VINBLASTINE SULFATE INJECTION SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

VINBLASTINE SULFATE

Prieinama:

SANDOZ CANADA INCORPORATED

ATC kodas:

L01CA01

INN (Tarptautinis Pavadinimas):

VINBLASTINE

Dozė:

1MG

Vaisto forma:

SOLUTION

Sudėtis:

VINBLASTINE SULFATE 1MG

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

10ML

Recepto tipas:

Prescription

Gydymo sritis:

ANTINEOPLASTIC AGENTS

Produkto santrauka:

Active ingredient group (AIG) number: 0103625001; AHFS:

Autorizacija statusas:

CANCELLED PRE MARKET

Leidimo data:

2019-08-01

Prekės savybės

_Vinblastine Sulfate Injection _
_Page 1 of 10_
PRODUCT MONOGRAPH
PR
VINBLASTINE SULFATE INJECTION
1 mg/mL
(10 mg/ 10 mL)
Sterile
Antineoplastic Agent
Sandoz Canada
Date of Preparation:
145, Jules-Léger
May 15, 2013
Boucherville, QC
J4B 7K8
Submission Control No.: 140855
_Vinblastine Sulfate Injection _
_Page 2 of 10_
PRODUCT MONOGRAPH
PR
VINBLASTINE SULFATE INJECTION
1 mg/mL
(10 mg/ l0 mL)
Sterile
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION
VINBLASTINE SULFATE IS A POTENT DRUG AND SHOULD BE USED ONLY BY
PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS.
BLOOD COUNTS SHOULD BE TAKEN ONCE OR TWICE WEEKLY. DISCONTINUE
OR REDUCE THE DOSAGE UPON EVIDENCE OF ABNORMAL DEPRESSION OF
THE BONE MARROW. VINBLASTINE SULFATE SHOULD NOT BE GIVEN
INTRATHECALLY.
ACTIONS AND CLINICAL PHARMACOLOGY
Tissue culture studies indicate that vinblastine is a selective
mitotic inhibitor of certain malignant
cells and as such appears to be different from other recognized
antineoplastic drugs.
There is evidence that vinblastine interferes with cell metabolism and
the entrance of glutamic
acid into the citric acid cycle and to urea. There is also evidence
that the anti-tumor effect of
vinblastine may possibly be due to its effect on cell energy
mechanisms and a decreased
adenosine diphosphate production resulting from retarded nucleotide
production. It has been
suggested that the therapeutic ratio may depend on the greater energy
needs of cancer cells along
with their decreased efficiency in generating energy because of their
reliance on the glycolytic
pathway. These energy related actions for vinblastine have been
brought forward because
although it has been demonstrated that vinblastine has a
stathmokinetic effect and produces
various atypical mitotic figures in treated cells it has been observed
clinically and experimentally
that these cytological changes may occur in the absence of oncolytic
effects.
It has also been demonstrated _in vitro_ that vinblastine can prevent
the invasion of normal tissue
by malignant cells,