Cetrotide 0.25 mg powder and solvent for solution forinjection

What Cetrotide is

Cetrotide contains a medicine called ?cetrorelix acetate?. This medicine stops your body from releasing an egg from your ovary (ovulation) during your menstrual cycle. Cetrotide belongs to a group of medicines called ?anti-gonadotropin-releasing hormones?.

What Cetrotide is used for

Cetrotide is one of the medicines used during ?assisted reproductive techniques? to help you get pregnant. It stops eggs being released straight away. This is because if the eggs are released too early (premature ovulation) it may not be possible for your doctor to collect them.

How Cetrotide works

Cetrotide blocks a natural hormone in your body called LHRH (?luteinising hormone releasing hormone?).

• LHRH controls another hormone, called LH (?luteinising hormone?).
• LH stimulates ovulation during your menstrual cycle. This means that Cetrotide stops the chain of events that leads to an egg being released from your ovary. When your eggs are ready to be collected, another medicine will be given to you that will release them (ovulation induction).

Do not use Cetrotide

• if you are allergic (hypersensitive) to cetrorelix acetate or any of the other ingredients of Cetrotide listed in section 6.
• if you are allergic (hypersensitive) to medicines similar to Cetrotide (any other peptide hormones)
• if you are pregnant or breast-feeding
• if you have already reached your menopause
• if you have a moderate or severe kidney or liver disease.

Do not use Cetrotide if any of the above applies to you. If you are not sure, talk to your doctor before using this medicine.

Take special care with Cetrotide

Allergies
Tell your doctor before using Cetrotide if you have an active allergy or have had allergies in the past.

Ovarian Hyper-Stimulation Syndrome (OHSS)

Cetrotide is used together with other medicines that stimulate your ovaries to develop more eggs ready to be released. During or after you receive these medicines, you may develop Ovarian Hyper-Stimulation Syndrome (OHSS). This is when your follicles develop too much and become large cysts. For possible signs to look out for and what to do if this happens see section 4 ? Possible side effects?.

Using Cetrotide during more than one cycle

Experience of using Cetrotide during more than one cycle is small. Your doctor will carefully look at the benefits and risks for you, if you need to have Cetrotide during more than one cycle.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use Cetrotide if you are pregnant, think you may be pregnant, or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicines

Driving and using machines

Cetrotide is not expected to affect you being able to drive and use machines.

Always use Cetrotide exactly as your doctor has told you. Check with your doctor if you are not sure.

Using this medicine
This medicine is only for injection just under the skin of your belly (subcutaneous). To reduce skin irritation, select a different part of your belly each day.

• Your doctor must supervise your first injection. Your doctor or nurse will show you how to prepare and inject the medicine.
• You can carry out the following injections yourself as long as your doctor has made you aware of the symptoms that may indicate allergy and of the possibly serious or life threatening consequences that would need immediate treatment (Please see Section 4 ? Possible side effects?).
• Please carefully read and follow the instructions at the end of this leaflet called ?How to mix and inject Cetrotide?.
• You start by using another medicine on day 1 of your treatment cycle. You then start using Cetrotide a few days later. (See next section ?How much to use?). How much to use Inject the contents of one vial (0.25 mg Cetrotide) once each day. It is best to use the medicine at the same time each day, leaving 24 hours between each dose. You can choose to inject every morning or every evening.
• If you are injecting every morning: Start your injections on day 5 or 6 of the treatment cycle. Your doctor will tell you the exact date and time. You will keep using this medicine up until and including the morning that your eggs are collected (ovulation induction). OR
• If you are injecting every evening: Start your injections on day 5 of the treatment cycle. Your doctor will tell you the exact date and time. You will keep using this medicine up until and including the evening before your eggs are collected (ovulation induction). If you use more Cetrotide than you should Bad effects are not expected if you accidentally inject more of this medicine than you should. The effect of the medicine will last for longer. No specific measures are usually required. If you forget to use Cetrotide
• If you forget a dose, inject it as soon as you remember and talk to your doctor.
• Do not inject a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Cetrotide can cause side effects, although not everybody gets them.

