Bemfola 75units0.125ml solution for injection pre-filled pen

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Follitropin alfa

Tilgjengelig fra:

Gedeon Richter (UK

ATC-kode:

G03GA05

INN (International Name):

Follitropin alfa

Dosering :

600unit/1ml

Legemiddelform:

Solution for injection

Administreringsrute:

Subcutaneous

Klasse:

No Controlled Drug Status

Resept typen:

VMP not recommended to prescribe - patient training required

Produkt oppsummering:

BNF: 06050100; GTIN: 7640165220269

Informasjon til brukeren

1
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
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 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 di

Preparatomtale

OBJECT 1
BEMFOLA 75 IU/0.125 ML SOLUTION FOR INJECTION IN A
PRE-FILLED PEN
Summary of Product Characteristics Updated 17-Aug-2017 | Gedeon
Richter (UK) Ltd
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 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 the 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 syndrome, PCOS) 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
(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 Gonadotropin (hCG)
therapy.
4.2 Posology and method of administration
Treatment