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GANIRELIX SUN 0.25 MG/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): GANIRELIX ACETATE

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Driving and using machines
The effects of Ganirelix on ability to drive and use machines have not been studied.
Ganirelix contains sodium
Ganirelix contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially “sodium-free”.

Package leaflet: Information for the user

Ganirelix 0.25 mg/0.5 ml solution for injection in pre-filled syringe
3. How to use Ganirelix

ganirelix
Ganirelix is used as part of the treatment for assisted reproduction techniques (ART) including in vitro fertilisation (IVF).
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness
are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

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

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 Ganirelix (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.
Ganirelix 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 Ganirelix should be continued up to the day that sufficient follicles of adequate size are present.

1. What Ganirelix is and what it is used for
Ganirelix belongs to a group of medicines called “anti-gonadotrophin-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). Ganirelix inhibits the
action of GnRH, resulting in suppression of the release of especially LH.
Ganirelix 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 is used to prevent
the premature LH surge that might cause such a premature release of egg cells.

Stage 3
Final maturation of the egg cells in the follicles can be induced by administering human chorionic gonadotrophin (hCG). The
time between two Ganirelix injections as well as the time between the last Ganirelix 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
Ganirelix in the morning you must also have Ganirelix on the day when you will receive the hCG treatment to trigger ovulation.
If you have been injecting Ganirelix in the afternoon the last Ganirelix injection should be given in the afternoon prior to the
day of triggering ovulation.
Instructions for use
Injection site
Ganirelix 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 Ganirelix
with any other medicines.

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 Ganirelix
Do not use Ganirelix
- 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.

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.

Warnings and precautions
Talk to your doctor or pharmacist before using Ganirelix
- 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.
- 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 gonadotrophincontaining 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 Ganirelix is not different from that after using other GnRH analogues in the course of assisted reproduction
techniques.
- there is a slightly increased risk of extra-uterine pregnancy in women with damaged fallopian tubes.
- 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.

Inserting the needle
Remove the needle cover. Pinch up a large area of skin between finger and thumb. Insert the needle at the base of the
pinched-up skin at an angle of 45° to the skin surface. Use a different place for each injection.

Children and adolescents
There is no relevant use of Ganirelix in children.
Other medicines and Ganirelix
Tell your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines.

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 Ganirelix. 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.

Pregnancy, breast-feeding and fertility
Ganirelix should be used during controlled ovarian stimulation for assisted reproduction techniques (ART). Do not use
Ganirelix 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.

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.

Fold Size
90 x 31 mm

350 mm
Size: 350x430 mm
EUUK - United Kingdom

100

95

75

25

5

0

Ganirelix SUN 0-25 mg-0-5 ml soln for inj in pfsyg-350x430mm-EUUK-REV1-29-12-14
29 December 2014 09:42:45

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do not print here

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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
If you use more Ganirelix than you should
Contact your doctor.
If you forget to use Ganirelix
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
Do not stop using Ganirelix 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.
Common (may affect up to 1 in 10 people)
- local skin reactions at the site of injection (predominantly redness, with or without swelling). The local reaction normally
disappears within 4 hours of administration.

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

This medicinal product is authorised in the Member states of the EEA under the following names:
Austria:
Ganirelix SUN 0,25 mg/0,5 ml Injektionslösung in einer Fertigspritze
Denmark:
Ganirelix SUN 0,25 mg/0,5 ml injektionsvæske, opløsning i fyldt injektionssprøjte
Finland:
Ganireliksi SUN 0,25 mg/0,5 ml injektioneste, liuos esitäytetty ruisku
France:
Ganirelix SUN 0,25 mg/0,5 ml solution injectable en seringue pré-remplie
Germany:
Ganirelix SUN 0,25 mg/0,5 ml Injektionslösung in einer Fertigspritze
Italy:
Ganirelix SUN 0,25 mg/0,5 ml soluzione iniettabile in siringa preriempita
The Netherlands:
Ganirelix SUN 0,25 mg/0,5 ml oplossing voor injectie in voorgevulde spuit
Norway:
Ganirelix SUN 0,25 mg/0,5 ml injeksjonsvæske, oppløsning, i ferdigfylt sprøyte
Spain:
Ganirelix SUN 0,25 mg/0,5 ml solución inyectable en jeringa precargada EFG
Sweden:
Ganirelix SUN 0,25 mg/0,5 ml injektionsvätska, lösning, förfylld spruta
United Kingdom:
Ganirelix SUN 0.25 mg/0.5 ml solution for injection in pre-filled syringe
This leaflet was last revised in 12/2014

Uncommon (may affect up to 1 in 100 people)
- headache
- nausea
- malaise (general feeling of being sick, feeling bad).

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).

044BP2115B

Very rare (may affect up to 1 in 10,000 people)
- more widespread possibly allergic reactions have been observed as early as with the first dose.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ganirelix
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.

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 Ganirelix 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 glacial acetic acid (E260), mannitol (E421) and water for injections. The pH (a measurement of the
acidity) may have been adjusted with sodium hydroxide and glacial acetic acid.

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Inspect the syringe before use. Use only syringes with clear, particle-free solutions and from undamaged containers.

What Ganirelix looks like and contents of the pack
Ganirelix is a clear and colourless aqueous solution for injection. The solution is ready for use and intended for subcutaneous
administration.
Ganirelix is available in packs of 1 or 5 pre-filled syringes with injection needles (27 G).
Not all pack sizes may be marketed.

Fold Size
90 x 31 mm

350 mm
Size: 350x430 mm
EUUK - United Kingdom

100

95

75

25

5

0

Ganirelix SUN 0-25 mg-0-5 ml soln for inj in pfsyg-350x430mm-EUUK-REV1-29-12-14
29 December 2014 09:42:46

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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