GONAL-F

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

FOLLITROPIN ALFA

Fáanlegur frá:

MERCK SERONO LTD

ATC númer:

G03GA05

Lyfjaform:

SOLUTION FOR INJECTION

Samsetning:

FOLLITROPIN ALFA 600 IU/ML

Stjórnsýsluleið:

S.C

Gerð lyfseðils:

Required

Framleitt af:

MERCK EUROPE B.V., THE NETHERLANDS

Meðferðarhópur:

FOLLITROPIN ALFA

Lækningarsvæði:

FOLLITROPIN ALFA

Ábendingar:

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.

Leyfisdagur:

2014-08-31

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
Solution for injection in a pre-filled pen
For subcutaneous injection
Active ingredient:
Follitropin Alfa 600 IU*/1 mL (44 mcg/1 mL)
Available in the following doses:
GONAL-f
®
300 IU/0.5 mL
GONAL-f
®
450 IU/0.75 mL
GONAL-f
®
900 IU/1.5 mL
(*IU – international units)
Inactive ingredients and allergens in this medicine – see section 6.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the doctor or
pharmacist. Keep this leaflet at hand; you may need to read it again.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems that their medical condition is similar.
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.
1.
WHAT IS THE MEDICINE INTENDED FOR
GONAL-f is a medicine that contains follitropin alfa. This is a type
of Follicle Stimulating
Hormone (FSH) which belongs to the family of hormones called
“gonadotropins” that are
involved in reproduction and fertility. Follitropin alfa is generated
using genetic engineering
technology.
GONAL-f is used for the following situations:
In women:
•
To help in release of an egg from the ovary (ovulation) in women who
cannot ovulate
and who have not responded to treatment with a medicine called
“clomiphene citrate”.
•
In combination with another medicine called “lutropin alfa”
(luteinizing hormone or LH) -
to help release an egg from the ovary (ovulation) in women who do not
ovulate because
their bodies produce very little gonadotropins (FSH and LH).
•
To help in the development of several follicles (which contain eggs)
in women
undergoing fertility treatments (a procedure that helps you to become
pregnant), such
as in vitro fertiliz

Vara einkenni

PRESCRIBING INFORMATION
GONAL
® F
1.
NAME OF THE MEDICINAL PRODUCT
GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in
a pre-filled pen.
GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection
in a pre-filled pen.
GONAL-f 900 IU/1.5 mL (66 micrograms/1.5 mL) solution for injection in
a pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 600 IU of follitropin alfa*, (equivalent
to 44 micrograms).
Each pre-filled multidose pen delivers 300 IU (equivalent to 22
micrograms) in 0.5 mL.
Each pre-filled multidose pen delivers 450 IU (equivalent to 33
micrograms) in 0.75 mL.
Each pre-filled multidose pen delivers 900 IU (equivalent to 66
micrograms) in 1.5 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 a pre-filled pen.
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 patients undergoing
superovulation for assisted reproductive
technologies (ART) such as
_in vitro_
fertilization (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 < 1.2 IU/L
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
gonadotrophin (hCG) therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with GONAL-f sho