HuCoG 5000IU (Chorionic Gonadotrophin Injection BP-Freeze Dried)

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CHORIONIC GONADOTROPHIN

Available from:

BSV BIOSCIENCE MALAYSIA SDN. BHD.

INN (International Name):

CHORIONIC GONADOTROPHIN

Units in package:

1vial Vials; 1ml mL

Manufactured by:

BHARAT SERUMS AND VACCINES LTD.

Summary of Product characteristics

PANTONE PROCESS BLACK C
Paper : 40 gsm, ITC Print Paper
Outline & Cutting marks not to print
1 Vertical & 2 Horizontal Folds
Back to Back Printing
Artwork Code No. : IN90051E1MY
NEW SIZE : L X H = 215 X 135 MM
IN90051E1MY
Product Registration Holder :
BSV BIOSCIENCE MALAYSIA SDN. BHD.
No.3, JLN 19/1, 46300, P.J, Selangor, Malaysia.
_For the use only of a Registered Medical Practitioner or a Hospital
or a Laboratory_
Chorionic Gonadotrophin Injection B.P.
For Subcutaneous / Intramuscular Injection only
FREEZE DRIED
H u C o G
5000 I.U.
COMPOSITION :
Each vial contains :
Chorionic Gonadotrophin B.P. .......................................
5000 I.U.
One I.U. of Chorionic Gonadotrophin is defined as the activity
contained in 1.279 mg of the
2nd International Standard Preparation.
Excipients :
Mannitol B.P., Sucrose B.P., Sodium Ascorbate B.P., Anhydrous
Di-sodium Hydrogen
Phosphate B.P. and Phosphoric Acid B.P.
Each vial of
_HuCoG _
contains: Chorionic Gonadotrophin and each vial is accompanied by
an ampoule of Sodium Chloride Injection B.P. 1ml.
PRODUCT DESCRIPTION :
Before Reconstitution
A white or almost white amorphous powder of cake.
After Reconstitution
A clear colourless liquid.
Solvent Sodium Chloride Injection
A clear colourless solution.
PHARMACODYNAMICS :
HCG is a preparation of human chorionic gonadotrophin obtained from
the urine of
pregnant women. It stimulates the steroid genesis in the gonads by
virtue of a biological
effect similar to that of LH (Luteinizing hormone, which is the same
as interstitial cell
stimulating hormone). In the male it promotes the production of
testosterone and in the
female the production of estrogens and particularly of progesterone
after ovulation. In
certain
cases,
this
preparation
is
used
in
combination
with
human
menopausal
gonadotrophin (HMG).
ATC Code: G03GA01 - Chorionic Gonadotropin.
PHARMACOKINETICS :
_(HCG)_
is administered by intramuscular injection. The maximum serum level of
_(HCG)_
is
reached after 4 to 12 hours (dose-dependent) and decreases afterwards
with a h