HMG-LEPORI
Human Menopause Gonadotrophin (HMG)

It has been broadly demonstrated that the gonadotrophins initiate gametogenesis and its regulation.
The gonadotrophins, protein-structure pituitary hormones, are homologous in nature, which means that for use in human beings they must be obtained from the latter.
HMG-lepori, human menopause gonadotrophin (HMG), highly purified and biologically titrated, is extracted from the urine of menopausal women, and therefore presents no risk of producing antibodies that could reduce or annul its therapeutic effects.
HMG-lepori contains follicle-stimulating gonadotrophin (FSH) and luteinizing hormone (LH-ICSH), with biological activity titrated by means of specific methods capable of separately determining each one of the FSH hormones and LH-ICSH expressed in international units.
HMG-lepori has a pharmacological and therapeutic action equivalent to the pituitary FSH. In men it directly stimulates the germinative epithelium of the testicle, promoting the spermatogenic maturation, whereas in woman it stimulates the maturation of the Graafian follicle.

COMPOSITION
Each lyophilised vial contains: follicle-stimulating hormone (FSH), from human urine, 75 IU; luteinizing hormone (LH), from human urine, 75 IU, approx. Excipient: lactose. Each solvent ampoule contains: sterile physiological solution, 1 ml.

THERAPEUTIC INDICATIONS
HMG-lepori is indicated in the treatment of male functional sterility due to insufficient pituitary secretion or lack of testicular response to the normal pituitary stimulus. Oligospermia, asthenospermia, oligoasthenospermia, azoospermia through pituitary failure, functional hypogonadism, functional eunuchoidism and cryptorchidism.
HMG-lepori is indicated in the treatment of female functional sterility due to insufficient pituitary secretion or lack of ovarian response to the normal pituitary stimulus. Primary and secondary amenorrhea, oligomenorrhea and anovulatory cycles.

POSOLOGY
In view of the characteristics of HMG-lepori, and its specific indications and individual variations in response, the posology must be individualised.
Female sterility: The dosing schedule must be adapted to the ovarian cycle. For this purpose, 1 or 2 injectable solutions of HMG-lepori will be given daily until an optimal estrogenic response is obtained, with 3 or 4 injectable solutions of HCG-lepori 2,500 IU then given once, after one day of rest. Sexual intercourse is recommended on the day HCG-lepori is given. The treatment with HMG and HCG-lepori should be repeated over several cycles, provided that there are signs that ovulation has occurred without a subsequent pregnancy or in case of lack of ovarian response.
Male sterility: Due to the physiological duration of spermatogenesis, the treatment must be continued without interruption for 120 days, necessary to guarantee the culmination of a whole spermatogenic cycle, and this schedule may be repeated until the results desired are achieved.
Dosage varies from 1 injectable solutions every second day up to 2 injectable solutions daily of HMG-lepori, together with 1 injectable solution daily or every second day of HCG-lepori 500 IU, in 120-day cycles.
Once the therapeutic response has been obtained, maintenance treatment with 1 or 2 injectable solutions of HMG-lepori a week should be initiated.
Cryptorchidism: 1 injectable solution of HMG-lepori together with another one of HCG-lepori 500 IU in the same injection and with the same solvent every second day for 6 weeks.
The dosing schedules provided are given by way of guidance only. The doctor's opinion will determine therapy in each case.

INSTRUCTIONS FOR USE
The solution for injection is obtained by dissolving the content of the lyophilizate with 1 ml of solvent, which should be given immediately and exclusively by the intramuscular route.
The injectable solutions of HCG-lepori and HMG-lepori may be mixed in the same syringe.

CONTRAINDICATIONS AND PRECAUTIONS
It should not be used during pregnancy. Female infertility treatments with HMG-lepori and HCG-lepori must always be performed under strict medical monitoring (control of urine estrogens or plasma estradiol) with a view to preventing possible ovarian hyperstimulation).
This treatment should not be used in patients with evident thyroidal or suprarenal dysfunction, intracranial organic lesion (pituitary tumour), sterility ascribable to non-functional causes, uterine haemorrhages of unknown origin, background of thromboembolic diseases or ovarian cysts.
In case of cryptorchidism, the treatment should be suspended if any type of precocious puberty appeared.

INCOMPATIBILITIES
None described.

WARNINGS
Athletes are informed that this medicine contains an ingredient that may give a positive result in a doping analysis.

UNDESIRABLE EFFECTS
Symptoms of ovarian hyperstimulation may occur, in which case the administration should be interrupted. On rare occasions cases of thrombophlebitis have been reported, as well as to feverish reactions caused by hypersensitivity.

OVERDOSE
None described.
In case of overdose intoxication or accidental intake call the Toxicological Information Service. Phone number 91 562 04 20.

EXPIRY
This medicine should not be used after the expiry date indicated on the container.

PRESENTATIONS
Box with 1 vial of liophilizate of HMG-lepori and 1 solvent ampoule.
Box with 10 vials of liophilizate of HMG-lepori and 10 solvent ampoules .

BY PRESCRIPTION ONLY

Keep medicines out of the reach of children.

Farma-Lepori, S.A.
C. Osi, 7- 08034 Barcelona

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