Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
topotecan
Teva B.V.
L01CE01
topotecan
Antineoplastic agents
Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
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. , 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: 8
Withdrawn
2009-09-21
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE USER TOPOTECAN TEVA 1 MG/1 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 Teva is and what it is used for 2. What you need to know before you use Toptecan Teva 3. How to use Topotecan Teva 4. Possible side effects 5. How to store Topotecan Teva 6. Contents of the pack and other information 1. WHAT TOPOTECAN TEVA IS AND WHAT IT IS USED FOR Topotecan Teva helps to kill tumour cells. Topotecan Teva 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 Teva is combined with another medicine called cisplatin. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TOPOTECAN TEVA DO NOT USE TOPOTECAN TEVA: - 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 cells count is 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 you think any of these could apply to you. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Topotecan Teva: - if you have any kidney problems. Your dose of Topotecan Teva may need to be adjusted. The use of Topotecan Teva is not recommended in patients with severe renal impairment; - if you have liver problems. Your dose of Topotecan Teva may need to be adjusted. The use of Topotecan Teva is not recommended in patients with severe liver impairment; - if you currently have lung p Pročitajte cijeli dokument
1 _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Topotecan Teva 1 mg/1 ml concentrate for solution for infusion Topotecan Teva 4 mg/4 ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Topotecan Teva 1 mg/1 ml concentrate for solution for infusion 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride). Topotecan Teva 4 mg/4 ml concentrate for solution for infusion 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride). One vial of 4 ml of concentrate for solution for infusion contains 4 mg topotecan (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear pale yellow liquid. 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 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 topotecan is 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 cou Pročitajte cijeli dokument