Karma-HMG®

Description

Karma-HMG® is a hormonal substance containing FSH and LH in a ratio of 1:1.

In women, karma-HMG® stimulates both the growth and the maturation of follicles, it induces an increase in the estrogen levels and a proliferation of the endometrium. In men, karma-HMG® stimulates spermatogenesis by acting on the production of the androgen-binding protein in the seminiferous tubules of the Sertoli cells.

Karma-HMG® packed as three vials with lyophilized powder and accompanied by three ampoules of 1ml Sodium Chloride injection B.P. as solvent.

Karma-HMG® is manufactured in BSV Co. (Bioscience Gmbh) and is developed by Homa Pharmed Co. under the license of Karma Pharmatech, Germany.

Labeled Indications

• Women: Karma-HMG® is indicated for the induction of multiple follicle development and pregnancy in ovulatory women as part of an assisted reproductive technology cycle (ART)

• Men: Karma-HMG® with concomitant Karma-HCG® (Chorionic Gonadotrophin Injection) therapy is indicated for the stimulation of spermatogenesis in men with azoospermia and treatment of secondary hypogonadism.

Administration

Karma-HMG® is given by intramuscular or subcutaneous injection. The powder for injection should be reconstituted with the diluent in the package (Sodium Chloride) immediately before use. Discard any unused portion.

Side effects

• All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Injection site reactions, fever, arthralgia, gynecomastia.

Contraindication

Woman:

Hypersensitivity to menotropins or any component of the formulation; primary ovarian failure as indicated by a high follicle-stimulating hormone level; uncontrolled nongonadal endocrinopathies (eg, thyroid, adrenal, pituitary); pituitary or hypothalamic tumors; sex hormone-dependent tumors of the reproductive tract and accessory organs; abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement not due to polycystic ovary syndrome; pregnancy.

Men:

Patients with elevated endogenous FSH levels indicative of primary testicular failure are usually unresponsive to Karma-HMG® and Karma-HCG® (Chorionic Gonadotrophin Injection) therapy. Appropriate treatment should first be given for hypothyroidism, adrenocortical deficiency, hyperprolactinemia, or pituitary tumor. An acceptable semen analysis should be available before Karma-HMG® treatment.

Storage

Karma-HMG® should be stored between °2C–°8C and protected from light. Do not freeze. The solution of Karma-FSH® reconstituted in Sodium Chloride Injection should be used immediately after preparation. Discard any unused portion. Keep away from children

Pregnancy and Lactation:

Menotropins are used for the induction of ovulation and with assisted reproductive technology (ART); use is contraindicated in women who are already pregnant.

It is not known if menotropins are present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends a decision be made to discontinue breastfeeding or to discontinue the drug, considering the importance of treatment to the mother.