What GONAL-f contains
- The active substance is follitropin alfa.
- Each vial contains 5.5 micrograms of follitropin alfa.
- After preparation of the final solution for injection, there are 75 IU (5.5 micrograms) of follitropin alfa in each millilitre of solution.
- The other ingredients are sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
- The solvent is water for injections.
What GONAL-f looks like and contents of the pack
- GONAL-f is presented as a powder and solvent for solution which are used to prepare a injection.
- The powder is a white pellet in a glass vial.
- The solvent is a clear colourless liquid in a pre-filled syringe, each containing 1 ml.
- GONAL-f is supplied in packs of 1, 5, 10 vials of powder with the corresponding number of solvent in pre-filled syringes. Not all pack sizes may be marketed.
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:
- 1 pre-filled syringe containing the solvent (the clear liquid)
- 1 vial containing GONAL-f (the white powder) Not provided in the pack:
- 2 alcohol swabs
- 1 needle for preparation
- 1 fine bore needle for injection under the skin
- 1 sharp container
3. Preparing the solution
- Remove the protective caps from the powder vial and from the pre-filled syringe.
- Attach the needle for preparation to the pre-filled syringe, insert it into the powder vial and slowly inject all the solvent. Swirl gently without removing the syringe. Do not shake.
- Check that the resulting solution is clear and does not contain any particles.
- Turn the vial upside down and gently draw the solution back into the syringe by pulling the plunger.
- Remove the syringe from the vial and set it down carefully. Do not touch the needle and do not allow the needle to touch any surface.
If you have been prescribed more than one vial of GONAL-f, slowly re-inject the solution into another powder vial, until you have the prescribed number of powder vials dissolved in the solution. If you have been prescribed lutropin alfa in addition to GONAL-f, you may also mix the two medicines as an alternative to injecting each product separately. After dissolving the lutropin alfa powder, draw the solution back into the syringe and re-inject it into the vial containing GONAL-f. Once the powder has dissolved, draw the solution back into the syringe. Inspect for particles as before, and do not use if the solution is not clear. Up to three containers of powder may be dissolved in 1 ml of solvent.
4. Getting ready the syringe for injection
- Change the needle for the fine bore needle.
- Remove any 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.
5. 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.
6. After the injection
Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers safely preferably in the sharp container. Any unused solution must be discarded.