Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
topotecan
Sandoz Pharmaceuticals d.d.
L01CE01
topotecan
Antineoplastic agents
Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.
Revision: 39
Authorised
1996-11-12
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER HYCAMTIN 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION HYCAMTIN 4 MG POWDER FOR 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. • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Hycamtin is and what it is used for 2. What you need to know before you are given Hycamtin 3. How Hycamtin is used 4. Possible side effects 5. How to store Hycamtin 6. Contents of the pack and other information 1. WHAT HYCAMTIN IS AND WHAT IT IS USED FOR Hycamtin helps to destroy tumours. A doctor or a nurse will give you the medicine as an infusion into a vein in hospital. HYCAMTIN 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, Hycamtin is combined with another medicine called cisplatin. Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HYCAMTIN YOU SHOULD NOT RECEIVE HYCAMTIN • if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6). • if you are breast-feeding. • if your blood cell counts are too low. Your doctor will tell you whether this is the case, based on the results of your last blood test. TELL YOUR DOCTOR if any of these applies to you. WARNINGS AND PRECAUTIONS Before you are given this medicine your doctor needs to know: • if you have any kidney or liver problems. Your dose of Hycamtin may need to be adjusted. • if you are pregnant or plan to become pregnant. See sect Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT HYCAMTIN 1 mg powder for concentrate for solution for infusion HYCAMTIN 4 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION HYCAMTIN 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride). The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended. HYCAMTIN 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride). The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Light yellow to greenish powder. 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 The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy. Topotecan should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6). Posology When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted. 3 Prior to administration of the first course of topotecan, Lesen Sie das vollständige Dokument