Prospect: information for the user

Ganirelix Gedeon Richter 0.25 mg/0.5 ml injectable solution in preloaded syringe

ganirelix

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

Ganirelix Gedeon Richter contains the active ingredient ganirelix and belongs to a group of medicines called “gonadotropin-releasing hormone antagonists” that acts against the action of the endogenous 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. FSH is necessary in women for the growth and development of follicles in the ovaries. Follicles are small rounded vesicles that contain the oocytes. LH is necessary for the mature oocytes to be released from the follicles of the ovaries (i.e., ovulation). This medicine inhibits the action of GnRH, which causes the suppression of the release especially of LH.

What is Ganirelix Gedeon Richter used for

In women undergoing assisted reproduction techniques, such as in vitro fertilization (IVF) and other methods, premature ovulation may occasionally occur, which causes a significant reduction in the probability of becoming pregnant. This medicine is used to prevent the premature release of LH, which can cause premature ovulation.

In clinical studies, ganirelix was used with recombinant follicle-stimulating hormone (FSH) or with corifolitropin alfa, a prolonged-acting follicular stimulant.

Do not use Ganirelix Gedeon Richter

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Ganirelix Gedeon Richter.

Allergic reactions

If you have an active allergy, inform your doctor. Your doctor will decide, depending on the severity, if additional controls are needed during treatment. Cases of allergic reactions, even after the first dose, have been observed.

Generalized and localized allergic reactions, including hives (urticaria), facial swelling, lip, tongue, and/or throat swelling that may cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis) (see also section 4). If you have an allergic reaction, stop using Ganirelix Gedeon Richter and seek medical assistance immediately.

Ovarian Hyperstimulation Syndrome (OHSS)

During or after hormonal stimulation of the ovaries, Ovarian Hyperstimulation Syndrome (OHSS) may develop. This syndrome is related to the gonadotropin stimulation procedure. We recommend that you read the prospectus of the gonadotropin medication that you have been prescribed.

Multiple births or birth defects

The incidence of congenital malformations after the use of assisted reproduction techniques may be slightly higher than after spontaneous conceptions. This slightly higher incidence is considered to be related to the characteristics of patients undergoing fertility treatments (e.g., age of the woman, semen characteristics) and the higher incidence of multiple pregnancies registered after the use of assisted reproduction techniques. The incidence of congenital malformations after the use of Ganirelix in assisted reproduction techniques is not different from the incidence with the use of other GnRH analogs in assisted reproduction techniques.

Pregnancy complications

There is a slight increase in the risk of an ectopic pregnancy in women with damaged fallopian tubes.

Women weighing less than 50 kg or more than 90 kg

The efficacy and safety of Ganirelix have not been established in women weighing less than 50 kg or more than 90 kg. Consult your doctor for more information.

Children and adolescents

The use of Ganirelix Gedeon Richter is not appropriate in children or adolescents.

Use of Ganirelix Gedeon Richter with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Pregnancy, breastfeeding and fertility

Ganirelix Gedeon Richter should be used during controlled ovarian stimulation for assisted reproduction techniques (ART).

Do not use Ganirelix Gedeon Richter during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Driving and operating machines

The effects of Ganirelix Gedeon Richter on the ability to drive and operate machines have not been studied.

Ganirelix Gedeon Richter contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per injection, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Ganirelix Gedeon Richter is used as part of the treatment in assisted reproduction techniques (ART), including in vitro fertilization (IVF).

Ovarian stimulation with follicle-stimulating hormone (FSH) or with corifolitropin may start on the second or third day of your menstruation. Ganirelix Gedeon Richter (0.25 mg) must be injected into the fatty layer just below the skin once a day, starting on the fifth or sixth day of stimulation. Depending on your ovarian response, your doctor may decide to start on another day.

Ganirelix Gedeon Richter and FSH must be administered approximately at the same time. However, these medications should not be mixed and should be injected in different locations.

Daily treatment with Ganirelix Gedeon Richter should be continued until there are sufficient follicles of adequate size. The final maturation of the oocytes in the follicles may be induced by administering human chorionic gonadotropin (hCG). The time elapsed between two injections of Ganirelix Gedeon Richter and the injection of hCG should not exceed 30 hours, otherwise premature ovulation (i.e., release of oocytes) may occur.

Therefore,if the Ganirelix Gedeon Richter injection is in the morning, treatment with Ganirelix Gedeon Richter should be maintained throughout the entire treatment period with gonadotropin, including the day when ovulation is induced.

