Human Menopause Gonadotrophin (HMG)
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
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.
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.
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.
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.
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.
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.
Athletes are informed that this medicine contains an ingredient that may
give a positive result in a doping analysis.
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.
In case of overdose intoxication or accidental intake call the Toxicological
Information Service. Phone number 91 562 04 20.
This medicine should not be used after the expiry date indicated on the
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
medicines out of the reach of children.
C. Osi, 7- 08034 Barcelona