BRAVELLE

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

UROFOLLITROPIN

Boleh didapati daripada:

Ferring Ireland Ltd

Kod ATC:

G03GA04

INN (Nama Antarabangsa):

UROFOLLITROPIN

Dos:

75 International Unit

Borang farmaseutikal:

Pdr+Solv for Soln for Inj

Jenis preskripsi:

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

Kawasan terapeutik:

urofollitropin

Status kebenaran:

Not Marketed

Tarikh kebenaran:

2006-01-09

Risalah maklumat

Package leaflet: InformatIon for the user
BRAVELLE
75 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, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their symptoms are the same
as yours.
• If you get any side effects, talk to your doctur or nurse. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What BRAVELLE is and what it is used for
2.
What you need to know before you use BRAVELLE
3.
How to use BRAVELLE
4.
Possible side effects
5.
How to store BRAVELLE
6.
Contents of the pack and other information
1. WHAT BRAVELLE IS AND WHAT IT IS USED FOR
BRAVELLE is provided as a powder which must be mixed with liquid
(solvent) before it is used. It is given as an injection under the
skin.
BRAVELLE contains a hormone called follicle stimulating hormone (FSH).
FSH is a natural hormone produced in both males and females. It helps
the reproductive organs to work normally. The FSH in this medicine is
obtained from the urine of postmenopausal women. It is highly
purified,
and is then known as urofollitropin.
BRAVELLE is used to treat female infertility in the following two
situations:
i. Women who cannot become pregnant because their ovaries do not
produce eggs (including polycystic ovarian disease). BRAVELLE is used
in women who have already been given a medicine called clomiphene
citrate to treat their infertility, but this medicine has not helped.
ii. Women in assisted reproduction programmes (including
in vitro
fertilisation/embryo transfer [IVF/ET], gamete intra-fallopian
transfer
[GIFT] and intracytoplasmic sperm injection [ICSI]). BRAVELLE helps
the
ovaries develop many egg sacs (follicles) where an egg might develop
(multiple follicular develo

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BRAVELLE 75 IU powder and solvent for solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 82.5 IU of highly purified urinary
follicle stimulating hormone (FSH), urofollitropin.
When reconstituted with the solvent provided, each vial delivers 75 IU
of FSH.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of powder: Lyophilised, white to off-white caked mass.
Appearance of solvent: Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BRAVELLE is indicated for the treatment of female infertility in the
following clinical situations:
Anovulation (including polycystic ovarian disease (PCOD)) in women who
have been unresponsive to treatment with
clomiphene citrate.
Controlled ovarian hyperstimulation to induce
the
development
of
multiple
follicles
for
assisted reproductive
technologies (ART) (e.g.
_in vitro_ fertilisation/embryo transfer (IVF/ET),
gamete intra-fallopian transfer (GIFT) and
intracytoplasmic sperm injection (ICSI)).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with BRAVELLE should be initiated under the supervision of a
physician experienced in the treatment of
fertility problems.
POSOLOGY
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 monitoring of ovarian response
by ultrasonography alone or preferably in
combination with measurement of oestradiol levels. BRAVELLE can be
given alone or in combination with a
gonadotropin-releasing hormone (GnRH) agonist or antagonist for
controlled ovarian hyperstimulation. There is no
clinical trial experience with the use of BRAVELLE in combination with
GnRH antagonists in this indication.
Recommendations about dosage and du