Active substance:

Fermented aqueous extract of Oak tree

Mistletoe

 

Iscador Qu 20 mg

Iscador Qu 10 mg

Iscador Qu 1 mg

Iscador Qu 0.1 mg

Iscador Qu 0.01 mg

  

1. What Iscador Qu is and what it is used for?

2. What you need to know before you use Iscador Qu

3. How to use Iscador Qu

4. Possible side effects

5. How to store Iscador Qu

6. Contents of the pack and other information

 

 1. What Iscador QU is and what it is used for?  (Top(

Iscador Qu (host tree: Oak) has been used in complementary and alternative medicine (CAM) for improving the quality of life and overall survival in patients with solid tumor.

Indications

• in malignant tumorous diseases, such as oesophagus, stomach, liver, pancreas, gall bladder, kidney, bladder, prostate, testes, larynx, bronchia and thyroid

• in benign tumorous diseases of oesophagus, stomach, liver, pancreas, gall bladder, kidney, bladder, prostate, testes, larynx, bronchia and thyroid

• as tumour recurrence prophylaxis following tumour surgery;

  

2. What you need to know before you use Iscador QU  (Top(

 Do not use Iscador Qu:

• if you are allergic to mistletoe preparations or any of the other ingredients of this Medicine.

• if you have disorders accompanied by acute inflammation or high fever (body temperature

• exceeding 38 °C (100.4 °F)): treatment should be discontinued until the signs of inflammation have abated.

• if you have chronic granulomatous diseases and autoimmune diseases with very distinct symptoms or if you are treated with an agent suppressing your immune response (immunosuppressive therapy).

• if you have an over active thyroid gland (hyperthyroidism) with increased heart beat

(tachycardia).

 

 Warnings and precautions:

• Talk to your doctor or pharmacist before using Iscador.M

• In primary cerebral and spinal cord tumours or intracranial metastases with risk of increased intracranial pressure, Iscador should only be administered if explicitly prescribed by a doctor.

• The ampoule should be warmed briefly in the hand before injecting.

 

Other medicines and Iscador Qu:

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

No studies are available on interactions with other immunomodulatory substances (e.g. thymus extracts). If such preparations are used within the same timeframe, careful dosage and monitoring of relevant immune parameters are recommended.

Interactions with other medicinal products have not been investigated, but are also not known.

 

Pregnancy and breast-feeding:

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Effects of Iscador Qu on pregnancy, birth and the development of the child after birth, above all on the formation of blood cellular components and the immune system of the foetus/infant, have not been investigated. Thus, the potential risk for humans is not

            known. Caution is urged when used during pregnancy and the breast-feeding period.

 

3. How to use Iscador QU  (Top(

Method of administration:

If possible, subcutaneous injection should be in proximity to the tumour or metastasis, otherwise at changing sites on the body (e.g. abdominal skin, upper arm or thigh).

• Do not inject into inflamed skin regions or irradiated fields. The injection technique used must be strictly subcutaneous.

• It is recommended as a precaution not to combine Iscador with other medicinal products in a syringe.

• It is recommended to learn the injection technique from a person experienced in this.

• Iscador Qu ampoules should be used immediately after opening. Opened ampoules must not be kept for later use, as the sterility of the solution for injection is no longer guaranteed.

 

Dosage:

Dosing is always on an individual basis. Unless prescribed otherwise by the doctor, the usual dosage is as follows:

 

Initial phase:

In order to avoid excessive responses, it is recommended to start the treatment with Iscador Qu gradually escalating the dose using Iscador Qu Series 0.

2–3 times a week 1 ml is injected subcutaneously in increasing strengths according to the composition of the Series.

If Series 0 is tolerated well it is permissible to proceed to Iscador Qu Series I or possibly

Series II until the individual reaction dose of the patient is reached. The optimum strength or dose must be determined individually. According to the current state of knowledge, this determination must be based on the following reactions, which may occur in isolated form or in combinations:

a) Change in subjective condition: exhaustion, chills, general malaise, headaches and brief episodes of dizziness witch lasts for more than 2 days.

b) Temperature reaction: rising in body temperature for more than 38º C after injection.  

c) Immunological reaction: e.g. increase of white blood cells (leucocytes).

d) Local inflammatory reaction: Local injection site reaction up to max. 5 cm in diameter.

