OVAMEX 0.25 MG/0.5 ML Injectable solution in pre-filled syringe

Зміст інструкції

1. Ovamex 0.25 mg/0.5 ml injectable solution in pre-filled syringe
   1. What is Ovamex and what is it used for
   2. What you need to know before using Ovamex
   3. How to use Ovamex
   4. Possible side effects
   5. How to store Ovamex
   6. Contents of the pack and other information

Ovamex 0.25 mg/0.5 ml injectable solution in pre-filled syringe

ganirelix
Generic medicine

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Ovamex and what is it used for

Ovamex contains the active ingredient ganirelix and belongs to a group of medicines called
“gonadotropin-releasing hormone antagonists” which counteracts the actions of the natural
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. In women, FSH is necessary for the growth and
development of follicles in the ovaries. Follicles are small, round sacs that contain egg cells.
LH is needed to release mature egg cells from the follicles and ovaries (i.e., for
ovulation). Ovamex inhibits the action of GnRH, resulting in the suppression of the release
especially of LH.
Ovamex is used for
In women undergoing assisted reproductive technologies, including in vitrofertilization (IVF)
and other methods, ovulation can sometimes occur too early, causing a
significant reduction in the chances of becoming pregnant. Ovamex is used to prevent the premature
release of LH, which can cause a premature release of egg cells.
In clinical studies, ganirelix has been used with recombinant follicle-stimulating hormone (FSH) or
corifollitropin alfa, a follicle-stimulating hormone with a long duration of action.

2. What you need to know before using 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 allergic to gonadotropin-releasing hormone (GnRH) or a GnRH analogue;
• if you suffer from moderate or severe kidney or liver disease;
• if you are pregnant or breastfeeding. Warnings and precautionsTalk to your doctor, pharmacist or nurse before using Ovamex
• if you suffer from an existing allergic condition, report it to your doctor. The doctor will decide, depending on the severity, whether additional checks will be necessary during treatment. Cases of allergic reactions have been reported, even with the first dose.
• Allergic reactions, both generalized and local, have been reported, including 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 have an allergic reaction, stop taking Ovamex and consult a doctor immediately.
• During or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may occur. This syndrome is related to the stimulation procedure with

prescribed.

• The incidence of congenital malformations (birth defects) after the application of assisted reproductive technologies may be slightly higher than that after spontaneous conception. This slightly higher incidence is thought to be related to the characteristics of patients undergoing fertility treatment (e.g. woman's age, sperm characteristics) and the higher incidence of multiple pregnancies (pregnancy with more than one baby at a time) after the application of assisted reproductive technologies. The incidence of congenital malformations after application of assisted reproductive technologies using Ovamex is not different from that observed with the use of other GnRH analogues during assisted reproductive technologies.
• There is a slight increase in the risk of ectopic pregnancy (pregnancy outside the uterus) in women with damage to the fallopian tubes.
• The efficacy and safety of Ovamex have not been established in women weighing less than 50 kg or more than 90 kg. Ask your doctor for further information.

Children and adolescents
The use of Ovamex in children or adolescents is not appropriate.

Other medicines and Ovamex
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Ovamex must be used during controlled ovarian stimulation in assisted reproductive
techniques (ART).
Do not use Ovamex during pregnancy and breastfeeding.

Driving and using machines
No studies have been performed on the ability to drive vehicles and use machines.

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

3. How to use Ovamex

Ovamex is used as part of the treatment for assisted reproductive technologies (ART),
including in vitrofertilization (IVF).
You will need to administer the injections yourself, so your doctor will explain what you need to do.
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

Step 1
Ovarian stimulation with follicle-stimulating hormone (FSH) or corifollitropin can begin on
day 2 or 3 of the cycle.

Step 2
The contents of the Ovamex syringe (0.25 mg) must be injected just under the skin
(subcutaneously), once a day, starting on day 5 or 6 of stimulation. Based on the
ovarian response, the doctor may decide to start on another day.
Ovamex and FSH should be administered at approximately the same time. However, the preparations
should not be mixed and the injections should be given at different sites.
Daily treatment with Ovamex should continue until the day when there is a sufficient number
of follicles of adequate size.

