FYREMADEL 0.25 mg/0.5 ml Injectable solution

Зміст інструкції

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

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

1. What Fyremadel is and what it is used for

Fyremadel contains the active substance 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). Fyremadel inhibits the action of GnRH, resulting in the suppression of the release
especially of LH.
Fyremadel is used
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. Fyremadel is used to prevent the premature release
of LH which can cause a premature release of egg cells.
In clinical studies Fyremadel 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 Fyremadel

Do not use Fyremadel

• if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in section 6)
• if you are hypersensitive (allergic) to gonadotropin-releasing hormone (GnRH) or a GnRH analogue
• if you have moderate or severe kidney or liver disease
• if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Fyremadel

• if you suffer from an ongoing 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.
• during or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may occur. This syndrome is related to the prescribed stimulation procedure.
• the incidence of congenital malformations after the application of assisted reproductive technologies may be slightly higher than 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 after the application of assisted reproductive technologies. The incidence of congenital malformations after the application of assisted reproductive technologies using Fyremadel 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 in women with damage to the fallopian tubes.
• the efficacy and safety of Fyremadel have not been established in women weighing less than 50 kg or more than 90 kg. Ask your doctor for further information. For athletes: the use of the drug without therapeutic need constitutes doping and may still result in a positive doping test.

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

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

Pregnancy, breastfeeding and fertility
Fyremadel must be used during controlled ovarian stimulation in assisted reproductive technologies (ART). Do not use Fyremadel during pregnancy and breastfeeding.
If you are pregnant, suspect you are 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.

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

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

3. How to use Fyremadel

Fyremadel is used as part of the treatment for assisted reproductive technologies (ART),
including in vitro fertilization (IVF).
You will need to administer the injections yourself, so your doctor will explain what you need to do. Use this
medicinal product following the doctor's or pharmacist's instructions exactly. If you have any 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 Fyremadel 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.
Fyremadel and FSH should be administered at approximately the same time. However, the
preparations must not be mixed and the injections must be given at different sites.
Daily treatment with Fyremadel 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 Fyremadel injections and between
the last Fyremadel injection and that of hCG must not exceed 30 hours, otherwise premature
ovulation may occur (i.e. the release of oocytes). Therefore, if Fyremadel was administered
in the morning, it is necessary to administer Fyremadel on the day you receive treatment with hCG
for induction of ovulation. If Fyremadel was administered in the afternoon, the last injection
of Fyremadel must be administered in the afternoon before the day of ovulation induction.

Instructions for use

Injection site
Fyremadel 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. If you will
administer the injections yourself or if they will be given by your partner, carefully follow the instructions below.
Do not mix Fyremadel 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 Fyremadel. 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 appropriately. Start again with a new syringe.

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

Removal of the syringe
Quickly remove 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 Fyremadel than you should
Contact your doctor.

If you forget to use Fyremadel
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 Fyremadel
Do not stop treatment with Fyremadel unless advised by your doctor, as this
may affect the outcome of the treatment.
If you have any doubts about using 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.

Common (may affect up to 1 in 10 people)

• 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 people)

• headache
• nausea
• malaise (general feeling of discomfort, of feeling unwell).

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

• more widespread reactions of probable allergic nature, even with the first dose.

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

• 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 case, worsening of a pre-existing
skin rash (eczema) was reported after the first dose of Fyremadel.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 Fyremadel

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. Package contents and other information

What Fyremadel contains

• The active ingredient 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 (E260), mannitol (E421), water for injections. The pH (measure of acidity) may be adjusted with sodium hydroxide and glacial acetic acid.

Description of Fyremadel and package contents
Fyremadel is a clear and colourless aqueous solution for injection. The solution is ready for use and
intended for subcutaneous administration.
Fyremadel 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 and manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Legal representative for Italy:
Ranbaxy Italia S.p.A.
Viale Giulio Richard, 1
20143 Milano

Distributor
FERRING S.p.A.
Via C. Imbonati 18
20159 Milano
Tel: +39 02 640 00 11

This medicinal product is authorised in the Member States of the European Economic Area with the
following designations:
Austria: Ganirelix Astro 0.25 mg/0.5 ml Injection solution in a pre-filled syringe
Denmark: Fyremadel 0.25 mg/0.5 ml injection fluid, solution, in filled injection syringe
Finland: Fyremadel 0.25 mg/0.5 ml injection solution, solution, prefilled syringe
France: Fyremadel 0.25 mg/0.5 ml solution injectable in pre-filled syringe
Germany: Fyremadel 0.25 mg/0.5 ml Injection solution in a pre-filled syringe
Italy: Fyremadel 0.25 mg/0.5 ml solution for injection in pre-filled syringe
Netherlands: Fyremadel 0.25 mg/0.5 ml solution for injection in pre-filled syringe
Norway: Fyremadel 0.25 mg/0.5 ml injection fluid, solution, in prefilled syringe
Spain: Fyremadel 0.25 mg/0.5 ml solution for injection in pre-filled syringe EFG
Sweden: Fyremadel 0.25 mg/0.5 ml injection fluid, solution, prefilled syringe
United Kingdom: Fyremadel 0.25 mg/0.5 ml solution for injection in pre-filled syringe