Страна: Европейски съюз
Език: английски
Източник: 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 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).
Revision: 11
Authorised
2011-01-06
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE USER POTACTASOL 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION POTACTASOL 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 Potactasol is and what it is used for 2. What you need to know before you use Potactasol 3. How to use Potactasol 4. Possible side effects 5. How to store Potactasol 6. Contents of the pack and other information 1. WHAT POTACTASOL IS AND WHAT IT IS USED FOR Potactasol contains the active substance topotecan which helps to kill tumour cells. Potactasol is used to treat: - ovarian cancer or small cell lung cancer that has come back after chemotherapy - advanced cervical cancer if surgery or radiotherapy is not possible. In this case Potactasol treatment is combined with medicines containing cisplatin. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE POTACTASOL DO NOT USE POTACTASOL - 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 YOU DOCTOR if you think any of these could apply to you. WARNINGS AND PRECAUTIONS Talk to your doctor before using Potactasol: - if you have any kidney problems. Your dose of Potactasol may need to be adjusted. Potactasol is not recommended in case of severe kidney impairment; - if you have liver problems. Potactasol is not recommended in case of severe liver impairment; - if you suffer from lung inflammation with signs such as cough, fever and difficulties in Прочетете целия документ
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Potactasol 1 mg powder for concentrate for solution for infusion 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. Potactasol 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride). After reconstitution, 1 ml concentrate contains 1 mg topotecan. Excipient with known effect Each vial contains 2.07 mg (0.09 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 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 firs Прочетете целия документ