CHORIONIC GONADOTROPIN kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHORIOGONADOTROPIN ALFA (UNII: 6413W06WR3) (CHORIOGONADOTROPIN ALFA - UNII:6413W06WR3)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

CHORIOGONADOTROPIN ALFA

Composition:

CHORIOGONADOTROPIN ALFA 10000 [USP'U] in 10 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY.  THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR ‘‘NORMAL’’ DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. - Prepubertal cryptorchidism not due to anatomical obstruction.  In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty.  HCG thus may help predict whether or not orchiopexy will be needed in the future.  Although, in some cases, descent following HCG administration is permanent, in most cases, the response is temporary.  Therapy is usually instituted between the ages four and nine. - Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males. - Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulati

Product summary:

Chorionic Gonadotropin for Injection, USP, lyophilized, is supplied in two-vial packages including Bacteriostatic Water for Injection as diluent as follows: The product is assayed in accord with the USP method and potencies refer to USP units (International Units) defined in terms of the USP Chorionic Gonadotropin Reference Standard. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

CHORIONIC GONADOTROPIN- CHORIONIC GONADOTROPIN
FRESENIUS KABI USA, LLC
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CHORIONIC GONADOTROPIN FOR INJECTION, USP
Rx only
DESCRIPTION:
Human chorionic gonadotropin (HCG), a polypeptide hormone produced by
the human placenta, is
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 is obtained from the human
pregnancy urine. It is standardized by a biological assay procedure.
Chorionic Gonadotropin for Injection, USP is available in multiple
dose vials containing 10,000 USP
units with accompanying Bacteriostatic Water for Injection for
reconstitution. When reconstituted with
10 mL of the accompanying diluent each vial contains:
Chorionic gonadotropin 10,000 units
mannitol 100 mg
benzyl alcohol 0.9%
water for injection q.s.
Buffered with dibasic sodium phosphate and monobasic sodium phosphate.
Hydrochloric acid and/or
sodium hydroxide may have been used for pH adjustment (6.0-8.0).
Nitrogen gas is used in the freeze
drying process.
CLINICAL PHARMACOLOGY:
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. 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. This descent is usually reversible when HCG is discontinued.
During the normal menstrual
cycle, LH participates with FSH in the development and maturation of
the normal ovarian follicle, and
the mid-cycle LH surge triggers ovul