PREGNYL- choriogonadotropin alfa kit

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Physicians Total Care, Inc.

INN (nume internaţional):

CHORIOGONADOTROPIN ALFA

Compoziție:

CHORIOGONADOTROPIN ALFA 10000 [USP'U] in 10 mL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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,

Rezumat produs:

Two-vial package containing: 1-10 mL lyophilized multiple dose vial containing: 10,000 USP Units chorionic gonadotropin per vial, NDC 54868-4997-0. 1-10 mL vial of solvent containing: water for injection with sodium chloride 0.56% and benzyl alcohol 0.9%, When reconstituted, each 10 mL vial contains: If required pH adjusted with sodium hydroxide and/or phosphoric acid. Store at controlled room temperature 15–30°C (59–86°F). Reconstituted solution is stable for 60 days when refrigerated. Rx Only Manufactured for Organon USA Inc. Roseland, NJ 07068 by Baxter Pharmaceutical Solutions LLC Bloomington, IN 47403 ©2006 Organon USA Inc. Rev. 4/11 35039007T Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

PREGNYL - CHORIOGONADOTROPIN ALFA
PHYSICIANS TOTAL CARE, INC.
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PREGNYL
(CHORIONIC GONADOTROPIN FOR INJECTION, USP)
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.
PREGNYL® (chorionic gonadotropin for injection, USP) is a highly
purified pyrogen-free preparation
obtained from the urine of pregnant females. It is standardized by a
biological assay procedure. It is
available for intramuscular injection in multiple dose vials
containing 10,000 USP Units of sterile dried
powder with 5 mg monobasic sodium phosphate and 4.4 mg dibasic sodium
phosphate. 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,
WHICH IS NOT FOR USE IN NEWBORNS. If required, pH is adjusted with
sodium hydroxide and/or
hydrochloric acid.
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 surg