If the Ganirelix Gedeon Richter injection is in the afternoon, the last injection of Ganirelix Gedeon Richter should be administered in the evening before the day when ovulation is induced.

Instructions for use

Before administering this medication, it is very important that you also read carefully and follow exactly the detailed instructions for use provided at the end of this leaflet.

Injection site

Ganirelix Gedeon Richter is presented in pre-filled syringes and should be injected slowly just below the skin, preferably in the thigh. Check the solution before use. Do not use the solution if it contains particles or is not transparent. You may notice air bubbles in the pre-filled syringe. This is expected to occur and is not necessary to remove the air bubbles. If you administer the injections yourself or your partner, follow exactly the instructions that appear below and at the end of the leaflet. Do not mix Ganirelix Gedeon Richter with other medications.

Preparation of the injection site

Wash your hands thoroughly with water and soap. The injection site should be cleaned with a disinfectant (e.g. alcohol) to eliminate bacteria from the surface. Clean a 5 cm area around the point where you will be pinched and let the disinfectant dry for at least one minute before injecting.

Insertion of the needle

Remove the needle protector. Pinch a large area of skin between your index and middle fingers. Insert the needle into the base of the area where you have pinched the skin at an angle of 45° with respect to the skin surface. The injection site should be varied for each injection.

Checking the correct position of the needle

Withdraw the plunger gently to check if the needle is in the correct position. If blood enters the syringe, it means that the tip of the needle has penetrated a blood vessel. If this occurs, do not inject Ganirelix Gedeon Richter, but rather remove the syringe, cover the injection site with a gauze pad with disinfectant and press; it should stop bleeding within one or two minutes. Do not use this syringe and dispose of it properly. Start again with a new syringe.

Injection of the solution

Once the needle is correctly positioned, press the plunger slowly and constantly to inject the solution correctly and not to damage the skin tissues. Press the plunger until the syringe is empty and wait 5 seconds.

Removal of the syringe

Withdraw the syringe quickly and press on the injection site with a gauze pad with disinfectant. Use the pre-filled syringe only once.

If you use more Ganirelix Gedeon Richter than you should

Consult your doctor.

If you forget to use Ganirelix Gedeon Richter

If you realize that you have forgotten to inject a dose, administer it as soon as possible. Do not administer a double dose to compensate for the missed doses.

If you delay more than 6 hours (i.e., the interval between two injections is prolonged more than 30 hours), administer the dose as soon as possible and consult your doctor for advice.

If you interrupt treatment with Ganirelix Gedeon Richter

Do not stop using Ganirelix Gedeon Richter unless your doctor tells you to, as this may affect the outcome of your treatment.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The possibility of experiencing an adverse effect is classified in the following categories:

Very common (may affect more than 1 in 10 women)

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

Rare (may affect up to 1 in 100 women)

• Headache
• Nausea
• General feeling of discomfort (discomfort)

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

• Allergic reactions have been observed, even after the first dose.

• Rash
• Facial swelling
• Difficulty breathing (dyspnea)
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis)
• Hives (urticaria)

• After the first dose of ganirelix, worsening of an existing eczema has been reported in a patient.

In addition, adverse effects related to controlled ovarian hyperstimulation treatment (such as abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when the embryo develops outside the uterus), and miscarriage (see the prospectus of the FSH medication you are using)) have been observed.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V.. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and the box after CAD. The expiration date is the last day of the month indicated.

Do not freeze.

Store in the original container to protect it from light.

Inspect the syringe before use. The syringe should only be used if the solution is transparent and particle-free and the container is not damaged.

Each preloaded syringe is for a single use of the injection.

For the administration of this medication, you will need alcohol swabs, gauze, and a sharps container, but they are not included in the packaging.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Ganirelix Gedeon Richter

• The active ingredient is ganirelix (0.25 mg in 0.5 ml of solution).
• The other components are: glacial acetic acid, mannitol (E 421), water for injectable preparations. The pH (acidity measurement) may have been adjusted with sodium hydroxide (see section 2 “Ganirelix Gedeon Richter contains sodium”).

Appearance of Ganirelix Gedeon Richter and contents of the package

Ganirelix Gedeon Richter is a transparent and colorless injectable solution. The medication is packaged in a glass syringe with a stainless steel needle, closed with a stopper and a plunger rod. The injection needle is provided with a rigid protector.

