Orgalutran 0.25 mg/0.5 ml solution for injection

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 forIn women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, occasionally ovulation may occur too early causing a significant reduction in the chance of getting pregnant. Orgalutran is used to prevent the premature LH surge that might cause such a premature release of egg cells.

In clinical studies Orgalutran was used with recombinant follicle stimulating hormone (FSH) or corifollitropin alfa, a follicle stimulant with a long duration of action.

Do not use Orgalutran

• if you are allergic (hypersensitive) to ganirelix or any of the other ingredients of Orgalutran;
• if you are hypersensitive to gonadotrophin releasing hormone (GnRH) or a GnRH analogue;
• if you have a moderate or severe kidney or liver disease;
• if you are pregnant or breast-feeding.

Take special care with Orgalutran

• if you have an active allergic condition, please tell your doctor. He will decide, depending on the severity, if additional monitoring is required during treatment.
• during or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may develop. This syndrome is related to the stimulation procedure with gonadotrophins. Please refer to the Package Leaflet of the gonadotrophin-containing medicine prescribed for you.
• The incidence of congenital malformations after assisted reproduction techniques may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to characteristics of the patients undergoing fertility treatment (e.g. age of the woman, sperm characteristics) and to the higher incidence of multiple gestations after assisted reproduction techniques. The incidence of congenital malformations after assisted reproduction techniques using Orgalutran is not different from that after using other GnRH analogues in the course of assisted reproduction techniques.
• There is a slightly increased risk of extra-uterine pregnancy in women with damaged fallopian tubes.
• The efficacy and safety of Orgalutran has not been established in women weighing less than 50 kg or more than 90 kg. Ask your doctor for further information.

Use in children

There is no relevant use of Orgalutran in children.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Orgalutran should be used during controlled ovarian stimulation for assisted reproduction techniques (ART). Do not use Orgalutran during pregnancy and breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

The effects of Orgalutran on ability to drive and use machines have not been studied.

Important information about some of the ingredients of Orgalutran

This medicine contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ?sodium-free?.

Always use Orgalutran exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Orgalutran is used as part of the treatment for assisted reproduction techniques (ART) including in-vitro fertilisation (IVF).
Ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin may start at day 2 or 3 of your period. Orgalutran (0.25 mg) should be injected just under the skin once daily, starting on day 5 or day 6 of stimulation. Based on your ovarian response, your doctor may decide to start on another day.
Orgalutran and FSH should be administered approximately at the same time. However, the preparations should not be mixed and different injection sites are to be used.

Daily treatment with Orgalutran should be continued up to the day that sufficient follicles of adequate size are present. Final maturation of the egg cells in the follicles can be induced by administering human chorionic gonadotrophin (hCG). The time between two Orgalutran injections as well as the time between the last Orgalutran injection and hCG injection should not exceed 30 hours, as otherwise a premature ovulation (i.e. release of egg cells) may occur. Therefore, when injecting Orgalutran in themorning treatment with Orgalutran should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation. When injecting Orgalutran in the afternoon the last Orgalutran injection should be given in the afternoon prior to the day of triggering ovulation.

Instructions for use

Injection site

Orgalutran is supplied in pre-filled syringes and should be injected slowly, just under the skin, preferably in the upper leg. Inspect the solution before use. Do not use if the solution contains particles or is not clear. If you administer the injections yourself or have it done by your partner, follow the instructions below carefully. Do not mix Orgalutran with any other medicines.

Preparing the injection site

Wash your hands thoroughly with soap and water. Swab the injection site with a disinfectant (for example alcohol) to remove any surface bacteria. Clean about 5 cm (two inches) around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.

Inserting the needle

Remove needle cover. Pinch up a large area of skin between finger and thumb. Insert the needle at the base of the pinched-up skin at an angle of 45° to the skin surface. Vary the injection site with each injection.

Checking the correct needle position

Gently draw back the plunger to check if the needle is positioned correctly. Any blood drawn into the syringe means the needle tip has penetrated a blood vessel. If this happens, do not inject Orgalutran, but remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure; bleeding should stop in a minute or two. Do not use this syringe and dispose of it properly. Start again with a new syringe.

Injecting the solution

Once the needle has been correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.

Removing the syringe

Pull the syringe out quickly and apply pressure to the site with a swab containing 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 realise that you forgot a dose, administer it as soon as possible.
Do not inject a double dose to make up for a forgotten dose.
If you are more than 6 hours late (so the time between two injections is longer than 30 hours) administer the dose as soon as possible and contact your doctor for further advice.

If you stop using Orgalutran

Do not stop using Orgalutran unless advised to by your doctor, as this may affect the outcome of your treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Orgalutran can cause side effects, although not everybody gets them.

Common side effects (affects 1 to 10 users in 100) are local skin reactions at the site of injection (predominantly redness, with or without swelling). The local reaction normally disappears within 4 hours of administration. Very rarely, in less than 1 user in 10,000, more widespread possibly allergic reactions have been observed.

Uncommon side effects (affects 1 to 10 users in1,000) are headache, nausea and malaise.

In addition, side effects are reported which are known to occur with controlled ovarian hyperstimulation treatment (e.g. abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when the embryo develops outside the womb) and miscarriage (see the patient information leaflet of the FSH-containing preparation you are treated with)).

Worsening of a pre-existing rash (eczema) has been reported in one subject after the first Orgalutran dose.

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.

Keep out of the reach and sight of children.
Do not use Orgalutran after the expiry date which is stated on the carton 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, in order to protect from light.

Inspect the syringe before use. Use only syringes with clear, particle-free solutions and from undamaged containers.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Orgalutran contains

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

What Orgalutran looks like 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 packsizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

N.V. Organon,
Kloosterstraat 6,
Postbus 20,
5340 BH Oss,
The Netherlands.

Manufacturer
Organon (Ireland) Ltd,
P.O. Box 2857,

Drynam Road, Swords,
Co. Dublin,
Ireland.

N.V. Organon,

Kloosterstraat 6,

Postbus 20,
5340 BH Oss,

The Netherlands.

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