GLYCOPYRROLATE INJECTION MULTIDOSE SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
06-10-2016

Aktīvā sastāvdaļa:

GLYCOPYRROLATE

Pieejams no:

OMEGA LABORATORIES LIMITED

ATĶ kods:

A03AB02

SNN (starptautisko nepatentēto nosaukumu):

GLYCOPYRRONIUM

Deva:

0.2MG

Zāļu forma:

SOLUTION

Kompozīcija:

GLYCOPYRROLATE 0.2MG

Ievadīšanas:

INTRAMUSCULAR

Vienības iepakojumā:

20ML

Receptes veids:

Ethical

Ārstniecības joma:

ANTIMUSCARINICS ANTISPASMODICS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2012-04-03

Produkta apraksts

                                PRODUCT MONOGRAPH
GLYCOPYRROLATE INJECTION MULTIDOSE
0.2 MG / ML
(CONTAINS BENZYL ALCOHOL)
ANTICHOLINERGIC
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
STERILE SOLUTION FOR INJECTION
Omega Laboratories, Ltd.
11 177 Hamon
Montreal, Canada
H3M 3E4
Submission Control No. 194739
Date of Revision: SEPTEMBER 27, 2016
- 2 -
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.
- 3 -
INDICATIONS
GASTROINTESTINAL DISORDERS: Glycopyrrolate Injection may b
                                
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