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HUMATROPE- somatropin kit


  1. Patient Information
  2. Must A New Needle Be Used For Each Injection?
  3. What Should I Do If The Cartridge Label And Pen Do Not Match?
  4. What Should I Do If The Humatrope Is Not Clear After Mixing?
  5. Why Doesnt The Screw Move Out When There Is No Cartridge Attached To The Pen?
  6. What Should I Do If I Cant Attach The Cartridge To The Pen Body?
  7. Why Is It Difficult To Push The Injection Button When I Try To Inject The Dose?
  8. Why Doesnt The Dose Knob Go To Zero When I Inject The Dose?
  9. How Do I Throw Away Used Needles?
  10. Why Are There Air Bubbles In The Cartridge?
  11. Why Doesnt The Screw Move Out When There Is No Cartridge Attached To The Pen?
  12. What Should I Do If I Cant Attach The Cartridge To The Pen Body?
  13. Why Doesnt The Dose Knob Go To Zero When I Inject The Dose?
  14. Why Doesnt The Screw Move Out When There Is No Cartridge Attached To The Pen?
  15. What Should I Do If I Cant Attach The Cartridge To The Pen Body?
  16. Why Doesnt The Dose Knob Go To Zero When I Inject The Dose?

Patient Information 

  • Pen Needles are not included. You may need a prescription to get the Needles from your pharmacist.
  • Becton, Dickinson and Company Pen Needles are suitable for use with the HumatroPen 6 mg.
  • Ask your healthcare professional what Needle gauge and length is best to use.
  • Follow your healthcare professional's instructions on safe handling of needles.

Must A New Needle Be Used For Each Injection? 

  • Yes, a new Needle must be used for each injection.
  • Remove the Needle immediately after each injection. Use a new Needle for each injection. This will help minimize the risk of infection, prevent leakage of Humatrope, keep out air bubbles, and reduce Needle clogs.

What Should I Do If The Cartridge Label And Pen Do Not Match? 

  • DO NOT USEthe Pen if the Cartridge strength on the Humatrope Cartridge label does not match the number on the Pen's Front Housing. This is important to ensure the correct dose of Humatrope is given.
  • Contact your healthcare professional for assistance or to obtain a replacement.
  • What Should I Do If The Humatrope Is Not Clear After Mixing? 

    • Be sure to gently invert the Pen up and down 10 times.DO NOT SHAKE.Then, let the Pen sit for at least three minutes. If the solution remains cloudy or has particles, gently invert the Pen up and down 10 more times. Let the Pen sit for five more minutes.
    • If the solution remains cloudy or contains particles after reconstitution (mixing),DO NOT USE.Contact your healthcare professional for assistance.
  • Why Doesnt The Screw Move Out When There Is No Cartridge Attached To The Pen? 

    • The Screw may not move out when you push the Injection Button unless there is a Cartridge in the Pen. This feature allows you to easily push the Screw into the Pen Body when replacing a Cartridge.
    • Once a Cartridge is attached, the Screw will move out when the Injection Button is pushed.
  • What Should I Do If I Cant Attach The Cartridge To The Pen Body? 

    • Check that the Cartridge is not damaged or broken.
    • Carefully line up the Cartridge with the Pen Body and screw together until secure. If the Cartridge and Pen cannot be screwed together contact your healthcare professional.
  • Why Is It Difficult To Push The Injection Button When I Try To Inject The Dose? 

    • The Needle may be clogged. Try attaching a new Needle.
    • Pushing the Injection Button down quickly may make the Injection Button harder to push. Pushing the Injection Button more slowly may make it easier.
    • Using a larger diameter Needle will make it easier to push the Injection Button during injection. Ask your healthcare professional which Needle is best for you.
    • The Injection Button may become harder to push if the inside of the Pen gets dirty with Humatrope, food, drink, or other materials.
  • Why Doesnt The Dose Knob Go To Zero When I Inject The Dose? 

    • This can happen if the Humatrope Cartridge does not have enough Humatrope left in it for the full dose. It is possible to set a dose larger than the amount of Humatrope left in the Cartridge. At the end of the injection, the number in the Dose Window should be 0.00. If it is not, this is the amount of Humatrope thatWAS NOTdelivered. Consult with your healthcare professional on how to handle a partial dose. Remove the Needle and empty Cartridge. For the next daily use attach a new Cartridge as shown in Section 2, Step A, and continue with New Cartridge Setup (Section 2).
  • Why do I
    • The injection is complete when:
      -
      You have slowly counted to five while you are still holding the Injection Button in and before you remove the Needle from the skin.

