karma-HMG

Menotrophins

karma-HMG homapharmed
karma-hmg hmg homapharmed
path-6-dimention

DESCRIPTION:

Each vial contains:

Highly Purified Menotropins B.P. equivalent to activity of:

Follicle stimulating Hormone..............75 I.U.

Luteinizing Hormone..............................75 I.U.

PROPERTIES:

karma-HMG® (Human Menopausal Gonadotrophin) is a hormonal substance containing FSH and LH in a ratio of 1:1. In the female, 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 the male, karma-HMG® stimulates the spermatogenesis by acting on the production of the androgen-binding protein in the seminiferous tubules of the Sertoli cells.

about women hmg

WOMEN

karma-HMG® and subsequently karma-HCG® (Chorionic Gonadotrophin Injection) are indicated for the induction of ovulation in the amenorrhoeic patient or anovulatory women with regular or irregular cycles.

about women hmg

MEN

karma-HMG® with concomitant karma-HCG® (Chorionic Gonadotrophin Injection) therapy is indicated for the stimulation of spermatogenesis in men who have primary or secondary Hypogonadotrophic hypogonadism.

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DOSAGE & ADMINISTRATION:

karma-HMG® is given by intramuscular or subcotaneous injection. The powder for injection should be reconstituted with the Sodium Chloride Injection immediately prior to use. Discard any unused portion.

Women:

If the patient wishes to conceive, she is recommended to have coitus on the day when karma-HCG® (Chorionic Gonadotrophin Injection) is given and on the following day. The dose of karma-HMG® required to evoke the desired response is critical and varies both from patient to patient and in the same patient at different times. Monitoring by hormones assay is therefore essential.

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Two dosage schedules may be employed:

Schedule 1: Alternate day therapy

Three equal doses of karma-HMG® are given on alternate days. In menstruating woman the initial dose of karma-HMG® should be given on day 7, 8 or 9 of the cycle. A single dose of karma-HCG® (Chorionic Gonadotrophin Injection) 10000 I.U. is given one week after the first injection of karma-HMG® provided the clinical and biochemical responses are adequate and not excessive.

Schedule 2: Daily therapy

Daily injections of karma-HMG® are given until an adequate response is achieved. This is judged on the basis of daily estrogen determinations. In the absence of a response, the dose of karma-HMG® may be increased or the course abandoned. A single karma-HCG® (Chorionic Gonadotrophin Injection) of 10000 I.U. is administered 24 - 28 hours after the last dose of karma-HMG®. Schedule 2 is most commonly used.

Men:

Treatment should begin with karma-HCG® (Chorionic Gonadotrophin Injection) 2000 I.U. 2–3 times a week to produce evidence of adequate masculinization. If the response to karma-HCG® (Chorionic Gonadotrophin Injection) is only androgenic, karma-HMG® (1 vial 3 times a week) and karma-HCG® (Chorionic Gonadotrophin Injection) 2000 I.U. (twice a week) are required to be administered.

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CONTRA-INDICATION AND WARNINGS:

Treatment should begin with karma-HCG® (Chorionic Gonadotrophin Injection) 2000 I.U. 2–3 times a week to produce evidence of adequate masculinization. If the response to karma-HCG® (Chorionic Gonadotrophin Injection) is only androgenic, karma-HMG® (1 vial 3 times a week) and karma-HCG® (Chorionic Gonadotrophin Injection) 2000 I.U. (twice a week) are required to be administered.

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, hyperprolactinaemia or pituitary tumour. An acceptable semen analysis should be available before karma-HMG® treatment.

WOMEN

karma-HMG® therapy is precluded when an effective response cannot be obtained e.g. Ovarian dysgenesis, Absence of uterus, Premature menopause, Tubular occlusion.

SIDE EFFECTS:

In the female, a local reaction at the injection site, fever and arthralgia have been observed in rare cases. In the male, a combined treatment with karma-HMG® and karma-HCG® (Chorionic Gonadotrophin Injection) may cause gynecomastia.

STORAGE:

Vials of karma-HMG® should be stored between 2°C - 8°C. Do not freeze. Solution reconstituted should be used immediately. Discard any unused portion.

PRESENTATION:

karma-HMG® Inj. 75 IU packed as three vials with dry substance and accompanied by three ampoules of 1ml Sodium Chloride Injection B.P. as solvent.

SHELF LIFE:

Sealed and unopened containers, when stored as recommended have a shelf life of 24 months from date of manufacturing. Keep out of reach of children.

Marketing Authorization Holder: Homa Pharmed Co.

Under License: karma Pharmatech - Germany