MENOGON

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FOLLICLE STIMULATING HORMONE (FSH); LUTEINIZING HORMONE

Available from:

FERRING PHARMACEUTICALS LTD

ATC code:

G03GA

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

FOLLICLE STIMULATING HORMONE (FSH) 75 IU/VIAL; LUTEINIZING HORMONE 75 IU/VIAL

Administration route:

I.M, S.C

Prescription type:

Required

Manufactured by:

FERRING GmbH ,GERMANY

Therapeutic group:

GONADOTROPINS

Therapeutic indications:

Sterility in females with hypo or normogonadotropic ovarian insufficiency: stimulation of follicle growth. Sterility in males with hypo or normogonadotropic hypogonadism.

Authorization date:

2021-07-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
MENOGON
POWDER FOR RECONSTITUTING A SOLUTION FOR INJECTION
ACTIVE INGREDIENT:
Each ampule with powder contains menotropin (HMG): 75 IU FSH
(follicle-stimulating
hormone) and 75 IU LH (luteinizing hormone).
Inactive ingredients and allergens: See the section ‘Important
information about some of this
medicine’s ingredients’ and section 6 ‘Additional information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about the medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
WOMEN: infertility that is caused by ovary failure, promoting follicle
growth in fertility
treatments.
Infertility in women with ovarian failure and normal secretion of
gonadotropins: stimulating
follicle growth.
MEN: Infertility caused by testicular failure.
Infertility in men with hypogonadism who have low or normal secretion
of gonadotropins.
THERAPEUTIC GROUP: gonadotropins.
MENOGON contains human menopausal gonadotropin (HMG), a substance
secreted in the
urine of post-menopausal women that is used to treat infertility in
women and men.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE:
•
if you are sensitive (allergic) to menotropin or any of the other
ingredients in this
medicine.
WOMEN
•
if you are pregnant or breastfeeding
•
if you have been diagnosed with enlarged ovaries or cysts that are not
caused by
polycystic ovary syndrome (a disorder associated with formation of
ovarian cysts and
hormonal disorders)
•
if you have vaginal bleeding for an unknown reason
•
if you have cancer of the womb, ovaries, or breasts.
In addition, do not use MENOGON with conditions that make normal
pre

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Menogon
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ampoule with powder contains Menotropin (human menopausal
gonadotropin, HMG)
corresponding to 75 IU FSH and 75 IU LH.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Sterility in females with hypo- or normogonadotropic ovarian
insufficiency: Stimulation of
follicle growth.
•
Sterility in males with hypo- or normogonadotropic hypogonadism.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Sterility in females:
The dosage of HMG for the induction of follicle growth in normo- or
hypogonadotropic women
varies according to the individual. The amount depends on ovarian
response 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 intramuscularly or subcutaneously and in general,
the therapy is begun
with a daily dosage corresponding to 75–150 IU FSH. 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 desired
pre-ovulatory estradiol
serum level is attained. If the level rises too quickly, the dosage
should be reduced. To induce
ovulation, 5000 or 10000 IU HCG are injected i.m. 1 to 2 days after
the last HMG
administration.
Note: After a HMG dosage too high for the corresponding individual has
been administered
the following HCG administration can cause an unintentional
hyperstimulation of the ovaries.
Sterility in males:
Initially, 3 X 1000 to 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) per
week is administered IM for a few months.
METHOD OF ADMINISTRATION
Menogon is administered