Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ganirelix

Document Subject

Generated Narrative: MedicinalProductDefinition mpf39d85b5533e098d34a976dedd3b1e91

identifier: http://ema.europa.eu/identifier/EU/1/22/1658/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ganirelix Gedeon Richter 0.25 mg/0.5 mL solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f39d85b5533e098d34a976dedd3b1e91

identifier: http://ema.europa.eu/identifier/EU/1/22/1658/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ganirelix

Attesters

What is in this leaflet

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

Ganirelix Gedeon Richter contains the active substance ganirelix and belongs to a group of medicines called antigonadotropin-releasing hormones which act against the actions of the natural gonadotropin-releasing hormone (GnRH). GnRH regulates the release of gonadotropins (luteinising 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 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). Ganirelix Gedeon Richter inhibits the action of GnRH, resulting in suppression of the release of especially LH.

Ganirelix Gedeon Richter is used for In 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. Ganirelix Gedeon Richter is used to prevent the premature LH surge that might cause such a premature release of egg cells. In clinical studies ganirelix was used with recombinant follicle stimulating hormone (FSH) or corifollitropin alfa, a follicle stimulant with a long duration of action.

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 gonadotropin-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.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ganirelix Gedeon Richter.

Allergic reactions If you have an active allergic condition, please tell your doctor. Your doctor will decide, depending on the severity, if additional monitoring is required during treatment. Cases of allergic reactions have been reported, as early as with the first dose. Allergic reactions, both generalised and local, including hives (urticaria), swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing and/or swallowing (angioedema and/or anaphylaxis) have been reported (see also section 4). If you have an allergic reaction, stop using Ganirelix Gedeon Richter and seek immediate medical assistance.

Ovarian hyperstimulation syndrome (OHSS) During or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may develop. This syndrome is related to the stimulation procedure with gonadotropins. Please refer to the package leaflet of the gonadotropin-containing medicine prescribed for you.

Multiple births or birth defects 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 ganirelix is not different from that after using other GnRH analogues in the course of assisted reproduction techniques.

Pregnancy complications There is a slightly increased risk of pregnancy outside of the uterus (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 has not been established in women weighing less than 50 kg or more than 90 kg. Ask your doctor for further information.

Children and adolescents There is no relevant use of Ganirelix Gedeon Richter in children or adolescents.

Other medicines and Ganirelix Gedeon Richter Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy, breast-feeding 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 breast-feeding.

Ask your doctor or pharmacist for advice before using this medicine.

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

Ganirelix Gedeon Richter contains sodium This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially sodium-free .

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Ganirelix Gedeon Richter 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. Ganirelix Gedeon Richter (0.25 mg) should be injected into the fatty layer 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.

Ganirelix Gedeon Richter and FSH should be administered approximately at the same time. However, these medicines should not be mixed and different injection sites are to be used.

Daily treatment with Ganirelix Gedeon Richter 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 gonadotropin (hCG). The time between two injections of Ganirelix Gedeon Richter as well as the time between the last injection of Ganirelix Gedeon Richter and hCG injection should not exceed 30 hours, as otherwise a premature ovulation (i.e. release of egg cells) may occur. Therefore, when injecting Ganirelix Gedeon Richter in the morning treatment with Ganirelix Gedeon Richter should be continued throughout the gonadotropin treatment period including the day of triggering ovulation.
When injecting Ganirelix Gedeon Richter in the afternoon the last injection of Ganirelix Gedeon Richter should be given in the afternoon prior to the day of triggering ovulation.

Instructions for use Before the administration of this medicine it is very important that you also carefully read and closely follow the detailed instructions for use provided at the end of this package leaflet.

Injection site Ganirelix Gedeon Richter is supplied in pre-filled syringes and should be injected slowly, into the fatty layer 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. You may notice air bubble(s) in the pre-filled syringe. This is expected, and removal of the air bubble(s) is not needed. If you administer the injections yourself or have it done by your partner, follow the instructions below and at the end of the Package leaflet carefully. Do not mix Ganirelix Gedeon Richter 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 shield. Pinch a fold of skin between index 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 Ganirelix Gedeon Richter, 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, push the plunger down slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged. Push the plunger down until the syringe is empty and wait for 5 seconds.

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 Ganirelix Gedeon Richter than you should Contact your doctor.

If you forget to use Ganirelix Gedeon Richter 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 Ganirelix Gedeon Richter Do not stop using Ganirelix Gedeon Richter 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, pharmacist or nurse.

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

The chance of having a side effect is described by the following categories:

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

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

Uncommon (may affect up to 1 in 100 women)

Headache

Nausea

Feeling generally unwell (malaise)

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

Allergic reactions have been observed, as early as with the first dose.

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

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

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 package leaflet of the FSH-containing preparation you are treated with).

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 on the carton 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.

Each pre-filled syringe is only for a single use of injection.

Alcohol swabs, gauze pads and sharps container are needed for administration of this medicine but they are not provided in the pack.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ganirelix Gedeon Richter contains

• The active substance is ganirelix (0.25 mg in 0.5 mL solution).
• The other ingredients are: glacial acetic acid, mannitol (E 421), water for injection. The pH (measurement of the acidity) may have been adjusted with sodium hydroxide (see section 2 Ganirelix Gedeon Richter contains sodium ).

What Ganirelix Gedeon Richter looks like and contents of the pack Ganirelix Gedeon Richter is a clear and colourless solution for injection (injection). The medicine is filled in a glass syringe with staked stainless steel needle, closed with a plunger stopper and supplied with a plunger rod. The injection needle is provided with a rigid needle shield.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Gedeon Richter Plc. Gy mr i t 19-21. 1103 Budapest Hungary

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: