देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
VINBLASTINE SULFATE
ABIC MARKETING LTD, ISRAEL
L01CA01
SOLUTION FOR INJECTION
VINBLASTINE SULFATE 1 MG / 1 ML
I.V
Not required
PHARMACHEMIE B.V., (TEVA GROUP) ,THE NETHERLANDS
VINBLASTINE
VINBLASTINE
Vinblastine has proved effective in the treatment of the following neoplasms, either alone or in conjunction with other oncolytic drugs:Frequently Responsive Malignancies :• Generalized Hodgkin's disease (Stages III and IV, Ann Arbor modification of Rye staging system)• Non-Hodgkin's lymphoma: - Reticulum-cell sarcoma - Lymphosarcoma• Mycosis fungoides.• Neuroblastoma.• Histiocytosis X.Less Frequently Responsive Malignancies :• Choriocarcinoma resistant to other chemotherapeutic agents.• Embryonal carcinoma of the testis.• Carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy.
2016-08-31
SUMMARY OF PRODUCT CHARACTERISTICS BLASTOVIN ® TEVA Solution for Injection For I.V. Injection 1. NAME OF THE MEDICINAL PRODUCT Blastovin ® Teva 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 10 ml contains 10 mg of vinblastine sulfate. 1 ml of solution for injection contains 1 mg vinblastine sulfate. Excipient with known effect: Sodium chloride. A 10 ml vial contains 35 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Blastovin Teva is a clear solution. Osmolarity 286 mOsm/L; pH 3.5-5.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vinblastine has proved effective in the treatment of the following neoplasms, either alone or in conjunction with other oncolytic drugs: Frequently Responsive Malignancies: • Generalized Hodgkin's disease (Stages III and IV, Ann Arbor modification of Rye staging system). • Non-Hodgkin's lymphoma: - Reticulum-cell sarcoma. - Lymphosarcoma. • Mycosis fungoides. • Neuroblastoma. • Histiocytosis X. Less Frequently Responsive Malignancies: • Choriocarcinoma resistant to other chemotherapeutic agents. • Embryonal carcinoma of the testis. • Carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _This preparation is for intravenous use only. It should be administered only _ _by individuals experienced in vinblastine administration._ _FATAL IF GIVEN BY OTHER ROUTES. FOR INTRAVENOUS USE ONLY._ _IN CASE OF MISTAKEN ADMINISTRATION BY INTRATHECAL ROUTE, SEE SECTION 4.4._ For instructions on the use/handling of the product see section 6.6. Before each administration a monitoring of neutrophil count is necessary. POSOLOGY _STARTING DOSE_ _Adults:_ It is sensible to start the therapy with a single dose of 0.1 mg/kg (or 3.7 mg/m 2 ) I.V. once per week, followed by a leukocyte count to be performed in order to establish the sensitivity of the patient to the product. _Children:_ It is sensible to start the therapy with a single dose पूरा दस्तावेज़ पढ़ें