Elonva (solution for injection 100mcg0.5ml)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CORIFOLLITROPIN ALFA

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

CORIFOLLITROPIN ALFA

Unit dalam pakej:

0.5ml mL

Dikeluarkan oleh:

VETTER PHARMA-FERTIGUNG GMBH & CO KG

Risalah maklumat

Copyright 2021 Organon group of companies. All rights reserved.
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ELONVA
® SOLUTION FOR INJECTION
corifollitropin alfa (100 mcg/0.5ml, 150 mcg/0.5ml)
WHAT IS IN THIS LEAFLET
1.
What
_ELONVA _
is used for
2.
How
_ELONVA _
works
3.
Before you use
_ELONVA _
4.
How to use
_ELONVA _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_ELONVA _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT _ELONVA _IS USED FOR
_ELONVA _
is used to help achieve
pregnancy in women undergoing
infertility treatment.
HOW _ELONVA _WORKS
_ELONVA _
contains corifollitropin
alfa, a medicine belonging to the
group of 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.
_ELONVA _
is especially designed to
work much longer than FSH. One
single injection of
_ELONVA _
can
replace a whole week of daily FSH
injections in women having
infertility treatment, such as
_in vitro _
fertilization (IVF). IVF involves
collecting the follicles from the
ovary, fertilizing them in the
laboratory, and transferring the
embryos into the uterus a few days
later.
_ELONVA _
causes the growth and
development of several follicles
(small round sacs in your ovaries that
contain the eggs) at the same time by
a controlled stimulation of the
ovaries.
BEFORE YOU USE _ELONVA _
_-_
_ _
_When you must not use it _
_ _
DO NOT USE _ELONVA _IF YOU:

are
ALLERGIC
(hypersensitive) to
corifollitropin alfa or any of the
other ingredients of
_ELONVA _
(for a list of all ingredients, see
“
PRODUCT DESCRIPTION
”)

are pregnant or think you may
be pregnant

have
CANCER
of the ovary, breast,
uterus, or brain (pituitary gland
or hypothalamus)

have recently had
UNEXPECTED
VAGINAL BLEEDING, OTHER THAN
MENSTRUAL, WITHOUT A
DIAGNOSED CAUSE

have ovaries that do not

Ciri produk

S-LPC-OG8962-SOi-022019
Copyright 2021 Organon group of companies. All rights reserved.
1.
NAME OF THE MEDICINAL PRODUCT
Elonva 100 micrograms solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 100 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, using a chemically defined cell culture
medium without the
addition of antibiotics, human- or animal-derived proteins
(protein-free) or any other components
of human or animal origin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colorless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
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.
S-LPC-OG8962-SOi-022019
Copyright 2021 Organon group of companies. All rights reserved.
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 Gn