Country: Ísrael
Tungumál: enska
Heimild: Ministry of Health
MELPHALAN
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
L01AA03
TABLETS
MELPHALAN 2 MG
PER OS
Required
EXCELLA GMBH & CO.KG., GERMANY
MELPHALAN
MELPHALAN
For the treatment of : Multiple myeloma and Advanced ovarian adenocarcinoma
2019-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only ALKERAN TABLETS 2 MG ACTIVE INGREDIENT AND ITS QUANTITY: EACH TABLET CONTAINS: MELPHALAN 2 MG Inactive ingredients and allergens in the preparation - see section 6 “Further Information” in the leaflet. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Alkeran Tablets 2 mg is intended for the treatment of multiple myeloma and ovarian adenocarcinoma (advanced stage). THERAPEUTIC GROUP: The medicine belongs to the group of cytotoxic medicines (also called chemotherapy), antineoplastic and immunomodulatory factors, alkylating agents and nitrogen mustard analogs. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient melphalan or to any of the other ingredients of this medicine (see section 6 “Further Information”). • You are breastfeeding. If you are not sure, refer to the doctor or pharmacist before taking the medicine. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH ALKERAN, TELL THE DOCTOR IF: • You are undergoing, or have recently undergone, chemotherapy or radiotherapy. • You have a kidney problem. • You are going to have a vaccination or were recently vaccinated. This is because some vaccines (like polio, measles, mumps and rubella) may give you an infection if you have them whilst you are using Alkeran Tablets 2 mg. • You are using combined oral contraception (the Pill). This is because of the increased risk of venous thromboembolism (a blood clot that forms in a vein and migrates to another location) in pati Lestu allt skjalið
_1_ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alkeran Tablets 2 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg melphalan. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off-white, round, biconvex film-coated tablets, one side engraved with an "A" and the other side engraved "GX EH3". 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of multiple myeloma and advanced ovarian adenocarcinoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Since Alkeran is myelosuppressive, frequent blood counts are essential during therapy and the dosage should be delayed or adjusted if necessary (see section 4.4). Posology _Multiple_ _ _ _myeloma _ A typical oral dosage schedule is 0.15 mg/kg bodyweight/day in divided doses for 4 days repeated at intervals of six weeks. Numerous regimens have, however, been used and the scientific literature should be consulted for details. The administration of oral Alkeran and prednisone may be more effective than Alkeran alone. The combination is usually given on an intermittent basis. Prolonging treatment beyond one year in responders d oes not appear to improve results. _Advanced_ _ _ _ovarian_ _ _ _adenocarcinoma _ A typical regimen is 0.2 mg/kg bodyweight/day given orally in divided doses for 5 days. This is repeated every 4 to 8 weeks, or as soon as the bone marrow has recovered. _Paediatric population _ Alkeran is only rarely indicated in the paediatric population and absolute dosage guidelines cannot be provided. _Older people _ Although Alkeran is frequently used at conventional dosage in the older people, there is no specific information available relating to its administration to this patient sub - group. However, caution should be taken where there is renal impairment. _Renal im_ _pairment_ _ _ Alkeran clearance, though variable, may be decreased in renal impairment (see section 4.4). _2_ Currently available pharmacokinetic data do not justify an absolute recommendation on Lestu allt skjalið