Elonva

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

corifollitropin alfa

Saadav alates:

N.V. Organon

ATC kood:

G03GA09

INN (Rahvusvaheline Nimetus):

corifollitropin alfa

Terapeutiline rühm:

Sex hormones and modulators of the genital system,

Terapeutiline ala:

Reproductive Techniques, Assisted; Ovulation Induction; Investigative Techniques

Näidustused:

Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program.Elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG).

Toote kokkuvõte:

Revision: 23

Volitamisolek:

Authorised

Loa andmise kuupäev:

2010-01-25

Infovoldik

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELONVA 100 MICROGRAMS SOLUTION FOR INJECTION
ELONVA 150 MICROGRAMS SOLUTION FOR INJECTION
corifollitropin alfa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or pharmacist.
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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.
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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 Elonva is and what it is used for
2.
What you need to know before you use Elonva
3.
How to use Elonva
4.
Possible side effects
5.
How to store Elonva
6.
Contents of the pack and other information
1.
WHAT ELONVA IS AND WHAT IT IS USED FOR
Elonva contains the active ingredient corifollitropin alfa and belongs
to the group of medicines called
gonadotropic hormones. Gonadotropic hormones play an important role in
human fertility and
reproduction. One of these gonadotropic hormones is Follicle
Stimulating Hormone (FSH), which is
needed in women for the growth and development of follicles (small
round sacs in your ovaries that
contain the eggs) and in adolescent males (14 years and older) for
treatment of delayed puberty due to
hypogonadotropic hypogonadism (HH), in combination with a medicine
called human Chorionic
Gonadotropin (hCG).
In women
Elonva is used to help achieve pregnancy in women having infertility
treatment, such as
_in vitro_
fertilisation (IVF). IVF involves collecting the eggs from the ovary,
fertilising them in the laboratory,
and transferring the embryos into the uterus a few days later. Elonva
causes the growth and
development of several follicles at the same time by a controlled
stimulation of the ovaries.
In adolescent males (14 years

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Elonva 100 micrograms solution for injection
Elonva 150 micrograms solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Elonva 100 micrograms solution for injection
Each pre-filled syringe contains 100 micrograms of corifollitropin
alfa* in 0.5 mL solution for
injection.
Elonva 150 micrograms solution for injection
Each pre-filled syringe contains 150 micrograms of corifollitropin
alfa* in 0.5 mL solution for
injection.
*corifollitropin alfa is a glycoprotein produced in Chinese Hamster
Ovary (CHO) cells by
recombinant DNA technology.
Excipient(s) with known effect
This medicinal product contains less than 1 mmol sodium (23 mg) per
injection, that is to say
essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Elonva is indicated for Controlled Ovarian Stimulation (COS) in
combination with a Gonadotropin
Releasing Hormone (GnRH) antagonist for the development of multiple
follicles in women
participating in an Assisted Reproductive Technology (ART) program.
Elonva is indicated for the treatment of adolescent males (14 years
and older) with hypogonadotropic
hypogonadism, in combination with human Chorionic Gonadotropin (hCG).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Elonva for COS should be initiated under the
supervision of a physician experienced
in the treatment of fertility problems.
Treatment with Elonva for hypogonadotropic hypogonadism should be
initiated and supervised by a
physician experienced in the treatment of hypogonadotropic
hypogonadism.
Posology
In the treatment of women of reproductive age, the dose of Elonva is
based on weight and age.
3
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A single 100-microgram dose is recommended in women who weigh less
than or equal to
60 kilograms and who are 36 years of age or younger.
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A single 150-microgram dose