PUREGON SOLUTION FOR INJECTION

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

FOLLITROPIN BETA

Tersedia dari:

ORGANON PHARMA ISRAEL LTD., ISRAEL

Kode ATC:

G03GA06

Bentuk farmasi:

SOLUTION FOR INJECTION

Komposisi:

FOLLITROPIN BETA 833 IU / 1 ML

Rute administrasi :

S.C

Jenis Resep:

Required

Diproduksi oleh:

ORGANON LLC, USA

Kelompok Terapi:

FOLLITROPIN BETA

Area terapi:

FOLLITROPIN BETA

Indikasi Terapi:

Puregon is indicated for the treatment of female infertility in the following clinical situations: Anovulation (including polycystic ovarian disease, PCOD) in women who have beenunresponsive to treatment with clomiphene citrate. Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [ e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. In the male : Deficient spermatogenesis due to hypogonadotrophic hypogonadism.

Tanggal Otorisasi:

2014-02-28

Selebaran informasi

[Organon] Proprietary
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
PUREGON
®
SOLUTION FOR INJECTION
150 IU, 300 IU, 600 IU, 900 IU
Solution for Injection
Each cartridge contains:
Follitropin beta 150 IU/ 0.18 ml
Follitropin beta 300 IU/ 0.36 ml
Follitropin beta 600 IU/ 0.72 ml
Follitropin beta 900 IU/ 1.08 ml
For a list of inactive ingredients see section 6.1 "What PUREGON
contains".
Read all of this leaflet carefully before you start using this
medicine.
•
This leaflet contains concise information about PUREGON. If you have
any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
medical condition seems similar to yours.
•
PUREGON is not intended for use in children.
•
PUREGON is not intended for pregnant women.
1. WHAT IS THE MEDICINE INTENDED FOR?
PUREGON is used to treat infertility in any of the following
situations:
Women
In women who do not ovulate and do not respond to treatment with
clomifene citrate, PUREGON can be
used to cause ovulation.
In women undergoing assisted reproduction techniques, including _in
vitro_ fertilisation (IVF) and other
methods, PUREGON can bring about the development of multiple
follicles.
Men
In men who are infertile due to lowered hormone levels, PUREGON can be
used for the production of
sperm.
Therapeutic group: Gonadotrophins (sex hormones).
PUREGON solution for injection contains follitropin beta, a hormone
known as follicle-stimulating hormone
(FSH).
FSH belongs to the group of gonadotrophins (sex hormones), which play
an important role in human fertility
and reproduction. In women, FSH is needed for the growth and
development of follicles in the ovaries.
Follicles are small round sacs that contain the egg cells. In men, FSH
is needed for the production of
sperm.
2. BEFORE YOU TAKE PUREGON
2.1 Do not use PUREGON if you:
−
are hypersensitive (allergic) to folli

Karakteristik produk

[Organon] Proprietary
1.
NAME OF THE MEDICINAL PRODUCT
Puregon solution for injection
150 IU/0.18 mL, 300 IU/0.36 mL, 600 IU/0.72 mL or 900 IU/1.08 mL.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One cartridge contains a net total dose of 150 IU, 300 IU, 600 IU or
900 IU recombinant follicle-stimulating
hormone (FSH) in 0.18, 0.36, 0.72 or 1.08 ml aqueous solution. The
solution for injection contains the active
substance follitropin beta, produced by genetic engineering of a
Chinese hamster ovary (CHO) cell line, in a
concentration of 833 IU/mL aqueous solution. This strength corresponds
to 83.3 microgram of protein / ml
(specific _in vivo_ bioactivity equal to approximately 10,000 IU FSH /
mg protein).
Excipient(s) with known effect:
This medicinal product contains 10 mg of benzyl alcohol per mL. For a
full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
In cartridges, designed to be used in conjunction with a pen injector.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
_In the female: _
Puregon is indicated for the treatment of female infertility in the
following clinical situations:
•
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 medically
assisted reproduction programs [e.g. _in vitro_ fertilisation/embryo
transfer (IVF/ET), gamete intra-
fallopian transfer (GIFT) and intracytoplasmic sperm injection
(ICSI)].
_ _
_In the male _
•
Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
4.2
Posology and method of administration
Treatment with Puregon should be initiated under the supervision of a
physician experienced in the
treatment of fertility problems.
The first injection of Puregon should be performed under direct
medical supervision.
Posology
_ _
_Dosage in the female _
There are great inter- and intra-individual variations in the response
of the o