What Cetrotide contains
- The active substance is cetrorelix acetate. Each vial contains 3 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 a pack with one vial.
In addition to the vial, the pack contains
- one syringe pre-filled with sterile water for injection (solvent). This water is for mixing the powder in the vial.
- one needle with a yellow mark - for injecting the 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
Baxter Oncology GmBH, Kantstrasse 2, D-33790 Halle, Germany
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
Deutschland Merck Serono GmbH Alsfelder Straße 17 D-64289 Darmstadt Tel 49-6151-6285-0 Norge Merck Serono Norge Luhrtoppen 2 N-1470 Lørenskog Tlf 47 67 90 35 90
Eesti Merck Serono OÜ Tornimäe 7 - 132, EE-10145, Tallinn Tel 372 682 5882 Österreich Merck GesmbH. Zimbagasse 5 A-1147 Wien Tel 43 1 57600-0
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
Portugal Merck, s.a. Rua Alfredo da Silva, 3-C P-1300-040 Lisboa Tel 351-21-361 35 00 España Merck S.L. María de Molina, 40 E-28006 Madrid Línea de Información 900 200 400 Tel 34-91-745 44 00
România MERCK d.o.o., Dunajska cesta 119 SI-1000 Lubliana, Slovenia Tel 386 1 560 3 800 France Merck Serono s.a.s. 37, rue Saint-Romain F-69379 Lyon cedex 08 Tél. 33-4-72 78 25 25 Numéro vert 0 800 888 024
Slovenija MERCK d.o.o. Dunajska cesta 119 SI-1000 Ljubljana Tel 386 1 560 3 800 Ireland Merck Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX United Kingdom Tel 44-20 8818 7200
Ísland Icepharma hf Lynghálsi 13 IS-110 Reykjavík Tel 354 540 8000 Slovenská republika Merck spol. s r.o. Tuhovská 3 SK-831 06 Bratislava Tel 421 2 49 267 111
Italia Merck Serono S.p.A. Via Casilina 125 I-00176 Roma Tel 39-06-70 38 41 SuomiFinland Merck Oy Pihatörmä 1 C FIN-02240 Espoo PuhTel 358-9-8678 700
Sverige Merck AB S-195 87 Stockholm Tel 46-8-562 445 00 . . 35, CY-2234 , . 357 22490305
Latvija Merck Serono SIA Duntes iela 23A LV-1005, Rga Tel 371 67152500 United Kingdom Merck Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX - UK Tel 44-20 8818 7200
Merck Serono UAB
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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.
- 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.