VINCRISTINE SULFATE INJECTION USP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

VINCRISTINE SULFATE

Διαθέσιμο από:

UMAN PHARMA INC

Φαρμακολογική κατηγορία (ATC):

L01CA02

INN (Διεθνής Όνομα):

VINCRISTINE

Δοσολογία:

1MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

VINCRISTINE SULFATE 1MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

2ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2021-03-12

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
VINCRISTINE SULFATE INJECTION USP
1 MG/ML
Sterile
Antineoplastic Agent
Uman Pharma Inc.
Date of Preparation: September 8, 2009
100, boul. de l’Industrie
Candiac, QC
J5R 1J1
CONTROL # 132326
_PRODUCT MONOGRAPH: Vincristine Sulfate Injection USP – Uman Pharma
Inc. _
_Page 2 of 16 _
PRODUCT MONOGRAPH
PR
VINCRISTINE SULFATE INJECTION USP
1 MG/ML
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
WARNINGS
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
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.
FATAL
IF
GIVEN
INTRATHECALLY.
FOR
INTRAVENOUS
USE
ONLY.
SEE
WARNINGS SECTION FOR THE TREATMENT OF PATIENTS GIVEN INTRATHECAL
VINCRISTINE SULFATE
INJECTION.
ACTION AND CLINICAL PHARMACOLOGY
The complete mode of action of Vincristine Sulfate Injection is
unknown.
_In vitro _
investigations
have demonstrated that vincristine is a spindle inhibitor. This
inhibition has been linked to a
reversible binding of the drug to microtubule and spindle proteins in
S phase. Vincristine has
also been associated with an interference of RNA synthesis. Whether as
a result or independent
of these actions, vincristine has