Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
CISPLATIN
Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece
L01XA01
CISPLATIN 1 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
CISPLATIN 1 mg/ml
POM
ANTINEOPLASTIC AGENTS
Authorised
2006-12-28
Page 1 of 9 2021-0073402, 2022-0075287 PACKAGE LEAFLET: INFORMATION FOR THE USER CISPLATIN 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION cisplatin 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 pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cisplatin 1mg/ml Concentrate for Solution for Infusion is and what it is used for 2. What you need to know before you use Cisplatin 1mg/ml Concentrate for Solution for Infusion 3. How to use Cisplatin 1mg/ml Concentrate for Solution for Infusion 4. Possible side effects 5. How to store Cisplatin 1mg/ml Concentrate for Solution for Infusion 6. Contents of the pack and other information 1. WHAT CISPLATIN 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Cisplatin 1mg/ml Concentrate for Solution for Infusion contains the active substance cisplatin which 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 cyostatics. WHAT IS IT USED FOR? Cisplatin can destroy cells in your body that may cause certain types of cancer (tumour of testis, tumour of ovary, tumour of the bladder, head and neck epithelial tumour, lung cancer and for cervical cancer in combination with radiotherapy). Your doctor will be able to provide you with more information. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CISPLATIN 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION DO NOT USE CISPLATIN • if you are allerg Baca dokumen lengkapnya
Page 1 of 15 2022-0075540 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cisplatin 1 mg/ml Concentrate for Solution for Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 1 mg of cisplatin. 1 vial of 10 ml concentrate for solution for infusion contains 10 mg of cisplatin. 1 vial of 50 ml concentrate for solution for infusion contains 50 mg of cisplatin. 1 vial of 100 ml concentrate for solution for infusion contains 100 mg of cisplatin. Excipients with known effect: Cisplatin 10 mg/10 ml (1 mg/ ml) concentrate for solution for infusion contains 35.4 mg of sodium in each 10 ml vial. Cisplatin 50 mg/50 ml (1 mg/ ml) concentrate for solution for infusion contains 177 mg of sodium in each 50 ml vial. Cisplatin 100 mg/100 ml (1 mg/ ml) concentrate for solution for infusion contains 354 mg of sodium in each 100 ml vial. For the full list of excipients, see 6.1. 3. PHARMACEUTICAL FORM Concentrate for Solution for Infusion. Clear, colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cisplatin is intended for the treatment of: - Advance or metastasised testicular cancer - Advance or metastasised ovarian cancer - Advance or metastasised bladder carcinoma - Advance or metastasised squamous cell carcinoma of the head and neck - Advance or metastasised non-small cell lung carcinoma - Advance or metastasised small cell lung carcinoma Cisplatin is indicated in the treatment of cervical carcinoma in combination with other chemotherapeutics or with radiotherapy. Cisplatin can be used as monotherapy and in combination therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS AND CHILDREN Page 2 of 15 2022-0075540 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. Method of administration For monotherapy, the following two dosag Baca dokumen lengkapnya