CHORIONIC GONADOTROPIN FOR INJECTION, USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CHORIONIC GONADOTROPIN

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

G03GA01

INN (International Name):

CHORIONIC GONADOTROPHIN

Dosage:

10000UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CHORIONIC GONADOTROPIN 10000UNIT

Administration route:

INTRAMUSCULAR

Units in package:

1/2.5/5/10ML

Prescription type:

Prescription

Therapeutic area:

GONADOTROPINS AND ANTIGONADOTROPINS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2008-01-10

Summary of Product characteristics

PRESCRIBING INFORMATION
PR
CHORIONIC GONADOTROPIN FOR INJECTION, USP
10 000 USP Units
Sterile Lyophilized Powder
For Intramuscular or Subcutaneous Use
GONADOTROPIN
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Preparation:
August 20, 2019
Submission Control No: 230972
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Chorionic Gonadotropin for Injection, USP – Prescribing Information_
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PRESCRIBING INFORMATION
PR
CHORIONIC GONADOTROPIN FOR INJECTION, USP
10 000 USP Units
Sterile Lyophilized Powder
Gonadotropin
DESCRIPTION
Chorionic Gonadotropin for Injection, USP (hCG) is extracted from the
urine of pregnant
women. It is a water-soluble polypeptide hormone produced by the human
placenta composed
of an alpha and a beta sub-unit. The alpha sub-unit is essentially
identical to the alpha sub-units
of the human pituitary gonadotropins, luteinizing hormone (LH) and
follicle stimulating
hormone (FSH), as well as to the alpha sub-unit of human
thyroid-stimulating hormone (TSH).
The beta sub-units of these hormones differ in amino acid sequence.
Chorionic Gonadotropin for Injection, USP (hCG) is biologically
standardized and the potency is
declared in terms of the USP Reference Standard.
ACTIONS
The action of hCG is virtually identical to that of pituitary LH,
although hCG appears to have a
small degree of FSH activity as well.
MALE: Chorionic Gonadotropin for Injection, USP is given to males in
an effort to stimulate the
interstitial cells of the testes (cells of Leydig) to produce
androgen. The response to hCG may be
considered similar to the effect caused by the interstitial cell
stimulating hormone (ICSH) from
the anterior lobe of the pituitary. 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. This descent is usually reversible
when hCG is discontinued.
Chorionic Gonadotropin for Injection, USP is likely to be of benefit
in all conditions directly
related to insufficient secretion