PREGNYL- choriogonadotropin alfa kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Merck Sharp & Dohme 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 in children between the ages of 4 and 9. - 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 anovula

Product summary:

Two-vial package containing: One 10 mL multiple-dose vial for administration by one patient, containing lyophilized powder of 10,000 USP units of chorionic gonadotropin per vial, NDC 0052-0315-10. One 10 mL multiple-dose vial of solvent containing: water for injection with sodium chloride 0.56% and benzyl alcohol (preservative) 0.9%, NDC 0052-0325-10. Storage: Store unopened vial at controlled room temperature 15°C to 30°C (59°F to 86°F). If reconstituted solution in vial is not used immediately, then store refrigerated [2°C to 8°C (36°F to 46°F)] until use and discard after 60 days. Do not shake. Do not freeze.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

PREGNYL- CHORIOGONADOTROPIN ALFA
MERCK SHARP & DOHME LLC
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PREGNYL
(CHORIONIC GONADOTROPIN) FOR INJECTION
DESCRIPTION
Chorionic gonadotropin, a gonadotropin, is a polypeptide hormone
produced by the
human placenta and obtained from the urine of pregnant persons.
Chorionic
gonadotropin is a purified preparation composed of an alpha and a beta
subunit. The
alpha subunit is essentially identical to the alpha subunits of the
human pituitary
gonadotropins, luteinizing hormone (LH) and follicle-stimulating
hormone (FSH), as well
as to the alpha subunit of human thyroid-stimulating hormone (TSH).
The beta subunits
of these hormones differ in amino acid sequence.
PREGNYL
(chorionic gonadotropin) for injection is a sterile, dried powder for
intramuscular injection after reconstitution. Each multiple-dose vial
is only for use in one
patient and contains 10,000 USP units of chorionic gonadotropin with
dibasic sodium
phosphate (4.4 mg) and monobasic sodium phosphate (5 mg). If required,
pH is
adjusted with sodium hydroxide and/or phosphoric acid.
Each package also contains a 10-mL vial of solvent containing: water
for injection with
0.56% sodium chloride and 0.9% BENZYL ALCOHOL (preservative), WHICH IS
NOT FOR
USE IN NEWBORNS. If required, pH is adjusted with sodium hydroxide
and/or
hydrochloric acid.
CLINICAL PHARMACOLOGY
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. This descent is usually reversible when hCG is
discontinued.
During the normal menstrual cycle, LH participates with FSH in the
development and
maturation of