Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
TOPOTECAN HYDROCHLORIDE
Martindale Pharmaceuticals Ltd
TOPOTECAN HYDROCHLORIDE
4 Milligram
Pdr/Conc/Soln for Infus
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Topotecan Martindale Pharma 4 mg powder for concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 4 mg topotecan (as hydrochloride) 1ml of reconstituted solution contains 1mg of topotecan. For a 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 and should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6). 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 ≥ 9g/dl (after transfusion if necessary). Topotecan must be reconstituted and further dil Прочитать полный документ