Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ovamex 0.25 mg/ 0.5 mL solution for injection in pre-filled syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ganirelix acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Ovamex contains the active substance ganirelix and belongs to a group of medicines called "antigonadotrophin-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). Ovamex inhibits the action of GnRH, resulting in suppression of the release of especially LH. [Ovamex 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. Ovamex 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. 2.
What you need to know before you take it
e Ovamex
Do not use Ovamex –
if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in section 6). if you are hypersensitive to gonadotrophin releasing hormone (GnRH) or a GnRH analogue if you have a moderate or severe kidney or liver disease 2
Ganirelix 0.25 mg / 0.5 mL Solution for injection in pre-filled syringe Module 1
–
Section 1.3.1
Page 3/8
if you are pregnant or breast-feeding
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Ovamex –
–
–
–
–
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 taking Ovamex and seek immediate medical assistance. 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 Ovamex is not different from that after using other GnRH analogues in the course of assisted reproduction techniques. there is a slightly increased risk of pregnancy outside of the uterus (an ectopic pregnancy) in women with damaged fallopian tubes. the efficacy and safety of Ovamex 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 Ovamex in children or adolescents. Other medicines and Ovamex Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy, breast-feeding and fertility Ovamex should be used during controlled ovarian stimulation for assisted reproduction techniques (ART). Do not use Ovamex during pregnancy and breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines The effects of Ovamex on ability to drive and use machines have not been studied.
3
Ganirelix 0.25 mg / 0.5 mL Solution for injection in pre-filled syringe Module 1
Section 1.3.1
Page 4/8
Ovamex contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially "sodiumfree". 3.
How to take it
Ovamex
Ovamex is used as part of the treatment for assisted reproduction techniques (ART) including in vitro fertilisation (IVF). You will be giving yourself the injections and so your doctor will explain what you have to do. Always use this medicine exactly as your doctor or pharmacist has told you. If you have not understood the instructions check with your doctor or pharmacist. Stage 1 Ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin may start at day 2 or 3 of your period. Stage 2 The content of the syringe Ovamex (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. Ovamex and FSH should be administered approximately at the same time. However, the preparations should not be mixed and different injection sites must be used. Daily treatment with Ovamex] should be continued up to the day that sufficient follicles of adequate size are present. Stage 3 Final maturation of the egg cells in the follicles can be induced by administering human chorionic gonadotrophin (hCG). The time between two Ovamex injections as well as the time between the last Ovamex injection and hCG injection should not exceed 30 hours, as otherwise a premature ovulation (i.e. release of egg cells) may occur. Therefore, if you have been injecting Ovamex in the morning you must also have Ovamex on the day when you will receive the hCG treatment to trigger ovulation. If you have been injecting Ovamex in the afternoon the last Ovamex injection should be given in the afternoon prior to the day of triggering ovulation. Instructions for use Injection site Ovamex is supplied in pre-filled syringes which contain one dose. The contents 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 Ovamex with any other medicines.
4
= Ganirelix 0.25 mg / 0.5 mL Solution for injection in pre-filled syringe
Module 1
Section 1.3.1
Page 5/8
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 the needle cover. Gently pinch up the clean area of the skin to make a skin fold. Insert the needle at the base of the pinched-up skin. Insert the needle at an angle of 45° to the skin surface.
Use a different place for each injection. Checking the correct needle position Gently draw back the plunger of the syringe to check if the needle is positioned correctly If any blood is drawn into the syringe it means the needle tip has penetrated a blood vessel. If this happens, do not continue with the injection of Ovamex. 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 the same syringe again 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 Apply pressure to the site with a swab containing disinfectant.Use the pre-filled syringe only once.
If you use more Ovamex than you should Contact your doctor If you forget to use Ovamex 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.
5
Ganirelix 0.25 mg / 0.5 mL Solution for injection in pre-filled syringe Module 1
Section 1.3.1
Page 6/8
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 Ovamex Do not stop using Ovamex 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. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common (may affect more than 1 in 10 women) –
Local skin reaction 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 malaise (general feeling of being sick, feeling bad).
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).
In addition, side effects are reported which are known to occur with controlled ovarian hyperstimulation treatment, e.g.:
- abdominal pain
- ovarian hyperstimulation syndrome (OHSS). (OHSS happens when your ovaries overreact to the fertility medicines you're taking.)
- ectopic pregnancy (when the embryo develops outside the womb)
- 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 ganirelix dose. 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 to the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
6
Ganirelix 0.25 mg / 0.5 mL Solution for injection in pre-filled syringe Module 1
5.