      AND

      -
      0.00is in the center of the Dose Window.
  • Manufacturer:
    Eli Lilly and Company
    Pharmaceutical Delivery Systems
    Lilly Corporate Center
    Indianapolis, IN 46285, USA

    Humatrope, HumatroPen6 mg and the H Block design are registered trademarks of Eli Lilly and Company.

    The HumatroPen 6 mg is for use with Humatrope 6 mg Cartridges only.

    2009, 2019, Eli Lilly and Company. All rights reserved.

    Literature revised May 17, 2019

    HTRPEN6-0001-IFU-20190517

    Figure

    Humatrope
    somatropin (rDNA origin) for injection

    HumatroPen12 mg
    Growth Hormone Delivery System
    Injection Device for Use with Humatrope[somatropin (rDNA origin) for injection] Cartridges

    Figure
    12
    mg
    PEN USER MANUAL

    Figure

    SECTION 1Read this section completely before you begin.
    Then, move on to Section 2.

    WHAT YOU NEED TO KNOW ABOUT THE HUMATROPEN12 MG

    Read these instructions carefully BEFORE using the HumatroPen12 mg. You need to use the Pen correctly in order to get the most benefit from the Humatropetreatment. Failure to follow these instructions completely may result in too much or too little Humatrope being injected.

    INTRODUCTION

    The HumatroPen 12 mg is an injection device intended for use with Humatrope 12 mg Cartridges. Your healthcare professional has prescribed the Humatrope dose and Pen that you or your child should receive.

    DO NOT CHANGE the dose or Pen unless directed by your healthcare professional.

    If your healthcare professional changes the prescribed cartridge size from the 12 mg Humatrope Cartridge to the 6 mg or 24 mg Humatrope Cartridge, you must get a new HumatroPen to match the new cartridge size.

    Before using the HumatroPen 12 mg, make sure that you thoroughly read this user manual. It explains the Pen operations and has a troubleshooting guide, should questions arise.

    These instructions do not take the place of talking with your healthcare professional about your or your child's medical condition, or its treatment. If you are having problems using the HumatroPen 12 mg, call 1-800-545-5979.

    IMPORTANT INFORMATION ABOUT THE HUMATROPEN 12 MG

    • Where you

      • Pen Needles are not included. You may need a prescription to get the Needles from your pharmacist.
      • Becton, Dickinson and Company Pen Needles are suitable for use with the HumatroPen 12 mg.
      • Ask your healthcare professional what Needle gauge and length is best to use.
      • Follow your healthcare professional's instructions on safe handling of needles.

    How Do I Throw Away Used Needles? 

    • Throw away used Needles in a puncture-proof container. Follow your healthcare professional's instructions on how to do this safely.

    CARE AND STORAGE FOR THE HUMATROPEN 12 MG

    Care

    • Soiled parts can be cleaned with a damp cloth. DO NOT USE alcohol or other cleaning agents.
    • DO NOT SOAK or immerse the Pen in liquid.
    • DO NOT APPLY oil or any other lubricant.

    Storage

    • Store the HumatroPen 12 mg with attached Humatrope Cartridge in the storage case in the refrigerator until the time of the next injection. DO NOT FREEZE.
    • All Humatrope Cartridges and diluent must be refrigerated at temperatures between 36 F to 46 F (+2 C and +8 C). DO NOT FREEZE. A prepared Cartridge can be left on a Pen for 28 days in the refrigerator. DO NOT USE any prepared Cartridge after 28 days.
    • Let the HumatroPen 12 mg with attached Humatrope Cartridge stand at room temperature for 10 minutes before injecting. Discomfort may be noticed at the injection site if Humatrope is injected cold.
    • Daily room temperature exposure should not exceed 30 minutes.
    • DO NOT STORE the Pen with the Needle attached.

    REPLACEMENT

    Do not use your pen for more than 3 years after the first use or past the expiration date on the carton, whichever comes first.

    Record the date the Pen was first used here: __ / __ / __.
    Record the expiry date from your carton here: __ / __ / __.

    Contact your healthcare professional if a new HumatroPen 12 mg is needed, or when the Pen has been used for 3 years.

    Please

    • No. The New Cartridge Setup is performed only once for each Cartridge, just before a new Cartridge is used for the first time.
    • The purpose of the setup is to make sure the HumatroPen 12 mg and 12 mg Cartridge are ready to use.
    • If you repeat the New Cartridge Setup before each routine dose, you may run out of Humatrope early. The small amount of product used in the New Cartridge Setup will not affect the supply of Humatrope.
  • Why Are There Air Bubbles In The Cartridge? 