 

Maintenance phase:

Treatment is continued with the optimum individual strength/ represents the highest strength, or the corresponding sort pack is used (pack with ampoules of one strength). Rhythmic administration is recommended to avoid habituation effects:

• Alternation with lower strengths/doses in the form of increasing or possibly decreasing dosage Series

• Rhythmization of the injection intervals, e.g. injection on days 1, 2 and 5 of each week

• Insertion of pauses, e.g. pausing for 1–2 weeks after 4 weeks of therapy;

If the therapy pause lasts 4 weeks or longer, a more pronounced initial reaction may be caused by resumption of therapy. It is therefore recommended to start again with the next lower strength/Series, e.g.: therapy before pause with Iscador Series II, resume after pause with 1 pack of Iscador Qu Series I, followed by continuation of therapy with Series II.

At intervals of 3 – 6 months the dosage level should be reviewed based on patient reaction and tumour behaviour.

 

Dosage in cases of impaired renal function:

The available data are insufficient to provide concrete dosage recommendation for cases of impaired renal function. General experience with the product has to date not revealed a need for dosage adjustment.

 

Duration of administration:

The treating doctor will determine the duration of administration. Duration of administration is not limited in principle. The physician will make a decision in this regard based on the risk of recidivation in each case and on individual condition/ findings.

 

If you use more Iscador than you should

If you administered more Iscador than you should have, please contact your doctor

or pharmacist.

 

If you forget to use Iscador

Do not use a double dose to make up for a forgotten injection but continue treatment

with the normal dose foreseen for the next point in time.

 

4. Possible side effects  (Top(

Like all medicines, this medicine can cause side effects, although not everybody gets them:

• A slight increase in body temperature and local reaction at the subcutaneous injection site are almost regular occurrences at onset of therapy and constitute signs of the patient’s reaction status. Temporary slight swelling of regional lymph nodes is also harmless.

• In case of fever higher than 38 °C (100.4 °F) (possibly accompanied by exhaustion, chills, general malaise, headaches and brief episodes of dizziness) or larger local reactions exceeding 5 cm in diameter, the next injection should not be administered

• Localized or systemic allergic or allergy-like (allergoid) reactions may occur (usually in the form of generalized itching, nettle rash or skin rashes, occasionally also with allergic swelling in mouth and throat [Quincke‘s oedema], chills, shortage of breath and cramped respiratory tracts, in isolated cases with shock or as acute inflammatory reaction of the skin or mucosae [erythema exsudativum multiforme]) which would necessitate discontinuation of the preparation and immediate initiation of medical treatment.

• Activation of pre-existing inflammation and inflammatory irritations of surface veins in the injection area are possible. Here as well, a temporary therapy pause is required, until the inflammatory reaction has abated.

• Occurrence of chronic granulomatous inflammations (sarcoidosis, erythema nodosum) and autoimmune diseases (dermatomyositis) has been reported during mistletoe therapy.

• Symptoms of increased intracranial pressure in cases of cerebral tumors/metastases have also been reported during mistletoe therapy.

 

5. How to store Iscador  (Top(

• Store in a refrigerator (2 °C – 8 °C (36 – 46 °F)).

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the ampoule after «EXP».The expiry date refers to the last day of that month.

 

6. Contents of the pack and other information  (Top(

What Iscador looks like:

Iscador is a clear and, according to strength, colourless to yellow coloured solution for injection.

contents of the pack:

Iscador Qu Series packs each containing 7 ampoules with 1 ml solution for injection of different strengths consist of:

Iscador Qu

Serie 2

Number of ampoules

strength

2

1 mg

2

10 mg

3

20 mg

Iscador Qu

Serie 1

Number of ampoules

strength

2

0.1 mg

2

1 mg

3

10 mg

Iscador Qu

Serie 0

Number of ampoules

strength

2

0.01 mg

2

0.1 mg

3

mg 1

 

The Series packs contain in each case solutions for injections of different strengths.

For an application of increasing strength the ampoules must be used from left to right.