Bemfola

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

follitropin alfa

Saatavilla:

Gedeon Richter Plc.

ATC-koodi:

G03GA05

INN (Kansainvälinen yleisnimi):

follitropin alfa

Terapeuttinen ryhmä:

Sex hormones and modulators of the genital system,

Terapeuttinen alue:

Anovulation

Käyttöaiheet:

In adult women:anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate;stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT);follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l.In adult men:follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.

Tuoteyhteenveto:

Revision: 10

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-03-26

Pakkausseloste

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
BEMFOLA 75 IU/0.125 ML SOLUTION
FOR INJECTION IN PRE-FILLED PEN
BEMFOLA 150 IU/0.25 ML SOLUTION
FOR INJECTION IN PRE-FILLED PEN
BEMFOLA 225 IU/0.375 ML SOLUTION
FOR INJECTION IN PRE-FILLED PEN
BEMFOLA 300 IU/0.50 ML SOLUTION
FOR INJECTION IN PRE-FILLED PEN
BEMFOLA 450 IU/0.75 ML SOLUTION
FOR INJECTION IN PRE-FILLED PEN
follitropin alfa
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 Bemfola is and what it is used for
2.
What you need to know before you use Bemfola
3.
How to use Bemfola
4.
Possible side effects
5.
How to store Bemfola
6.
Contents of the pack and other information
1.
WHAT BEMFOLA IS AND WHAT IT IS USED FOR
WHAT BEMFOLA IS
This medicine contains the active substance follitropin alfa, which is
almost identical to a natural
hormone produced by your body called “follicle-stimulating
hormone” (FSH). FSH is a gonadotropin,
a type of hormone that plays an important role in human fertility and
reproduction. In women, FSH is
needed for the growth and development of the sacs (follicles) in the
ovaries that contain the egg cells.
In men, FSH is needed for the production of sperm.
WHAT BEMFOLA IS USED FOR
IN ADULT WOMEN
, Bemfola is used:
•
to help release an egg from the ovary (ovulation) in women that cannot
ovulate and that did not
respond to treatment with a medicine called “clomiphene citrate”.
•
together with another medicine called “lutropin alfa”
(“luteinising hormone” or LH) to help
release an egg fr

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen
Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen
Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen
Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen
Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of the solution contains 600 IU (equivalent to 44 micrograms)
of follitropin alfa*.
Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen:
Each pre-filled pen delivers 75 IU (equivalent to 5.5 micrograms) in
0.125 mL.
Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen:
Each pre-filled pen delivers 150 IU (equivalent to 11 micrograms) in
0.25 mL.
Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen:
Each pre-filled pen delivers 225 IU (equivalent to 16.5 micrograms) in
0.375 mL.
Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen:
Each pre-filled pen delivers 300 IU (equivalent to 22 micrograms) in
0.5 mL.
Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen:
Each pre-filled pen delivers 450 IU (equivalent to 33 micrograms) in
0.75 mL.
* recombinant human follicle stimulating hormone (r-hFSH) produced in
Chinese Hamster Ovary
(CHO) cells by recombinant DNA technology.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear colourless solution.
The pH of the solution is 6.7 to 7.3.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adult women
•
Anovulation (including polycystic ovarian syndrome) in women who have
been unresponsive to
treatment with clomiphene citrate.
•
Stimulation of multifollicular development in women undergoing
superovulation for assisted
reproductive technologies (ART) such as
_in vitro_
fertilisation (IVF), gamete intra-fallopian
transfer and zygote intra-fallopian transfer.
•
Follitropin alfa in association with a lut