Menofactor

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.

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.

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

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

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.

Female Sex hormones

Treatment with Human Menopausal Gonadotrophin can lead to hyper-stimulation of the ovaries. This, however, mostly becomes clinically relevant only after HCG has been administered to induce ovulation (please see Undesirable effects paragraph). No therapy is necessary when a slight hyper-stimulation is present (Level I) accompanied by a slight enlargement of the ovaries (over size 5-7 cm), excessive steroid secretion, and abdominal pain. The patient should be informed, however, and carefully watched. Clinical supervision and symptomatic treatment, and perhaps an intravenous volume replacement in case of high hemoglobin concentration, is necessary if hyper-stimulation (Level II) with ovarian cysts (ovary size 8-10 cm) is present, accompanied by abdominal symptoms, nausea, and vomiting. Hospitalization is imperative when serious hyper-stimulation (Level III) with large ovarian cysts (ovary size more than 10 cm) is present accompanied by ascites, hydrothorax, enlarged abdomen, abdominal pain, dyspnea, salt retention, hemoglobin concentration, increased blood viscosity, and platelet aggregation with the danger of thromboembolisms. Undesirable effects Sensitivity to Human Menopausal Gonadotrophin – Febrile reaction which may be accompanied by chills, musculoskeletal aches or pain, malaise and fatigue have occurred after the administration of Human Menopausal Gonadotrophin. It is not clear whether or not these were pyrogenic responses or possible allergic reactions. In addition, reports of “flu-like symptoms” including fever, Chills, musculoskeletal aches, joint pains, nausea, headache and malaise have been received – Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps, bloating). – Pain, rash, swelling and/or irritation at the site of injection. – Body rashes. – Dizziness, tachycardia, dyspnea, tachypnea. The following medical events have been reported subsequent to pregnancies resulting from Human Menopausal Gonadotrophin therapy: – Ectopic pregnancy. – Congenital abnormalities

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.