HELIXOR P series pack IV ampoules, 7 pcs

Instructions for use for Helixor P series pack IV

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 to prevent relapses after tumor operations.

What do you need to consider before using Helixor®?

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

Particular caution is required if you are hypersensitive to other substances.In this case, particularly careful dosage must be ensured, with careful follow-up by the doctor.In the case of primary brain and spinal cord tumors or intracranial metastases with a risk of increased intracranial pressure, the preparations should only be administered according to strict indications and under close clinical control.

If Helixor® is used with other medicines, especially 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.

Helixor® is injected subcutaneously, if possible near the tumor or metastasis, otherwise at different locations in the intact skin.Do not inject into inflamed skin areas or radiation areas.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 a subcutaneous injection 2 - 3 times weekly.Therapy begins with an induction phase, during which the 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.

The optimal dose must be determined individually.The following reactions should be taken into account: change in subjective condition, temperature reaction, immunological reaction and 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.

In the maintenance phase, treatment continues with the optimal individual dose determined in this way. To avoid habituation effects, rhythmic use, alternation with lower doses, rhythmization of the injection intervals and the introduction of breaks are recommended.

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 should you do if you overdose or forget to use it?

Overdose may result in excessive inflammatory reactions measuring more than 5 cm in diameter at the injection sites.In this case, moist, cool compresses or anti-inflammatory ointment dressings can help.The next injection may only be administered in a significantly reduced dose after the inflammatory reaction has subsided.If shortness of breath, itching and/or rash over the entire body, feeling of heat, drop in blood pressure, rapid heart rate, nausea/vomiting occur, immediate emergency medical treatment is required.

If you forget to use Helixor®, use the same dose as soon as possible.

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.

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.

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 and box.Store the ampoules in the original packaging to protect the contents from light.Helixor® 0.01 mg - 0.1 mg: Store in the refrigerator.Helixor® 1 mg - 100 mg: Do not store above 30 °C.

Contents of the pack and further information

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

What 2 ml injection solution (1 ampoule) Helixor® A/M/P 100 mg contains: Active ingredient: Extract from fresh pine mistletoe/apple tree mistletoe/pine mistletoe (plant to extract = 1:20) 2,012 mg.Extracting agent: water for injections, 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.The other ingredients are table salt, sodium hydroxide and, for Helixor® 0.01 mg to 30 mg, additional water for injection purposes.

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.

Multipacks (BP) containing 28 (4x7) ampoules are also available from the II and IV series.

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

If you would like further information about the medicine, please contact the medical advice of the pharmaceutical company.

This leaflet was last revised in July 2018.

Notes

For information about risks and side effects, read the package leaflet and ask your doctor or pharmacist.

Manufacturer: HELIXOR heil GmbH, Fischermühle 1, 72348 Rosenfeld