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Lilly HumatroPen 6 mg User Manual

Growth hormone delivery system injection device for use with somatropin rdna origin for injection cartridges
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[H Block graphic]
®
Humatrope
somatropin (rDNA origin)
for injection
HumatroPen
Growth Hormone Delivery
System
Injection Device for Use
with Humatrope
[somatropin (rDNA origin)
for injection] Cartridges
SECTION 1
WHAT YOU NEED TO KNOW ABOUT THE HUMATROPEN
Read
these instructions carefully BEFORE using the
correctly in order to get the most benefit from the Humatrope
instructions completely may result in too much or too little Humatrope being
INTRODUCTION
The HumatroPen 6 mg is an injection device intended for use with Humatrope 6 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 6 mg Humatrope
Cartridge to the 12 mg or 24 mg Humatrope Cartridge, you must get a new HumatroPen to match the
new cartridge size.
Before using the
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 6 mg, call 1-800-545-5979.
Reference ID: 3004202
®
6 mg
®
PEN USER MANUAL
Read this section completely before you begin.
Then, move on to Section 2.
HumatroPen 6
mg, make sure that you thoroughly read this user manual. It explains
®
HumatroPen
6
mg. You need to use the Pen
®
treatment. Failure to follow these
injected.
1
PV 6501 AMP
6
mg
®
6 MG

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Summary of Contents for Lilly HumatroPen 6 mg

  • Page 1 Humatrope being injected. INTRODUCTION The HumatroPen 6 mg is an injection device intended for use with Humatrope 6 mg Cartridges. Your healthcare professional has prescribed the Humatrope dose and Pen that you or your child should receive.
  • Page 2 • Confirm that you have a 6 mg Humatrope Cartridge to match the HumatroPen 6 mg. If it does not match DO NOT USE and contact your healthcare professional. This is important to ensure the correct dose of Humatrope is given.
  • Page 3 REPLACEMENT The HumatroPen 6 mg has been designed to be used for up to 3 years after first use. Record the date the Pen was first used here: __ / __ / __. Contact your healthcare professional if a new HumatroPen 6 mg is needed, or when the Pen has been used for 3 years.
  • Page 4 NEW CARTRIDGE SETUP STEP A - CHECK THE PEN AND CARTRIDGE Be sure to check the Cartridge: Pull off the Pen Cap. Look at the Injection Button and • For 6 mg Cartridge label the Front Housing to confirm it is a • For expiration date 6 mg Pen.
  • Page 5 • Setting up the new Cartridge is important to remove large air bubbles that may be present after reconstitution (mixing). • If a stream is not seen after several attempts, contact your healthcare professional or Lilly. STEP E – CONTINUE ON TO DAILY USE • DO NOT REPEAT Cartridge Setup before each dose.
  • Page 6 Needle after the injection. NOTE Hidden Needle Cover is available separately from the HumatroPen 6 mg Cartridge Kit. Refer to the Hidden Needle Cover user manual for instructions. STEP 3 – DIAL AND INJECT THE DOSE...

