Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
CISPLATIN
ABIC MARKETING LTD, ISRAEL
L01XA01
CONCENTRATE FOR SOLUTION FOR INFUSION
CISPLATIN 1 MG/ML
I.V
Required
PHARMACHEMIE BV, HOLLAND (TEVA GROUP)
CISPLATIN
CISPLATIN
Palliative therapy to be employed either alone, or more commonly in established combination therapy with orher approved chemotherapeutic agents and in patients with metastatic testicular tumor and metastatic ovarian tumor who have alreasy received appropriate surgical and/or radiotherapeutic procedures and in patients with advanced bladder cancer.
2014-08-31
SUMMARY OF PRODUCT CHARACTERISTICS ABIPLATIN TEVA CONCENTRATE FOR SOLUTION FOR INFUSION FOR I.V. INFUSION 1. NAME OF THE MEDICINAL PRODUCT Abiplatin Teva 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Abiplatin Teva concentrate for solution for infusion contains 1 mg/ml of cisplatin. Excipient 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, light yellow solution, essentially free from visible particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Palliative therapy to be employed either alone, or more commonly in established combination therapy with other approved chemotherapeutic agents and in patients with metastatic testicular tumor and metastatic ovarian tumor who have already received appropriate surgical and/or radiotherapeutic procedures and in patients with advanced bladder cancer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _General_ Abiplatin Teva 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. 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). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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. Abiplatin Teva concentrate for solution for infusion does not contain any antimicrobial preservative, and is intended for single-dose administration only. In patients with renal dysfunction or bone marrow depressi Đọc toàn bộ tài liệu