PREGNYL KIT

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

CHORIONIC GONADOTROPIN

MAH:

ORGANON CANADA INC.

ATC_code:

G03GA01

INN:

CHORIONIC GONADOTROPHIN

dosage:

10000UNIT

pharmaceutical_form:

KIT

composition:

CHORIONIC GONADOTROPIN 10000UNIT

administration_route:

INTRAMUSCULAR

units_in_package:

10ML

prescription_type:

Prescription

therapeutic_area:

GONADOTROPINS AND ANTIGONADOTROPINS

leaflet_short:

Active ingredient group (AIG) number: 0106481003; AHFS:

authorization_status:

APPROVED

authorization_date:

2009-02-18

SPC

PACKAGE INSERT
PREGNYL
®
(CHORIONIC GONADOTROPIN FOR INJECTION, USP)
10,000 UNITS/VIAL
HUMAN GONADOTROPIN
Date of Initial Approval:
October 13, 2010
ORGANON CANADA INC.
16766 route Transcanadienne
Kirkland QC Canada H9H 4M7
Date of Revision:
March 30, 2021
Submission Control No: 249487
®
N.V. Organon. Used under license.
2
PACKAGE INSERT
PREGNYL
®
(CHORIONIC GONADOTROPIN FOR INJECTION, USP)
10,000 UNITS/VIAL
THERAPEUTIC CLASSIFICATION
HUMAN GONADOTROPIN
ACTION
The action of human chorionic gonadotropin (hCG) is virtually
identical to that of pituitary LH,
although hCG appears to have a small degree of FSH activity as well.
It stimulates production of
gonadal steroid hormones by stimulating the interstitial cells (Leydig
cells) of the testis to produce
androgens and the corpus luteum of the ovary to produce progesterone.
Androgen stimulation in the male leads to the development of secondary
sex characteristics and
may stimulate testicular descent when no anatomical impediment to
descent is present.
HCG has no known effect on fat mobilization, appetite or sense of
hunger, or body fat distribution.
Following IM administration, an increase in serum chorionic
gonadotropin concentrations may be
observed within 2 hours. Peak concentrations occur within 6 hours and
persist for approximately
36 hours. Serum chorionic gonadotropin levels begin to decline at 48
hours reaching undetectable
levels after 72 hours. Chorionic gonadotropin is distributed primarily
in the testes and ovaries of
the male and female respectively, with small amounts possible
distributing into the proximal
tubules of the renal cortex.
Blood levels of chorionic gonadotropin decline in a biphasic manner.
The initial phase half-life
has been reported between 5.6 and 11 hours, whereas the terminal phase
half-life has been reported
3
between 23 and 37.2 hours. Following IM administration of therapeutic
doses, approximately 10-
12% of the dose is excreted in urine within 24 hours.
INDICATION
Pregnyl
®
(chorionic gonadotropin for injection, USP) is indica