abnobaVISCUM.

Investigational studies conducted on animals with abnobaVISCUM Fraxini do not indicate any

direct or indirect harmful effects on pregnancy and embryonic development. There are no

investigational studies on animals available regarding the effects on delivery and postnatal

development, in particular on hematopoiesis and the immune system of the fetus/infant (see

section 5.3). The potential risk to humans in these areas is unknown. Caution is advised when

used during pregnancy and lactation.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and operate machines have been performed.

Therefore, it is unknown whether abnobaVISCUM influences the ability to drive or use

machines. However, if symptoms such as fever occur in association with the use of

abnobaVISCUM, the patient must not actively participate in road traffic or use machines until

these symptoms have dissipated.

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim

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4.8 Undesirable effects

A slight increase in body temperature and local inflammatory reactions at the subcutaneous

injection site occur at the beginning of therapy almost regularly and are signs of the patient’s

responsiveness. Temporary mild swelling of regional lymph nodes is also harmless.

In case of a fever greater than 38°C (possibly with fatigue, shivering, general malaise,

headache, temporary dizziness) or in cases of large local reactions in excess of 5 cm in

diameter, the following injection should only be administered after such symptoms have

subsided; and then, at a reduced concentration or dose.

AbnobaVISCUM-induced fever should not be suppressed by antipyretic medications. Should

fever persist for longer than three days, possible infectious processes or tumor fever should be

taken into consideration.

Localized or systemic allergic or allergoid reactions may occur (usually in the form of

generalized itching, urticaria or exanthema, occasionally also with Quincke’s edema, chills,

dyspnea and bronchospasms, in isolated cases with shock or erythema exsudativum

multiforme) which require discontinuation of the preparation and the introduction of medical

treatment.

Activation of existing inflammations and inflammatory manifestations of irritation of superficial

veins in the injection area are possible. In this case as well, a temporary therapeutic pause

until the inflammatory reaction has subsided is necessary.

The occurrence of chronic granulomatous inflammations (sarcoidosis, erythema nodosum)

and autoimmune diseases (dermatomyositis) have been reported during mistletoe therapy.

Symptoms of an increase in intracranial pressure have also been reported during mistletoe

therapy of brain tumors/metastases.

Reporting of suspected undesirable effects

The reporting of suspected undesirable effects following marketing authorization is of great

importance. It enables a continuous monitoring of the risk/benefit relationship of the medicinal

product. Members of the health professions are required to report any suspected case of an

undesirable effect to the Federal Institute for Drugs and Medical Devices, Dept.

Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, 53175 Bonn, Germany, web site:

www.bfarm.de.

4.9 Emergency measures, symptoms and antidotes

The emergency treatment of anaphylactic shock is based on the clinical symptoms:

Initial measures

Venous access, supply of crystalloid solutions.

Supply of oxygen (endotracheal intubation if necessary or cricothyrotomy and ventilation)

Medicinal therapy

Volume supply:

Treatment of hypovolemia by the rapid administration of crystalloid solutions (full electrolyte

solutions).

Intravenous catecholamines:

1 mg epinephrine is diluted with 0.9% saline solution up to 10 ml; 1 ml/min of this diluted

solution (= 100 μg epinephrine) is administered by slow i.v. injection (monitoring of pulse and

blood pressure, possibly ECG).

In the case of severe, epinephrine-refractory hypotension, additional norepinephrine: 1 mg

norepinephrine is diluted with 0.9% saline solution up to 10 ml; 0.5-1 ml of this diluted solution

(= 50-100 μg norepinephrine) is administered by i.v. injection (has to be repeated if necessary).

Glucocorticoids:

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim

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In cases of severe bronchospasms as well as delayed, progressive symptoms, a one-time

intravenous administration of 500-1000 mg prednisolone.

For the prevention of recurring reactions and the treatment of delayed reactions,

administration of glucocorticoids over a 24-hour period, e.g., 3 times 125 mg prednisolone

intravenously. In patients with insulin-dependent diabetes mellitus or diabetes mellitus treated

with other anti-diabetic therapies, a short-term adjustment of the insulin dose may be

necessary.

Histamine antagonists (in addition to the primary therapy with volume supply):

To reduce histamine-mediated vasodilation and bronchoconstriction: H1 and H2 antagonists in

combination, with the H1 antagonist being administered first, e.g., 2 mg clemastine followed by

50 mg ranitidine intravenously.

Theophylline:

In addition, if necessary, in cases of severe bronchospastic reactions if these do not respond to

epinephrine and glucocorticoids: initially 5 mg/kg body weight.

