VINBLASTINE SULFATE- vinblastine sulfate injection

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

VINBLASTINE SULFATE (UNII: N00W22YO2B) (VINBLASTINE - UNII:5V9KLZ54CY)

Disponible depuis:

Fresenius Kabi USA, LLC

DCI (Dénomination commune internationale):

VINBLASTINE SULFATE

Composition:

VINBLASTINE SULFATE 1 mg in 1 mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Vinblastine Sulfate Injection is indicated in the palliative treatment of the following: I. Frequently Responsive Malignancies - Generalized Hodgkin’s disease (Stages III and IV, Ann Arbor modification of Rye staging system) - Lymphocytic lymphoma (nodular and diffuse, poorly and well differentiated) - Histiocytic lymphoma - Mycosis fungoides (advanced stages) - Advanced carcinoma of the testis - Kaposi’s sarcoma - Letterer-Siwe disease (histiocytosis X) II. Less Frequently Responsive Malignancies - Choriocarcinoma resistant to other chemotherapeutic agents - Carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy Current principles of chemotherapy for many types of cancer include the concurrent administration of several antineoplastic agents.  For enhanced therapeutic effect without additive toxicity, agents with different dose-limiting clinical toxicities and different mechanisms of action are generally selected.  Therefore, although vinblastine

Descriptif du produit:

Store products in refrigerator 2° to 8°C (36° to 46°F) to assure extended stability. PROTECT FROM LIGHT.  Retain vial in carton until time of use.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

VINBLASTINE SULFATE - VINBLASTINE SULFATE INJECTION
FRESENIUS KABI USA, LLC
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VINBLASTINE SULFATE INJECTION
Rx only
WARNINGS
CAUTION: THIS PREPARATION SHOULD BE ADMINISTERED BY INDIVIDUALS
EXPERIENCED IN THE
ADMINISTRATION OF VINBLASTINE SULFATE. IT IS EXTREMELY IMPORTANT THAT
THE INTRAVENOUS NEEDLE OR
CATHETER BE PROPERLY POSITIONED BEFORE ANY VINBLASTINE SULFATE IS
INJECTED. LEAKAGE INTO
SURROUNDING TISSUE DURING INTRAVENOUS ADMINISTRATION OF VINBLASTINE
SULFATE MAY CAUSE
CONSIDERABLE IRRITATION. IF EXTRAVASATION OCCURS, THE INJECTION SHOULD
BE DISCONTINUED IMMEDIATELY,
AND ANY REMAINING PORTION OF THE DOSE SHOULD THEN BE INTRODUCED INTO
ANOTHER VEIN. LOCAL
INJECTION OF HYALURONIDASE AND THE APPLICATION OF MODERATE HEAT TO THE
AREA OF LEAKAGE HELP
DISPERSE THE DRUG AND ARE THOUGHT TO MINIMIZE DISCOMFORT AND THE
POSSIBILITY OF CELLULITIS.
FOR INTRAVENOUS USE ONLY - FATAL IF GIVEN BY OTHER ROUTES.
_SEE _WARNINGS_ FOR THE TREATMENT OF PATIENTS GIVEN INTRATHECAL
VINBLASTINE SULFATE INJECTION._
DESCRIPTION:
Vinblastine sulfate is the salt of an alkaloid extracted from _Vinca
rosea _Linn., a common flowering herb
known as the periwinkle (more properly known as _Catharanthus roseus
_G. Don). Previously, the generic
name was vincaleukoblastine, abbreviated VLB. It is a stathmokinetic
oncolytic agent. When treated _in_
_vitro _with this preparation, growing cells are arrested in
metaphase.
Chemical and physical evidence indicate that vinblastine sulfate is a
dimeric alkaloid containing both
indole and dihydroindole moieties. The accompanying structural formula
has been proposed.
Each mL contains: Vinblastine sulfate 1 mg; sodium chloride 9 mg;
benzyl alcohol 0.9% (v/v) as a
preservative; water for injection, q.s. (pH 3.5 to 5.0).
CLINICAL PHARMACOLOGY:
Experimental data indicate that the action of vinblastine sulfate is
different from that of other recognized
antineoplastic agents. Tissue-culture studies suggest an interference
with metabolic pathways of amino
acids leading from glutamic acid to the citric acid