Karma-HCG®

Description

Karma-HCG® is a highly purified preparation of human chorionic gonadotropin (hCG) extracted from the urine of pregnant women. It exhibits predominantly luteinizing hormone (LH)-like activity and is used to mimic the natural LH surge.

Karma-HCG® is supplied as a pack containing 3 vials of sterile lyophilized powder for injection and 3 ampoules of sterile 0.9% Sodium Chloride solvent.

Karma-HCG® is manufactured by BSV BioScience GmbH (Germany) and developed/produced by Homa Pharmed Co. under license from Karma Pharmatech GmbH (Germany).

Indications

In women (anovulatory infertility):

– To trigger follicular rupture and ovulation as part of a treatment regimen following follicular maturation stimulated by gonadotropins (e.g., menotropins such as Karma-HMG® or FSH such as Karma-FSH®).

In men:

– Treatment of hypogonadotropic hypogonadism (stimulation of androgen production and development of secondary sexual characteristics).

– Stimulation and maintenance of spermatogenesis in hypogonadotropic hypogonadism (in combination with menotropins).

– Treatment of delayed puberty associated with insufficient gonadotropic pituitary function.

– Treatment of cryptorchidism (not due to anatomical obstruction).

Administration

Karma-HCG® should be administered by intramuscular (IM) or subcutaneous (SC) injection under the supervision of a healthcare professional experienced in fertility treatment.

The lyophilized powder should be reconstituted immediately before use with the provided 0.9% Sodium Chloride solvent. Gently swirl to dissolve; do not shake vigorously. Use the reconstituted solution immediately and discard any unused portion.

Warnings

In women:

– Administration of hCG may lead to multiple ovulation and increase the risk of Ovarian Hyperstimulation Syndrome (OHSS). If signs of excessive ovarian response (e.g., significant ovarian enlargement or elevated estrogen levels) are detected, withhold hCG in that treatment cycle.

In men:

– High doses may cause fluid retention (edema); reduce the dose substantially if this occurs.

– If signs of precocious puberty appear (in pediatric patients), reduce the dose or discontinue treatment.

Storage

– Store Karma-HCG® refrigerated at 2–8°C.

– Do not freeze.

– Protect from light.

– The reconstituted solution should be used immediately; discard any unused portion.

– Keep out of the reach of children.