  • Page 7: Section 4 Commonly Asked Questions

    Cartridge is used for the first time. • The purpose of the setup is to make sure the HumatroPen 6 mg and 6 mg Cartridge are ready to use. • If you repeat the New Cartridge Setup before each routine dose, you may run out of Humatrope early.
  • Page 8 • If the solution remains cloudy or contains particles after reconstitution (mixing), DO NOT USE. Contact your healthcare professional for assistance. 4. 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.
  • Page 9 Erl Wood Manor, Windlesham, Surrey GU20 6PH, UK CE 0344 Humatrope®, HumatroPen® 6 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.
  • Page 10 PV 6511 AMP [H Block graphic] ® Humatrope somatropin (rDNA origin) for injection ® HumatroPen 12 mg Growth Hormone Delivery System Injection Device for Use ® with Humatrope [somatropin (rDNA origin) for injection] Cartridges PEN USER MANUAL Read this section completely before you begin. SECTION 1 Then, move on to Section 2.
  • Page 11 IMPORTANT INFORMATION ABOUT THE HUMATROPEN 12 MG • Where you see in this manual, please pay special attention. • DO NOT USE the Pen if any part of the Pen or Cartridge appears broken or damaged. Contact your healthcare professional. •...
  • Page 12 • DO NOT STORE the Pen with the Needle attached. REPLACEMENT The HumatroPen 12 mg has been designed to be used for up to 3 years after first use. Record the date the Pen was first used here: __ / __ / __. Contact your healthcare professional if a new HumatroPen 12 mg is needed, or when the Pen has been used for 3 years.
  • Page 13 NEW CARTRIDGE SETUP STEP A - CHECK THE PEN AND CARTRIDGE Be sure to check the Cartridge: Pull off the Pen Cap. Look at the Injection Button and • For 12 mg Cartridge label the Front Housing to confirm it is a • For expiration date 12 mg Pen.
  • Page 14 • Setting up the new Cartridge is important to remove large air bubbles that may be present after reconstitution (mixing). • If a stream is not seen after several attempts, contact your healthcare professional or Lilly. STEP E – CONTINUE ON TO DAILY USE •...
  • Page 15 STEP 2 – ATTACH THE NEEDLE • Pull off the Outer Cap and the Remove the Paper Tab from the Push the Needle straight onto the end of the Outer Cap. 12 mg Cartridge and screw on Inner Cap. • Keep the Outer Cap to remove clockwise until secure.
  • Page 16 STEP 3 – DIAL AND INJECT THE DOSE Turn the Dose Knob to desired Insert the Needle as directed by NOTE dose. your healthcare professional. It is possible to set a dose larger Place your thumb on the Injection than the amount of Humatrope left EXAMPLE Button, then slowly and firmly push in the Cartridge.
  • Page 17 SECTION 4 COMMONLY ASKED QUESTIONS 1. Do I need to perform the New Cartridge Setup before every dose? • 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.
  • Page 18 • 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.
  • Page 19 Erl Wood Manor, Windlesham, Surrey GU20 6PH, UK CE 0344 Humatrope®, HumatroPen® 12 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.
  • Page 20 PV 6521 AMP [H Block graphic] ® Humatrope somatropin (rDNA origin) for injection ® HumatroPen 24 mg Growth Hormone Delivery System Injection Device for Use ® with Humatrope [somatropin (rDNA origin) for injection] Cartridges PEN USER MANUAL Read this section completely before you begin. SECTION 1 Then, move on to Section 2.
  • Page 21 IMPORTANT INFORMATION ABOUT THE HUMATROPEN 24 MG • Where you see in this manual, please pay special attention. • DO NOT USE the Pen if any part of the Pen or Cartridge appears broken or damaged. Contact your healthcare professional. •...
  • Page 22 • DO NOT STORE the Pen with the Needle attached. REPLACEMENT The HumatroPen 24 mg has been designed to be used for up to 3 years after first use. Record the date the Pen was first used here: __ / __ / __. Contact your healthcare professional if a new HumatroPen 24 mg is needed, or when the Pen has been used for 3 years.
  • Page 23 NEW CARTRIDGE SETUP STEP A - CHECK THE PEN AND CARTRIDGE Be sure to check the Cartridge: Pull off the Pen Cap. Look at the Injection Button and • For 24 mg Cartridge label the Front Housing to confirm it is a • For expiration date 24 mg Pen.
  • Page 24 • Setting up the new Cartridge is important to remove large air bubbles that may be present after reconstitution (mixing). • If a stream is not seen after several attempts, contact your healthcare professional or Lilly. STEP E – CONTINUE ON TO DAILY USE • DO NOT REPEAT Cartridge Setup before each dose.
  • Page 25 STEP 2 – ATTACH THE NEEDLE • Pull off the Outer Cap and the Remove the Paper Tab from the Push the Needle straight onto the end of the Outer Cap. 24 mg Cartridge and screw on Inner Cap. • Keep the Outer Cap to remove clockwise until secure.
  • Page 26 STEP 3 – DIAL AND INJECT THE DOSE Turn the Dose Knob to desired Insert the Needle as directed by NOTE dose. your healthcare professional. It is possible to set a dose larger than the amount of Humatrope left EXAMPLE Place your thumb on the Injection in the Cartridge.
  • Page 27 SECTION 4 COMMONLY ASKED QUESTIONS 1. Do I need to perform the New Cartridge Setup before every dose? • 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 24 mg and 24 mg Cartridge are ready to use.
  • Page 28 7. 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.
  • Page 29 Erl Wood Manor, Windlesham, Surrey GU20 6PH, UK CE 0344 Humatrope®, HumatroPen® 24 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.