Država: Malta
Jezik: angleščina
Source: Medicines Authority
CISPLATIN
Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
L01XA01
CISPLATIN 1 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
CISPLATIN 1 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2013-06-26
PACKAGE LEAFLET: INFORMATION FOR THE USER CISPLATIN TEVA 1 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION _ _ Cisplatin READ ALL OF THIS_ _ LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cisplatin Teva is and what it is used for 2. Before you are given Cisplatin Teva 3. How you are given Cisplatin Teva 4. Possible side effects 5. How to store Cisplatin Teva 6. Contents of the pack and other information 1. WHAT CISPLATIN TEVA IS AND WHAT IT IS USED FOR Cisplatin forms part of a group of medicines called cytostatics, which are used in the treatment of cancer. Cisplatin can be used alone but more commonly Cisplatin is used in combination with other cytostatics. WHAT IS IT USED FOR? Cisplatin can destroy cells in your body that may cause certain types of cancer (tumor of testis, tumor of ovary, tumor of the bladder, head and neck epithelial tumor, lung cancer and for cervical cancer in combination with radiotherapy). Your doctor will be able to provide you with more information. _ _ 2. BEFORE YOU ARE GIVEN CISPLATIN TEVA DO NOT USE CISPLATIN IF: you are allergic to cisplatin or any of the other ingredients of this medicine (listed in section 6) you are allergic to any other medicine that contains platinum compounds you have kidney problems (renal dysfunction) you suffer from dehydration you suffer from severe suppression of bone marrow functionality, symptoms may be: extreme tiredness, easy bruising or bleeding, occurrence of infections your hearing is impaired you suffer from nervous disorders caused by cisplatin you are breastfeeding combined with yellow fever vaccine and phenytoin (see “Other medicines and Cisp Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cisplatin Teva 1 mg/ml, Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cisplatin Teva 1 mg/ml concentrate for solution for infusion contains 1 mg/ml of cisplatin. Each ml of solution contains 3.5 mg of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, light yellow solution free from visible particles 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cisplatin Teva is intended for the treatment of: advanced or metastasised testicular cancer advanced or metastasised ovarian cancer advanced or metastasised bladder carcinoma advanced or metastasised squamous cell carcinoma of the head and neck advanced or metastasised non-small cell lung carcinoma advanced or metastasised small cell lung carcinoma. Cisplatin is indicated in combination with radiotherapy in the treatment of cervical carcinoma. Cisplatin can be used as monotherapy and in combination therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Cisplatin Teva 1 mg/ml concentrate for solution for infusion is to be diluted before administration. For instructions on dilution of the medicinal product before administration, see section 6.6. _Adults and children_ The cisplatin dosage depends on the primary disease, the expected reaction, and on whether cisplatin is used for monotherapy or as a component of combination chemotherapy. The dosage directions are applicable for both adults and children. For monotherapy, the following two dosage regimens are recommended: Single dose of 50 to 120 mg/m² body surface every 3 to 4 weeks; 15 to 20 mg/m²/day for five days, every 3 to 4 weeks. If cisplatin is used in combination chemotherapy, the dose of cisplatin must be reduced. A typical dose is 20 mg/m² or more once every 3 to 4 weeks. For treatment of cervical cancer cisplatin is used in combination with radiotherapy. A typical dose is 40 mg/m 2 weekly for 6 we Preberite celoten dokument