Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
VINBLASTINE SULFATE (UNII: N00W22YO2B) (VINBLASTINE - UNII:5V9KLZ54CY)
Fresenius Kabi USA, LLC
VINBLASTINE SULFATE
VINBLASTINE SULFATE 1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
VINBLASTINE SULFATE - VINBLASTINE SULFATE INJECTION FRESENIUS KABI USA, LLC ---------- 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 Lugege kogu dokumenti