ORGALUTRAN 0.25 MG/0.5 ML Injectable solution

Зміст інструкції

1. Orgalutran 0.25 mg/0.5 mL injectable solution
   1. What is Orgalutran and what is it used for
   2. What you need to know before using Orgalutran
   3. How to use Orgalutran
   4. Possible side effects
   5. How to store Orgalutran
   6. Contents of the pack and other information

Orgalutran 0.25 mg/0.5 mL injectable solution

ganirelix

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Orgalutran is and what it is used for
• 2. What you need to know before you use Orgalutran
• 3. How to use Orgalutran
• 4. Possible side effects
• 5. How to store Orgalutran
• 6. Contents of the pack and other information

1. What is Orgalutran and what is it used for

Orgalutran contains the active ingredient ganirelix and belongs to a group of medicines called
"gonadotropin-releasing hormone antagonists" which counteracts the actions of the natural
gonadotropin-releasing hormone (GnRH). GnRH regulates the release of gonadotropins (luteinizing hormone (LH) and follicle-stimulating hormone (FSH)).
Gonadotropins play an important role in human fertility and reproduction. In women,
FSH is necessary for the growth and development of follicles in the ovaries. Follicles are small, round sacs
that contain egg cells. LH is necessary to release mature egg cells from the
follicles and ovaries (i.e., for ovulation). Orgalutran inhibits the action of GnRH resulting in the
suppression of the release, especially of LH.
Orgalutran is used for
In women undergoing assisted reproductive technologies, including in vitrofertilization (IVF)
and other methods, ovulation can sometimes occur too early, causing a
significant reduction in the chances of becoming pregnant. Orgalutran is used to prevent the premature release of LH which can cause a premature release of egg cells.
In clinical studies, Orgalutran has been used with recombinant follicle-stimulating hormone (FSH)
or corifollitropin alfa, a follicle-stimulating hormone with a long duration of action.

2. What you need to know before using Orgalutran

Do not use Orgalutran

• if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in section 6),
• if you are hypersensitive (allergic) to gonadotropin-releasing hormone GnRH or a GnRH analogue,
• if you have moderate or severe kidney or liver disease,
• if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before usingOrgalutran
Allergic reactions
If you suffer from an existing allergic condition, tell your doctor. The doctor will decide, depending on the
severity, whether additional checks will be necessary during treatment. Cases of
allergic reactions have been reported, even with the first dose.
Allergic reactions, both generalized and local, have been reported, including hives,
swelling of the face, lips, tongue and/or throat that can cause difficulty breathing and/or swallowing
(angioedema and/or anaphylaxis). (See also section 4.) If you have an allergic reaction, stop
taking Orgalutran and consult a doctor immediately.
Ovarian hyperstimulation syndrome (OHSS)
During or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may occur.
This syndrome is related to the prescribed stimulation procedure.
Multiple pregnancies or congenital anomalies
The incidence of congenital malformations after the application of assisted reproductive technologies may
be slightly higher than that after spontaneous conception. This slightly higher incidence is thought to be related
to the characteristics of patients undergoing fertility treatment (e.g. woman's age, sperm characteristics) and
the higher incidence of multiple pregnancies after the application of assisted reproductive technologies. The
incidence of congenital malformations after application of assisted reproductive technologies using
Orgalutran is not different from that observed with the use of other GnRH analogues during assisted
reproductive technologies.
Pregnancy complications
There is a slight increase in the risk of ectopic pregnancy (a pregnancy outside the uterus) in women with
damage to the fallopian tubes.
Women weighing less than 50 kg or more than 90 kg
The efficacy and safety of Orgalutran have not been established in women weighing less than 50 kg or
more than 90 kg. Ask your doctor for further information.

Children and adolescents
The use of Orgalutran in children or adolescents is not appropriate.

Other medicines and Orgalutran
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy, breastfeeding and fertility
Orgalutran must be used during controlled ovarian stimulation in assisted reproductive technologies (ART). Do
not use Orgalutran during pregnancy and breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
No studies have been performed on the ability to drive vehicles and use machines.

Orgalutran contains sodium
Orgalutran contains less than 1 mmol (23 mg) of sodium per injection, i.e. essentially “sodium-free”.

