PUREGON SOLUTION FOR INJECTION 50 iu0.5 ml

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

FOLLITROPIN BETA

Dostupné z:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC kód:

G03GA06

Dávkovanie:

50 iu/0.5 ml

Forma lieku:

INJECTION

Zloženie:

FOLLITROPIN BETA 50 iu/0.5 ml

Spôsob podávania:

SUBCUTANEOUS, INTRAMUSCULAR

Typ predpisu:

Prescription Only

Výrobca:

N.V. ORGANON

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2003-02-06

Príbalový leták

 
S-CCDS-MK8328-SOi-082013 

1. NAME OF THE MEDICINAL PRODUCT 

Puregon 50, 100 or 150 IU/0.5 mL solution for injection 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

One vial contains 50, 100, 150 IU
recombinant follicle-stimulating hormone (FSH) 
activity in 0.5 mL aqueous solution. This corresponds to
strengths of 100, 200, 
300 IU/mL. One vial contains 5, 10, 15 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 colourless 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 

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 ex

Súhrn charakteristických

S-CCDS-MK8328-SOi-062019
1. NAME OF THE MEDICINAL PRODUCT
PuregonⓇ 50, 100 or 150 IU/0.5 mL solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 50, 100, 150 IU recombinant follicle-stimulating
hormone (FSH)
activity in 0.5 mL aqueous solution. This corresponds to strengths of
100, 200,
300 IU/mL. One vial contains 5, 10, 15 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
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 determination of ser