Fostimon 150 IU, powder and solvent for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Urofollitropin

Available from:

IBSA Farmaceutici Italia S.r.l

ATC code:

G03GA; G03GA04

INN (International Name):

Urofollitropin

Dosage:

150 international unit(s)

Pharmaceutical form:

Powder and solvent for solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Gonadotropins; urofollitropin

Authorization status:

Not marketed

Authorization date:

2007-11-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSTIMON 75 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
FOSTIMON 150 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
UROFOLLITROPIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or
pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illeness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1.
What Fostimon is and what it is used for
2.
What you need to know before you use Fostimon
3.
How to take Fostimon
4.
Possible side-effects
5.
How to store Fostimon
6.
Content of the pack and other information
1.
WHAT FOSTIMON IS AND WHAT IT IS USED FOR
•
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.
Urofollitropin
is a highly purified human follicle stimulating hormone, belonging to
a group of
medicines called gonadotropins.
This medicinal product must be used under the supervision of your
doctor
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FOSTIMON
_ _
You and your partner’s fertility will be evaluated before your
treatment is started.
DO NOT USE FOSTIMON IF YOU HAVE ANY OF THE FOLLOWING:
•
Enlarged ovaries or cysts not caused by a hormonal disorder
(polycystic ovarian
disease).
•
Bleeding of unknown cause.
•
Cancer of the ovaries, uterus or breast.
•
Abnormal swelling (tumour) of the pituitary gland or hypothalamus
(brain).
•
Hypersensitivity (allergy) to Urofollitropin or any of the ingredients
in FOSTIMON.
This medicine should

Summary of Product characteristics

Health Products Regulatory Authority
28 August 2019
CRN00951T
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fostimon 150 IU, powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 urofolliptropin when respectively 1, 2, or 3
vials are reconstituted in 1 ml of solvent.
The specific _in vivo_ activity is equal or superior to 5000 IU of FSH
per mg of protein.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white to off-white and the solvent is clear and
colourless.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sterility in women:

Anovulation (including polycystic ovarian syndrome, PCOS) in women who
have been unresponsive to treatment
with clomifene citrate.

Controlled ovarian hyperstimulation to induce the development of
multiple follicles in Assisted Reproductive
Technologies
(ART)
such
as
_in _
_vitro _
fertilisation
(IVF),
Gamete
Intra-fallopian
Transfer
(GIFT)
and
Zygotes
Intra-fallopian Transfer (ZIFT).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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 scheme. The dosage should,
therefore, be adjusted individually depending on the ovarian
response. This requires ultrasonography and may also include
monitoring of oestradiol levels.

Anovulation (including PCOS):
The objective of a treatment with FOSTIMON is to develop a single
mature de Graaf follicle from which the ovum will be
released after the administration of human chorionic gonadotropins
(hCG).
FOSTIMON can be administered by daily injection. In m