Ganirelix Gedeon Richter is available in packages of 1 or 6 preloaded syringes.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Last review date of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu

Instructions for use

HOW TO PREPARE AND ADMINISTER GANIRELIX GEDEON RICHTER IN A PRELOADED SYRINGE

Before administering this medicine, read these instructions carefully and the entire leaflet.

These instructions will help you know how to administer the Ganirelix Gedeon Richter injection yourself or to your partner. If you are unsure about administering the injection or have any doubts, consult your doctor or pharmacist.

Do not mix Ganirelix Gedeon Richter with any other medicine.

Administer the injection at the same time every day.

Each preloaded syringe contains a daily dose of ganirelix.

Each preloaded syringe contains a daily dose of ganirelix.

CONTENT OF THE INSTRUCTIONS FOR USE

1. Preparation of the injection
2. Preparation of the injection site
3. Injection of the medicine
4. After the injection

1. Preparation of the injection

• Wash your hands thoroughly with water and soap. It is essential that your hands and the utensils you use are as clean as possible to avoid infections.
• Find a clean area to place the utensils you need for the injection, for example, a clean table or a horizontal surface.
• Gather everything you need and place it in the clean area:

• Disinfectant swabs (e.g. alcohol)
• 1 preloaded syringe with the medicine

• Do not hold the syringe by the plunger to avoid it coming apart.
• Do not use this medicine after the expiration date indicated on the label and the box after CAD. The expiration date is the last day of the month indicated.
• A container for sharp objects (e.g. a plastic bottle with a sufficiently large opening) to safely dispose of the used syringe.

• Inspect the solution before using it.
• It is possible to see air bubbles in the preloaded syringe. This is expected, and it is not necessary to remove the air bubble(s).
• Do not use the syringe if:

• it is cracked or damaged, or
• the needle protector has been removed or is not properly placed or
• there is a leak of liquid or
• the solution has an abnormal appearance (contains particles or is not colorless).

If any of these situations occur, you must safely dispose of the syringe in the container for sharp objects and use another one.

1. Preparation of the injection site

• Choose the injection site, preferably in the thigh. The injection site should be varied to prevent damaging the tissue under the skin.

• Do not inject in any sensitive, damaged, or bruised area. Always choose an intact area of skin for injecting the medicine.
• Do not inject through clothing.
• Administer Ganirelix Gedeon Richter and the follicle-stimulating hormone (FSH) approximately at the same time. However, these medicines should not be mixed and should be administered in different locations.
• Clean the injection site with a disinfectant (e.g. alcohol) at the chosen injection site to remove any superficial bacteria. Clean a 5 cm (2 inch) diameter area around the point where the needle will enter and let the disinfectant dry for about 1 minute before proceeding.
• Do not touch the injection site or blow on it before the injection.

1. Injection of the medicine

• You will receive Ganirelix Gedeon Richter in preloaded syringes with an integrated needle, ready for administration without further adjustments to the syringe.
• Take 1 syringe from the package by holding it by the middle of the syringe body.
• Remove the needle protector from the syringe by holding it horizontally and pointing in the opposite direction to you. Pull the needle protector off, do not turn it.

• When handling the syringe, do not touch the needle tip or the needle with your fingers to avoid contamination.
• At the chosen and cleaned injection site, pinch a fold of skin between your index and middle fingers.

• Administer Ganirelix Gedeon Richter subcutaneously, that is, in the fatty layer just below the skin.
• Hold the syringe with one hand to be able to place your thumb on the plunger when needed. Insert the needle completely with a quick and firm movement in the center of the skin fold at an angle of 45° relative to the skin surface.

• Withdraw the plunger gently to check if the needle is correctly placed.
• If blood enters the syringe, it means that the needle has penetrated a blood vessel. If this occurs, do not inject Ganirelix Gedeon Richter, remove the syringe, cover the injection site with a disinfectant swab, and press; the bleeding should stop in one or two minutes.
• Do not use this syringe, dispose of it safely, and use a new one.
• Once the needle is correctly placed, push the plunger down slowly and steadily with your thumb to inject the solution correctly and not to damage the skin tissues.
• Push the plunger down until the syringe is empty.

1. After the injection

• Wait 5 seconds (count slowly to 5), then release the skin you are pinching.
• Remove the syringe quickly from your skin and apply pressure to the injection site with a disinfectant swab.

• Do not rub the skin after the injection.
• Use each preloaded syringe only once.
• Do not cover the needle to avoid a possible puncture.
• Dispose of the used syringe safely immediately and return it to the pharmacy for proper disposal. Ask your pharmacist how to dispose of unused medicines.