BLASTOVIN TEVA

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

VINBLASTINE SULFATE

Disponível em:

ABIC MARKETING LTD, ISRAEL

Código ATC:

L01CA01

Forma farmacêutica:

SOLUTION FOR INJECTION

Composição:

VINBLASTINE SULFATE 1 MG / 1 ML

Via de administração:

I.V

Tipo de prescrição:

Not required

Fabricado por:

PHARMACHEMIE B.V., (TEVA GROUP) ,THE NETHERLANDS

Grupo terapêutico:

VINBLASTINE

Área terapêutica:

VINBLASTINE

Indicações terapêuticas:

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.

Data de autorização:

2016-08-31

Características técnicas

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