Fostimon PFS 225 IU Powder and Solvent for Solution for Injection

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Urofollitropin

Inapatikana kutoka:

IBSA Farmaceutici Italia S.r.l

ATC kanuni:

G03GA; G03GA04

INN (Jina la Kimataifa):

Urofollitropin

Kipimo:

225 international unit(s)

Dawa fomu:

Powder and solvent for solution for injection

Dawa ya aina:

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

Eneo la matibabu:

Gonadotropins; urofollitropin

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2013-02-22

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSTIMONKIT 225 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
FOSTIMONKIT 300 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 Fostimonkit is and what it is used for
2.
What you need to know before you use Fostimonkit
3.
How to take Fostimonkit
4.
Possible side-effects
5.
How to store Fostimonkit
6.
Content of the pack and other information
1.
WHAT FOSTIMONKIT IS AND WHAT IT IS USED FOR
•
FOSTIMONKIT 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 FOSTIMONKIT
You and your partner’s fertility will be evaluated before your
treatment is started.
DO NOT USE FOSTIMONKIT IF YOU HAVE ANY OF THE FOLLOWING:
a.
Enlarged ovaries or cysts not caused by a hormonal disorder
(polycystic ovarian
disease).
b.
Bleeding of unknown cause.
c.
Cancer of the ovaries, uterus or breast.
d.
Abnormal swelling (tumour) of the pituitary gland or hypothalamus
(brain).
e.
Hypersensitivity (allergy) to Urofollitropin or any of the ingredients
in Fostimo

Tabia za bidhaa

Health Products Regulatory Authority
11 December 2019
CRN008HGV
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fostimon PFS 225 IU Powder and Solvent for Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 225 IU of urofollitropin (follicle-stimulating
hormone FSH): 1 ml of reconstituted solution contains either 225
IU or 450 IU of urofollitropin when respectively 1 or 2 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 PFSshould 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 PFS 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 PFS can be administered by daily injection. In menstruati