HMG 150 IU/vial

INDICATIONS

Sterility in females with hypo- or normogonadotropic ovarian insufficiency: Stimulation of follicle growth. Sterility in males with hypo- or normogonadotropic hypogonadism: In combination with HCG to stimulate spermatogenesis.

PHARMACOLOGY

Pharmacodynamic properties: Human Menopausal Gonadotrophin directly affects the ovaries and the testes. Human Menopausal Gonadotrophin has gametotropic and steroidogenic effect. In the ovaries, the FSH-component in Human Menopausal Gonadotrophin induces an increase in the number of growing follicles and stimulates their development. FSH increase the production of estradiol in the granulose cells by aromatizing androgens that originate in the Theca cells under the influence of the LH-component. In the testes, FSH induces the transformation of premature to mature Sertoli cells. It mainly causes the maturation of the seminal canals and development of the spermatozoa. However, a high concentration of androgens within the testes is necessary and can be attained by a prior treatment using HCG.Pharmacokinetic properties: Human Menopausal Gonadotrophin is not effective when taken orally and is injected i.m. or s.c. Human Menopausal Gonadotrophin's biological effectiveness is mainly due to its FSH and LH content. The pharmacokinetics of Human Menopausal Gonadotrophin following i.m. or s.c. administration were tested product specifically. The maximum serum level of FSH is reached 6-48 hours hours after i.m. injection and 6-36 hours after s.c. injection respectively. After that, the serum level decreases by a half-life of 56 hours (i.m.) and 51 hours (s.c.) respectively. Administered Human Menopausal Gonadotrophin is predominantly discharged renally.

DOSAGE

Sterility in females: The dosage of Human Menopausal Gonadotrophin for the induction of follicle growth in normo-or hypogonadotropic women varies according to the individual. The amount depends on ovarian reaction and should be checked by ultrasound examinations of the ovarian and measuring estradiol levels. If the Human Menopausal Gonadotrophin dosage is too high for the treated individual, multiple uni-and bilateral follicle growth can occur. Human Menopausal Gonadotrophin is administered intramuscularly or subcutaneously and in general, the therapy is begun with a daily dosage corresponding to 75-150 IU FSH. If the ovaries do not respond, the dosage can slowly be increased until a rise in estradiol secretion and follicle growth is evident. Treatment with the same dosage of Human Menopausal Gonadotrophin continues until the pre-ovulatory estradiol serum level is attained. If the level rises too quickly, the dosage should be reduced. To induce ovulation, 5000 or 10000 IU HCG are injected i.m. 1 to 2 days after the last Human Menopausal Gonadotrophin administration.Note: After a Human Menopausal Gonadotrophin dosage too high for the corresponding individual has been administered the following HCG administration can cause an unintentional hyperstimulation of the ovaries.Sterility in males: Initially, 2 X 5000 IU HCG a week are administered until a normal testosterone serum level is reached. Then, an additional dose of Human Menopausal Gonadotrophin (3 X 75-150 IU FSH + 75 - 150 IU LH) per week is administered for a few months.

INTERACTION

Interaction with other medicaments are unknown. Human Menopausal Gonadotrophin can be injected together with HCG when treating infertile males.

PREGNANCY & LACTATION

There is no indication for Human Menopausal Gonadotrophin to be used during pregnancy and lactation period

PRECAUTIONS & WARNINGS

In pregnancies occurring after induction of ovulation with gonadotropic preparations, there is an increased risk of miscarriage, multiples and ectopic pregnancies. Human Menopausal Gonadotrophin should not be administered to induce ovulation in females whose ovaries have unintentionally been hyper-stimulated. When treating sterile women, ovarian activity should be checked (ultrasound and estradiol levels in serum respectively) prior to HMG administration. During treatment, these tests should be carried out every one to two days until stimulation occurs. Ovarian reaction can also be measured using a cervix index. Close supervision is imperative during treatment. Treatment should be immediately discontinued if unintentional hyper-stimulation occurs. This warning is particularly important with respect to patients with polycystic ovarian disease. The severe form of ovarian hyper-stimulation syndrome may be life-threatening and is characterized by large ovarian cysts (prone to rupture), ascites, very often hydrothorax and occasionally thromboembolic phenomena.

THERAPEUTIC CLASS

Female Sex hormones

STORAGE CONDITIONS

Store at 2°C to 8°C, Do not freeze. Store below 25°C for single period of not more than 3 months. Protect from light and keep in dry place. The reconstituted solution of the vial should be used immediately after piercing of the rubber stopper. Discard any remaining solution.