מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
topotecan
Pfizer Europe MA EEIG
L01CE01
topotecan
Other 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: 19
Authorised
2010-06-09
23 B. PACKAGE LEAFLET 24 Package leaflet: Information for the user Topotecan Hospira 4 mg/4 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. - 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 Topotecan Hospira is and what it is used for 2. What you need to know before you are given Topotecan Hospira 3. How Topotecan Hospira is used 4. Possible side effects 5. How to store Topotecan Hospira 6. Contents of the pack and other information 1. What Topotecan Hospira is and what it is used for Topotecan Hospira helps to destroy tumours. A doctor or a nurse will give you the medicine as an infusion into a vein in hospital. Topotecan Hospira 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 Hospira is combined with another medicine called cisplatin. Your doctor will decide with you whether Topotecan Hospira therapy is better than further treatment with your initial chemotherapy. 2. What you need to know before you are given Topotecan Hospira You should not receive Topotecan Hospira: 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 Topotecan Hospira may need to be adjusted. if you are pre קרא את המסמך השלם
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride). Each 4 ml vial 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 (sterile concentrate). A clear yellow to yellow-green solution. 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. 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). Ovarian and small cell lung carcinoma Initial dose The recommended dose of topotecan is 1.5 mg/m 2 body surface area per day administered by intravenous infusion over 30 minutes daily for f קרא את המסמך השלם