Elonva solution for injection

Land: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

corifollitropin alfa

Fáanlegur frá:

N.V. Organon

ATC númer:

G03GA09

INN (Alþjóðlegt nafn):

corifollitropin alfa

Skammtar:

100mcg/0,5ml

Lyfjaform:

solution for injection

Einingar í pakka:

(1) pre-filled syringe 0,5ml and needle

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2017-09-05

Vara einkenni

1
1.
NAME OF THE MEDICINAL PRODUCT
ELONVA
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 100 or 150 micrograms of
corifollitropin alfa in a 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 (23 mg) sodium per
injection, i.e.,
essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for subcutaneous injection. Сlear aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Elonva® should be initiated under the supervision of a
physician experienced in
the treatment of fertility problems.
Posology
In the treatment of women of reproductive age, the dose of Elonva is
based on weight and age.
_-_
_ _
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.
_-_
_ _
A single 150-microgram dose is recommended in women:
-
who weigh more than 60 kilograms, regardless of age.
-
who weigh 50 kilograms or more and who are older than 36 years of age.
Women older than 36 years of age who weighed less than 50 kilograms
were not studied.
Body Weight
Less than 50 kg
50 – 60 kg
More than 60 kg
Age
36 years or
younger
100 micrograms
100 micrograms
150 micrograms
Older than 36
years
Not studied.
150 micrograms
150 micrograms
The recommended doses of Elonva have only been established in a
treatment cycle with a GnRH
antagonist
that
was
administered
from
stimulation
day
5
or
day
6
onwards
(see
also
sections “Therapeutic indications”, “Precautions for use” and
“Pharmacodynamic properties”)