Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Carboplatin
Teva Pharma B.V.
L01XA; L01XA02
Carboplatin
10 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Platinum compounds; carboplatin
Marketed
2001-03-09
PACKAGE LEAFLET: INFORMATION FOR THE USER CARBOPLATIN–TEVA 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION carboplatin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • 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 CARBOPLATIN-TEVA IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE CARBOPLATIN-TEVA 3. HOW TO RECEIVE CARBOPLATIN-TEVA 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CARBOPLATIN-TEVA 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CARBOPLATIN-TEVA IS AND WHAT IT IS USED FOR Carboplatin-Teva is a platinum containing compound. It is an anti-cancer agent, which is used either alone or in combination with other medicines. Carboplatin-Teva is used to treat advanced ovarian cancer and lung cancer (small cell cancer of the lung). Ask your doctor or nursing staff if you need additional information. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE CARBOPLATIN-TEVA DO NOT RECEIVE CARBOPLATIN-TEVA IF YOU: are allergic (hypersensitive) to carboplatin, cisplatin or other platinum-containing compounds or any of the other ingredients of this medicine (listed in section 6) have severe kidney problems have any bone marrow problems suffer from significant bleeding (bleeding tumors) are pregnant, may be pregnant or breast-feeding are due to receive, or have recently received, the yellow fever vaccine. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE YOU RECEIVE THIS MEDICINE IF YOU: • are elderly (over 65 years old). OTHER PRECAUTIONS WHILST YOU ARE RECEIVING CARBOPLATIN-TEVA: • Your nervous system function will be checked regula Læs hele dokumentet
Health Products Regulatory Authority 14 March 2024 CRN00F21G Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carboplatin-Teva 10 mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml of concentrate for solution for infusion contains 10mg of carboplatin. Each 5ml vial contains 50mg carboplatin; Each 15 ml vial contains 150mg carboplatin; Each 45 ml vial contains 450mg carboplatin; Each 60ml vial contains 600 mg carboplatin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Clear, colourless to faintly yellow solution, free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carboplatin is indicated for the treatment of: 1) advanced ovarian carcinoma of epithelial origin in: a) first line therapy b)second line therapy, after other treatments have failed. 2)small cell carcinoma of the lung. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage and Administration: Carboplatin should be used by the intravenous route only. The recommended dosage of Carboplatin in previously untreated adult patients with normal kidney function, i.e. creatinine clearance > 60 ml/min is 400 mg/m 2 as a single short term IV dose administered by a 15 to 60 minute infusion. Alternatively, the Calvert formula shown below may be used to determine dosage: DOSE (MG) = TARGET AUC (MG/ML X MIN) X [GFR ML/MIN + 25] TARGET AUC PLANNED CHEMOTHERAPY PATIENT TREATMENT STATUS 5-7 mg/ml.min Single agent Carboplatin Previously untreated 4-6 mg/ml.min Single agent Carboplatin Previously treated 4-6 mg/ml.min Carboplatin plus cyclophosphamide Previously untreated Note: With the Calvert formula, the total dose of Carboplatin is calculated in mg, not mg/m 2 . Calvert's formula should not be used in patients who have received extensive pretreatment**. ** Patients are considered heavily pretreated if they have received any of the following: Health Products Regulatory Authority 14 March 2024 CRN00F21G Pag Læs hele dokumentet