Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
carboplatin
Accord Healthcare Polska Sp. z o.o.
L01XA02
carboplatin
10mg/ml
concentrate for solution for infusion
45ml glass vial
Prescription
Registered
2021-03-18
PACKAGE LEAFLET: INFORMATION FOR THE USER CARBOPLATIN 10MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Carboplatin 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, pharmacist or nurse. If you get any side effects, talk to your doctor. This includes any possible side effect not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Carboplatin Infusion is and what it is used for 2. What you need to know before you use Carboplatin Infusion 3. How to use Carboplatin Infusion 4. Possible side ffects 5. How to store Carboplatin Infusion 6. Contents of the pack and other information 1. WHAT CARBOPLATIN INFUSION IS AND WHAT IT IS USED FOR Carboplatin Infusion contains carboplatin, which belongs to a group of medicines known as platinum coordination compounds, which are used to treat cancer. Carboplatin Infusion is used against advanced cancer of the ovary and small cell cancer of the lung. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CARBOPLATIN INFUSION DO NOT USE CARBOPLATIN INFUSION If you are allergic to Carboplatin or any of the other ingredients of this medicine (listed in section 6) or similar platinum containing medicines if you have severe kidney disease if you have fewer blood cells than normal (your doctor will check this with a blood test) if you have tumour that bleeds if you plan to receive a yellow fever vaccination or have just received one. Tell your doctor if any of the above applies to you before this medicine is used. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Carboplatin Infusion if you are pregnant or if there is a chance you may be pregnant if you are breast feeding if you have mild renal disease. Your doctor will want to monitor you more regularly. if you are elderly (over 65 years old) if you have been treated with cisplatin or simi Baca dokumen lengkap
Module 1.3.1 Page 1 of 16 1. NAME OF THE MEDICINAL PRODUCT Carboplatin 10 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 10mg of Carboplatin Each 5 ml vial contains 50 mg carboplatin Each 15 ml vial contains 150 mg carboplatin Each 45 ml vial contains 450 mg carboplatin Each 60 ml vial contains 600 mg carboplatin For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Concentrate for solution for infusion A clear, colourless to slightly pale yellow solution free from particles 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carboplatin is indicated for the treatment of: 1. advanced ovarian carcinoma of epithelial origin in: (a) first line therapy (b) second line therapy, after other treatments have failed. 2. small cell carcinoma of the lung. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage and Administration: Carboplatin should be used by the intravenous route only. The recommended dosage of Carboplatin in previously untreated adult patients with normal kidney function, i.e. creatinine clearance > 60 ml/min is 400 mg/m² as a single short term IV dose administered by a 15 to 60 minutes infusion. Alternatively, the Calvert formula shown below may be used to determine dosage: Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25] Module 1.3.1 Page 2 of 16 DOSE (MG) = TARGET AUC (MG/ML X MIN) X [GFR ML/MIN + 25] TARGET AUC PLANNED CHEMOTHERAPY PATIENT TREATMENT STATUS 5-7mg/ml .min single agent Carboplatin Previously untreated 4-6 mg/ml .min single agent Carboplatin Previously treated 4-6mg/ml .min Carboplatin plus cyclophosphamide Previously untreated Note: With the Calvert formula, the total dose of Carboplatin is calculated in mg, not mg/m². Therapy should not be repeated until four weeks after the previous Carboplatin course and/or until the neutrophil count is at least 2,000 cells/mm³ and the platelet count is at least 100,000 cells/mm³. Initial dosage should be reduced by 20-25% in patients w Baca dokumen lengkap