0.25 mg / 0.5 ml solution for injection
ganirelix
What Orgalutran is and what it is used for
Orgalutran contains the active substance ganirelix and belongs to a group of medicines called ‘anti-gonadotropin-releasing hormones’ which counteract the effects of the natural gonadotropin-releasing hormone ( GnRH ). GnRH controls the release of one of the gonadotropins (luteinizing hormone ( LH ) and follicle-stimulating hormone ( FSH )). Gonadotropins play an important role in human fertility and reproduction. In women, FSH is needed for the growth and maturation of follicles in the ovaries. Follicles are small round blisters that contain egg cells. LH is needed for the mature egg cells to detach from the follicles and ovaries (ie ovulation). Orgalutran counteracts the effect of GnRH, which results in a reduction in the release of one of, above all, LH.
What Orgalutran is used for
For women undergoing assisted reproduction, including in vitro fertilization (IVF) and other methods, premature ovulation can occasionally occur, leading to a significantly reduced chance of becoming pregnant. Orgalutran is used to prevent premature LH increases that can cause premature ovulation.
In clinical trials, Orgalutran was used in combination with a recombinant follicle -stimulating hormone ( FSH ) or chorifollitropin alfa, a long-acting follicle stimulator.
What you need to know before you use 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 to gonadotropin-releasing hormone ( GnRH ) or GnRH analogue
- if you have moderate or severe renal or hepatic impairment
- if you are pregnant or breastfeeding.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Orgalutran
Allergic reactions
If you have an active allergic condition, talk to your doctor. Your doctor will decide, depending on the severity, if additional checks are needed during treatment. Cases of allergic reactions have been reported, as early as after the first dose.
Allergic reactions, both general and local, including hives ( urticaria ), swelling of the face, lips, tongue, and / or throat that may cause difficulty breathing and/or swallowing ( angioedema and/or anaphylaxis ) have been reported (see also section 4). If you get an allergic reaction, stop taking Orgalutran and seek immediate medical attention.
Latex allergy
The needle cover contains latex (dry natural rubber) which comes into contact with the needle, and can cause allergic reactions.
Ovarian hyperstimulation syndrome (OHSS)
During and after hormonal stimulation of the ovaries, and overstimulation condition may develop. This condition is related to the stimulation procedure with gonadotropins. See the package leaflet for the gonadotropin preparation you have been prescribed.
Multiple births or congenital malformations
The incidence of congenital malformations after assisted reproduction may be slightly higher than after spontaneous conception. This slightly increased risk is thought to be related to the characteristics of patients undergoing fertility treatment (eg woman’s age, sperm characteristics) and because multiple pregnancies are more common after assisted reproduction. The incidence of congenital malformations after assisted reproduction using Orgalutran does not differ from the use of other GnRH analogs during assisted reproduction.
Pregnancy complications
There is a slightly increased risk of ectopic pregnancy (ectopic pregnancy) in women with damaged 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 more information.
Children and young people
There is no relevant use of Orgalutran for children or adolescents.
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 should be used in controlled ovarian stimulation for assisted reproduction (ART).
Do not use Orgalutran during pregnancy and lactation.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
The effects of Orgalutran on the ability to drive and use machines have not been studied.
Orgalutran contains sodium
Orgalutran contains less than 1 mmol (23 mg) sodium per injection, ie essentially ‘sodium-free’.
How to use Orgalutran
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Orgalutran is used as part of assisted reproduction (ART) treatment including in vitro fertilization (IVF).
Stimulation of the ovaries with follicle-stimulating hormone ( FSH ) or chorifollitropin can start on day 2 or 3 of your period. Orgalutran (0.25 mg) should be injected directly under the skin once daily, starting on day 5 or day 6 of the stimulation. Depending on how your ovaries react, your doctor may decide that you should start on another day. Orgalutran should not be mixed with FSH, but both preparations should be given at approximately the same time but not at the same injection site.
