What GONAL-f contains
- The active substance is follitropin alfa.
- Each vial contains 1,200 IU of follitropin alfa.
- After reconstitution, there are 1,050 IU (77 micrograms) of follitropin alfa in 1.75 ml solution, that means there are 600 IU (44 micrograms) in each millilitre of solution.
- The other ingredients are sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
- The solvent contains water for injections.
What GONAL-f looks like and contents of the pack
- GONAL-f is presented as a powder and solvent which are used to prepare a solution for injection.
- The powder is a white pellet in a multidose glass vial.
- The solvent is a clear colourless liquid in a pre-filled syringe, each containing 2 ml.
- GONAL-f is supplied in packs of 1 vial of powder with 1 pre-filled syringe of solvent and 15 disposable syringes for administration graduated in International Units (IU FSH).
Marketing Authorisation Holder
Merck Serono Europe Limited, 56 Marsh Wall, London E14 9TP, United Kingdom.
Merck Serono S.p.A., Via delle Magnolie 15, I-70026 Modugno (Bari), Italy.
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 E. Merck AB 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 Ahtri 12, EE-10151, Tallinn Tel 372 6116220 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 E. 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
Savanoriu pr. 192,
Tel: +370 37320603
This leaflet was last approved in
HOW TO PREPARE AND USE THE GONAL-f POWDER AND SOLVENT
- This section tells you how to prepare and use your GONAL-f powder and solvent.
- Before starting the preparation, please read these instructions the whole way through first.
- Give yourself the injection at the same time each day.
1. Wash your hands and find a clean area
- It is important that your hands and the items you use be as clean as possible.
- A good place is a clean table or kitchen surface.
2. Get together everything you need and lay them out::
- 2 alcohol swabs
- The pre-filled syringe containing the solvent (the clear liquid)
- The vial containing GONAL-f (the white powder)
- An empty syringe for injection (see illustration below)
3.Preparing the solution
- Remove the protective caps from the powder vial and from the pre-filled syringe.
- Take your pre-filled syringe, insert the needle into the powder vial and slowly inject all the solvent into the vial containing the powder.
- Remove the syringe from the vial and throw it away (put the protective cap to avoid injuries).
- This vial contains several doses of GONAL-f. You will have to keep it several days and only draw the prescribed dose every day.
4. Getting ready the syringe for injection
- Swirl gently the vial of GONAL-f prepared in step 3, do not shake. Check that the solution is clear and does not contain any particles.
- Take the syringe for injection and fill it with air by pulling the plunger to the correct dose in International Units (IU FSH).
- Insert the needle into the vial, turn the vial upside down and inject the air into the vial.
- Draw the prescribed dose of GONAL-f into the syringe for administration by pulling the plunger until it reaches the correct dose in IU FSH.
5. Removing air bubbles
- If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top. Push the plunger until the air bubbles are gone.
6. Injecting the dose
- Immediately inject the solution: Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh). To minimise skin irritation, select a different injection site each day.
- Clean the chosen skin area with an alcohol swab using a circular motion.
- Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
- Inject under the skin by pushing gently the plunger, as you were taught. Do not inject directly into a vein. Take as much time as you need to inject all the solution.
- Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
7. After the injection
- Once you have finished your injection, immediately discard the used syringes safely, preferably in a sharp container.
- Store the glass vial with the prepared solution in a safe place. You may need it again. The prepared solution is for your use alone and must not be given to other patients.
- For further injections with the prepared solution of GONAL-f, repeat steps 4. to 7.