Posology : מינונים

4.2 Posology and method of administration
Treatment with MENOPUR should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Method of administration
MENOPUR is intended for subcutaneous (S.C.) or intramuscular (I.M.) injection after reconstitution with the solvent provided. The powder should be reconstituted prior to use. The reconstituted solution is for multiple injections and can be used for up to 28 days. Vigorous shaking should be avoided. The solution should not be used if it contains particles or if it is not clear.
Dosage
Dosage regimens described below are identical for S.C. and I.M. administration.
There are great inter-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. MENOPUR can be given alone or in combination with a gonadotrophin-releasing hormone (GnRH) agonist or antagonist. Recommendations about dosage and duration of treatment may change depending on the actual treatment protocol.
Women with anovulation (including PCOD):
The object of MENOPUR therapy is to develop a single Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).

MENOPUR therapy should start within the initial 7 days of the menstrual cycle. The recommended initial dose of MENOPUR is 75-150 IU daily, which should be maintained for at least 7 days. Based on clinical monitoring (including ovarian ultrasound alone or in combination with measurement of oestradiol levels) subsequent dosing should be adjusted according to individual patient response. Adjustments in dose should not be made more frequently than every 7 days. The recommended dose increment is 37.5 IU per adjustment, and should not exceed 75 IU. The maximum daily dose should not be higher than 225 IU. If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should recommence treatment at a higher starting dose than in the abandoned cycle.
When an optimal response is obtained, a single injection of 5,000 IU to 10,000 IU hCG should be given 1 day after the last MENOPUR injection. The patient is recommended to have coitus on the day of and the day following hCG administration. Alternatively intrauterine insemination (IUI) may be performed. If an excessive response to MENOPUR is obtained treatment should be stopped and hCG withheld (see section 4.4) and the patient should use a barrier method of contraception or refrain from having coitus until the next menstrual bleeding has started.
Women undergoing controlled ovarian hyperstimulation for multiple follicular development for assisted reproductive technologies (ART):
In line with clinical trials with MENOPUR that involved downregulation with GnRH agonists, MENOPUR therapy should start approximately 2 weeks after the start of agonist treatment. The recommended initial dose of MENOPUR is 150-225 IU daily for at least the first 5 days of treatment. Based on clinical monitoring (including ovarian ultrasound alone or in combination with measurement of oestradiol levels) subsequent dosing should be adjusted according to individual patient response and should not exceed more than 150 IU per adjustment. The maximum daily dose given should not be higher than 450 IU daily and, in most cases, dosing beyond 20 days is not recommended.
In protocols not involving downregulation with GnRH agonist, MENOPUR therapy should start on day 2 or 3 of the menstrual cycle. It is recommended to use the dose ranges and regimen of administration suggested above for protocols with downregulation with GnRH agonists.
When a suitable number of follicles have reached an appropriate size a single injection of up to 10,000 IU hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. Patients should be followed closely for at least 2 weeks after hCG administration. If an excessive response to MENOPUR is obtained treatment should be stopped and hCG withheld (see section 4.4) and the patient should use a barrier method of contraception or refrain from having coitus until the next menstrual bleeding has started.
Renal/hepatic impairment
Patients with renal and hepatic impairment have not been included in clinical trials (see section 5.2).