NOVAREL- gonadotrophin, chorionic kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHORIONIC GONADOTROPIN (UNII: 20ED16GHEB) (CHORIONIC GONADOTROPIN - UNII:20ED16GHEB)

Available from:

Ferring Pharmaceuticals Inc.

INN (International Name):

Gonadotrophin, Chorionic

Composition:

Gonadotrophin, Chorionic 10000 [USP'U]

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 anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to 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 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 anovulation is seco

Product summary:

NOVAREL (chorionic gonadotropin) for Injection, USP, is available as individually packaged multiple-dose vials containing 5,000 or 10,000 USP Units per vial. Each vial of NOVAREL is accompanied by a vial of sterile diluent containing 10 mL of Bacteriostatic Water for Injection, USP containing 0.9% benzyl alcohol. NOVAREL is available in the following presentations: Store at room temperature at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F) [See USP Controlled Room Temperature]. REFRIGERATE RECONSTITUTED PRODUCT AT 2° to 8°C (36° to 46°F) AND USE WITHIN 30 DAYS.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

NOVAREL- GONADOTROPHIN, CHORIONIC
FERRING PHARMACEUTICALS INC.
----------
NOVAREL (CHORIONIC GONADOTROPIN) FOR INJECTION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1974
RX ONLY
DESCRIPTION
Human chorionic gonadotropin (HCG), a polypeptide hormone produced by
the human
placenta, is 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.
NOVAREL (chorionic gonadotropin) for injection is a water soluble
glycoprotein derived
from human pregnancy urine and administered intramuscularly after
reconstitution. The
sterile lyophilized powder is stable. When reconstituted with
Bacteriostatic Water for
Injection preserved with benzyl alcohol 0.9%, the solution should be
refrigerated and
used within 30 days.
Each 5,000 USP units vial contains:
chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16
mg, Mannitol
100 mg, and Monobasic Sodium Phosphate 4 mg.
Each 10,000 USP units vial contains:
chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16
mg, Mannitol
100 mg, and Monobasic Sodium Phosphate 4 mg.
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 fo