Puregon Solution for Injection in Cartridges 833IUml

Country: Malaysia

Language: English

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

Active ingredient:

FOLLITROPIN BETA; FOLLITROPIN BETA

Available from:

ORGANON MALAYSIA SDN. BHD.

INN (International Name):

FOLLITROPIN BETA; FOLLITROPIN BETA

Units in package:

0.84ml mL; 0.480ml mL; 1.23ml mL; 1.23 mL; 0.48 mL; 0.84 mL

Manufactured by:

N.V. ORGANON

Patient Information leaflet

Not Applicable

Summary of Product characteristics

LPC-OG8328-SOI-062019
1.
NAME OF THE MEDICINAL PRODUCT
Puregon 150 IU/0.18 mL, 300 IU/0.36 mL, 600 IU/0.72 mL or 900 IU/1.08
mL solution for injection
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) activity in 0.18, 0.36, 0.72 or 1.08 mL
aqueous solution.
The solution for injection contains the active substance recombinant
follicle-stimulating hormone
(FSH) (follitropin beta), 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).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colorless 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 _ 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
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 _
When using the pen injector, it should be realized that the pen is a
precision device that accurately
delivers the dose to which it is set. It was shown that on average an
18% higher amount of FSH is
given with the pen compared w