Label: CHORIONIC GONADOTROPIN kit

Rx only

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 is a sterile lyophilized powder available in multiple dose vials containing 10,000 USP units to be reconstituted with accompanying Bacteriostatic Water for Injection and administered intramuscularly after reconstitution. When reconstituted with 10 mL of the accompanying diluent each vial contains:

Chorionic gonadotropin                                         10,000 USP units

benzyl alcohol                                                        0.9%

dibasic sodium phosphate                                      13 mg

mannitol                                                                 100 mg

monobasic sodium phosphate                                3 mg

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.

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 ovulation. HCG can substitute for LH in this function. During a normal pregnancy, HCG secreted by the placenta maintains the corpus luteum after LH secretion decreases, supporting continued secretion of estrogen and progesterone and preventing menstruation. HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION.

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.

1.

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.

2.

Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.

3.

Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.

Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG.

HCG should be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions and adverse reactions described in the package insert for menotropins. The principal serious adverse reactions are: (1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain and/or pleural effusion, (2) Rupture of ovarian cysts with resultant hemoperitoneum, (3) Multiple births and (4) Arterial thromboembolism.

Anaphylaxis and other hypersensitivity reactions have been reported with urinary-derived HCG products.

Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia and pain at the site of injection.

Chorionic Gonadotropin, lyophilized powder, is supplied in two-vial packages including Bacteriostatic Water for Injection as diluent as follows:

Store at room temperature 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. If needed, the reconstituted vial may be refrigerated between 2℃ to 8℃ (36℉ to 46℉) and must be discarded after 60 days. Do not freeze and do not shake.

Manufactured by:

www.fresenius-kabi.com/us

US License Number 2146

45792J

Revised: February 2025

NDC 63323-030-10

Chorionic

Gonadotropin

for Injection

10,000 USP units

per vial

For intramuscular

use only.

Multiple Dose Vial

Rx only

Bacteriostatic

Water

for Injection, USP

NOT FOR USE IN

NEWBORNS.

10 mL

Multiple Dose Vial                Rx only

NDC 63323-030-11

Chorionic Gonadotropin

for Injection

10,000 USP units

per vial

For intramuscular use only.

With Bacteriostatic Water for Injection, USP

as diluent.

Rx only

One multiple-dose vial containing

chorionic gonadotropin and One

multiple-dose vial of diluent

10 mL

Multiple Dose Vials