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Merck GONAL-f 450 IU Instructions For Use Manual
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Merck GONAL-f 450 IU Instructions For Use Manual

Pre-filled pen 0.75ml
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Summary of Contents for Merck GONAL-f 450 IU

  • Page 2 PRE-FILLED PEN 450 IU/0.75 mL Instructions for use...

  • Page 3: Table Of Contents

    Contents How to use the GONAL-f pre-filled pen How to use your GONAL-f pre-filled pen Treatment diary Before you start using your GONAL-f pre-filled pen Getting your GONAL-f pre-filled pen ready for injection Setting the dose prescribed by your doctor Injecting the dose After the injection GONAL-f pre-filled pen Treatment diary (see table at the end)

  • Page 4: How To Use The Gonal-F Pre-Filled Pen

    - 2 - 1. How to use the GONAL-f pre-filled pen • Do not share the pen. The pen is for subcutaneous injection only. • The numbers on the Dose Feedback Window are measured in International Units or IUs. Your doctor will have told you how many IUs to inject each day.

  • Page 5: How To Use Your Gonal-F Pre-Filled Pen Treatment Diary

    2. How to use your GONAL-f pre-filled pen Treatment Diary A treatment diary is included on the last page. Use the treatment diary to record the amount of injected IUs you use each time. • Record the treatment day number (1), date (2) and time (3) of your injection. •...
  • Page 6 that you received the full prescribed dose. - 4 - An example of a treatment diary: Treatment Date Time Pen Volume Prescribed Dose Feedback Window Dose 450 IU/0.75 mL Number Amount Set to Amount Displayed After Injection Inject if not "0", need second injection if "0", 450 IU 10/06...

  • Page 7: Before You Start Using Your Gonal-F Pre-Filled Pen

    3. Before you start using your GONAL-f pre-filled pen • Wash your hands with soap and water. • Find a clean area and a flat surface. • Verify the expiration date on the pen label. • Gather everything you need and lay it out: Lot: 123456 EXP:...
  • Page 8 Dose setting knob Threaded needle connector Inner needle shield Dose Feedback Window Pen cap 10. Outer needle cap Plunger piston Peel-off seal tab 11. Alcohol swabs Reservoir holder Removable needle 12. Sharps disposal container - 7 -...

  • Page 9: Getting Your Gonal-F Pre-Filled Pen Ready For Injection

    Getting your GONAL-f pre-filled pen ready for injection 4.1. Take off the pen cap 4.2. Verify that the Dose Feedback Window is set to ‘’0’’. - 8 - 4.3. Prepare your needle for injection...
  • Page 10 - 8 - 4.3. Prepare your needle for injection Example of Example of a good seal a bad seal • Get a new needle – only use the ‘’single-use’’ needles supplied. • Hold the outer needle cap firmly. • Check that the peel-off seal on the outer needle cap is not damaged or loose: •...
  • Page 11 4.4. Attach the needle • Screw the threaded tip of the GONAL-f pre-filled pen into the outer needle cap until you feel a light resistance. Warning: Do not attach the needle too tightly; the needle could be difficult to remove after the injection. •...
  • Page 12 - 10 - 4.5. Look closely at the tip of the needle for tiny drop(s) of fluid • If you see a tiny drop(s) of fluid proceed to Section 5: Setting the dose prescribed by your doctor. Warning: ONLY check for drop(s) the FIRST TIME you use a new GONAL-f pre-filled pen to remove air in the system.
  • Page 13 If you do not see a tiny drop(s) of fluid at or near the tip the first time you use a new pen: Gently turn the dose setting knob clockwise until it reads 25 in the Dose Feedback Window. You can turn the dose knob backwards if you turn it past 25.
  • Page 14 Hold the pen with the needle pointing upward. Tap the reservoir holder gently. Press the dose setting knob as far as it will go. A tiny drop of liquid will appear at the tip of the needle. Verify that the Dose-Feedback Window reads ‘’0’’. Proceed to Section 5: Setting the dose prescribed by your doctor.

  • Page 15: Setting The Dose Prescribed By Your Doctor

    Setting the dose prescribed by your doctor 5.1. The pen contains 450 IU follitropin alpha. • The 450 IU pen maximum single-dose setting is 450 IU and the smallest single-dose setting is 12.5 IU. 5.2. Turn the dose setting knob until your intended dose shows in the Dose Feedback Window. •...
  • Page 16 - 14 - 5.3. Set the dose that was prescribed by your doctor (in the example shown in the figure, it is 50 IU). Warning: Check that the Dose Feedback Window displays your complete prescribed dose before you move on to the next step. - 15 -...

  • Page 17: Injecting The Dose

    6. Injecting the dose 6.1. Choose an injection site in the area your doctor or nurse has told you to give the injection. To minimize skin irritation, select a different injection site each day. 6.2. Clean the skin by wiping with an alcohol swab. Injection area 6.3.
  • Page 18 - 16 - • Hold the dose knob down for a minimum of 5 seconds to ensure you inject the full dose (2). The larger the dose, the longer it will take to inject. • The dose number shown in the Dose Feedback Window will turn back to 0.

  • Page 19: After The Injection

    7. After the injection 7.1. Verify you have given a complete injection. • Check that the Dose Feedback Window shows “0”. Warning: If the Dose Feedback Window shows a number higher than 0, the GONAL-f pre-filled pen is empty and you have not received your full prescribed dose. - 18 - 7.2.
  • Page 20 - 18 - 7.2. Complete a partial injection (only when needed). • The Dose Feedback Window will indicate the missing amount you need to inject using a new pen. • Repeat Section 3 (“Before you start using your GONAL-f pre-filled pen“) through Section 4 (“Getting your GONAL-f pre-filled pen ready for injection“) with a second pen.
  • Page 21 7.3. Removing the needle after each injection. • Place the outer needle cap on a flat surface. • Hold the GONAL-f pre-filled pen firmly with one hand, and slip the needle into the outer needle cap. • Continue by pushing the capped needle against a firm surface until you hear a click “click.”...
  • Page 22 - 20 - • Never reuse any used needle. Never share needles. • Recap the pen. 7.4. Storing the GONAL-f pre-filled pen. CAUTION: Never store the pen with the needle attached. Always remove the needle from the GONAL-f pre-filled pen before replacing the pen cap. •...

  • Page 23: Gonal-F Pre-Filled Pen Treatment Diary (See Table At The End)

    8. GONAL-f pre-filled pen Treatment Diary Treatment Date Time Pen Volume Prescribed Dose Dose Feedback Window 450 IU/0.75 mL Number Amount Displayed After Injection Amount Set to Inject if "0", if not "0", need second injection 450 IU injection complete Inject this amount ...using new pen if "0", if not "0", need second injection 450 IU...
  • Page 24 if "0", if not "0", need second injection 450 IU injection complete Inject this amount ...using new pen if "0", if not "0", need second injection 450 IU injection complete Inject this amount ...using new pen if "0", if not "0", need second injection 450 IU injection complete Inject this amount ...using new pen...
  • Page 25 Treatment Date Time Pen Volume Prescribed Dose Dose Feedback Window 450 IU/0.75 mL Number Amount Displayed After Injection Amount Set to Inject if "0", if not "0", need second injection 450 IU injection complete Inject this amount ...using new pen if "0", if not "0", need second injection 450 IU injection complete...
  • Page 26 if "0", if not "0", need second injection 450 IU injection complete Inject this amount ...using new pen if "0", if not "0", need second injection 450 IU injection complete Inject this amount ...using new pen if "0", if not "0", need second injection 450 IU injection complete Inject this amount ...using new pen...