ELONVA 100 MCG 0.5 ML

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

CORIFOLLITROPIN ALFA

Fáanlegur frá:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC númer:

G03GA09

Lyfjaform:

SOLUTION FOR INJECTION

Samsetning:

CORIFOLLITROPIN ALFA 100 MCG / 0.5 ML

Stjórnsýsluleið:

S.C

Gerð lyfseðils:

Required

Framleitt af:

ORGANON LLC, USA

Meðferðarhópur:

CORIFOLLITROPIN ALFA

Lækningarsvæði:

CORIFOLLITROPIN ALFA

Ábendingar:

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.

Leyfisdagur:

2016-12-31

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
ELONVA
® 100 MCG/0.5 ML
SOLUTION FOR INJECTION
ELONVA
® 150 MCG/0.5 ML
SOLUTION FOR INJECTION
Each syringe contains:
Each syringe contains:
Corifollitropin alfa 100 mcg/0.5 mL solution
Corifollitropin alfa 150 mcg/0.5 mL solution
For a list of inactive ingredients see section 6.1 "WHAT ELONVA
CONTAINS".
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
This leaflet contains concise information about ELONVA. If you have
any further questions, ask your doctor
or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
medical condition seems similar to yours.
1. WHAT ELONVA IS AND WHAT IT IS USED FOR?
1.1 WHAT IS ELONVA?
THERAPEUTIC GROUP: 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).
1.2 WHAT IS ELONVA USED FOR?
ELONVA causes the growth and development of several follicles at the
same time by a controlled stimulation
of the ovaries in women having infertility treatment.
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.
2. BEFORE YOU USE ELONVA
2.1 DO NOT USE ELONVA IF YOU:
_-_
_ _
are allergic (hypersensitive) to corifollitropin alfa or any of the
other ingredients of this medicine
(listed in section 6)
_-_
_ _
have cancer of the ovary, breast, uterus, or brain (pituitary gland or
hypothalamus)
_-_
_ _
hav

Vara einkenni

1
1.
NAME OF THE MEDICINAL PRODUCT
ELONVA
® 100 MCG /0.5 ML
ELONVA
®
150 MCG /0.5 ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 100 or 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.
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.
2
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 4.1