Ganirelix Gedeon Richter 0.25 mg/0.5 ml solution for injection in pre-filled syringe EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ganirelix Gedeon Richter 0.25 mg/0.5 ml solution for injection in pre-filled syringe

ganirelix

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ganirelix Gedeon Richter is and what it is used for
2. What you need to know before using Ganirelix Gedeon Richter
3. How to use Ganirelix Gedeon Richter
4. Possible adverse effects
5. How to store Ganirelix Gedeon Richter
6. Contents of the pack and other information

1. What Ganirelix Gedeon Richter is and what it is used for

Ganirelix Gedeon Richter contains the active substance ganirelix and belongs to a group of medicines called “gonadotropin-releasing hormone antagonists” that act against the action of 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 required in women for the growth and development of follicles in the ovaries. Follicles are small, rounded sacs that contain the eggs. LH is necessary for mature eggs to be released from the ovarian follicles (i.e., ovulation). This medicine inhibits the action of GnRH, resulting in suppression of the release of LH, in particular.

What Ganirelix Gedeon Richter is used for

In women undergoing assisted reproductive technologies such as in vitro fertilization (IVF) and other methods, premature ovulation may occasionally occur, significantly reducing the chance of becoming pregnant. This medicine is used to prevent premature release of LH, which could otherwise cause premature ovulation.

In clinical studies, ganirelix was used in combination with recombinant follicle-stimulating hormone (FSH) or with corifollitropin alfa, a long-acting follicle stimulant.

2. What you need to know before using Ganirelix Gedeon Richter

Do not use Ganirelix Gedeon Richter

• if you are allergic to ganirelix or to any of the other ingredients of this medicine (listed in section 6);
• if you are hypersensitive to gonadotropin-releasing hormone (GnRH) or its analogues;
• 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 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, whether additional monitoring is required during treatment. Cases of allergic reactions have been observed, even after the first dose.

Allergic reactions, both generalized and local, have been reported, including hives (urticaria), swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis) (see also section 4). If you experience an allergic reaction, stop using Ganirelix Gedeon Richter and seek immediate medical attention.

Ovarian hyperstimulation syndrome (OHSS)

Ovarian hyperstimulation syndrome may develop during or after hormonal stimulation of the ovaries. This syndrome is related to the gonadotropin stimulation procedure. You are advised to read the package leaflet of the gonadotropin medicine prescribed to you.

Multiple births and birth defects

The incidence of congenital malformations following assisted reproductive techniques may be slightly higher than after spontaneous conceptions. This slightly increased incidence is considered to be related to patient characteristics associated with fertility treatments (e.g., maternal age, semen characteristics) and the higher rate of multiple pregnancies observed after assisted reproductive techniques. The incidence of congenital malformations following assisted reproductive techniques using ganirelix is not different from that observed with other GnRH analogues used in assisted reproductive techniques.

Pregnancy complications

There is a slightly increased risk of ectopic pregnancy (a pregnancy outside the uterus) 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 further information.

Children and adolescents

Ganirelix Gedeon Richter is not intended for use in children or adolescents.

Use of Ganirelix Gedeon Richter with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding and fertility

Ganirelix Gedeon Richter is to be used during controlled ovarian stimulation for assisted reproductive techniques (ART).

Do not use Ganirelix Gedeon Richter during pregnancy or breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Driving and use of machines

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

Ganirelix Gedeon Richter contains sodium

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

3. How to use Ganirelix Gedeon Richter

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Ovarian stimulation with follicle-stimulating hormone (FSH) or corifollitropin may begin on day 2 or 3 of your menstruation. Ganirelix Gedeon Richter (0.25 mg) should be injected once daily into the fatty layer just beneath the skin, starting on day 5 or day 6 of stimulation. Depending on your ovarian response, your doctor may decide to start on a different day.

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

Daily treatment with Ganirelix Gedeon Richter should continue until there are enough follicles of adequate size. Final oocyte maturation within the follicles can be induced by administering human chorionic gonadotropin (hCG). The time interval between the last injection of Ganirelix Gedeon Richter and the hCG injection should not exceed 30 hours; otherwise, premature ovulation (i.e., release of oocytes) may occur.

Therefore, if the Ganirelix Gedeon Richter injection is given in the morning, treatment with Ganirelix Gedeon Richter should continue throughout the gonadotropin treatment period, including on the day when ovulation is triggered.

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

Instructions for use

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

Injection site

Ganirelix Gedeon Richter is supplied in pre-filled syringes and should be injected slowly just beneath the skin, preferably in the thigh. Check the solution before use. Do not use the solution if it 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 or your partner administer the injections, follow exactly the instructions below and those provided at the end of the leaflet. Do not mix Ganirelix Gedeon Richter with other medicines.

Preparing the injection site

Wash your hands thoroughly with water and soap. The injection site should be cleaned with a disinfectant (e.g., alcohol) to remove bacteria from the surface. Clean an area of about 5 cm around the injection point and allow the disinfectant to dry for at least one minute before injecting.

Inserting the needle

Remove the needle cap. Pinch a large area of skin between your index and thumb fingers. Insert the needle at the base of the pinched skin at a 45º angle to the skin surface. The injection site should be varied with each injection.

