Puregon solution for s/c injection

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

follitropin beta (recombinant)

متاح من:

N.V. Organon

ATC رمز:

G03GA06

INN (الاسم الدولي):

follitropin beta (recombinant)

جرعة:

600IU/0,72ml

الشكل الصيدلاني:

solution for s/c injection

الوحدات في الحزمة:

cartridge 0,78ml, (6/2x3/) needles

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2022-02-02

خصائص المنتج

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Puregon 300 IU/0.36 mL solution for injection
Puregon 600 IU/0.72 mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One cartridge contains 300 IU or 600 IU (concentration of 833 IU/mL)
of follitropin beta (recombinant).
This strength corresponds to 83.3 microgram of protein/mL (specific
_in vivo_ bioactivity equal to
approximately 10 000 IU FSH/mg protein). Total dose meant for 6
injections. When more injections are
given the net total may be lowered, because each injection has to be
preceded by an air shot.
Excipient(s) with known effect:
This medicinal product contains 10 mg of benzyl alcohol per mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for subcutaneous injection
Clear and colourless aqueous solution.
In cartridges, designed to be used in conjunction with a pen injector.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_In 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_ fertilization/embryo
transfer (IVF/ET), gamete intra-fallopian
transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
_In 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 of Puregon® should be performed under direct
medical supervision.
_Method of administration _
Puregon® solution for injection in cartridges has been developed for
use in the Puregon Pen and should be
administered subcutaneously. The injection site should