Bemfola 75IU/0.125ml solution for injection in a pre-filled pen

Maa: Euroopan unioni

Kieli: englanti

Lähde: myHealthbox

Aktiivinen ainesosa:

follitropin alfa

Saatavilla:

Finox Biotech AG

ATC-koodi:

G03GA05

INN (Kansainvälinen yleisnimi):

follitropin alfa

Annos:

75 IU/0.125ml

Lääkemuoto:

Solution for injection in pre-filled pen (injection).

Antoreitti:

subcutaneous administration

Kpl paketissa:

1, 5 and 10 pre-filled pens

Prescription tyyppi:

Medicinal product subject to medical prescription

Valmistaja:

Polymun Scientific Immunbiologische Forschung GmbH

Terapeuttinen ryhmä:

Sex hormones and modulators of the genital systems

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.

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2014-03-27

Pakkausseloste

77 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

BEMFOLA 75 IU/0.125 ML SOLUTION

FOR INJECTION IN A PRE-FILLED PEN 
BEMFOLA 150 IU/0.25 ML SOLUTION

FOR INJECTION IN A PRE-FILLED PEN 
BEMFOLA 225 IU/0.375 ML SOLUTION

FOR INJECTION IN A PRE-FILLED PEN 
BEMFOLA 300 IU/0.50 ML SOLUTION

FOR INJECTION IN A PRE-FILLED PEN 
BEMFOLA 450 IU/0.75 ML SOLUTION

FOR INJECTION IN A PRE-FILLED PEN 

Follitropin alfa 

This medicine is subject to additional monitoring. This will
allow quick identification of new 
safety information. You can help
by reporting any side effects you may get. See the end
of section 4 
for how to report side effects. 

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 symptoms 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�

Valmisteyhteenveto

2 
This medicinal product is subject to additional monitoring.
This will allow quick identification of 
new safety information. Healthcare professionals are
asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 

1. 
NAME OF THE MEDICINAL PRODUCT 

Bemfola 75 IU/0.125 ml solution for injection
in a pre-filled pen 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each ml of the solution contains 600 IU (equivalent to
44 micrograms) of follitropin alfa*. Each pre-
filled pen delivers 75 IU (equivalent to 5.5 micrograms) in
0.125 ml. 

* recombinant human
follicle stimulating hormone (r-hFSH) produced in
Chinese Hamster Ovary 
(CHO) cells by recombinant DNA technology. 
_ _
For a full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Solution for injection in pre-filled pen (injection). 

Clear colourless solution. 

The pH of the solution is 6.7 - 7.3. 

4. 
CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 

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