Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
CISPLATIN
Hospira UK Limited
L01XA01
CISPLATIN
1 Mg/Ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Platinum compounds
Authorised
1986-11-19
S10462 PACKAGE LEAFLET: INFORMATION FOR THE USER CISPLATIN 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION 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. • 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 Concentrate for Solution for Infusion is and what it is used for 2. What you need to know before you use Cisplatin Concentrate for Solution for Infusion 3. How to use Cisplatin Concentrate for Solution for Infusion 4. Possible side effects 5. How to store Cisplatin Concentrate for Solution for Infusion 6. Contents of the pack and other information 1. WHAT CISPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION 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 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CISPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION DO NOT USE CISPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION • if you are allergic to cisplatin or similar anti-cancer medicines in the past or any of the other ingredients of this medicine (see section 6) • if you have very low numbers of blood cells (called ‘myelosuppression’), (your doctor will check this with a blood test) • if you are pregnant or breast feeding • if you have severe kidney disease • if you have hearing diff Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cisplatin 1 mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml of concentrate for solution for infusion contains 1mg 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. Also contains sodium 9mg/ml For a full list of excipients, see section 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 Cisplatin 1 mg/ml Concentrate for solution for infusion is to be diluted before administration. For instructions for dilution of the product before administrate, see section 6.6. The dilution should be administered only intravenously by infusion (see below). For administration, any device containing aluminium that may come in contact with cisplatin (sets for intravenous infusion, needles, catheters, syringes) must be avoided. 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Baca dokumen lengkap