ORGALUTRAN 0.25 MG0.5 ML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GANIRELIX

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

H01CC01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

GANIRELIX 0.25 MG / 0.5 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

GANIRELIX

Therapeutic area:

GANIRELIX

Therapeutic indications:

The prevention of premature luteinsing hormone (LT) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).

Authorization date:

2017-05-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
ORGALUTRAN
® 0.25 MG/0.5 ML
SOLUTION FOR INJECTION, FOR SUBCUTANEOUS USE
Each pre-filled syringe contains:
0.25 mg ganirelix in 0.5 ml aqueous solution.
For a list of inactive ingredients see section 6 "FURTHER
INFORMATION". See also section
“Important information about some of the ingredients of
ORGALUTRAN”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about the medicine. 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 ailment seems similar to 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.
1. WHAT THE MEDICINE IS INTENDED FOR?
ORGALUTRAN IS INTENDED FOR THE PREVENTION OF PREMATURE LUTEINISING
HORMONE (LH) SURGES IN
WOMEN UNDERGOING CONTROLLED OVARIAN HYPERSTIMULATION (COH) FOR
ASSISTED REPRODUCTION
TECHNIQUES (ART).
THERAPEUTIC GROUP: anti-gonadotrophin-releasing hormones.
ORGALUTRAN belongs to a group of medicines called
“anti-gonadotrophin-releasing
hormones” which act against the actions of the natural gonadotrophin
releasing hormone
(GnRH). GnRH regulates the release of gonadotrophins (luteinising
hormone (LH) and follicle
stimulating hormone (FSH)).
Gonadotrophins play an important role in human fertility and
reproduction. In women, FSH is
needed for the growth and development of follicles in the ovaries.
Follicles are small round
sacs that contain the egg cells. LH is needed to release the mature
egg cells from the
follicles and ovaries (i.e. ovulation). ORGALUTRAN inhibits the action
of GnRH, resulting in
suppression of the release of especially LH.
ORGALUTRAN is used for
In women undergoing assisted reproduction techniques, including in
vitro fertili

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Orgalutran
®
0.25 mg/0.5 mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 mL
aqueous
solution. The active substance ganirelix (INN) is a synthetic
decapeptide with
high antagonistic activity to the naturally occurring gonadotrophin
releasing
hormone (GnRH). The amino acids at positions 1, 2, 3, 6, 8 and 10 of
the
natural GnRH decapeptide have been substituted resulting in
N-Ac-D-Nal(2)
1
,
D-pClPhe
2
, D-Pal(3)
3
, D-hArg(Et2)
6
, L-hArg(Et2)
8
, D-Ala
10
]-GnRH with a
molecular weight of 1570.4.
Excipient 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.
Clear and colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The prevention of premature luteinising hormone (LH) surges in women
undergoing controlled ovarian hyperstimulation (COH) for assisted
reproduction techniques (ART).
In clinical studies Orgalutran was used with recombinant follicle
stimulating
hormone (FSH) or corifollitropin alfa, the sustained follicle
stimulant.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Orgalutran should only be prescribed by a specialist experienced in
the treatment of
infertility.
Posology_ _
Orgalutran is used to prevent premature LH surges in women undergoing
COH.
Controlled ovarian hyperstimulation with FSH or corifollitropin alfa
may start at day 2
or 3 of menses. Orgalutran (0.25 mg) should be injected subcutaneously
once daily,
starting on day 5 or day 6 of FSH administration or on day 5 or day 6
following the
administration of corifollitropin alfa. The starting day of Orgalutran
is depending on
the ovarian response, i.e. the number and size of growing follicles
and/or the amount
of circulating oestradiol.The start of Orgalutran may be delayed in
absence of
follicular growth, although clinical experience is based on s