Elonva Solution for Injection 100mcg0.5ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Corifollitropin alfa

Available from:

ORGANON SINGAPORE PTE. LTD.

ATC code:

G03GA09

Dosage:

0.100mg

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Corifollitropin alfa 0.100mg

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Vetter Pharma-Fertigung, GmbH & Co.KG

Authorization status:

ACTIVE

Authorization date:

2011-03-31

Patient Information leaflet

SG-CCPPI-MK8962-SOi-022019
PACKAGE LEAFLET: INFORMATION FOR THE USER
Elonva®, 100 micrograms/0.5 mL solution for injection
Elonva®, 150 micrograms/0.5 mL solution for injection
corifollitropin alfa
Read all of this leaflet carefully before you start using this
medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please 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 symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Elonva is and what it is used for
2.
Before you use Elonva
3.
How to use Elonva
4.
Possible side effects
5.
How to store Elonva
6.
Further information
1.
WHAT ELONVA IS AND WHAT IT IS USED FOR
Elonva is a solution for injection in a syringe for single use. The
syringe has an automatic safety
system,
which
prevents
needle
stick
injuries
after
use.
It
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).
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 eggs from the
ovary, fertilizing them in the
laboratory, and transferring the embryos into the uterus a few days
later.
Elonva is used to help achieve pregnancy
in women undergoing infertility treatment. It causes
the growth and development of several follicles at the same time by a
controlled stimulation of
the ovaries.
2.
BEFORE YOU USE

Summary of Product characteristics

SG-CCDS-MK8962-SOi-022019
1.
NAME OF THE MEDICINAL PRODUCT
Elonva® 100 micrograms/0.5 mL solution for injection.
Elonva® 150 micrograms/0.5 mL solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
pre-filled
syringe
contains
100 micrograms
of
corifollitropin
alfa
in
0.5 mL 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,
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.
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