GLYCOPYRROLATE INJECTION MULTIDOSE SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

GLYCOPYRROLATE

Saadav alates:

JUNO PHARMACEUTICALS CORP.

ATC kood:

A03AB02

INN (Rahvusvaheline Nimetus):

GLYCOPYRRONIUM

Annus:

0.2MG

Ravimvorm:

SOLUTION

Koostis:

GLYCOPYRROLATE 0.2MG

Manustamisviis:

INTRAMUSCULAR

Ühikuid pakis:

100

Retsepti tüüp:

Ethical

Toote kokkuvõte:

Active ingredient group (AIG) number: 0102396002; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2023-07-05

Toote omadused

PRODUCT MONOGRAPH
GLYCOPYRROLATE INJECTION MULTIDOSE
0.2 MG / ML
(CONTAINS BENZYL ALCOHOL)
ANTICHOLINERGIC
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
STERILE SOLUTION FOR INJECTION
HOUSE STANDARD
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Submission Control No.
275408
Date
of
Preparation:
JUL
05, 2023
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GLYCOPYRROLATE INJECTION MULTIDOSE
0.2 MG / ML
THERAPEUTIC CLASSIFICATION
Anticholinergic
ACTION AND CLINICAL PHARMACOLOGY
Glycopyrrolate, like other anticholinergic (antimuscarinic) agents,
competitively antagonizes the
action of acetylcholine on structures innervated by postganglionic
cholinergic nerves and on
smooth muscles that respond to acetylcholine but lack cholinergic
innervation.
Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea,
bronchospasm, bradycardia
and intestinal hypermotility) induced by cholinergic drugs such as
anticholinesterases.
As a premedicant, Glycopyrrolate Injection reduces excessive
pharyngeal, tracheal and bronchial
secretions and, during anesthesia, it appears to protect the heart
against excessive vagal stimulation.
The polar ammonium moiety of glycopyrrolate limits its passage across
lipid membranes such as
the blood-brain barrier, in contrast to the belladonna alkaloids (such
as atropine), which are
nonpolar tertiary amines.
Consequently, Glycopyrrolate Injection does not cause the central
nervous system effects seen with the belladonna alkaloids.
The onset of action following intramuscular injection of injectable
glycopyrrolate is 20 to 40
minutes. Peak effects occur approximately 30 to 45 minutes after
administration and the duration
of action ranges from 4 to 6 hours. With intravenous injection, the
onset of action is generally
evident within one minute; the duration of action varies, as does that
of all other anticholinergics.
Following intravenous glycopyrrolate, the vagal blocking effects
persist for 2 to 3 hours and the
antisialagogue effects persist up to 7 hours.
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INDICATIONS
GASTROINTESTINAL DISORDERS:
Gl