What GONAL-f contains
- The active substance is follitropin alfa.
- There are 600 IU (44 micrograms) of follitropin alfa in each millilitre of liquid. Each pre-filled pen with multidose cartridge delivers 450 IU (33 micrograms) in 0.75 ml.
- The other ingredients are poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, concentrated phosphoric acid, sodium hydroxide and water for injections.
What GONAL-f looks like and contents of the pack
- GONAL-f is presented as a clear, colourless liquid for injection in a pre-filled pen.
- It is supplied in packs with 1 pre-filled pen and 7 disposable needles .
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 USE THE GONAL-f PRE-FILLED PEN
- This section tells you how to use your pen.
- Before starting to use your pen, please read these instructions the whole way through first.
- Only use this pen for you ? do not let anyone else use it.
- The numbers on the black dose selection dial and the red dose control scale are measured in International Units or IU. Your doctor will have told you how many IU to inject each day.
- Give yourself the injection at the same time each day.
Before you start
1. Wash your hands
- It is important that your hands and the things you use to get your pen ready are as clean as possible.
2. Find a clean area
- A good place is a clean table or kitchen surface.
3. Get together everything you need and lay them out:
- 2 alcohol swabs
- the pre-filled pen
- a needle.
1. pen cap 9. dose arrow
2. outer needle cap 10. black dose selection dial (in IU FSH)
3. peel-off seal 11. red dose control scale
4. inner needle cap 12. grey marker of complete dose
5. removable needle delivery
6. threaded tip 13. injection button
7. liquid holder
8. plunger piston
Please note: The scale that can be seen through the liquid holder shows how much of the medicine is left in the pen. Do not use it to set the dose.
Getting a new pen ready for the first time
1. Take off the pen cap
2. Put on a needle
- Take a new needle ? only use the ?single-use? needles supplied for the GONAL-f pre-filled pen.
- Check that the peel-off seal on the outer needle cap is not damaged or loose. If it is damaged or loose, do not use the needle and get another. Throw away the unused needle with the outer needle cap still on, in your household rubbish.
- Pull off the peel-off seal.
- Hold the outer needle cap firmly.
- Press the threaded tip of the pen into the outer needle cap and twist it clockwise.
- Twist it until it is firmly fixed.
3. Getting the liquid in the pen ready for use (also called ?priming? the pen)
- Set the dose arrow to 37.5 using the black dose selection dial - look for the small dot.
- Pull out the injection button as far as it will go.
- Take off the outer needle cap.
- Then take off the inner needle cap and hold the pen with the needle pointing upwards.
- Tap the liquid holder gently with your finger.
- this lets any air bubbles rise up towards the needle.
- With the needle still pointing upwards, press the injection button fully.
- A drop of liquid will appear at the tip of the needle; this shows that your pen is ready for injection.
- This liquid at the needle tip is the ?over-fill? from the pen.
- If no liquid appears the first time, pull out the injection button as far as it will go and press the button again until a drop of liquid appears.
Setting the dose
1. Set the dose you need by turning the black dose dial in either direction
- Turn the dial until the arrow is pointing to the dose you need.
- The black dial lets you set the dose in steps of 37.5 IU.
- The smallest dose is 37.5 IU and the largest is 450 IU.
- Important: carefully check the dose dial before moving on to the next step. This is because the dose cannot be changed after you have pulled out the injection button.
- If you realise that you have set and loaded a wrong dose, do not inject it. Discard the wrong dose in the sink and set the dose again.
2. Once you have set your dose, load the dose by pulling the injection button out as far as it
- Take care to pull the button straight and not to twist it out ? twisting it might change the dose which you have set.
- When the injection button is pulled out, the loaded dose is shown on the red dose control scale which appears. It is shown by the last mark (flat arrow).
- The example in the picture shows the injection button pulled out and a loaded dose of 150 IU. The grey marker can now be seen.
- Important: check the red dose control scale on the injection button to make sure that the full dose has been loaded.
- If the loaded dose is lower than the set dose, then there was not enough medicine left in your pen for this dose.
- If this happens, follow the instructions given at the bottom of this column in the second bullet point of the ?More information about the red dose control scale? section.
- If the same dose is required every time, then the dose arrow can be left pointing at the same position on the dose dial.
Injecting the dose
1. Choose the place to give the injection ? where your doctor or nurse has told you (e.g. tummy,
front of thigh). To minimise skin irritation, select a different injection site each day.
2. Clean the skin where the injection is going by wiping with an alcohol swab
3. Inject the dose as you were told by your doctor or nurse
- Put the needle into the skin and press the injection button as far as it will go.
- Check that the grey marker on the injection button is no longer visible.
- This confirms that the dose has been given.
- You must keep the needle in the skin with the injection button pressed down for at least 10 seconds.
- After 10 seconds, keep the injection button pressed down, and take the needle out of the skin.
After the injection
1. Taking off the needle
- Take off the needle after each injection.
- Hold the pen firmly by the liquid holder.
- Carefully put back the outer needle cap onto the needle.
- Then grip the outer needle cap and unscrew the needle ? do this by turning anti-clockwise.
- Throw away the used needle with outer needle cap on, in your household rubbish.
- Now put the pen cap back onto the pen.
2. Storing the pen
- First take off the needle and put back on the pen cap - as described above.
- Then store the pen in a safe place.
- It is best to put it back into its original package.
- When the pen is empty, throw it away in your household rubbish.
More information about the red dose control scale
- When the pen is nearly empty, there may not be enough left for your last dose from that pen. The red dose control scale on the injection button is for you to check whether there is enough for your last dose from the pen. ? It can only be pulled out as far as the mark (flat arrow) showing the amount of medicine left in the pen.
- If the loaded dose is not enough to complete your injection, you can do one of two things: ? Either inject the part dose ? what is left in the pen. If you do this, write down straight away how much you have injected. Then give the rest of your dose from a new pen. ? Or throw away the pen and inject the full dose using a new pen.