GONAL-f
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
09-10-2023
Produktets egenskaber
(SPC)
09-10-2023
Offentlige vurderingsrapport
(PAR)
28-09-2010
Aktiv bestanddel:
follitropin alfa
Tilgængelig fra:
Merck Europe B.V.
ATC-kode:
G03GA05
INN (International Name):
follitropin alfa
Terapeutisk gruppe:
Sex hormones and modulators of the genital system,
Terapeutisk område:
Anovulation; Reproductive Techniques, Assisted; Infertility, Female; Hypogonadism
Terapeutiske indikationer:
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).GONAL-f 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
Produkt oversigt:
Revision: 26
Autorisation status:
Authorised
Autorisation dato:
1995-10-20
Indlægsseddel
124
B. PACKAGE LEAFLET
125
PACKAGE LEAFLET: INFORMATION FOR THE USER
GONAL-F
75 IU POWDER AND SOLVENT
FOR SOLUTION FOR INJECTION
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 GONAL-f is and what it is used for
2.
What you need to know before you use GONAL-f
3.
How to use GONAL-f
4.
Possible side effects
5.
How to store GONAL-f
6.
Contents of the pack and other information
How to prepare and use the GONAL-f powder and solvent
1.
WHAT GONAL-F IS AND WHAT IT IS USED FOR
WHAT GONAL-F IS
GONAL-f contains a medicine called “follitropin alfa”. Follitropin
alfa is a type of “follicle
stimulating hormone” (FSH) which belongs to the family of hormones
called “gonadotropins”.
Gonadotropins are involved in reproduction and fertility.
WHAT GONAL-F IS USED FOR
IN ADULT WOMEN,
GONAL-f 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 egg from the ovary (ovulation) in women whose body is
producing very little
gonadotropins (FSH and LH).
•
to help develop several follicles (each containing an egg) in women
undergoing assisted
reproductive technology procedures (procedures that may help you to
become pregnant) such as
“
_in vitro_
fertilisation”, “gamete intra-fallopian transfer” or “zygote
intra-fallopian transfer”.
IN ADULT
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
GONAL-f 75 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 5.5 micrograms of follitropin alfa* equivalent to
75 IU. Each mL of the
reconstituted solution contains 75 IU.
* 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
Powder and solvent for solution for injection.
Appearance of the powder: white lyophilised pellet.
Appearance of the solvent: clear colourless solution.
The pH of the reconstituted solution is 6.5 to 7.5.
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.
•
GONAL-f in association with a luteinising hormone (LH) preparation is
indicated for the
stimulation of follicular development in women with severe LH and FSH
deficiency.
In adult men
_ _
•
GONAL-f 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 with GONAL-f should be initiated under the supervision of a
physician experienced in the
treatment of fertility disorders.
Posology
The dose recommendations given for GONAL-f are those in use for
urinary FSH. Clinical assessment
of GONAL-f indicates that its daily doses, regimens of administration,
and treatment monitoring
procedures should not be different from those currently used for
urinary FSH-containing medicinal
products. It is advised to a
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