Ovaleap

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

follitropin alfa

Διαθέσιμο από:

Theramex Ireland Limited

Φαρμακολογική κατηγορία (ATC):

G03GA05

INN (Διεθνής Όνομα):

follitropin alfa

Θεραπευτική ομάδα:

Sex hormones and modulators of the genital system,

Θεραπευτική περιοχή:

Anovulation

Θεραπευτικές ενδείξεις:

In adult womenAnovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene 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;Ovaleap 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 menOvaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.

Περίληψη προϊόντος:

Revision: 10

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-09-27

Φύλλο οδηγιών χρήσης

32
B. PACKAGE LEAFLET
33
Package leaflet: Information for the user
Ovaleap 300 IU/0.5 mL solution for injection
Ovaleap 450 IU/0.75 mL solution for injection
Ovaleap 900 IU/1.5 mL 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
What is in this leaflet
1.
What Ovaleap is and what it is used for
2.
What you need to know before you use Ovaleap
3.
How to use Ovaleap
4.
Possible side effects
5.
How to store Ovaleap
6.
Contents of the pack and other information
1.
What Ovaleap is and what it is used for
What Ovaleap 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 Ovaleap is used for
In adult women, Ovaleap is used:
•
to help ovulation (release of a mature egg cell from the follicle) in
women that cannot ovulate
and that have not responded to treatment with a medicine called
“clomifene citrate”.
•
to help follicles develop 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 combination with a

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ovaleap 300 IU/0.5 mL solution for injection
Ovaleap 450 IU/0.75 mL solution for injection
Ovaleap 900 IU/1.5 mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of the solution contains 600 IU (equivalent to 44 micrograms)
follitropin alfa*.
Ovaleap 300 IU/0.5 mL solution for injection
Each cartridge contains 300 IU (equivalent to 22 micrograms)
follitropin alfa in 0.5 mL solution for
injection.
Ovaleap 450 IU/0.75 mL solution for injection
Each cartridge contains 450 IU (equivalent to 33 micrograms)
follitropin alfa in 0.75 mL solution for
injection.
Ovaleap 900 IU/1.5 mL solution for injection
Each cartridge contains 900 IU (equivalent to 66 micrograms)
follitropin alfa in 1.5 mL solution for
injection.
*Follitropin alfa (recombinant human follicle-stimulating hormone
[r-hFSH]) is produced in Chinese
Hamster Ovary Cells (CHO DHFR
-
) by recombinant DNA technology.
Excipient(s) with known effect:
Ovaleap contains 0.02 mg per mL of benzalkonium chloride
Ovaleap contains 10.0 mg per mL of benzyl alcohol
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 6.8 to 7.2.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
In adult women
•
Anovulation (including polycystic ovarian syndrome) in women who have
been unresponsive to
treatment with clomifene 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.
•
Ovaleap in association with a luteinising hormone (LH) preparation is
indicated for the
stimulation of follicular development in women with severe LH and FSH
deficiency.
3
In adult men
•
Ovaleap is indicated for the stimulation of spermatogenesis in men who
have congenital or
acquired hypogonadotropic hypogonad