5 Pharmacological properties

5.1 Pharmacodynamic properties

Cancerostatic and immune modulating properties are described for abnobaVISCUM extracts

in vitro, in animal experiments and in human pharmacology.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Animal trials on acute toxicity and pharmacological safety conducted with abnobaVISCUM

Fraxini 20 mg and abnobaVISCUM Pini 20 mg show a good therapeutic index of the medicinal

product. There was no evidence of chronic toxicity.

Animal experiments on immunotoxicity in the mouse, which were conducted representatively

with the abnobaVISCUM product containing the most lectins (abnobaVISCUM Fraxini 20 mg),

showed no immunotoxicologically relevant impact on general and specific immune parameters

or on the humoral and cellular immune response at doses up to four times greater than the

daily maximum therapeutic dose. In further animal experiments, there was evidence of a

weakening of the resistance to mouse melanoma cells at doses four times greater than the

daily maximum dose of the preparation abnobaVISCUM Fraxini 20 mg.

Investigations with abnobaVISCUM Fraxini 20 mg and abnobaVISCUM Pini 20 mg on

embryotoxicity yielded no evidence of an embryotoxic risk for abnobaVISCUM Fraxini 20 mg

and abnobaVISCUM Pini 20 mg in clinical use.

In in-vitro and in-vivo tests with abnobaVISCUM Fraxini 20 mg and abnobaVISCUM Pini

20 mg, there was no evidence of mutagenicity.

6 Pharmaceutical particulars

6.1 List of excipients

20 mg strength:

No excipients

2 mg and 0.2 mg strengths:

Sodium monohydrogen phosphate 2 H2O, ascorbic acid, water for injection

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim

Page 10 of 12

0.02 mg strength:

Sodium monohydrogen phosphate 2 H2O, sodium dihydrogen phosphate H2O, ascorbic acid,

water for injection

Potency levels D 6, D 10, D 20, D 30:

No excipients

6.2 Incompatibilities

See section 4.2 Mode of application

6.3 Shelf life

20 mg, 2 mg, 0.2 mg, 0.02 mg strengths: 3 years

Potency levels D 6, D 10, D 20, D 30: 5 years

6.4 Special precautions for storage

20 mg, 2 mg, 0.2 mg and 0.02 mg strengths:

Store in a refrigerator (2°C to 8°C). Do not freeze.

Potency levels D 6, D 10, D 20 and D 30:

Do not store above 25°C. Do not freeze. Storage in a refrigerator is recommended.

6.5 Nature and contents of container

All abnobaVISCUM® preparations:

Pack with 8 ampoules of 1 ml solution for injection or liquid dilution for injection.

Pack with 48 ampoules of 1 ml solution for injection or liquid dilution for injection.

20 mg to 0.02 mg strengths:

Pack with 21 ampoules of 1 ml solution for injection.

6.6 Special precautions for disposal

No special requirements.