Step 3
The final maturation of the oocytes in the follicles can be induced by administering
human chorionic gonadotropin (hCG). The time interval between two Ovamex injections and between
the last Ovamex injection and that of hCG should not exceed 30 hours, otherwise premature
ovulation may occur (i.e., the release of oocytes). Therefore, if Ovamex was administered
in the morning, it is necessary to administer Ovamex on the day you receive treatment with hCG for
inducing ovulation. If Ovamex was administered in the afternoon, the last injection of
Ovamex must be administered in the afternoon before the day of ovulation induction.

Instructions for use

Injection site
Ovamex is supplied in pre-filled syringes containing a single dose. The contents must be
injected slowly just under the skin, preferably in the thigh. Check the solution before
use. Do not use if the solution 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 will administer the injections yourself or if they will be administered by your partner, carefully
follow the instructions below. Do not mix Ovamex with any other medicine.

Preparation of the injection site
Wash your hands thoroughly with soap and water. Wipe the injection site with a disinfectant
(e.g., alcohol) to remove bacteria from the surface. Clean approximately 5 centimeters (two inches)
around the point where the needle will penetrate and allow the area to dry for at least one minute before
proceeding.

Introduction of the needle
Remove the cap from the needle. Pinch a wide area of skin between your thumb and index finger. The needle must
be inserted at the base of the pinched skin area between the two fingers, at an angle of 45°
with respect to the skin surface. Vary the injection site with each administration.

Checking the correct position of the needle
Gently pull back the syringe plunger to check if the needle is in the correct position. The
presence of any blood in the syringe indicates that the needle has penetrated a blood vessel. If this
happens, do not inject Ovamex. Remove the syringe, cover the injection site with a swab
soaked with disinfectant and apply some pressure; the bleeding will stop in a minute or two.
Do not use the syringe but dispose of it properly. Start again with a new syringe.

Injection of the solution
Once the needle has been positioned correctly, push the plunger slowly and with a steady hand, so that the solution is correctly injected and the skin tissue is not
damaged.

Removal of the syringe
Quickly withdraw the needle and apply some pressure to the injection site with a swab
soaked with 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 think you have forgotten a dose, administer the injection as soon as possible.
Do not use a double dose to make up for a missed dose.
If more than 6 hours have passed since the usual time of the injection (so that the time interval between the two
injections is more than 30 hours), administer the injection as soon as possible and consult your doctor for further
advice.

If you stop using Ovamex
Do not stop treatment with Ovamex unless advised by your doctor, as this may
affect the outcome of the treatment.
If you have any doubts about 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 reactions at the injection site (especially redness, with or without swelling). The local reaction usually disappears within 4 hours of administration.

Uncommon (may affect up to 1 in 100 women)

• Headache
• Nausea
• Feeling unwell (general feeling of discomfort, of feeling sick).

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

• Allergic reactions have been observed, even with the first dose.
• Skin rash
• Facial swelling
• Difficulty breathing (dyspnea)
• Swelling of the face, lips, tongue and/or throat that can cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis)
• Hives.

In addition, side effects have been reported that are attributable to treatment for
controlled ovarian hyperstimulation, e.g.:

• abdominal pain
• ovarian hyperstimulation syndrome (OHSS). (OHSS occurs when your ovaries react too much to the fertility medicines you are taking)
• ectopic pregnancy (when the embryo develops outside the uterus)

In one subject, worsening of a pre-existing
skin rash (eczema) was reported after the first dose of ganirelix.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. 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 the label, after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Check the syringe before use. Use only syringes containing clear solutions, free from
particles and with intact packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This 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 of ganirelix (as acetate) in 0.5 ml of aqueous solution.
• The other ingredients are glacial acetic acid, mannitol, water for injections. The pH (the measure of acidity) may be adjusted with sodium hydroxide and glacial acetic acid.

Description of the appearance of Ovamex 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).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Theramex Ireland Limited
3 Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Portugal: Ovamex
Belgium: Ovamex
Poland: Ovamex
Greece: Ovamex 0.25 mg/0.5 mL Ενέσιμο διάλυμα σε προγεμισμένη σύριγγα
Czech Republic: Ovamex
Italy: Ovamex