البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
topotecan
Actavis Group PTC ehf
L01CE01
topotecan
Antineoplastic agents
Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate. 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.,
Revision: 6
Withdrawn
2009-07-24
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE USER TOPOTECAN ACTAVIS 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION TOPOTECAN ACTAVIS 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 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 Actavis is and what it is used for 2. What you need to know before you use Topotecan Actavis 3. How to use Topotecan Actavis 4. Possible side effects 5. How to store Topotecan Actavis 6. Contents of the pack and other information 1. WHAT TOPOTECAN ACTAVIS IS AND WHAT IT IS USED FOR Topotecan Actavis contains the active substance topotecan which helps to kill tumour cells. Topotecan Actavis is used to treat: - small cell lung cancer that has come back after chemotherapy, or - advanced cervical cancer if surgery or radiotherapy is not possible. In this case Topotecan Actavis treatment is combined with medicines containing cisplatin. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TOPOTECAN ACTAVIS DO NOT USE TOPOTECAN ACTAVIS - if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding. You should stop breast-feeding before starting treatment with Topotecan Actavis; - if your blood cell counts are too low. TELL YOU DOCTOR if you think any of these could apply to you. WARNINGS AND PRECAUTIONS Talk to your doctor before using Topotecan Actavis: - if you have any kidney problems. Your dose of Topotecan Actavis may need to be adjusted. Topotecan Actavis is not recommended in case of severe kidney impairment; - if you have liver problems. Topotecan Actavis is not recommended in case of severe liver impairment; - if you su اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 1 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg topotecan (as hydrochloride). After reconstitution, 1 ml concentrate contains 1 mg topotecan. Excipient with known effect: Each vial contains 0.52 mg (0.0225 mmol) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Yellow lyophilisate. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topotecan monotherapy is indicated for the treatment of 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 and should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6). Posology When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted. Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 10 9 /l, a platelet count of ≥ 100 x 10 9 /l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary). _Small Cell Lung Carcinoma _ _Initial dose _ The recommended dose of topotecan is 1.5 mg/m 2 body surface area/day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three week interval between the start 3 of each course. If well tolerated, treatment may continue un اقرأ الوثيقة كاملة