VINCRISTINE SULFATE INJECTION SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
12-10-2022

Aktivni sastojci:

VINCRISTINE SULFATE

Dostupno od:

TEVA CANADA LIMITED

ATC koda:

L01CA02

INN (International ime):

VINCRISTINE

Doziranje:

1MG

Farmaceutski oblik:

SOLUTION

Sastav:

VINCRISTINE SULFATE 1MG

Administracija rute:

INTRAVENOUS

Jedinice u paketu:

1/2/5ML

Tip recepta:

Prescription

Područje terapije:

ANTINEOPLASTIC AGENTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0107646001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2014-03-06

Svojstava lijeka

                                PRODUCT MONOGRAPH
PR
VINCRISTINE SULFATE INJECTION
USP
1 mg/mL
THERAPEUTIC
CLASSIFICATION
Antineoplastic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario,
Canada M1B 2K9
Date of Revision:
October 12, 2022
CONTROL # 263864
PR
vinCRIStine SULFATE INJECTION
USP
1 mg/mL
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
___________________________________________________________________________
CAUTION: VINCRISTINE SULFATE INJECTION 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.
THIS PREPARATION SHOULD BE ADMINISTERED BY INDIVIDUALS EXPERIENCED IN
THE ADMINISTRATION OF
VINCRISTINE SULFATE INJECTION. IT IS EXTREMELY IMPORTANT THAT THE
INTRAVENOUS NEEDLE OR CATHETER
BE PROPERLY POSITIONED BEFORE ANY VINCRISTINE IS INJECTED. LEAKAGE
INTO SURROUNDING TISSUE
DURING INTRAVENOUS ADMINISTRATION OF VINCRISTINE SULFATE INJECTION MAY
CAUSE CONSIDERABLE
IRRITATION. IF EXTRAVASATION OCCURS, THE INJECTION SHOULD BE
DISCONTINUED IMMEDIATELY, AND ANY
REMAINING PORTION OF THE DOSE SHOULD THEN BE INTRODUCE D 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.
TO REDUCE THE POTENTIAL FOR FATAL MEDICATION ERRORS DUE TO INCORRECT
ROUTE OF ADMINISTRATION, VINCRISTINE
SULFATE INJECTION SHOULD BE DILUTED IN A FLEXIBLE PLASTIC CONTAINER
AND PROMINENTLY LABELLED AS INDICATED:
“
FOR INTRAVENOUS USE ONLY - FATAL IF GIVEN BY OTHER ROUTES.
”
SEE "WARNINGS" SECTION FOR THE TREATMENT OF PATIENTS INADVERTENTLY
GIVEN INTRATHECAL
VINCRISTINE SULFATE INJECTION.
ACTION AND CLINICAL PHARMACOLOGY
The
complete
mode of action of vincristine sulfate is unknown. _ In vitro _
investigations have
demonstrated that vincristine is a spindle inhibitor. This inhibition
has been linked to a reversible
bin
                                
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