3. How to use Orgalutran

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Orgalutran is used as part of a treatment for assisted reproductive technologies (ART),
including in vitrofertilization (IVF).
Ovarian stimulation with follicle-stimulating hormone (FSH) or corifollitropin can begin on
day 2 or 3 of the cycle. The injection of Orgalutran (0.25 mg) should be given just under the skin
(subcutaneously), once a day, starting on day 5 or 6 of the stimulation. Based on the
ovarian response, the doctor may decide to start on another day.
Orgalutran and FSH should be administered at approximately the same time. However, the
preparations should not be mixed and the injections should be given at different sites.
Daily treatment with Orgalutran should continue until the day when there is a sufficient number of
follicles of adequate size. The final maturation of the oocytes in the follicles
can be induced by administering human chorionic gonadotropin (hCG). The time
interval between two injections of Orgalutran and between the last injection of Orgalutran and that of hCG should not
exceed 30 hours, otherwise premature ovulation may occur (i.e. the release of oocytes).
Therefore, when administering Orgalutran in the morning, treatment with Orgalutran must be
continued throughout the treatment period with gonadotropin, including the day
of ovulation induction. When administering Orgalutran in the afternoon, the last injection of
Orgalutran should be administered in the afternoon before the day of ovulation
induction.

Instructions for use

Injection site
Orgalutran is supplied in pre-filled syringes and must be injected slowly just under the skin,
preferably in the thigh. Check the solution before use. Do not use if the
solution contains particles or is not clear. You may notice air bubbles in the pre-filled syringe.
This is expected and it is not necessary to remove the air bubbles. If you will be giving yourself the
injections or if they will be given by your partner, carefully follow the instructions below. Do not
mix Orgalutran with any other medicine.

Preparation of the injection site
Wash your hands thoroughly with soap and water. Wipe the injection site with a disinfectant
(e.g. alcohol) to remove bacteria from the surface. Clean approximately 5 centimeters (two inches)
around the point where the needle will penetrate and allow the area to dry for at least one minute before
proceeding.

Needle insertion
Remove the cap from the needle. Pinch a wide area of skin between your thumb and index finger. The needle must
be inserted at the base of the pinched skin area between the two fingers, at an angle of 45°
with respect to the skin surface. Vary the injection site with each administration.

Checking the correct position of the needle
Gently pull back the plunger to check if the needle is in the correct position. The presence of
any blood in the syringe indicates that the needle has penetrated a blood vessel. If this happens, do not
inject Orgalutran but remove the needle, cover the injection site with a swab moistened with
disinfectant and apply some pressure; the bleeding will stop in a minute or two. Do not use the
syringe but dispose of it appropriately. Start again with a new syringe.

Injection of the solution
Once the needle has been positioned correctly, push the plunger slowly and with a steady hand,
so that the solution is correctly injected and the skin tissue is not
damaged.

Removal of the syringe
Quickly remove the needle and apply some pressure to the injection site with a swab
moistened with disinfectant.
Use the pre-filled syringe only once.

If you use more Orgalutran than you should
Contact your doctor.

If you forget to use Orgalutran
If you think you have forgotten a dose, give the injection as soon as possible.
Do not use a double dose to make up for a missed dose.
If more than 6 hours have passed since the usual time of the injection (so that the time interval between the two
injections is more than 30 hours), give the injection as soon as possible andconsult your doctor for further
advice.

If you stop using Orgalutran
Do not stop treatment with Orgalutran unless advised by your doctor, as this
may affect the outcome of the treatment.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possibility of getting a side effect is described according to the following categories:

Very common: may affect more than 1 in 10 women

• Local skin reactions at the injection site (especially redness, with or without swelling). The local reaction usually disappears within 4 hours of administration.

Uncommon: may affect up to 1 in 100 women

• Headache
• Nausea
• Feeling unwell

Very rare: may affect up to 1 in 10,000 women

• Allergic reactions have been observed, even with the first dose.
• Skin rash
• Facial swelling
• Difficulty breathing (dyspnea)
• Swelling of the face, lips, tongue and/or throat that can cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis)
• Urticaria
• In one subject, after the first dose of Orgalutran, a worsening of a pre-existing skin rash (eczema) was reported.

