FOSTIMON 75 IU

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

UROFOLLITROPIN

Available from:

TZAMAL BIO-PHARMA LTD

ATC code:

G03GA04

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

UROFOLLITROPIN 75 IU/VIAL

Administration route:

I.M, S.C

Prescription type:

Required

Manufactured by:

IBSA INSTITUTE BIOCHIMIQUE SA, SWITZERLAND

Therapeutic group:

UROFOLLITROPIN

Therapeutic area:

UROFOLLITROPIN

Therapeutic indications:

A treatment with FSH followed by the administration of human chronic gonadotrophin (HCG) is indicated to induce ovulation in infertile women suffering from hypothalamus or hypophyseal disorders and in spanomenorrhoeic or amenorrhoeic women. These women belong to the WHO group II and have generally already been treated with clomiphene citrate. Most have polycystic ovarian syndrome. FSH offers good therapeutic prospects for patients whose LH:FSH ratio has to be adjusted, avoiding an exogenous supply of LH FSH may be used alone or in concomitance with human menopausal gonadotropin (HMG) in order to stimulate multiple follicular growth in patients involved in medically assisted reproduction programs (IVF-ET,GIFT).

Authorization date:

2022-08-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine requires a doctor’s prescription
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE
FOSTIMON 75 IU
FOSTIMON 150 IU
POWDER AND SOLVENT FOR INJECTION
ACTIVE INGREDIENT AND QUANTITY:
Each vial (powder) contains:
FOSTIMON 75 IU: Urofollitropin (FSH) 75 IU/vial
FOSTIMON 150 IU: Urofollitropin (FSH) 150 IU/vial
Each ampoule (solvent) contains:
Sodium chloride 0.9%, water for injection.
Inactive ingredients and allergens: see section 2 under ‘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 this 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?
THERAPEUTIC ACTIVITY:
•
FOSTIMON is used to promote ovulation in women who are not ovulating
and who have not
responded to other treatment (clomifene citrate).
•
It is used to bring about the development of several follicles (and
therefore several eggs) in
women receiving fertility treatment.
THERAPEUTIC GROUP:
Gonadotropins.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are pregnant or breast-feeding.
•
You are sensitive (allergic) to the active ingredient (urofollitropin
(FSH)) or to any of the other
ingredients in this medicine (see section 6).
•
You have enlarged ovaries or cysts not caused by a hormonal disorder
(polycystic ovarian
disease).
•
You have bleeding of unknown cause.
•
You have cancer of the ovaries, uterus or breast.
•
You have abnormal swelling (tumour) of the pituitary gland or
hypothalamus (brain).
•
You have an early menopause, a malformation of the sexual organs or
certain tumours of
the w

Summary of Product characteristics

FOSTIMON 75 IU FOSTIMON 150 IU
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Fostimon 75 IU
Fostimon 150 IU
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fostimon 75 IU:
One vial contains 75 IU of urofollitropin (follicle-stimulating
hormone FSH):
1 ml of reconstituted solution contains either 75 IU, 150 IU, 225 IU,
300 IU or 450 IU of
urofollitropin when respectively 1, 2, 3, 4, 5 or 6 vials are
reconstituted in 1 ml of solvent.
Fostimon 150 IU:
One vial contains 150 IU of urofollitropin (follicle-stimulating
hormone FSH): 1 ml of
reconstituted solution contains either 150 IU, 300 IU or 450 IU of
urofollitropin when
respectively 1, 2, or 3 vials are reconstituted in 1 ml of solvent.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of powder: White freeze-dried plug.
Appearance of solvent: Clear colourless and odourless solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A treatment with FSH followed by the administration of human chronic
gonadotrophin (hCG) is
indicated to induce ovulation in infertile women suffering from
hypothalamus or hypophyseal
disorders and in spanomenorrhoeic or amenorrhoeic women. These women
belong to the WHO
group II and have generally already been treated with clomiphene
citrate. Most have polycystic
ovarian syndrome. FSH offers good therapeutic prospects for patients
whose LH:FSH ratio has to
be adjusted, avoiding an exogenous supply of LH FSH may be used alone
or in concomitance with
human menopausal gonadotropin (HMG) in order to stimulate multiple
follicular growth in patients
involved in medically assisted reproduction programs (IVF-ET, GIFT).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with FOSTIMON
should be initiated under the supervision of a physician experienced
in
the treatment of infertility problems.
There are great inter- and intra-individual variations in the response
of the ovaries to exogenous
gonadotropins. This makes it impossible to set a uniform dosage
sche