Section 1.3.1
Page 7/8
How to store it
Ovamex
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 carton and on the label after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Inspect the syringe before use. Use only syringes with clear, particle-free solutions and from undamaged containers. 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.
6.
Contents of the pack and other information
What Ovamex contains –
The active substance is ganirelix. Each pre-filled syringe contains 0.25 mg ganirelix (as acetate) in 0.5 mL aqueous solution. The other ingredients are acetic acid, glacial, mannitol and water for injection. The pH (a measurement of the acidity) may have been adjusted with sodium hydroxide and acetic acid, glacial.
What Ovamex looks like and contents of the pack Ovamex is a clear and colourless aqueous solution for injection. The solution is ready for use and intended for subcutaneous administration. Ovamex is available in packs of 1 or 5 pre-filled syringes with injection needles (27 G),as specified below:
- 1 pre-filled syringe
- 5 pre-filled syringes Not all pack sizes may be marketed. Marketing Authorisation Holder Theramex HQ UK Limited Floor 5 50 Broadway London. UK SW1H 0BL Manufacturer GP-PHARM, S.A. Polígono Industrial Els Vinyets-Els Fogars, Sector 2, Carretera Comarcal C-244, Km 22, 08777 Sant Quintí de Mediona, Spain
7
Ganirelix 0.25 mg / 0.5 mL Solution for injection in pre-filled syringe Module 1
Section 1.3.1
This leaflet was last revised in 06/2023
8
Page 8/8
Frequently asked questions about Ovamex 0.25 mg/ 0.5 mL solution for injection in pre-filled syringe
How do I take Ovamex 0.25 mg/ 0.5 mL solution for injection in pre-filled syringe?
Ovamex 0.25 mg/ 0.5 mL solution for injection in pre-filled syringe comes as injection containing 0.25mg / 0.5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ovamex 0.25 mg/ 0.5 mL solution for injection in pre-filled syringe?
The active substance in Ovamex 0.25 mg/ 0.5 mL solution for injection in pre-filled syringe is ganirelix acetate.
Are there equivalent medicines to Ovamex 0.25 mg/ 0.5 mL solution for injection in pre-filled syringe?
Medicines with the same active substance, strength and form include: Fyremadel 0.25 mg/ 0.5 ml solution for injection in pre-filled syringe, Ganirelix Gedeon Richter 0.25 mg/0.5 mL solution for injection in pre-filled syringe. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ovamex 0.25 mg/ 0.5 mL solution for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ovamex 0.25 mg/ 0.5 mL solution for injection in pre-filled syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ganirelix acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Ganirelix is indicated for the prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
In clinical studies ganirelix was used with recombinant human follicle stimulating hormone (FSH) or corifollitropin alfa, the sustained follicle stimulant.
4.2. Posology and method of administration
Ganirelix should only be prescribed by a specialist experienced in the treatment of infertility.
Posology
Ganirelix is used to prevent premature LH surges in women undergoing COH. Controlled ovarian hyperstimulation with FSH or corifollitropin alfa may start at day 2 or 3 of menses. Ganirelix (0.25 mg) should be injected subcutaneously once daily, starting on day 5 or day 6 of FSH administration or on day 5 or day 6 following the administration of corifollitropin alfa. The starting day of ganirelix is depending on the ovarian response, i.e. the number and size of growing follicles and/or the amount of circulating oestradiol. The start of ganirelix may be delayed in absence of follicular growth, although clinical experience is based on starting ganirelix on day 5 or day 6 of stimulation.
Ganirelix 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.
FSH dose adjustments should be based on the number and size of growing follicles, rather than on the amount of circulating oestradiol (see section 5.1).
Daily treatment with ganirelix should be continued up to the day that sufficient follicles of adequate size are present. Final maturation of follicles can be induced by administering human chorionic gonadotrophin (hCG).
Timing of last injection
Because of the half-life of ganirelix, the time between two ganirelix injections as well as the time between the last ganirelix injection and the hCG injection should not exceed 30 hours, as otherwise a premature LH surge may occur. Therefore, when injecting ganirelix in the morning, treatment with ganirelix should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation. When injecting ganirelix in the afternoon the last ganirelix injection should be given in the afternoon prior to the day of triggering ovulation.
Ganirelix has shown to be safe and effective in women undergoing multiple treatment cycles.
The need for luteal phase support in cycles using ganirelix has not been studied. In clinical studies, luteal phase support was given according to study centres' practice or according to the clinical protocol.
