Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Cisplatin
Accord Healthcare Limited
L01XA; L01XA01
Cisplatin
1 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Platinum compounds; cisplatin
Marketed
2011-10-07
PACKAGE LEAFLET: INFORMATION FOR THE USER CISPLATIN 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Cisplatin The name of your medicine is ‘Cisplatin 1 mg/ml Concentrate for Solution for Infusion’ but in the rest of the leaflet it will be called “Cisplatin Injection”. 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 further questions, ask your doctor,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 Cisplatin Injection is and what it is used for 2. What you need to know before you use Cisplatin Injection 3. How to use Cisplatin Injection 4. Possible side effects 5. How to store Cisplatin Injection 6. Contents of the pack and other information 1. WHAT CISPLATIN INJECTION 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 (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 INJECTION DO NOT TAKE CISPLATIN IF: • you are allergic to cisplatin or to any of the other ingredients of this medicine (listed in section 6 • you are allergic (hypersensitive) to any other medicine that contains platina compounds • you have kidney problems (renal dysfunction) • y Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cisplatin 1mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 1 mg of Cisplatin. 10 ml of concentrate for solution for infusion contains 10 mg of Cisplatin 25 ml of concentrate for solution for infusion contains 25 mg of Cisplatin 50 ml of concentrate for solution for infusion contains 50 mg of Cisplatin 100ml of concentrate for solution for infusion contains 100 mg of Cisplatin. Excipients with known effect: 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, colourless to pale yellow solution in an amber glass vial, which is practically free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cisplatin 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 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 on dilution of the product before administration (see section 6.6). The diluted solution 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 (see section 6.2.). ADULTS AND CHILDREN: The cisplatin dosage depends on the primary disease, the expected reaction, and on whether cisplati Olvassa el a teljes dokumentumot