Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Vinblastine sulfate 10mg
Hospira NZ Ltd
Vinblastine sulfate 10 mg
10 mg
Powder for injection
Active: Vinblastine sulfate 10mg Excipient: Benzyl alcohol Sodium chloride Water for injection
Combination pack, vial powder + vial diluent, 10 mg
Prescription
Prescription
Fine Chemicals Corporation (Pty) Limited
Package - Contents - Shelf Life: Combination pack, vial powder + vial diluent - 10 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, diluent - 10 mL - - Vial, glass, single dose, powder for inj - 10 mg -
1986-01-27
Version: pfdvinbi11221 Supersedes: pfdvinbi10821 Page 1 of 13 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ DBL™ Vinblastine Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DESCRIPTION DBL Vinblastine Sulfate B.P. is the sulfate of an alkaloid, occurring in the VINCA ROSEA LINN., (a common, flowering herb). Vinblastine Injection is a sterile solution of DBL Vinblastine Sulfate B.P. in Sodium Chloride 0.9% Injection. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection The pH of the solution is 3.5 -5.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vinblastine is effective as a single agent, but its therapeutic effect is enhanced when used in combination with other antineoplastic drugs. Vinblastine has been used in the treatment of Hodgkin’s disease (Stages III and IV) in combination therapy (with adriamycin (doxorubicin), bleomycin and dacarbazine as ABVD) and in the treatment of advanced testicular carcinoma (with cisplatin and bleomycin). Vinblastine has been used in the palliative treatment of lymphocytic lymphoma, histiocytic lymphoma, advanced stages of mycosis fungoides, Kaposi's sarcoma and Histiocytosis X. Vinblastine may be used in the treatment of choriocarcinoma resistant to other chemotherapeutic agents; carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy. One of the most effective single agents for treatment of Hodgkin’s disease is vinblastine. A protocol substituting cyclophosphamide for nitrogen mustard and vinblastine for vincristine in MOPP [mechlorethamine hydrochloride (nitrogen mustard), vincristine sulfate, prednisone and procarbazine] is an alternative therapy for previously untreated patients with advanced Hodgkin’s disease. Patients suffering relapse have also responded to combination therapy that included vinblastine. Version: pfdvinbi11221 Supersedes: pfdvinbi10821 Page 2 of 13 Advanced testicular germ-cell cancers are sensitive to vinblastine alone but the administration of vinblastine c Прочетете целия документ