Allergic reactions

• Warm, red skin, itching (often in your groin or armpits), red, itchy, raised areas (hives), runny nose, fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing, serious difficulty breathing or dizziness . You may be having a possible serious, life-threatening allergic reaction to the medicine. This is uncommon (affects less than 1% of the women). If you notice any of the side effects above, stop using Cetrotide and contact your doctor immediately. Ovarian Hyper-Stimulation Syndrome (OHSS) This may occur due to the other medicines that you are using to stimulate your ovaries.
• Lower abdominal pain together with feeling sick (nausea) or being sick (vomiting) may be the symptoms of Ovarian Hyper-Stimulation Syndrome (OHSS). This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed. This event is common (affects between 1% and 10% of the women).
• The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing or fluid in your stomach or chest. This event is uncommon (affects less than 1% of the women). If you notice any of the side effects above, contact your doctor immediately. Other side effects Common (affects between 1% and 10% of the women):
• Mild and short lasting skin irritation may occur at the injection site like redness, itching, or swelling. Uncommon (affects less than 1% of the women):
• Feeling sick (nausea)
• Headache. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Cetrotide after the expiry date which is stated on the vial after EXP. The expiry date refers to the last day of that month.
The Cetrotide powder in the vial and the sterile water (solvent) in the pre-filled syringe have the same expiry date. It is printed on the labels and on the carton.

Do not store above 25°C.

Keep the vial in the outer carton in order to protect from light.

The solution should be used immediately after preparation.

Do not use Cetrotide if the white pellet in the vial has changed in appearance. Do not use it if the prepared solution in the vial is not clear and colourless or if it has particles in it.

If you have any further questions please ask your doctor or pharmacist.

What Cetrotide contains

• The active substance is cetrorelix acetate. Each vial contains 0.25 mg cetrorelix acetate.
• The other ingredient is mannitol.
• The solvent is sterile water for injection.

What Cetrotide looks like and contents of the pack

Cetrotide is a white powder for solution for injection in a glass vial with a rubber stopper. It is available in packs of one or seven vials (not all pack sizes may be marketed).
For each vial, the packs contain:

• one syringe pre-filled with sterile water for injection (solvent). This water is for mixing with the powder in the vial
• one needle with a yellow mark - for injecting the sterile water into the vial and drawing the made up medicine out from the vial
• one needle with a grey mark - for injecting the medicine into your belly
• two alcohol swabs for cleaning

Marketing Authorisation Holder

Merck Serono Europe Limited, 56 Marsh Wall, London E14 9TP, United Kingdom

Manufacturer
Baxter Oncology GmBH, Kantstrasse 2, D-33790 Halle, Germany
or
Æterna Zentaris GmbH, Weismüllerstrasse 50, D-60314 Frankfurt, Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien MERCK NVSA Brusselsesteenweg 288 B-3090 Overijse TélTel 32-2-686 07 11 LuxembourgLuxemburg MERCK NVSA Brusselsesteenweg 288 B-3090 Overijse, BelgiqueBelgien TélTel 32-2-686 07 11

Magyarország Merck Kft. Bocskai út 134-146. H-1113 Budapest Tel 36-1-463-8100 . . 83 1582 Te 359 28075 111

eská republika Merck spol. s r.o. Na Hebenech II. 171810 CZ-140 00 Praha 4 Tel. 420 272084211 Malta Cherubino Ltd Delf Building Sliema Road MT-GZR 06 Gzira Malta Tel 356-21-3432701234

Danmark Merck AS Strandvejen 102 B, 4th DK-2900 Hellerup Tlf 45 35253550 Nederland Merck BV Tupolevlaan 41-61 NL-1119 NW Schiphol-Rijk Tel 31-20-6582800

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Polska Merck Sp. z o.o. Al. Jerozolimskie 178 PL-02-486 Warszawa Tel. 48 22 53 59 700 Merck A.E. 41-45, GR-151 23 T 30-210-61 65 100

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Lietuva
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Tel: +370 37320603

This leaflet was last approved in

HOW TO MIX AND INJECT CETROTIDE

• This section tells you how to mix the powder and the sterile water (solvent) together and then how to inject your medicine.
• Before starting to use this medicine, please read these instructions the whole way through first.
• This medicine is only for you ? do not let anyone else use it.
• Use each needle, vial and syringe only once.

