Elonva

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Corifollitropin alfa 0.2 mg/mL;  

Disponibbli minn:

Organon (New Zealand) Limited

INN (Isem Internazzjonali):

Corifollitropin alfa 0.2 mg/mL

Dożaġġ:

100 mcg/0.5mL

Għamla farmaċewtika:

Solution for injection

Kompożizzjoni:

Active: Corifollitropin alfa 0.2 mg/mL   Excipient: Hydrochloric acid Methionine Polysorbate 20 Sodium citrate Sodium hydroxide Sucrose Water for injection

Unitajiet fil-pakkett:

Syringe, glass, Pre-filled glass syringe closed with rubber plunger and tip cap., 1 dose unit

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

NV Organon

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Package - Contents - Shelf Life: Syringe, glass, Pre-filled glass syringe closed with rubber plunger and tip cap. - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 1 months from date of manufacture stored at or below 25°C

Data ta 'l-awtorizzazzjoni:

2009-05-22

Fuljett ta 'informazzjoni

S-CCPPI-MK8962-SOi-022019
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.
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.
•
have malformations of the sexual
organs which make a normal
pregnancy impossible.
•
have fibroid tumours in the uterus
which make a normal pregnancy
impossible.
•
Have risk factors of ovarian
hyperstimulation syndrome
(OHSS). OHSS is a serious
medical problem that can happen
when the ovaries are overly
stimulated (see
_BEFORE YOU START _
_TO USE IT: OVARIAN _
_HYPERSTIMULATION SYNDROME _
_(OHSS) _
for further explanation).
o
have polycystic ovarian
syndrome (PCOS)
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

Karatteristiċi tal-prodott

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ELONVA
®
100 micrograms solution for injection
ELONVA
®
150 micrograms solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 100 micrograms or 150 micrograms of
corifollitropin alfa in 0.5 mL
solution for injection.
Corifollitropin alfa, a gonadotrophin designed as a sustained follicle
stimulant is a glycoprotein
consisting of two non-covalently linked non-identical subunits called
α and β. The α-subunit is identical
to that of human follicle-stimulating hormone (FSH); the β-subunit is
composed of the complete β-
subunit of human FSH (residues 1-111) extended with the
carboxy-terminal peptide (CTP) of the β–
subunit of human chorionic gonadotrophin (hCG) (residues 118-145).
_CAS No_.: 195962-23-3.
α
-subunit
APDVQDCPEC TLQENPFFSQ PGAPILQCMG CCFSRAYPTP
*
*
LRSKKTMLVQ KNVTSESTCC VAKSYNRVTV MGGFKVENHT
ACHCSTCYYH KS
β
-subunit
*
*
NSCELTNITI AIEKEECRFC ISINTTWCAG YCYTRDLVYK
DPARPKIQKT CTFKELVYET VRVPGCAHHA DSLYTYPVAT
&&
QCHCGKCDSD STDCTVRGLG PSYCSFGEMK ESSSSKAPPP
&
&
& &
SLPSPSRLPG PSDTPILPQ
* = N-glycosylation sites
& = O-glycosylation sites
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.
Excipient(s) with known effect:
ELONVA contains less than 1 mmol sodium (23 mg) per injection, i.e.
essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless aqueous solution.
Page 2 of 13
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