7 Marketing authorization holder

ABNOBA GmbH, Hohenzollernstr. 16, 75177 Pforzheim, Germany

Telephone: +49 (0) 7231 – 31 64 78, Fax: +49 (0) 7231 – 35 87 14

8 Marketing authorization numbers and

9 Date of marketing authorization

Name of the product

Product marketing

authorization number

Date of first

marketing

authorization

abnobaVISCUM Abietis 20 mg 4241.00.00 15.01.1985

abnobaVISCUM Abietis 2 mg 4241.01.00 15.01.1985

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim

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Name of the product

Product marketing

authorization number

Date of first

marketing

authorization

abnobaVISCUM Abietis 0.2 mg 4241.02.00 15.01.1985

abnobaVISCUM Abietis 0.02 mg 4241.03.00 15.01.1985

abnobaVISCUM Abietis D 6 24369.00.00 31.01.1992

abnobaVISCUM Abietis D 10 24369.01.00 31.01.1992

abnobaVISCUM Abietis D 20 24369.02.00 31.01.1992

abnobaVISCUM Abietis D 30 24369.03.00 31.01.1992

abnobaVISCUM Aceris 20 mg 11435.00.00 30.01.1992

abnobaVISCUM Aceris 2 mg 11435.01.00 30.01.1992

abnobaVISCUM Aceris 0.2 mg 11435.02.00 30.01.1992

abnobaVISCUM Aceris 0.02 mg 11435.03.00 30.01.1992

abnobaVISCUM Aceris D 6 11435.00.01 04.02.1992

abnobaVISCUM Aceris D 10 11435.01.01 04.02.1992

abnobaVISCUM Aceris D 20 11435.02.01 04.02.1992

abnobaVISCUM Aceris D 30 11435.03.01 04.02.1992

abnobaVISCUM Amygdali 20 mg 11439.00.00 29.01.1992

abnobaVISCUM Amygdali 2 mg 11439.01.00 29.01.1992

abnobaVISCUM Amygdali 0.2 mg 11439.02.00 29.01.1992

abnobaVISCUM Amygdali 0.02 mg 11439.03.00 29.01.1992

abnobaVISCUM Amygdali D 6 11439.00.01 05.02.1992

abnobaVISCUM Amygdali D 10 11439.01.01 05.02.1992

abnobaVISCUM Amygdali D 20 11439.02.01 05.02.1992

abnobaVISCUM Amygdali D 30 11439.03.01 05.02.1992

abnobaVISCUM Betulae 20 mg 11443.00.00 30.01.1992

abnobaVISCUM Betulae 2 mg 11443.01.00 30.01.1992

abnobaVISCUM Betulae 0.2 mg 11443.02.00 30.01.1992

abnobaVISCUM Betulae 0.02 mg 11443.03.00 30.01.1992

abnobaVISCUM Betulae D 6 11443.00.01 31.01.1992

abnobaVISCUM Betulae D 10 11443.01.01 31.01.1992

abnobaVISCUM Betulae D 20 11443.02.01 31.01.1992

abnobaVISCUM Betulae D 30 11443.03.01 31.01.1992

abnobaVISCUM Crataegi 20 mg 11447.00.00 29.01.1992

abnobaVISCUM Crataegi 2 mg 11447.01.00 29.01.1992

abnobaVISCUM Crataegi 0.2 mg 11447.02.00 29.01.1992

abnobaVISCUM Crataegi 0.02 mg 11447.03.00 29.01.1992

abnobaVISCUM Crataegi D 6 11447.00.01 31.01.1992

abnobaVISCUM Crataegi D 10 11447.01.01 31.01.1992

abnobaVISCUM Crataegi D 20 11447.02.01 31.01.1992

abnobaVISCUM Crataegi D 30 11447.03.01 31.01.1992

abnobaVISCUM Fraxini 20 mg 11451.00.00 24.01.1992

abnobaVISCUM Fraxini 2 mg 11451.01.00 24.01.1992

abnobaVISCUM Fraxini 0.2 mg 11451.02.00 24.01.1992

abnobaVISCUM Fraxini 0.02 mg 11451.03.00 24.01.1992

abnobaVISCUM Fraxini D 6 11451.00.01 06.02.1992

abnobaVISCUM Fraxini D 10 11451.01.01 06.02.1992

abnobaVISCUM Fraxini D 20 11451.02.01 06.02.1992

abnobaVISCUM Fraxini D 30 11451.03.01 06.02.1992

abnobaVISCUM Mali 20 mg 11455.00.00 30.01.1992

abnobaVISCUM Mali 2 mg 11455.01.00 30.01.1992

abnobaVISCUM Mali 0.2 mg 11455.02.00 30.01.1992

abnobaVISCUM Mali 0.02 mg 11455.03.00 30.01.1992

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim

Page 12 of 12

Name of the product

Product marketing

authorization number

Date of first

marketing

authorization

abnobaVISCUM Mali D 6 11455.00.01 31.01.1992

abnobaVISCUM Mali D 10 11455.01.01 31.01.1992

abnobaVISCUM Mali D 20 11455.02.01 31.01.1992

abnobaVISCUM Mali D 30 11455.03.01 31.01.1992

abnobaVISCUM Pini 20 mg 11459.00.00 29.01.1992

abnobaVISCUM Pini 2 mg 11459.01.00 29.01.1992

abnobaVISCUM Pini 0.2 mg 11459.02.00 29.01.1992

abnobaVISCUM Pini 0.02 mg 11459.03.00 29.01.1992

abnobaVISCUM Pini D 6 11459.00.01 31.01.1992

abnobaVISCUM Pini D 10 11459.01.01 31.01.1992

abnobaVISCUM Pini D 20 11459.02.01 31.01.1992

abnobaVISCUM Pini D 30 11459.03.01 31.01.1992

abnobaVISCUM Quercus 20 mg 11463.00.00 29.01.1992

abnobaVISCUM Quercus 2 mg 11463.01.00 29.01.1992

abnobaVISCUM Quercus 0.2 mg 11463.02.00 29.01.1992

abnobaVISCUM Quercus 0.02 mg 11463.03.00 29.01.1992

abnobaVISCUM Quercus D 6 11463.00.01 31.01.1992

abnobaVISCUM Quercus D 10 11463.01.01 31.01.1992

abnobaVISCUM Quercus D 20 11463.02.01 31.01.1992

abnobaVISCUM Quercus D 30 11463.03.01 31.01.1992

10 Date of revision of the text

July 2015

11 General classification for supply

Pharmacy-only medicine

ABNOBA GmbH · Hohenzollernstraße 16 · D-75177 Pforzheim