Zuellig Pharma
Full Prescribing Info
Each ampoule of dry substance contains menotrophin (human menopausal gonadotrophin, HMG) corresponding to 75 iu FSH (follicle-stimulating hormone) and 75 iu LH (luteinizing hormone) as well as lactose and sodium hydroxide for pH adjustment as inactive ingredients.
Each ampoule of solvent contains isotonic sodium chloride solution and dilute hydrochloric acid for pH adjustment.
Human menopausal gonadotrophin (HMG) is obtained from the urine of postmenopausal women. It possesses hormonal effects similar to those of the naturally occurring hormones in the human brain (anteropituitary hormones). The administration of Menogon stimulates the production of certain endogenous substances (sexual steroids) in the sexual organs. In males and females, Menogon has a hormonal effect on the reproductive glands, in females on the fallopian tubes (ovaries), and in males on the testes.
In females, Menogon promotes an increase in the growing follicles in the ovary and stimulates their development.
In males, Menogon promotes the formation of the male sexual hormone (testosterone) and the development of sperm.
Menogon can be used together with Choragon (human chorionic gonadotrophin, hCG) in females who desire children to induce ovulation after stimulating follicle growth, in males to stimulate the development of sperm.
Sterility in females with hypo- or normogonadotrophic ovarian insufficiency: Stimulation of follicle growth.
Sterility in males with hypo- or normogonadotrophic hypogonadism: In combination with hCG to stimulate spermatogenesis.
Dosage/Direction for Use
Unless prescribed otherwise, doses are as follows:
Sterility in Females: The dosage of HMG for the induction of follicle growth in normo- or hypogonadotrophic women varies according to the individual.
The amount depends on ovarian reaction and should be checked by ultrasound examinations of the ovaries and measuring estradiol levels. If the HMG dosage is too high for the treated individual, multiple uni- and bilateral follicle growth can occur.
HMG is administered IM or SC and in general, the therapy is begun with a daily dosage corresponding to 75-150 iu FSH + 75-150 iu LH. If the ovaries do not respond, the dosage can slowly be increased until a rise in estradiol secretion and follicle growth is evident. Treatment with the same dosage of HMG continues until the preovulatory estradiol serum level is attained. If the level rises too quickly, the dosage should be reduced. To induce ovulation, hCG 5000 or 10,000 iu are injected IM 1-2 days after the last HMG administration.
Note: After administering a HMG dosage which is too high for the corresponding individual, a subsequent hCG administration can cause an unintentional hyperstimulation of the ovaries.
Sterility in Males: Initially, 3 x 1000 and 3000 iu hCG a week are administered until a normal testosterone serum level is reached. Then, an additional dose of HMG 3 x (75-150 iu FSH + 75-150 iu LH)/week is administered IM for a few months.
Administration: For IM or SC injection following dissolution in the solvent attached.
Females: Pregnancy, enlargement of the ovaries or cysts that is not caused by polycystic ovarian syndrome, gynaecological bleeding of unknown cause and tumors in the uterus, ovaries and breasts.
Males: Carcinoma of the prostate and tumors in the testes.
The following conditions must be properly treated before therapy with HMG is begun: Dysfunctions of the thyroid gland and of the cortex of the suprarenal gland, a rise in the serum level of prolactin with different causes (hyperprolactinaemia), tumors in the pituitary gland (hypophysis) or in part of the diencephalon (hypothalamus).
Special Precautions
hCG should not be administered to induce ovulation in females whose ovaries have unintentionally been hyperstimulated.
When treating sterile women, ovarian activity should be checked (ultrasound and estradiol levels in serum response) prior to HMG administration. During treatment, these tests should be carried out every 1-2 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 hyperstimulation occurs.
Further remarks concerning the steps to be taken when ovarian hyperstimulation has occurred can be found under Actions.
Use In Pregnancy & Lactation
Menogon is contraindicated in pregnancy.
Side Effects
Occasionally, nausea and vomiting can occur.
In single cases, hypersensitivity reactions and fever can occur during treatment with HMG. The administration of Menogon may lead to reactions at the injection site: Reddening, pain, swelling and itching. In very rare cases, long-term usage can lead to the formation of antibodies, making the therapy ineffective.
Treatment with HMG can often lead to ovarian hyperstimulation that first becomes clinically relevant after the administration of hCG (pregnancy hormone) to induce ovulation. This can lead to the formation of large ovarian cysts that tend to rupture and to intra-abdominal bleeding.
In addition, the accumulation of fluids in the abdominal cavity (ascites), the accumulation of fluids in the chest cavity (hydrothorax), a decrease in the excretion of urine (oliguria), lowering of the blood pressure (hypotension), and occlusion of blood vessels by blood clots (thromboembolic phenomena) can occur. Treatment should be immediately discontinued when the first signs of hyperstimulation appear: Abdominal pain and a palpable (by the physician) enlargement in the lower abdomen, which can be detected sonographically.
If abdominal pain occurs, see the doctor.
With pregnancy, these side effects can intensify, continue over a long period of time, and be life threatening.
Unintentional multiple pregnancies occur more often during treatment with HMG.
Drug Interactions
Interactions with other medications are unknown.
HMG can be injected together with hCG when treating infertile males.
Store and protect from light. Menogon should not be stored at temperatures exceeding +25°C.
ATC Classification
G03GA02 - human menopausal gonadotrophin ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Amp 10's.
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