PUREGON SOLUTION FOR INJECTION IN VIALS 50 IU0.5mL

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

FOLLITROPIN BETA; FOLLITROPIN BETA

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

FOLLITROPIN BETA; FOLLITROPIN BETA

Unit dalam pakej:

1vial Vials

Dikeluarkan oleh:

N.V. Organon

Risalah maklumat

Not Applicable

Ciri produk

LPC-OG8328-SOI-062019
1.
NAME OF THE MEDICINAL PRODUCT
Puregon 50 or 100, IU/0.5 mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 50, 100 IU recombinant follicle-stimulating hormone
(FSH) activity in 0.5
mL aqueous solution. This corresponds to strengths of 100, 200 IU/mL.
One vial contains 5,
10 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 a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colorless solution.
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 _
fertilization/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
LPC-OG8328-SOI-062019
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 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 d