Iscador M – Fermented mistletoe extract

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1 mg, 10 mg, 20 mg, 0.01 mg + 0.1 mg + 1 mg, 0.1 mg + 1 mg + 10 mg, 1 mg + 10 mg + 20 mg, solution for injection ,
fermented mistletoe extract, host tree: apple tree

1. What Iscador M is and what it is used for

Iscador M is an herbal medicine used in individualized palliative cancer care as an adjuvant to standard therapy.

2. What you need to know before using Iscador M

Do not use Iscador M

  • if you are allergic (hypersensitive) to mistletoe or any of the other ingredients of this medicine (listed in section 6).
  • in case of acute inflammation or infection with fever above 38 ° C, treatment should be discontinued until the symptoms of inflammation have subsided.
  • in granulomatous diseases or autoimmune diseases. Talk to your doctor about this.
  • if you have recently used other medicines that affect the immune system. Talk to your doctor about this.

Warnings and cautions

Talk to your doctor or pharmacist before using Iscador M.

If you have a primary brain or spinal cord tumor or in case of brain metastases that carry a risk of increased pressure in the brain, Iscador M is only used if your doctor has specifically prescribed such treatment.

As more pronounced reactions to the injections are possible during or immediately after radiation therapy or chemotherapy, special care should then be taken and the doses increased carefully and gradually.

In the case of overactive thyroid with a high heart rate, the use of Iscador M should be avoided.

Other medicines and Iscador M

The possible effects of concomitant use of other drugs have not been studied.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility

If you are or think you may be pregnant, breastfeeding, or planning to have children (in women), do not use Iscador M.

Driving and using machines

Iscador M has no or negligible effect on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Iscador M contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free.

3. How to use Iscador M

Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

Your doctor will determine the appropriate dose and medication interval for you. Treatment is usually started with low doses, which gradually increase in dosage. After the initial phase, the doctor can move on to a maintenance phase where the highest dose that was best tolerated in the initial phase is used. Do not change the set dose yourself. If you have the impression that the medicine has too strong or too weak an effect, talk to your doctor. Iscador M is intended for subcutaneous use (injected under the skin) in various places with undamaged skin (eg abdomen, front, or outside of the thigh), usually near the tumorone. Your doctor or nurse will show you how to handle the syringes and perform the injections. Follow the instructions carefully.

Do not inject into inflamed skin areas (eg inflammatory reactions from previous injections, or venous inflammation), avoid irradiated skin areas.

If inflammation occurs at the injection site ( redness, swelling, hardening of the subcutaneous tissue) with a diameter greater than 5 cm, treatment must be stopped. Likewise, if fever or flu-like symptoms (malaise, chills, headache, joint, arm, or leg pain) occur in connection with the use of Iscador M. In all these cases, consult a doctor.

No maximum treatment duration has been determined. The duration of treatment is determined by a doctor depending on your state of health. Dosage one should be checked every 3 to 6 months.

The ampoules should not be injected with a refrigerator head, but the cold ampoule should be warmed up a little briefly in the hand.

Started ampoules must not be saved for future injections.

Use for children and adolescents

Iscador M should not be used by children and adolescents under 18 years of age.

If you use more Iscador M than you should 

If you have ingested too much medicine or if e.g. a child inhaled the medicine accidentally contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Iscador M

Do not take a double dose to make up for a forgotten injection, but continue treatment with the usual dose one planned for the next injection.

If you have stopped using Iscador M

If you have stopped treatment for more than 4 weeks, you should consult a doctor before resuming treatment. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Local or systemic hypersensitivity reactions may occur (usually as generalized itching, hives, or rash, including swelling of the lips or throat, chills, shortness of breath and bronchospasm, sporadic with shock ). These reactions require discontinuation of the preparation and, if necessary, medical treatment.

Activation of pre-existing inflammation, as well as inflammatory irritations of superficial veins in the injection area, may occur. In such cases, the treatment is temporarily postponed until the inflammatory reaction has subsided.

Chronic granulomatous inflammation (sarcodiosis, erythema nodosum) and autoimmune diseases ( dermatomyositis ) have been described during mistletoe therapy.

Symptoms of increased intracerebral pressure have been reported during mistletoe treatment of brain tumors and metastases (see also section 2).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Iscador M

Store in a refrigerator (2 ° C-8 ° C).

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 and the outer carton after EXP. The expiration date is the last day of the specified month.

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. Contents of the packaging and other information

Content declaration

  • The active substance is fermented extract of Viscum album L. ssp. Album (mistletoe), host tree Malus domestica Borkh. (apple tree).
    1 ml Iscador M, 0.01 mg contains 0.05 mg of extract corresponding to 0.01 mg of fresh mistletoe.1 ml Iscador M, 0.1 mg contains 0.5 mg of extract corresponding to 0.1 mg of fresh mistletoe.1 ml Iscador M, 1 mg contains 5 mg of extract corresponding to 1 mg of fresh mistletoe.1 ml Iscador M, 10 mg contains 50 mg of extract corresponding to 10 mg of fresh mistletoe.1 ml Iscador M, 20 mg contains 100 mg of extract corresponding to 20 mg of fresh mistletoe.
  • The other ingredients areWater for injectionsSodium chloride

What the medicine looks like and contents of the pack

Iscador M 0.01 mg is a clear, colorless solution, largely free of visible particles.

Iscador M 0.1 mg is a clear, colorless solution, largely free of visible particles.

Iscador M 1 mg is a clear, colorless to the light yellow solution, largely free of visible particles.

Iscador M 10 mg is a clear, light yellow to the yellow solution, largely free of visible particles. Iscador M 20 mg is a clear, yellow solution, largely free of visible particles.

Iscador M is supplied in an ampoule of 1 ml solution for injection .

Pack sizes:

Iscador M, 1 mg: 7 ampoule s

Iscador M, 10 mg: 7 ampoules are

Iscador M, 20 mg: 7 ampoules are

Iscador M, 0.01 mg + 0.1 mg + 1 mg: 7 ampoule s

(2 ampoules are 0.01 mg, 2 ampoules are 0.1 mg, 3 ampoules are 1 mg)

Iscador M, + 0.1 mg 1 mg + 10 mg: 7 ampoule s

(2 ampoules are 0.1 mg, 2 ampoules are 1 mg, 3 ampoules are 10 mg)

Iscador M, 1 mg + 10 mg + 20 mg: 7 ampoule s

(2 ampoules are 1 mg, 2 ampoules are 10 mg, 3 ampoules are 20 mg)

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Iscador AG

Spitalstraße 22

79539 Lörrach

Germany

Tel: +49 (0) 7621 162 26 00

Fax: +49 (0) 7621 162 26 01

info@iscador.de

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