    • Air bubbles may remain in the Cartridge after reconstitution (mixing).
    • If the Pen is stored with a Needle attached, air bubbles may form in the Cartridge.
      DO NOT STOREthe Pen with a Needle attached.
    • Perform the New Cartridge Setup to remove air bubbles from the Cartridge.
    • A small air bubble is normal. It will not cause any harm nor affect the dose.
  • Why Doesnt The Screw Move Out When There Is No Cartridge Attached To The Pen? 

    • The Screw may not move out when you push the Injection Button unless there is a Cartridge in the Pen. This feature allows you to easily push the Screw into the Pen Body when replacing a Cartridge.
    • Once a Cartridge is attached, the Screw will move out when the Injection Button is pushed.
  • What Should I Do If I Cant Attach The Cartridge To The Pen Body? 

    • Check that the Cartridge is not damaged or broken.
    • Carefully line up the Cartridge with the Pen Body and screw together until secure. If the Cartridge and Pen cannot be screwed together contact your healthcare professional.
  • Why Doesnt The Dose Knob Go To Zero When I Inject The Dose? 

    • This can happen if the Humatrope Cartridge does not have enough Humatrope left in it for the full dose. It is possible to set a dose larger than the amount of Humatrope left in the Cartridge. At the end of the injection, the number in the Dose Window should be 0.00. If it is not, this is the amount of Humatrope thatWAS NOTdelivered. Consult with your healthcare professional on how to handle a partial dose. Remove the Needle and empty Cartridge. For the next daily use attach a new Cartridge as shown in Section 2, Step A, and continue with New Cartridge Setup (Section 2).
  • Why do I
    • The injection is complete when:
      -
      You have slowly counted to five while you are still holding the Injection Button in and before you remove the Needle from the skin.

      AND

      -
      0.00is in the center of the Dose Window.
  • Manufacturer:
    Eli Lilly and Company
    Pharmaceutical Delivery Systems
    Lilly Corporate Center
    Indianapolis, IN 46285, USA

    Humatrope, HumatroPen12 mg and the H Block design are registered trademarks of Eli Lilly and Company.

    The HumatroPen 12 mg is for use with Humatrope 12 mg Cartridges only.

    2009, 2019, Eli Lilly and Company. All rights reserved.

    Literature revised May 17, 2019

    HTRPEN12-0001-IFU-20190517

    Figure

    Humatrope
    somatropin (rDNA origin) for injection

    HumatroPen24 mg
    Growth Hormone Delivery System
    Injection Device for Use with Humatrope[somatropin (rDNA origin) for injection] Cartridges
    Figure 24
    mg
    PEN USER MANUAL

    Figure

    SECTION 1Read this section completely before you begin.
    Then, move on to Section 2.

    WHAT YOU NEED TO KNOW ABOUT THE HUMATROPEN24 MG

    Read these instructions carefully BEFORE using the HumatroPen24 mg. You need to use the Pen correctly in order to get the most benefit from the Humatropetreatment. Failure to follow these instructions completely may result in too much or too little Humatrope being injected.

    INTRODUCTION

    The HumatroPen 24 mg is an injection device intended for use with Humatrope 24 mg Cartridges. Your healthcare professional has prescribed the Humatrope dose and Pen that you or your child should receive.

    DO NOT CHANGE the dose or Pen unless directed by your healthcare professional.

    If your healthcare professional changes the prescribed cartridge size from the 24 mg Humatrope Cartridge to the 6 mg or 12 mg Humatrope Cartridge, you must get a new HumatroPen to match the new cartridge size.

    Before using the HumatroPen 24 mg, make sure that you thoroughly read this user manual. It explains the Pen operations and has a troubleshooting guide, should questions arise.

    These instructions do not take the place of talking with your healthcare professional about your or your child's medical condition, or its treatment. If you are having problems using the HumatroPen 24 mg, call 1-800-545-5979.

    IMPORTANT INFORMATION ABOUT THE HUMATROPEN 24 MG

    • Where you

      • Pen Needles are not included. You may need a prescription to get the Needles from your pharmacist.
      • Becton, Dickinson and Company Pen Needles are suitable for use with the HumatroPen 24 mg.
      • Ask your healthcare professional what Needle gauge and length is best to use.
      • Follow your healthcare professional's instructions on safe handling of needles.

    Why Doesnt The Screw Move Out When There Is No Cartridge Attached To The Pen? 

