Puregon 300IU/0,36ml solution for s/c injection

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

follitropin beta (recombinant)

Tersedia dari:

N.V. Organon

Kode ATC:

G03GA06

INN (Nama Internasional):

follitropin beta (recombinant)

Dosis:

300IU/0,36ml

Bentuk farmasi:

solution for s/c injection

Unit dalam paket:

cartridge 0,42ml, (6/2x3/) needles

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2015-05-15

Karakteristik produk

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Puregon 50 IU/0.5 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 50 IU recombinant follicle-stimulating hormone (FSH)
in 0.5 ml aqueous solution.
This corresponds to a strength of 100 IU/ml. One vial contains 5
microgram of protein (specific
_in _
_vivo _
bioactivity equal to approximately 10 000 IU FSH / mg protein). The
solution for injection
contains the active substance follitropin beta, produced by genetic
engineering of a Chinese hamster
ovary (CHO) cell line.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_In adult females:_
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 adult males:_
•
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 with 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 ovaries to exogenous
gonadotrophins. This makes it impossible to set a uniform dosage
scheme. The dosage should,
therefore, be adjusted individually depending on the ovarian response.
This requires ultrasound
assessment of follicular development. The concurrent determination o