Lectinol Madaus Injection Solution Ampoules D, 25x0.5 ml

Instructions for use for Lectinol Madaus Injection Solution Ampoules D, 25x0.5 ml

Important notes (compulsory information):

Lectinol Madaus injection solution. Active ingredient: mistletoe extract. Areas of application: To support general measures to improve the quality of life for breast cancer during chemotherapy and in the aftertreatment phase.

Leaflet: Information for the User

Lectinol®
Injection solution
Active substance: mistletoe extract

Read the entire leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, in order to achieve the best possible treatment success, Lektinol® must be used properly.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If your complaints worse or no improvement occurs, you must definitely visit a doctor.
• If one of the listed side effects you significantly affect it or notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

This leaflet contains:

1. What is lectinol and what is it used for?
2. What do you need to consider before using lectinol?
3. How is lectinol to apply?
4. What side effects are possible?
5. How to keep lectinol?
6. Additional Information

1. What is lectinol and what is it used for?
Lectinol® is a vegetable medicine with cytostatic properties.
Field of use:
Lectinol® is used to support general measures to improve the quality of life for breast cancer during chemotherapy and aftertreatment phase. A life-prolonged or disintegrating effect could not be detected.

2. What do you need to consider before using lectinol?
Lectinol must not be used

• for hypersensitivity (allergy) against mistletoe preparations or any of the other ingredients of lectinol,
• with protein hypersensitivity,
• for chronic progression infections (eg TBC).
• for cold agglutinine syndrome,
• for tumor diseases of the blood-forming organs as well as renal cell carcinoma and malignant melanoma.

Take special care with the use of lectinol:
Lektinol® should not in inflamed skin areas (Venese inflammation) or in irradiation fields are sprayed.

children
Since there are no sufficient investigations with Lektinol® in children and adolescents, the preparation should be in patients under 18 years are not used.

Older people
For older people there are no special restrictions regarding the application.

When using Lektinol® with other medicines:
When using Lektinol®, no interactions are known.
Please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is non-prescription medicines.

pregnancy and breast feeding period
During pregnancy and in the lactation, Lektinol® should Not used because so far no sufficient insights are available.
Ask your doctor or pharmacist for advice before taking / application of all medicines.

Driveion and use of machines:
There are no special precautions required.

3. What is lectinol to apply?
Always use Lektinol® exactly as directed in this leaflet. Please ask your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by the doctor, the usual dose is:
Before starting treatment with Lektinol®, an intracutaneous next with 0.1 ml of a 1: 100 diluted lectinol® solution done to exclude any pre-existing hypersensitivity. For this purpose, 0.1 ml of lectinol® are first diluted in 10 ml of physiological saline and then 0.1 ml of the diluted solution sprayed into the skin. Shows 30 Minutes after injection no skin rotation or redness whose diameter is below 2 cm, can be started immediately with the administration of the therapeutic dose.
For each injection, 0.5 ml (1 ampoule) should be given.
Lectinol® is administered twice a week at a distance of 3 - 4 days (eg on Monday and Thursday or Tuesday and Friday).

Type of application:
For permanent application, the subcutaneous injection is recommended under the abdominal skin, in the thighs or in the upper arm.

Duration of application:
The duration of treatment should be at least three months and can be continued as needed for years. The following therapy scheme has proven: Treatment cycles of 3 months each with one month pause.
A renewed advancement is not necessary upon continuation of therapy.

If you have further questions about the application of the medicine, ask your doctor or pharmacist.

4. Which side effects are possible?
Like all medicines, lectinol can have side effects that do not have to occur each other.

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated by 1,000
Rarely:	1 to 10 treated by 10,000
Very rare:	less than 1 treated from 10,000
Not known:	Frequency on the basis of the available data does not estimate.

In subcutaneous injection, a temporary redness and swelling can often occur at the injection site.
Very rarely, chills, high fever, headache, pecular weight complaints, orthostatic circulatory disorders and allergic reactions may occur.

Special instructions:
In need of treatment, symptomatic therapy must be carried out. Please contact your attending physician.

Message of side effects
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet.
You can also share effects directly
Federal Institute for Pharmaceuticals and Medical Products,
Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3,
D-53175 Bonn, website: www.bfarm.de.

By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep lectinol?
Store drug out of reach of children.
You must not use the medicinal product after the expiry date specified on the container / carton to "usable until.

Storage conditions :
Store cooling and transporting (2 ° C -8 ° C).

6. Further information
What Lectinol® contains:
The active ingredient is:
1 ampoule with 0.5 ml injection solution contains:
Aqueous abstract 1: 1,1-1.5 made of uninterrupted mistletes with leaves 0.02 - 0.07 mg normalized to 15 ng active military agent, determined as ailingectin I

The other ingredients are:
Sodium chloride, sodium monohydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, sodium edetate, povidone (K < 18), water for injection purposes.

Like lectinol® looks like and content of the pack:
The injection solution of Lektinol® is a clear, colorless liquid in clear glass ampoules.

Original packs with 5 ampoules to 0.5 ml N1
Original packs with 25 ampoules to 0.5 ml N3

Pharmaceutic entrepreneur
Meda Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Tel.: (06172) 888-01
Fax: (06172) 888-2740
E-Mail: [email protected]

Manufacturer
Madaus GmbH, 51101 Cologne

This information information was last revised in April 2015.

Supplementary information about Lektinol®
Lectinol® is a herbal medicine from the mistletoe for use in cancer. In a complex process, the ingredients from the plant are obtained for lectinol® and processed into a medicament.

Essential ingredients of the mistletoe are the military artists. You activate a number of operations in the body that can be used for cancer patients.

For this reason, in the production of lectinol®, special attention is paid to a gentle preparation of the stagnectins. The delivery via cold chain and storage in refrigerator temperatures (2 - 8 ° C) contribute to a high quality of the medicine.

We wish you a good treatment success!
Your Meda Pharma GmbH & Co. KG

Source: Information of the leaflet
Status: 12/2018