How to use your gonal-f pre-filled pen

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How to use your gonal-f pre-filled pen Information in this user guide is based on the European product information for Gonal-f. It is not country specific and may vary from country to country. Please always refer to the patient leaflet and instructions for use provided in your medicine pack or speak to your doctor before using this User Guide.

Getting started with your GONAL-f pre-filled pen the GONAL-f pre-filled pen This document provides a step-by-step guide to self-injecting with your GONAL-f pre-filled pen. The diagram below shows the key components of the GONAL-f pre-filled pen, needle and other items you will need to complete your injection. This guide is intended only for patients who have been prescribed the GONAL-f pre-filled pen by a doctor experienced in treating fertility disorders. Before injecting with your GONAL-f pre-filled pen, please also read the Patient Leaflet and Instructions For Use leaflet that come in the pack with your pen. They contain important information about the GONAL-f pre-filled pen, including how to use and store it, and the possible side effects that you may experience. 1 2 0 150 3 300 450 600 750 900 4 5 150 6 If you have any questions about using your GONAL-f pre-filled pen, please speak to your healthcare professional. 7 8 10 12 9 11 1. Pen cap 2. Threaded needle connector 3. Reservoir holder 4. Plunger piston 5. Dose feedback window 6. Dose-setting knob 7. Inner needle shield 8. Removable needle 9. Outer needle cap 10. Peel-off seal tab 11. Alcohol swabs 12. Sharps disposable container

EXAMINE YOUR MEDICATION Check your medication is within the expiry date you can find this on the pen and the pack. Getting READY lot: 123456 EXP: JUL 2019 LT9Y0003A Before you get started If you keep your GONAL-f pre-filled pen in the refrigerator, take it out about half an hour before you plan to inject, to allow the medication to adjust to room temperature. This makes it more comfortable to inject than when it is cold. DO NOT USE IF THE EXPIRY DATE HAS PASSED Wash your hands with soap and water Make sure you have all the items you need for your injection this should include: Check that the medication in the reservoir holder is clear. 1 GONAL-f pre-filled pen 600 450 300 150 0 IF THE MEDICATION IS NOT CLEAR OR CONTAINS PARTICLES, DO NOT USE IT. YOU SHOULD CONTACT YOUR HEALTHCARE PROFESSIONAL. 2 One single-use needle 3 Alcohol swabs 750 900

PREPARE YOUr needle ATTACHING THE NEEDLE PREPARE YOUr PEN Check that the seal on the outer needle cap is intact. If it is damaged or loose, dispose of the needle safely and use a new needle. Your healthcare professional will advise how to dispose of your needles and pens, e.g. in sharps bin. 3. Remove the peel-off seal from the outer needle cap. ATTACH YOUr needle 0 1. First remove the pen cap. 2. Make sure that the dose feedback window is set at 0 The second time you use your pen and for all subsequent injections, you should wipe the threaded tip with an alcohol swab and allow it to dry before you attach the needle. There is no need to do this the first time as the pen is sterile. 4. Screw the threaded tip of the pen into the outer needle cap until it is firmly in place. Take care not to screw it in too tightly as it may become difficult to remove the needle after the injection.

remove the outer needle cap 5. Remove the outer needle cap by pulling it gently. Put this aside as you will need this later on. Check for air in the system check for drops of fluid The first time you use each of your GONAL-f pre-filled pens, you will need to check for air in the system. 6. Hold the pen with the needle pointing upwards. Carefully remove the green inner needle shield and dispose of it safely. Hold the pen with the needle pointing upwards and look closely at the tip of the needle for one or more tiny drops of fluid. If you see any, the pen is ready to inject. Go straight to Step 4: Setting the dose.