Special population
Renal impairment
There is no experience on the use of ganirelix in subjects with renal impairment, as they were excluded from clinical studies. Therefore, the use of ganirelix is contraindicated in patients with moderate or severe renal impairment (see section 4.3).
Hepatic impairment
There is no experience on the use of ganirelix in subjects with hepatic impairment, as they were excluded from clinical studies. Therefore, the use of ganirelix is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).
Paediatric population
There is no relevant use of ganirelix in the paediatric population.
Method of administration
Ganirelix should be administered subcutaneously, preferably in the upper leg. The injection site should be varied to prevent lipoatrophy. The patient or her partner may perform the injections of ganirelix themselves, provided that they are adequately instructed and have access to expert advice.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue.
• Moderate or severe impairment of renal or hepatic function.
• Pregnancy or breast-feeding.
4.4. Special warnings and precautions for use
Hypersensitivity reaction
Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalised and local) have been reported with ganirelix, as early as with the first dose, during post-marketing surveillance. These events have included anaphylaxis (including anaphylactic shock), angioedema and urticaria (see section 4.8). If a hypersensitivity reaction is suspected, ganirelix should be discontinued and appropriate treatment administered. In the absence of clinical experience, ganirelix treatment is not advised in women with severe allergic conditions.
Ovarian hyperstimulation syndrome (OHSS)
Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation. OHSS must be considered an intrinsic risk of gonadotrophin stimulation. OHSS should be treated symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.
Ectopic pregnancy
Since infertile women undergoing assisted reproduction, and particularly in vitro fertilization (IVF), often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
Congenital malformations
The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and an increased incidence of multiple gestations. In clinical studies investigating more than 1,000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using ganirelix is comparable with that reported after COH treatment using a GnRH agonist.
Women weighing less than 50 kg or more than 90 kg
The safety and efficacy of ganirelix have not been established in women weighing less than 50 kg or more than 90 kg (see also section 5.1 and 5.2).
Sodium
This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
The possibility of interactions with commonly used medicinal products, including histamine liberating medicinal products, cannot be excluded.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of ganirelix in pregnant women.
In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see section 5.3). The relevance of these data for humans is unknown.
Breast-feeding
It is not known whether ganirelix is excreted in breast milk.
The use of ganirelix is contraindicated during pregnancy and breast-feeding. (see section 4.3).
Fertility
Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in assisted reproduction programmes. Ganirelix is used to prevent premature LH surges that might otherwise occur in these women during the ovarian stimulation.
For posology and method of administration, see section 4.2.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Summary of safety profile
The table below shows all adverse reactions in women treated with ganirelix in clinical studies using recFSH for ovarian stimulation. The adverse reactions with ganirelix using corifollitropin alfa for ovarian stimulation are expected to be similar.
Tabulated list of adverse reactions
The adverse reactions are classified according to MedDRA system organ class and frequency; very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100). The frequency of hypersensitivity reactions (very rare, <1/10,000) has been deduced from post-marketing surveillance.
SYSTEM ORGAN CLASS
FREQUENCY
ADVERSE REACTION
Immune system disorders
Very rare
Hypersensitivity reactions (including rash, facial swelling, dyspnea, anaphylaxis (including anaphylactic shock), angioedema and urticaria)1
Worsening of a pre-existing eczema 2
Nervous system disorders
Uncommon
Headache
Gastrointestinal disorders
Uncommon
Nausea
General disorders and administration site conditions
Very common
Local skin reaction at the site of injection (predominantly redness, with or without swelling)3
Uncommon
Malaise
1 Cases have been reported, as early as with the first dose, among patients administered ganirelix.
2 Reported in one subject after the first ganirelix dose.
3 In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12% in ganirelix treated patients and 25% in patients treated subcutaneously with a GnRH agonist. The local reactions generally disappear within 4 hours after administration.
Description of selected adverse reactions
Other reported adverse reactions are related to the controlled ovarian hyperstimulation treatment for ART, notably pelvic pain, abdominal distension, OHSS (see also section 4.4), ectopic pregnancy and spontaneous abortion.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
Overdose in humans may result in a prolonged duration of action.
No data on acute toxicity of ganirelix in humans are available. Clinical studies with subcutaneous administration of ganirelix at single doses up to 12 mg did not show systemic adverse reactions. In acute toxicity studies in rats and monkeys non-specific toxic symptoms such as hypotension and bradycardia were only observed after intravenous administration of ganirelix over 1 and 3 mg/kg, respectively.
In case of overdose, ganirelix treatment should be (temporarily) discontinued.
💬 Ask about this leaflet
Ask anything about Ovamex 0.25 mg/ 0.5 mL solution for injection in pre-filled syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.