HELIXOR M ampoules 20 mg, 50 pcs

Instructions for use of Helixor M 20 mg

Dear patient, dear patient!

Please read the entire leaflet carefully as it contains important information for you.No prescription is required for this product.However, in order to achieve the best possible treatment success, Helixor® must be used correctly as directed by the doctor.

Keep the package leaflet.You may want to read these again later.Ask your doctor or pharmacist if you need further information or advice.If your symptoms worsen or do not improve, you should definitely see a doctor.If any of the side effects listed get serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is Helixor® and what is it used for?

Helixor® is an anthroposophic medicine for the extended treatment of tumor diseases.In accordance with the anthroposophical knowledge of humanity and nature, Helixor® is used in adults to stimulate form and integration forces to dissolve and reintegrate growth processes that have become independent.This includes malignant tumor diseases, including those with accompanying disorders of the blood-forming organs, benign tumor diseases, defined precancerous lesions and the prevention of relapses after tumor operations.

What do you need to consider before using Helixor®?

Helixor® must not be used if you are hypersensitive (allergic) to mistletoe preparations, suffer from an acute inflammatory or high fever illness, suffer from chronic granulomatous diseases or autoimmune diseases with severe symptoms, are under immunosuppressive treatment that suppresses immune function or suffer from an overactive thyroid (hyperthyroidism) with a racing heart (tachycardia).

Particular caution is required when using Helixor® in the event of hypersensitivity (allergy) to other substances, primary brain and spinal cord tumors or intracranial metastases with a risk of increased intracranial pressure.In these cases, the preparations should only be administered according to strict indications and under close clinical control.It is advisable to briefly warm the ampoule in your hand before injecting.

If Helixor® is used with other medicines, especially other immune-active medicines, it should only be used after consulting a doctor.Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.

Effects of Helixor® on pregnancy, the development of the unborn child, birth and on the development of the child after birth, in particular on the development of blood formation and the immune system in the unborn child/infant, have not been studied.The possible risk to humans is therefore unknown.Caution is advised when used during pregnancy and breastfeeding.

How to use Helixor® A/M/P?

Always use Helixor® exactly as your doctor has told you.Please ask your doctor or pharmacist if you are not sure.

Type of application: Subcutaneous injection (syringe under the skin) if possible in the vicinity of the tumor or metastasis, otherwise in varying areas of the intact skin (e.g. abdominal skin, upper arm, front or outside of the thighs).Do not inject into inflamed skin areas and avoid radiation fields.Strict subcutaneous injection technique must be observed.As a precaution, it is recommended not to draw up Helixor® in a syringe with other medicines.Opened ampoules must not be saved for later injection.

Unless otherwise prescribed, the usual dose is: one subcutaneous injection 2 - 3 times weekly.Therapy usually begins with an induction phase, during which the strength/dose is gradually increased from 1 mg to the maintenance therapy range.The dose increase will be stopped if an inflammatory reaction at the injection site, fever or flu-like symptoms occur following the use of Helixor®.

The optimal dose must be determined individually.According to current knowledge, the following reactions must be taken into account, which can occur individually or in combination: change in subjective condition, temperature reaction, immunological reaction, local inflammatory reaction at the injection site.

During radiation or chemotherapy, a reduction in the dose may be necessary due to the changed reaction situation.

Maintenance phase: The treatment is continued with the optimal individual dose determined in this way.To avoid habituation effects, rhythmic use is recommended: alternation with lower doses, rhythmization of the injection intervals, insertion of breaks.

After longer breaks in treatment of more than 4 weeks, the dose should initially be reduced to half as a precaution.Dosage and injection intervals are based on the following schemes, which should be varied individually depending on the patient's reaction.

How long is Helixor® used?

The treating doctor decides on the duration of use.The duration of use is in principle not limited.It is determined by the doctor and depends on the respective risk of relapse and the individual condition or findings of the patient.It should last for several years, with breaks of increasing length as a rule.

What side effects are possible?

A slight increase in body temperature, localized inflammatory reactions around the puncture site of the subcutaneous injection and temporary slight swelling of regional lymph nodes are harmless.If there is a fever over 38°C or larger local reactions over 5 cm in diameter, the next injection should only be given after these symptoms have subsided and at a reduced strength or dose.The fever caused by Helixor® injection should not be suppressed by fever-reducing medicines.If you have a fever above 38°C that lasts longer than three days, please see your doctor.

Local or general allergic or allergy-like reactions may occur, requiring discontinuation of the preparation and immediate medical attention.Activation of pre-existing inflammation and inflammatory irritation of superficial veins in the injection area are possible.Here too, a temporary break in therapy is required until the inflammatory reaction subsides.

The occurrence of chronic granulomatous inflammation and autoimmune diseases during mistletoe therapy has been reported.Symptoms of increased intracranial pressure in brain tumors/metastases during mistletoe therapy have also been reported.An immune function-reducing (immunosuppressive) effect of higher doses cannot be ruled out.There are no systematic studies on this.

Reporting side effects: If you notice any side effects, contact your doctor or pharmacist.This also applies to side effects that are not listed in this leaflet.

How should Helixor® be stored?

Keep medicines out of the reach of children.You must not use the medicine after the expiry date stated on each ampoule (after: EXP) and box (after: use by).The expiry date refers to the last day of the month.Store the ampoules in the original packaging to protect the contents from light.Store in the refrigerator.

Contents of the pack and further information

What 1 ml injection solution (1 ampoule) Helixor® contains: Active ingredient: Extract from fresh pine mistletoe/apple tree mistletoe/pine mistletoe (plant to extract = 1:20) x mg* Extract agent: water for injection purposes, sodium chloride (99.91: 0.09).

The strength in mg indicates the amount of fresh plant material used to produce 1 ampoule of Helixor® A/M/P.Example: “Helixor® A/M/P 1 mg” contains the extract of 1 mg of fresh mistletoe in an ampoule.The other ingredients are table salt, sodium hydroxide and, for Helixor® 0.01 mg to 30 mg, additional water for injection purposes.

What Helixor® looks like and contents of the pack: Helixor® is available in the following packs: Original packs (OP) with 8 ampoules of the same concentration (0.01-100 mg).Bulk packs (GP) containing 50 ampoules of the same concentration (1-100 mg).Series packs (SE) with 7 ampoules in increasing concentrations.

Pharmaceutical entrepreneur and manufacturer: Helixorheil GmbH & Co. KG, Fischermühle 1, 72348 Rosenfeld.

Notes

For information about risks and side effects, read the package leaflet and ask your doctor or pharmacist.Helixor M ampoules 20 mg (pack size: 50 pieces) require a pharmacy and can be purchased from your mail-order pharmacy.

Manufacturer: HELIXOR heil GmbH, Fischermühle 1, 72348 Rosenfeld.