removing air from the system 25 1. To remove air from the system, turn the dose-setting knob clockwise until 25 is displayed in the dose feedback window. If you go past 25, you can easily turn the knob back the other way to select 25. 2. Hold the pen with the needle pointing upwards. Gently tap the reservoir holder. setting your prescribed dose Your healthcare professional will have told you what dose you need to inject each day The GONAL-f pre-filled pen is available in 3 sizes: 300 IU, 450 IU and 900 IU. The minimum single-dose setting is 12.5 IU and the maximum single-dose setting is 300 IU, 450 IU and 900 IU, depending on which size pen you have been prescribed. 150 Turn the dose-setting knob clockwise until the dose prescribed by your doctor shows in the dose feedback window. 3. Press the dose-setting knob as far as it will go. A tiny drop of fluid will appear at the top of the needle. 4. Check that the dose feedback window displays 0 before you move on the next step and set the dose. 125 If you go past the dose you require, turn the knob back anti-clockwise to select the correct dose. 0 Always check the dose is the correct prescribed dose before injecting

inject your dose injecting your dose 1. Slowly push the needle into the skin completely at a 90 angle. Injection area PREPARE YOUr skin Your healthcare professional will have discussed with you how and where on your body to inject. Choosing a different injection site each day will help to minimize skin irritation. 2. Gently push down on the dose-setting knob as far as it will go and hold it down for at least 5 seconds. The larger the dose, the longer the injection will take. The dose feedback window will return to 0. 3. Pull the needle out of the skin, while keeping the dose-setting knob pressed down. Clean the skin at the chosen injection site by wiping with an alcohol swab. 4. Using an alcohol swab or cotton pad, gently press down on the injection site for a few seconds.

after your injection removing the needle check the full dose has been given the needle must be removed after each injection 0 1. Check the number shown in the dose feedback window has returned to 0 and your full prescribed dose has been given. 50 50 complete a partial injection (if required) 2. If a number higher than 0 appears in the dose feedback window, the pen is empty and you have not received your full prescribed dose. The number shown indicates the missing amount of GONAL-f solution that you will need to inject using your new pre-filled pen. Repeat steps 1 to 3 to prepare your new pen for injection. Then set the dose on your new pen to match the dose shown on your old pen to complete your full prescribed dose. 1. Place the outer needle cap on a flat surface. Holding the pen in one hand, push the needle into the outer needle cap. 3. Hold the outer needle cap and unscrew the needle by turning anti-clockwise. 2. Push the capped needle against a firm surface until you hear a click. 4. Replace the pen cap. NEVER PUT THE PEN CAP BACK ON WITH THE NEEDLE STILL IN PLACE.

safety STORING Your GONAL-f Always dispose of needles safely as recommended by your healthcare professional. When the pen is empty ask your healthcare professional how to dispose of it safely. It is recommended that your GONAL-f pre-filled pen should be stored in its original packaging in a refrigerator between 2 C and 8 C and should not be frozen. Within its shelf life, the product may alternatively be stored in its original packaging at room temperature (at or below 25 C) for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months. Please write the date of first use on the GONAL-f pre-filled pen. Once opened, it may be stored for a maximum of 28 days outside of the fridge at room temperature (at or below 25 C). Do not use any medicine left in your pre-filled pen after 28 days. At the end of the treatment any unused solution must be discarded. Do not use GONAL-f after the expiry date which is stated on the cartridge label or carton after EXP. The expiry date refers to the last day of that month. Do not use GONAL-f if you notice any visible signs of deterioration, if the liquid contains particles or is not clear. NEVER REUSE NEEDLES OR SHARE NEEDLES.

Frequently asked questions What should I do when I cannot push the dose-setting knob to deliver the dose? When you cannot push the dose-setting knob down, it means your pen is empty so you will not be able to inject using this pen. You may still see a small amount of medication remaining in the pen. This is normal. Before injecting with your GONAL-f pre-filled pen, please also read the Patient Leaflet and Instructions For Use Leaflet that come in the pack with your pen. If you have any questions about using your GONAL-f pre-filled pen, please speak to your healthcare professional. What do I do if there is not enough GONAL-f remaining in the pen for my prescribed dose? If the dose display shows a number higher than 0 after your injection, this indicates that the pen is empty and that the complete dose has not been given. If this happens, the number shown in the dose display indicates the missing amount of GONAL-f solution that is needed to complete your dose. This is the dose you need to inject using a new pen. Contact details: Nurse : --------------------------------------------------------------- --------------------------------------------------------------- Doctor : -------------------------------------------------------------- What do I do if I dial the wrong dose? To adjust the dose, simply turn the dose-setting knob either clockwise or anti-clockwise. After confirming the correct dose from the display window, you can proceed with your injection. --------------------------------------------------------------

GBPMLR/GON/0117/0003a Date of preparation: March 2017