Checking correct needle placement

Gently pull back the plunger to check whether the needle is correctly placed. If blood enters the syringe, this means the needle tip has entered a blood vessel. If this happens, do not inject Ganirelix Gedeon Richter; instead, remove the syringe, cover the injection site with a disinfectant swab, and apply pressure. Bleeding should stop within one or two minutes. Do not use this syringe; dispose of it properly. Start again with a new syringe.

Injecting the solution

Once the needle is correctly placed, press the plunger slowly and steadily to ensure proper injection and to avoid damaging skin tissue. Press the plunger until the syringe is empty and wait 5 seconds.

Removing the syringe

Remove the syringe quickly and press the injection site with a disinfectant swab. Use the pre-filled syringe only once.

If you use more Ganirelix Gedeon Richter than you should

Contact your doctor.

If you forget to use Ganirelix Gedeon Richter

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

If the delay exceeds 6 hours (thus, the interval between two injections exceeds 30 hours), administer the dose as soon as possible and contact your doctor for advice.

If you stop treatment with Ganirelix Gedeon Richter

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The likelihood of experiencing an adverse effect is classified into 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). Local reactions usually disappear within 4 hours after administration.

Uncommon (may affect up to 1 in 100 women)

• Headache
• Nausea
• General feeling of being unwell (malaise)

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)

• Worsening of pre-existing eczema has been reported after the first dose of ganirelix.

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

Reporting of 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 leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ganirelix Gedeon Richter

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

Do not use this medicine after the expiry date stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

Do not freeze.

Store in the original container to protect from light.

Inspect the syringe before use. The syringe should only be used if the solution is clear and free from particles and if the packaging is undamaged.

Each pre-filled syringe is for single-dose use only.

Alcohol swabs, gauze, and a sharps container are required for the administration of this medicine but are not included in the package.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Ganirelix Gedeon Richter

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

Appearance of Ganirelix Gedeon Richter and contents of the pack

Ganirelix Gedeon Richter is a clear, colourless injectable solution (injectable). The medicine is supplied in a glass syringe with a stainless steel needle, closed with a plunger stopper and a plunger rod. The injection needle is fitted with a rigid needle shield.

Ganirelix Gedeon Richter is available in packs of 1 or 6 pre-filled syringes.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Gedeon Richter Plc.
Gyömroi út 19-21
1103 Budapest
Hungary

Date of the most recent revision of this leaflet:

Other sources of information

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

Instructions for use

HOW TO PREPARE AND ADMINISTER GANIRELIX GEDEON RICHTER IN A PRE-FILLED SYRINGE

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

These instructions will help you or your partner learn how to self-administer the Ganirelix Gedeon Richter injection. If you are unsure about how to give 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 each day.

Each pre-filled syringe contains one daily dose of ganirelix.

Each pre-filled syringe contains one daily dose of ganirelix.

CONTENTS OF THE INSTRUCTIONS FOR USE

1. Preparing the injection

2. Preparing the injection site

3. Injecting the medicine

4. After the injection

5. Preparing the injection

• Wash your hands thoroughly with soap and water. It is important that your hands and equipment are as clean as possible to avoid infection.

• Find a clean area to place the equipment needed for the injection, e.g. a clean table or similar flat surface.

• Gather everything you need and place it on the clean surface:

• Antiseptic swabs (e.g. alcohol)

• 1 pre-filled syringe with the medicine

• Do not handle the syringe by the plunger to avoid accidental disassembly.

• Do not use this medicine after the expiry date stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

• A sharps container (e.g. a plastic bottle with a sufficiently wide opening) for safe disposal of the used syringe.

• Inspect the solution before use.

• Air bubbles may be visible in the pre-filled syringe. This is normal and there is no need to remove the air bubble(s).

• Do not use the syringe if:

• it is cracked or damaged, or

• the needle shield has been removed or is not properly in place, or

• there is leakage of liquid, or

• the solution appears abnormal (contains particles or is not colourless).

If any of these situations occur, dispose of the syringe safely in the sharps container and use a new one.

2. Preparing the injection site

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

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

3. Injecting the medicine

• You will receive Ganirelix Gedeon Richter in pre-filled syringes with an integrated needle, ready for administration without further adjustments to the syringe.
• Remove 1 syringe from the pack by holding it in the middle of the barrel.
• Remove the needle shield from the syringe while holding the syringe horizontally and pointing away from you. Pull the needle shield straight off—do not twist it.

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

• Administer Ganirelix Gedeon Richter subcutaneously, i.e. into the fatty layer just beneath the skin.
• Hold the syringe with the other hand so that you can place your thumb on the plunger when needed. Insert the needle fully with a quick, firm motion into the centre of the skin fold at a 45º angle to the skin surface.

• Gently pull back on the plunger to check whether the needle is correctly positioned.
• If blood enters the syringe, this means the needle has entered a blood vessel. If this happens, do not inject Ganirelix Gedeon Richter, remove the syringe, cover the injection site with an antiseptic swab and apply pressure; bleeding should stop within one or two minutes.
• Do not use this syringe; dispose of it properly and use a new syringe.
• Once the needle is correctly placed, push the plunger down slowly and steadily with your thumb to ensure proper injection and to avoid damaging the skin tissue.
• Push the plunger down until the syringe is empty.

4. After the injection

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

• Do not rub the skin after the injection.
• Use each pre-filled syringe only once.
• Do not recap the needle to avoid accidental needlestick injury.
• Immediately and safely dispose of the used syringe in a sharps container and return it to the pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines you no longer use.