ELONVA corifollitropin alfa 150 micrograms/0.5mL solution for injection prefilled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Corifollitropin alfa, Quantity: 0.3 mg/mL

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

Corifollitropin alfa

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium citrate dihydrate; sucrose; hydrochloric acid; polysorbate 20; water for injections; sodium hydroxide; methionine

Administration route:

Subcutaneous

Units in package:

1 pre-filled syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Controlled Ovarian Stimulation (COS) for the development of multiple follicles and pregnancy in women undergoing in-vitro fertilisation techniques.

Product summary:

Visual Identification: Clear and colourless aqueous solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2010-07-30

Patient Information leaflet

ELONVA®
1
ELONVA
®
_Corifollitropin alfa (rch) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ELONVA.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using ELONVA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, TELL YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT ELONVA IS USED
FOR
ELONVA contains corifollitropin
alfa, a medicine belonging to the
group of gonadotrophic hormones.
These hormones play an important
part in human fertility and
reproduction. One of these
gonadotrophic 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 participating in
in vitro fertilisation (IVF).
ELONVA is used to help achieve
pregnancy in women having
infertility treatment, such as IVF.
ELONVA causes the growth and
development of several follicles at
the same time by controlled
stimulation of the ovaries. The eggs
are collected from the ovary,
fertilised in the laboratory and the
embryos are transferred into the
uterus a few days later.
ELONVA is not addictive.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU USE
ELONVA
_WHEN YOU MUST NOT USE IT _
DO NOT USE ELONVA IF YOU:
•
are allergic (hypersensitive) to
corifollitropin alfa or to any of
the ingredients in ELONVA
listed at the end of this leaflet.
•
are pregnant or think you may be
pregnant.
•
are breastfeeding.
•
have cancer of the ovary, breast,
uterus, or brain (pituitary gland or
hypothalamus).
•
have recently had unexpected
v

Summary of Product characteristics

CCDS-MK8962-SOi-022019 A200415
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
ELONVA
®
(CORIFOLLITROPIN ALFA (RCH))
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Corifollitropin alfa (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Corifollitropin alfa solution for injection.
ELONVA (CORIFOLLITROPIN ALFA) 100 MICROGRAMS/ 0.5 ML
ELONVA (CORIFOLLITROPIN ALFA) 150 MICROGRAMS/ 0.5 ML
Each pre-filled syringe contains 100 micrograms or 150 micrograms of
corifollitropin alfa in 0.5
mL solution for injection.
Corifollitropin alfa is 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 the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for Injection.
ELONVA is presented as a sterile, ready for use, clear and colourless
aqueous solution for
subcutaneous administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Controlled ovarian stimulation (COS) for the development of multiple
follicles and pregnancy
in women undergoing _in-vitro_ fertilisation techniques.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with ELONVA should be initiated under the supervision of a
physician experienced
in the treatment of fertility problems.
ELONVA may be administered by the woman herself or her partner,
provided that proper
instructions are given by the physician. Self-administration of ELONVA
should only be
performed by women who are well-motivated, adequately trained and with
access to expert
advice.
Do not use if the solution contains particles or if the solution is
not clear. Product is for single
use in one patient only. Contains no antimicrobial preservative.
Discard any residue.
CCDS-MK8962-SOi-022019 A200415
Page 2 of 15
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