Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Cisplatin
Fresenius Kabi Deutschland GmbH
L01XA; L01XA01
Cisplatin
1 milligram(s)/millilitre
Concentrate for solution for infusion
Platinum compounds; cisplatin
Not marketed
2014-05-02
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 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. • Simultaneous use of medicines that inhibit the BONE MARROW function or radiation can potentiate the adverse effects of FERTILITY MALE PATIENTS treated with cisplatin are advised not to father a child during treatment and for up to 6 months after treatment. Further, male patients should seek advice regarding cryoconservation of sperm prior to treatment with Cisplatin. The following side effects may occur: VERY COMMON: MAY AFFECT MORE THAN 1 IN 10 PEOPLE • reduction in the number of white blood cells which makes infections more likely (leukopenia) THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY: PREPARATION AND HANDLING OF THE PRODUCT MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. cisplatin on the bone marrow. If you are pregnant or breast-feeding, think you may be pregnant • reduction in blood platelets which increases the risk of bruising − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your doctor, pharmacist or nurse. − 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 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 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. WHAT IS IT USED FOR? Cisplatin is used to treat Baca dokumen lengkap
Health Products Regulatory Authority 05 April 2019 CRN008RV3 Page 1 of 12 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 20 ml concentrate for solution for infusion contains 20 mg of cisplatin. One vial of 50 ml concentrate for solution for infusion contains 50 mg of cisplatin. One vial of 100 ml concentrate for solution for infusion contains 100 mg of cisplatin. Excipient(s) with known effect: Each ml of solution contains 0.1 to 0.2 millimoles per ml 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. The pH is between 3.5 to 6.5. The osmolarity is between 250 to 400 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 POSOLOGY 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. The dosage directions are applicable for both adults and children. For monotherapy, the following two dosage regimens are recommended: - Single dose of 50 to 120 mg/m² body surface every 3 to 4 weeks; - 15 to 20 mg/m²/day for five days, every 3 to 4 weeks. Baca dokumen lengkap