البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
TOPOTECAN
Fresenius Kabi Oncology PLC Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom
L01XX17
TOPOTECAN 1 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
TOPOTECAN 1 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2013-09-26
Page 1 of 8 Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER TOPOTECAN 1 MG/ ML CONCENTRATE FOR SOLUTION FOR INFUSION topotecan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or nurse. If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT TOPOTECAN IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TOPOTECAN 3. HOW TO USE TOPOTECAN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TOPOTECAN 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TOPOTECAN IS AND WHAT IT IS USED FOR Topotecan helps to destroy tumours. A doctor or a nurse will give you the medicine as an infusion into a vein (a drip) in hospital. TOPOTECAN IS USED TO TREAT: - OVARIAN CANCER OR SMALL CELL LUNG CANCER that has come back after chemotherapy - ADVANCED CERVICAL CANCER if surgery or radiotherapy treatment is not possible. When treating cervical cancer, Topotecan is combined with another drug called _cisplatin_. Your doctor will decide with you whether topotecan therapy is better than further treatment with your initial chemotherapy. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TOPOTECAN DO NOT USE TOPOTECAN: IF YOU ARE ALLERGIC (_hypersensitive_) to topotecan or any of the other ingredients of this medicine ( listed in section 6); IF YOU ARE BREAST FEEDING. IF YOUR BLOOD CELLS COUNT IS TOO LOW. Your doctor will tell you, based on the results of your last blood test. →TELL YOUR DOCTOR if you think any of these could apply to you. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse اقرأ الوثيقة كاملة
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topotecan 1 mg/ ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 1 mg topotecan (as hydrochloride). One vial of 1 ml of concentrate contains 1 mg topotecan (as hydrochloride). One vial of 4 ml of concentrate contains 4 mg topotecan (as hydrochloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear yellow to yellow green colour solution, free from visible particles. pH = 2.0-2.6. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topotecan monotherapy is indicated for the treatment of: • patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy. • patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6). Page 2 of 16 Topotecan must be further diluted before use (see section 6.6). The diluted solution should be clear, colourless to light yellow colour, free from visible particles. Posology When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted. Prior to admini اقرأ الوثيقة كاملة