Patient leaflet - Ovamex 0.25 mg/ 0.5 ml solution for injection in Pre-filled syringe
1. What Ovamex is and what it is used 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.
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 use 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
- 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.
Ovamex contains Sodium
This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially “sodiumfree”.
3. How to use 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.
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.
IPS THX 3680 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.
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.
5. How to store 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