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* Composition:
– 1 Vial with dry substance contains: highly purified Menotrophin (human menopausal gonadotrophin, HMG) corresponding to 75 I.U. FSH (Follicle Stimulating Hormone) and 75 I.U. LH (Luteinizing Hormone).
– 1 Ampoule with 1 mL solvent contains: isotonic sodium chloride solution.
* Indications:
Menopur is used to treat infertility in women by stimulating follicular growth and in men, in conjunction with hCG (human Chorionic Gonadotropin), by stimulating the development of mature male reproductive cells.
* Contraindications:
# Menopur is contraindicated in women in cases of:
– Pregnancy
– Ovarian enlargement
– Cysts not due to polycystic ovarian syndrome
– Vaginal bleeding of unknown cause
– Uterine, ovarian or breast cancer
# Menopur is contraindicated in men in cases of:
– Prostate cancer
– Testicular tumours
* Prior to initiating Menopur therapy the following conditions must be treated:
Defective action of the thyroid gland or adrenal cortex, elevated levels of prolactin in the blood and pituitary or hypothalamus tumors.
* Special warnings and special precuations for use:
– When treating infertility in women the effects on the ovaries should be checked prior to initiating Menopur therapy. During treatment such checks should be performed every day or every 2 days until stimulation is achieved.
– HCG (human Chorionic Gonadotropin) should not be used for ovarian stimulation in women whose ovaries have been unintentionally overstimulated. On signs of overstimulation treatment must be discontinued immediately.
– Menopur therapy should be administered by a specialist or at a specialist centre.
* Pregnancy and lactation:
– Should not be used during pregnancy.
– Lactation: Not applicable.
* Posology:
# Women:
– The required dose of Menopur varies from woman to woman. The dose is dependant on the ovarian response to the treatment. The ovarian response should be monitored by means of ultrasonography and by determining the estradiol level in the blood. If the dose is too high, too many follicles may mature.
– Inject Menopur deeply into a muscle or under the skin. The usual intitial dose is 75 to 150 IU of FSH daily. If no stimulation occurs, the dose may be slowly adjusted upwards until increased estradiol secretion and distinct follicular growth is achieved. Continue treatment with a constant dose of Menopur until the estradiol level in blood corresponds to the level observed immediately before ovulation. If the estradiol level increases too fast, lower the dose. To induce ovum maturation, administer 5,000 or 10,000 IU of hCG (human Chorionic Gonadotropin) deeply into a muscle 1 or 2 days after the latest Menopur injection.
– Note: If the dose is too high, the subsequent hCG (human Chorionic Gonadotropin) injection may result in unintentional overstimulation of the ovaries.
# Men:
– First, administer 1,000 to 3,000 IU of hCG (human Chorionic Gonadotropin) 3 times weekly until the testosterone level in the blood is normal. Then, administer 75 to 150 IU of Menopur 3 times weekly for a few months.
– Menopur may be injected concomitantly with hCG (human Chorionic Gonadotropin) to treat infertility.
* Instructions for handling and method of administration:
– Dissolve the powder in the solvent immediately before use. To prepare the solution, add 1 mL of solvent to 1 vial of powder.
– Inject Menopur deeply into a muscle or under the skin.
– Menopur should be used immediately after dissolution.
* Actions to be taken in case of overdose:
– Treatment with Menopur may result in overstimulation of the ovaries. Clinically significant overstimulation is most often observed after injection of hCG (human Chorionic Gonadotropin) to induce ovum maturation.
– Mild overstimulation with only slight ovarian enlargement, increase of steriod secretion and abdominal pain requires no treatment, but you should be kept under observation.
– Overstimulation with ovarian cysts, as well as abdominal symptoms, malaise and vomiting requires clinical supervision and symptomatic treatment. High haemoglobin concentrations in the blood may require intravenous administration of fluid.
– Severe overstimulation with large ovarian cysts and concomitant accumulation of fluid in the abdominal cavity, pleural fluid accumulation, abdominal enlargement, abdominal pain, dyspnoea, salt retention and thickening of the blood involving the risk of thrombosis requires hospitalisation.
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