    • The Screw may not move out when you push the Injection Button unless there is a Cartridge in the Pen. This feature allows you to easily push the Screw into the Pen Body when replacing a Cartridge.
    • Once a Cartridge is attached, the Screw will move out when the Injection Button is pushed.
  • What Should I Do If I Cant Attach The Cartridge To The Pen Body? 

    • Check that the Cartridge is not damaged or broken.
    • Carefully line up the Cartridge with the Pen Body and screw together until secure. If the Cartridge and Pen cannot be screwed together contact your healthcare professional.
  • Why Doesnt The Dose Knob Go To Zero When I Inject The Dose? 

    • This can happen if the Humatrope Cartridge does not have enough Humatrope left in it for the full dose. It is possible to set a dose larger than the amount of Humatrope left in the Cartridge. At the end of the injection, the number in the Dose Window should be 0.00. If it is not, this is the amount of Humatrope thatWAS NOTdelivered. Consult with your healthcare professional on how to handle a partial dose. Remove the Needle and empty Cartridge. For the next daily use attach a new Cartridge as shown in Section 2, Step A, and continue with New Cartridge Setup (Section 2).
  • Why do I
    • The injection is complete when:
      -
      You have slowly counted to five while you are still holding the Injection Button in and before you remove the Needle from the skin.

      AND

      -
      0.00is in the center of the Dose Window.
  • Manufacturer:
    Eli Lilly and Company
    Pharmaceutical Delivery Systems
    Lilly Corporate Center
    Indianapolis, IN 46285, USA

    Humatrope, HumatroPen24 mg and the H Block design are registered trademarks of Eli Lilly and Company.

    The HumatroPen 24 mg is for use with Humatrope 24 mg Cartridges only.

    2009, 2019, Eli Lilly and Company. All rights reserved.

    Literature revised May 17, 2019

    HTRPEN24-0001-IFU-20190517

    Figure

    HIDDEN NEEDLE COVER
    FOR USE WITH HUMATROPECARTRIDGES
    Figure Figure

    INSTRUCTIONS FOR USE

    ATTACHING AND USING THE HIDDEN NEEDLE COVER

    The Hidden Needle Cover allows you the option to inject with the Needle hidden from view. Be sure the Pen is set up per the Pen user manual instructions.

    1
    Be sure the Pen Cap is removed. Attach a new Needle to the Cartridge and remove the Outer Needle Shield and Inner Needle Shield. Refer to the Pen user manual for detailed instructions on set-up.
    Follow your healthcare professional's instructions on the safe handling of needles.
    2
    Confirm the Hidden Needle Cover is in the locked position. If it is not locked, turn the slider so that the Guide post is in the Guide Channel, as shown. Do not push the Slider. The Hidden Needle Cover should now be in the locked position. This is important to avoid needle sticks in the next step.
    Figure
    3
    Insert the Pen with attached Cartridge and Needle straight into the locked Hidden Needle Cover until it stops. In case the Hidden Needle Cover did not get locked, do not block the opening of the Hidden Needle Cover while performing this step. Dial the Pen to the usual dose. Refer to the Pen user manual for detailed instructions on dialing the dose.Figure
    4
    Unlock the Hidden Needle Cover by rotating the Slider clockwise until the Guide Post is located within the Guide Channel, as shown. To avoid Needle sticks, be careful not to push the Slider in after it is unlocked.Figure
    5
    Inject the Humatrope dose as instructed by your healthcare professional. First insert the Needle at a 90 angle by pushing into the skin. The Slider will move over the Hidden Needle Cover Body as the Needle is inserted.

    Then press the Injection Button. The Hidden Needle Cover will automatically lock as you remove the Needle from the skin.

    Refer to the Pen user manual for detailed instructions on injections.
    Figure
    6
    Confirm that the Hidden Needle Cover has returned to the locked position. Carefully pull the Hidden Needle Cover straight off and remove it from the Pen.

    Remove and dispose of the Needle in a puncture-proof container. Follow your healthcare professional's instructions on how to do this safely.

    Replace the Pen Cap.

    Soiled parts can be cleaned with a damp cloth. DO NOT USE alcohol or other cleaning agents.
    Figure
    Made for Eli Lilly and Company
    Pharmaceutical Delivery Systems
    Lilly Corporate Center
    Indianapolis, IN 46285, USA

    CE 0344

    Humatropeis a registered trademark of Eli Lilly and Company.

    2009, 2012, Eli Lilly and Company. All rights reserved.

    Literature revised August 2, 2012

    PV 6542 AMP
    Figure



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