Krajina: Cyprus
Jazyk: gréčtina
Zdroj: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
CISPLATIN
PFIZER HELLAS AE (0000003442) 243 MESSOGHION AVENUE, NEO PSYCHIKO, ATHENS, 15451
L01XA01
CISPLATIN
1MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
CISPLATIN (0015663271) 1MG
INTRAVENOUS USE
Εθνική Διαδικασία
CISPLATIN
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 50ML (880049302) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή
PACKAGE LEAFLET: INFORMATION FOR THE USER CISPLATIN 1 MG/ML STERILE CONCENTRATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU STARTUSING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What Cisplatin Sterile Concentrate is and what it is used for 2. Before you use Cisplatin Sterile Concentrate 3. How to use Cisplatin Sterile Concentrate 4. Possible side effects 5. How to store Cisplatin Sterile Concentrate 6. Further information 1. WHAT CISPLATIN STERILE CONCENTRATEIS AND WHAT IT IS USED FOR Cisplatin Sterile Concentrate is an anti-cancer medicine. Treatment with an anti- cancer medicine is sometimes called cancer chemotherapy. Cisplatin is used in the treatment of some types of cancer, for example ovarian cancer, testicular cancer, bladder cancer and cancer of the head and neck. Cisplatin may be used in combination with other anti-cancer medicines. 2. BEFORE YOU USE CISPLATIN STERILE CONCENTRATE DO NOT USE CISPLATIN STERILE CONCENTRATE if you have shown signs of hypersensitivity (severe allergy) to cisplatin or similar anti-cancer medicines in the past if you have severe kidney disease if you have hearing difficulties if you have very low numbers of blood cells (called ‘myelosuppression’), (your doctor will check this with a blood test) if you are dehydrated if you are breast-feeding if you need to have a vaccine for ‘yellow fever’ Tell your doctorif the above applies to you before this medicine is used. TAKE SPECIAL CARE WITH CISPLATIN STERILE CONCENTRATE if you have any symptoms of nerve damage (peripheral neuropathy)such as pins and needles, numbness or poor sense of touch if you have had radiation therapy to your head Tell your doctorifeither of the above applies to you before this medicine is used. TAKING/USING OTHER MEDICINE Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cisplatin 1 mg/ml Sterile Concentrate 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. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Concentrate for Solution for Infusion. Vials containing a clear, colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Cisplatin is indicated in metastatic, non-seminomatous germ cell carcinoma, advanced stage and refractory ovarian carcinoma, advanced stages and refractory bladder carcinoma and squamous cell carcinoma of head and neck. Cisplatin is indicated in combination with other antineoplastic agents for the treatment of metastatic testicular tumours. The combination of cisplatin, vinblastine and bleomycin is reported to be highly effective. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN Cisplatin should be administered by IV infusion over a 6-8 hour period. The recommended dose of cisplatin in adults and children is 50 to 100 mg/m 2 as a single IV dose every 3 to 4 weeks, or 15 to 20 mg/m 2 intravenously daily for 5 days every 3 to 4 weeks. INTERACTION WITH ALUMINIUM: Cisplatin may interact with metal aluminium to form a black precipitate of platinum. All aluminium-containing IV sets, needles, catheters and syringes should be avoided. (1) Pretreatment Hydration: Pretreatment hydration is required to induce diuresis during (and after) cisplatin administration. This hydration is achieved by giving 2 litres of either 0.9% sodium chloride or dextrose 4% in one-fifth normal saline (0.18%) over a 2-hour period. During the last 30 minutes of the pre-treatment hydration or after the hydration, administer by side arm drip 37.5 g of mannitol (i.e., 375 Prečítajte si celý dokument