Daily treatment with Orgalutran should be continued until you have a sufficient number of follicles of sufficient size. The final maturation of the egg cells in the follicles can be initiated by injection of human chorionic gonadotropin ( hCG ). The time between two Orgalutran injections and between the last Orgalutran injection one and hCG injection one should not exceed 30 hours, as premature ovulation
(ie release of egg cells) otherwise can occur. Therefore, when Orgalutran is injected in the morning, Orgalutran treatment should be continued throughout the treatment period with gonadotropin, including the day of ovulation induction. When injecting Orgalutran in the afternoon, the last Orgalutran injection should be given in the afternoon the day before ovulation induction.
User instructions
Injection site
Orgalutran is available as prefilled syringes and should be injected slowly directly under the skin, preferably in the thigh. Check the solution before using it. Do not use the solution if it is not free of particles or is not ready. You may see air bubbles in the pre-filled syringe, this is expected and it is not necessary to remove them. If you give the injections yourself or if your partner does, follow the instructions carefully. Do not mix Orgalutran with other medicines.
Preparation of the injection site
Wash your hands thoroughly with soap and water. Wash the injection site with a disinfectant (eg alcohol) to remove bacteria from the skin. Clean about 5 cm around the place where the needle is to be inserted and let the disinfectant dry for at least one minute before continuing.
Insertion of the needle
Remove the cover from the needle. Pinch between the thumb and forefinger a large area of the skin. Insert the needle at the base of the pinched skin at an angle of 45 ° to the surface of the skin. Vary the injection site with each injection.
Checking the position of the needle
Carefully pull back on the plunger to check that the needle is in the correct position. If blood is drawn into the syringe, it means that the tip of the needle has entered a blood vessel. If this happens, do not inject Orgalutran, but remove the syringe, cover the injection site with a swab soaked in disinfectant and apply pressure, it should stop bleeding within a minute or two. Do not use this syringe but dispose of it properly. Start over with a new syringe.
Injection of the solution
When the needle is positioned correctly, push the plunger in slowly and steadily so that the solution is injected correctly and the skin is not damaged.
Removal of the needle
Quickly pull out the needle and press against the injection site with a swab of 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 find that you have missed a dose, take it as soon as possible.
Do not take a double dose to make up for a forgotten dose.
If you are more than 6 hours late (so that the time between two injections is more than 30 hours) take a dose as soon as possible and contact your doctor for further advice.
If you stop using Orgalutran
Do not stop taking Orgalutran unless your doctor tells you to, as it may affect the outcome of your treatment.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The occurrence of 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 after injection .
Uncommon: may affect up to 1 in 100 women
- headache
- nausea
- general malaise.
Very rare: may affect up to 1 in 10,000 women
- Allergic reactions have been observed, as early as after the first dose .
- rash
- facial swelling
- shortness of breath ( dyspnoea )
- swelling of the face, lips, tongue and / or throat which may cause difficulty in breathing and / or swallowing ( angioedema and / or anaphylaxis )
- hives ( urticaria )
- Deterioration of an existing rash ( eczema ) has been reported in a patient after the first Orgalutrandos .
In addition, side effects have been reported that are known to be associated with controlled ovarian hyperstimulation therapy (eg abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when an embryo develops outside the uterus), and miscarriage (see package leaflet for the FSH product you are being treated with).
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 label and carton after EXP. The expiry date is the last day of that month.
Do not freeze.
Store in the original package. Sensitive to light.
Check the syringe before use. Only use syringes with the clear, particle-free solution and from undamaged packaging.
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.
Contents of the pack and other information
Content declaration
- 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 measure of the acidity) may have been adjusted with sodium hydroxide and acetic acid.
What the medicine looks like and contents of the pack
Orgalutran is a clear and colorless water solution for injection. The solution is ready to use and intended for subcutaneous administration. The needle cover contains latex (dry natural rubber) which comes into contact with the needle.
Orgalutran is available in packs of 1 or 5 pre-filled syringes.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
NV Organon
Kloosterstraat 6
5349 AB Us
The Netherlands
Manufacturer
NV Organon
Kloosterstraat 6
PO Box 20
5340 BH Oss
Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
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