In addition, side effects related to treatment for controlled ovarian hyperstimulation have been reported (e.g. abdominal pain, ovarian hyperstimulation syndrome (OHSS),
ectopic pregnancy (when the embryo develops outside the uterus) and abortion (see the package
leaflet of the FSH-containing product with which she is treated).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system as detailed in Annex V. By reporting side effects you can help
to provide more information on the safety of this medicine.

5. How to store Orgalutran

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the label, after
“Exp.”. The expiry date refers to the last day of that month.
Do not freeze.
Store in the original package to protect the medicine from light.
Check the syringe before use. Use only syringes containing clear solutions, free from
particles and with intact packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Orgalutran contains

• The active substance is ganirelix (0.25 mg in 0.5 mL of solution).
• The other ingredients are acetic acid, mannitol, water for injections. The pH (a measure of acidity) may be adjusted with sodium hydroxide and acetic acid.

Description of Orgalutran and contents of the pack
Orgalutran is a clear and colourless aqueous solution for injection. The solution is ready for use and
intended for subcutaneous administration.
Orgalutran is available in packs of 1 or 5 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
N.V. Organon
Kloosterstraat 6
5349 AB Oss
Netherlands
Manufacturer
N.V. Organon,
Kloosterstraat 6,
Postbus 20,
5340 BH Oss,
Netherlands.
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

Lietuva
Organon Pharma B.V. Lithuania representative office
Tel.: +370 52041693
[email protected]

България
Органон (И.А.) Б.В. - branch Bulgaria
Tel.: +359 2 806 3030
[email protected]

Luxembourg/Luxemburg
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

Česká republika
Organon Czech Republic s.r.o.
Tel: +420 233 010 300
[email protected]

Magyarország
Organon Hungary Kft.
Tel.: +36 1 766 1963
[email protected]

Danmark
Organon Danmark ApS
Tlf: +45 4484 6800
[email protected]

Malta
Organon Pharma B.V., Cyprus branch
Tel: +356 2277 8116
[email protected]

Deutschland
Organon Healthcare GmbH
Tel.: 0800 3384 726 (+49 (0) 89 2040022 10)
[email protected]

Nederland
N.V. Organon
Tel: 00800 66550123 (+32 2 2418100)
[email protected]

Eesti
Organon Pharma B.V. Estonian RO
Tel: +372 66 61 300
[email protected]

Norge
Organon Norway AS
Tlf: +47 24 14 56 60
[email protected]

Ελλάδα
BIANEΞ Α.Ε.
Τηλ: +30 210 80091 11
[email protected]

Österreich
Organon Healthcare GmbH
Tel: +49 (0) 89 2040022 10
[email protected]

España
Organon Salud, S.L.
Tel: +34 91 591 12 79
[email protected]

Polska
Organon Polska Sp. z o.o.
Tel.: +48 22 105 50 01
[email protected]

France
Organon France
Tél: +33 (0) 1 57 77 32 00

Portugal
Organon Portugal, Sociedade Unipessoal Lda.
Tel: +351 218705500
[email protected]

Hrvatska
Organon Pharma d.o.o.
Tel: +385 1 638 4530
[email protected]

România
Organon Biosciences S.R.L.
Tel: +40 21 527 29 90
[email protected]

Ireland
Organon Pharma (Ireland) Limited
Tel: +353 15828260
[email protected]

Slovenija
Organon Pharma B.V., Oss, branch Ljubljana
Tel: +386 1 300 10 80
[email protected]

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Organon Slovakia s. r. o.
Tel: +421 2 44 88 98 88
[email protected]

Italia
Organon Italia S.r.l.
Tel: +39 06 90259059
[email protected]

Suomi/Finland
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520
[email protected]

Κύπρος
Organon Pharma B.V., Cyprus branch
Tel: +357 22866730
[email protected]

Sverige
Organon Sweden AB
Tel: +46 8 502 597 00
[email protected]

Latvija
Foreign trader “Organon Pharma B.V.”
representation
Tel: +371 66968876
[email protected]

United Kingdom (Northern Ireland)
Organon Pharma (UK) Limited
Tel: +44 (0) 208 159 3593
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu .