PROFASI HP 10000 KIT

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

CHORIONIC GONADOTROPIN; WATER

MAH:

EMD SERONO, A DIVISION OF EMD INC., CANADA

ATC_code:

G03GA01

INN:

CHORIONIC GONADOTROPHIN

dosage:

10000UNIT; 10ML

pharmaceutical_form:

KIT

composition:

CHORIONIC GONADOTROPIN 10000UNIT; WATER 10ML

administration_route:

INTRAMUSCULAR

units_in_package:

SINGLE CARTONS (10000 U)

prescription_type:

Prescription

therapeutic_area:

GONADOTROPINS AND ANTIGONADOTROPINS

leaflet_short:

Active ingredient group (AIG) number: 0223327001; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2007-05-07

SPC

022
Control # 040064
Date of Approval:
May 5,1997
PACKAGE INSERT
Profasi
9
HP
chorionic gonadotropin for injection, USP
10,000 USP Units
gonadotropin
DESCRIPTION
Profasi® HP [chorionic gonadotropin for injection, USP (hCG)],
extracted from the urine
of pregnant women, 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.
Profasi® HP (chorionic gonadotropin for injection, USP) is
biologically standardized and
the potency is declared in terms ofthe 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: Profasi® HP (chorionic gonadotropin for injection, USP) is
given in an attempt to
stimulate the interstitial cells of the testes (cells of Leydig) to
produce androgen. The
response to Profasi® HP may be considered similar to the effect
produced by the
interstitial
cell stimulating
hormone
(ICSH) frpm 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.
Profasi® HP is likely to be of benefit in all conditions directly
related to insufficient
secretion
of
androgen, provided
the
interstitial
cells
of the
testes
are capable
of
stimulation.
Female: Profasi® HP is administered in the second phase of the cycle
in an attempt to
maintain the functional integrity of the corpus luteum and to
stimulate its secretion of
progesterone.
Response to
Profasi®
HP may be considered
similar to the
effect
produced by the luteotro