国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
CISPLATIN
Caduceus Pharma Ltd
L01XA01
CISPLATIN
1 Mg/Ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Platinum compounds
Authorised
2013-10-25
1 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 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cisplatin is and what it is used for 2. What you need to know before you use Cisplatin 3. How to use Cisplatin 4. Possible side effects 5. How to store Cisplatin 6. Contents of the pack and other information CISPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION IS GIVEN ONLY BY HEALTHCARE PERSONNEL, WHO CAN REPLY TO ANY QUESTIONS, WHICH YOU MAY HAVE AFTER READING THIS PACKAGE LEAFLET. 1. WHAT CISPLATIN 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. Cisplatin is used to treat cancers of the testis, ovary, urinary bladder, head and neck, and lung. Cisplatin is used to treat 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 DO NOT USE CISPLATIN: - if you are allergic to cisplatin or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to any other medicine that contains platinum compounds - if you have kidney problems (renal dysfunction) - if you suffer from dehydration - if you suffer from severe suppression of bone marrow functionality, symptoms may be extreme tiredness, easy bruising or bleeding, occurrence of infections - if your hearing 阅读完整的文件
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. One vial of 10 ml concentrate for solution for infusion contains 10 mg of cisplatin. One vial of 50 ml concentrate for solution for infusion contains 50 mg of cisplatin. Excipient with known effect: Each ml of solution contains 3.5 mg (< 1mmol) of sodium (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, slightly yellow solution free from visible particles. The pH is between 3.5 and 6.5. The osmolarity is 287 mOsmol/L. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cisplatin is intended for the treatment of: - advanced or metastatic testicular cancer - advanced or metastatic ovarian cancer - advanced or metastatic bladder carcinoma - advanced or metastatic squamous cell carcinoma of the head and neck - advanced or metastatic non-small cell lung carcinoma - advanced or metastatic 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 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 cisplatin is used for monotherapy or as a component of a combination chemotherapy. The dosage directions are applicable for bot 阅读完整的文件