Before you start

1. Wash your hands

• It is important that your hands and the things you use are as clean as possible.

2.Lay out everything you need on a clean surface:

• one vial of powder
• one syringe pre-filled with sterile water (solvent)
• one needle with a yellow mark ? for injecting the sterile water into the vial and drawing the made up medicine out from the vial
• one needle with a grey mark ? for injecting the medicine into your belly
• two alcohol swabs.

Mixing the powder and water to make up your medicine

1. Remove the plastic cap from the vial

• There will be a rubber stopper underneath ? keep this in the vial.
• Wipe the rubber stopper and metal ring with your first alcohol swab.

2. Adding the water from the pre-filled syringe to the powder in the vial

• Unwrap the needle with the yellow mark on it.
• Remove the cap from the pre-filled syringe and screw the yellow needle onto it. Remove the cap from the needle.
• Push the yellow needle through the centre of the rubber stopper of the vial.
• Slowly push in the plunger of the syringe to inject the water into the vial. Do not use any other sort of water.
• Leave the syringe in the rubber stopper.

3. Mixing the powder and water in the vial

• While carefully holding the syringe and vial, swirl gently to mix the powder and water together. When it is mixed, it will look clear and have no particles in it.
• Do not shake or you will create bubbles in your medicine.

4. Re-filling the syringe with the medicine from the vial

• Turn the vial upside down.
• Pull the plunger out to draw the medicine from the vial back into the syringe.
• If any medicine is left in the vial, pull out the yellow needle until the end of the needle is just inside the rubber stopper. If you look from the side through the gap in the rubber stopper, you can control the movement of the needle and the liquid.
• Make sure that you collect all of your medicine from the vial.
• Put the cap back on the yellow needle. Unscrew the yellow needle from the syringe and lay down the syringe.

Preparing the injection site and injecting your medicine

1. Removing air bubbles

• Unwrap the needle with the grey mark on it. Screw the grey needle onto the syringe and remove the cap from the grey needle.
• Hold the syringe with the grey needle pointing upwards and check for any air bubbles.
• To remove air bubbles, gently flick the syringe until all the air collects at the top - then slowly push the plunger in until the air bubbles are gone.
• Do not touch the grey needle and do not let the needle touch any surface.

2. Clean the injection site

• Choose an injection site on your belly. It is best around the belly button (navel). To reduce skin irritation, select a different part of your belly each day.
• Clean the skin at your chosen injection site with your second alcohol swab - use a circular motion.

3. Piercing your skin

• Hold the syringe in one hand ? like you would hold a pencil.
• Gently pinch up the skin around where you are going to inject and hold this firmly with your other hand.
• Slowly push the grey needle completely into your skin at an angle of about 45 to 90 degrees ? then let go of your skin.

4. Injecting your medicine

• Gently pull back the plunger of the syringe. If blood appears, follow Step 5 below.
• If no blood appears, slowly push the plunger in to inject your medicine.
• When the syringe is empty, take out the grey needle slowly at the same angle.
• Use your second alcohol swab to gently apply pressure where you have just injected.

5. If blood appears:

• take out the grey needle slowly at the same angle
• use your second alcohol swab to gently apply pressure where you have just pierced your skin
• empty your medicine into a sink and follow Step 6 below
• wash your hands and start again with a new vial and pre-filled syringe.

6. Disposal

• Use each needle, vial and syringe only once.
• Put the cap back on the needles so that they are safe to be thrown away.
• Ask your pharmacist how to safely dispose of used needles, vial and syringe.