Puregon
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
29-03-2023
Summary of Product characteristics
(SPC)
29-03-2023
Public Assessment Report
(PAR)
31-07-2009
Active ingredient:
follitropin beta
Available from:
N.V. Organon
ATC code:
G03GA06
INN (International Name):
follitropin beta
Therapeutic group:
Sex hormones and modulators of the genital system,
Therapeutic area:
Infertility; Hypogonadism
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 fertilisation / embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)).In the male:Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Product summary:
Revision: 34
Authorization status:
Authorised
Authorization date:
1996-05-02
Patient Information leaflet
33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
PUREGON 150 IU/0.18 ML SOLUTION FOR INJECTION
PUREGON 300 IU/0.36 ML SOLUTION FOR INJECTION
PUREGON 600 IU/0.72 ML SOLUTION FOR INJECTION
PUREGON 900 IU/1.08 ML SOLUTION FOR INJECTION
FOLLITROPIN BETA
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Puregon is and what it is used for
2.
What you need to know before you use Puregon
3.
How to use Puregon
4.
Possible side effects
5.
How to store Puregon
6.
Contents of the pack and other information
1.
WHAT PUREGON IS AND WHAT IT IS USED FOR
Puregon solution for injection contains follitropin beta, a hormone
known as follicle-stimulating
hormone (FSH).
FSH belongs to the group of gonadotrophins, which play an important
role in human fertility and
reproduction. In women, FSH is needed for the growth and development
of follicles in the ovaries.
Follicles are small round sacs that contain the egg cells. In men, FSH
is needed for the production of
sperm.
Puregon is used to treat infertility in any of the following
situations:
WOMEN
In women who do not ovulate and do not respond to treatment with
clomifene citrate, Puregon
can be
used to cause ovulation.
In women undergoing assisted reproduction techniques, including
_in vitro_
fertilisation (IVF) and other
methods, Puregon can bring about the development of multiple
follicles.
MEN
In men who are infertile due to lowered hormone levels, Puregon can be
used for the production of
sperm.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PUREGON
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Puregon 150 IU/0.18 mL solution for injection
Puregon 300 IU/0.36 mL solution for injection
Puregon 600 IU/0.72 mL solution for injection
Puregon 900 IU/1.08 mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Puregon 150 IU/0.18 mL solution for injection
One cartridge contains a net total dose of 150 IU recombinant
follicle-stimulating hormone (FSH) in
0.18 mL aqueous solution. The solution for injection contains the
active substance follitropin beta,
produced by genetic engineering of a Chinese hamster ovary (CHO) cell
line, 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).
Puregon 300 IU/0.36 mL solution for injection
One cartridge contains a net total dose of 300 IU recombinant
follicle-stimulating hormone (FSH) in
0.36 mL aqueous solution. The solution for injection contains the
active substance follitropin beta,
produced by genetic engineering of a Chinese hamster ovary (CHO) cell
line, 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).
Puregon 600 IU/0.72 mL solution for injection
One cartridge contains a net total dose of 600 IU recombinant
follicle-stimulating hormone (FSH) in
0.72 mL aqueous solution. The solution for injection contains the
active substance follitropin beta,
produced by genetic engineering of a Chinese hamster ovary (CHO) cell
line, 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).
Puregon 900 IU/1.08 mL solution for injection
One cartridge contains a net total dose of 900 IU recombinant
follicle-stimulating hormone (FSH) in
1.08 mL aqueous solution. The solution for
Read the complete document
