Lilly Humatropen 6 mg User manual

Humatrope®
somatropin
INTRODUCTION
STEP A - CHECK THE PEN AND CARTRIDGE
NEW CARTRIDGE SETUP
STEP B - ATTACH THE CARTRIDGE
STEP C - ATTACH THE NEEDLE
STEP D - REMOVE AIR FROM NEW CARTRIDGE
STEP E - CONTINUE ON TO DAILY USE
IMPORTANT INFORMATION ABOUT THE HUMATROPEN 6 MG
ABOUT PEN NEEDLES
CARE AND STORAGE FOR THE HUMATROPEN 6 MG
REPLACEMENT
Read these instructions carefully BEFORE using your HumatroPen® 6 mg. You need to use the Pen correctly in order
to get the most benefit from the Humatrope® treatment. Failure to follow these instructions completely may result
in too much or too little Humatrope being injected.
Be sure to follow the reconstitution (mixing) directions as described in the Humatrope Cartridge Kit.
Perform the New Cartridge Setup only once at the beginning of each new Cartridge. For daily use, DO NOT
REPEAT this one-time-only New Cartridge Setup. If you do, you may run out of Humatrope early.
HUMATROPEN® 6 mg
Growth Hormone Delivery System
Injection Device for Use with
Humatrope® (somatropin) Cartridges
6
mg
PEN USER MANUAL
Humatrope
6 mg Cartridge
(sold separately)
Screw
6 mg
Pen Body
Injection
Button
Pen
Cap Rubber
Seal
White
Tip
Front
Housing
Dose
Window
Dose
Knob
Outer Cap
Inner Cap Paper Tab
Needle
PEN NEEDLE PARTS (PEN NEEDLES NOT INCLUDED)
12
SECTION SECTION
Read this section completely before you begin.
Then, move on to Section 2.
Read and follow the directions in this section only after
you have read Section 1.
WHAT YOU NEED TO KNOW ABOUT THE HUMATROPEN® 6 MG GETTING STARTED
HUMATROPEN 6 MG PARTS
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.
Before using your HumatroPen 6 mg, make sure that you thoroughly read this user manual. It explains the Pen
operations and has a troubleshooting guide, should questions arise.
If you have any questions about your HumatroPen 6 mg, please contact your healthcare professional or
call Lilly Customer Response Centre at 1-888-545-5972.
WARNING: DO NOT USE THE HUMATROPEN 6 mg INJECTION DEVICE AND HUMATROPE CARTRIDGES IF YOU ARE
ALLERGIC TO METACRESOL OR GLYCERIN.
• 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 or the Lilly Customer Response Centre 1-888-545-5972.
• 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.
• ONLY follow Section 2 to set up a new Cartridge before first use of each new cartridge.
• Section 3 of this manual should be followed for daily injection.
• DO NOT SHARE your HumatroPen 6 mg or Pen Needles as this may risk transmission of infectious agents.
• The HumatroPen 6 mg is not recommended for use by blind or visually impaired individuals without the assistance
of a sighted individual trained in its use.
What kinds of Needles can be used with the HumatroPen 6 mg?
• 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 for you.
Must a new Needle be used for each injection?
• Yes, a new Needle must be used for each injection.
• Remove the Needle from the HumatroPen 6 mg prior to returning the device to its case. Use a new Needle for
each injection. Using a new Needle for each injection will help minimize the risk of infection, prevent leakage of
Humatrope, prevent air bubbles from entering the cartridge, and reduce Needle clogs.
How do I throw away used Needles?
• Throw away used Needles as directed by your healthcare professional.
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.
• Protect the pen and case from moisture especially when transporting in the travel cooler bag.
Storage
• Store the HumatroPen 6 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 +2°C and +8°C (36° to
46°F) . 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 6 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.
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.
HumatroPen 6 mg Limited Warranty
Eli Lilly Canada Inc. (“Lilly”) warrants the HumatroPen 6 mg against defects in workmanship and materials for a period of three
years from the date of its receipt by original user. This warranty does not apply if the pen has been modified, altered, improperly
handled, stored, or operated in a way not described in Lilly’s written specifications and instructions. This Limited Warranty is
NONTRANSFERABLE and NONASSIGNABLE.
If the HumatroPen 6 mg fails to function during the warranty period, Lilly will replace the pen at Lilly’s expense. In order to return
a HumatroPen 6 mg for warranty replacement, please call Lilly’s Customer Response Centre (1-888-545-5972) for instructions.
Lilly will replace the HumatroPen 6 mg with a new HumatroPen 6 mg.
This limited warranty is the user’s exclusive remedy for any: 1. breach of this warranty; 2. claim; 3. loss; or 4. damage arising out of
the use of the HumatroPen 6 mg, whether based on contract, tort, or strict liability. Lilly is not liable for any incidental, consequential
or other damages of any kind, however occasioned, whether by negligence or otherwise. Some provinces may not allow some or
all of this exclusion or the exclusion of incidental or consequential damages, so some or all of this exclusion may not apply to you.
THIS THREE-YEAR LIMITED WARRANTY IS IN LIEU OF AND SPECIFICALLY EXCLUDES AND REPLACES ALL OTHER EXPRESS OR
IMPLIED WARRANTIES, WHETHER ORAL, WRITTEN OR IN ANY OTHER FORM, INCLUDING BUT NOT LIMITED TO WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Some provinces may not allow all of this limitation or how long
a warranty lasts, so this limitation may not apply to you.
This Limited Warranty gives you specific legal rights. You may have rights other than those provided for above.
Please see the accompanying complete Humatrope Patient Information Sheet . For additional information, call 1-888-545-5972
• Cartridge Setup is only done at the start of every new cartridge.
• Leave the Cartridge attached and DO NOT REMOVE until the Cartridge is empty.
• Go to Section 3, Step 3, for instructions on how to inject the first dose.
• The Pen and cartridge must be set up before injecting the first dose from each new 6 mg Cartridge.
• 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 at 1-888-545-5972.
• The Hidden Needle Cover should not be used during the pen and cartridge set up.
Dial 1.25 mg. • Point the Needle straight up.
• Push the Injection Button and hold for five seconds.
• Dial 0.05 mg and repeat these steps until you see a stream of liquid.
Remove the Paper Tab from the end
of the Outer Cap.
Push the Needle straight onto
the 6 mg Cartridge and screw on
clockwise until secure.
• Pull off the Outer Cap and the Inner
Cap.
• Keep the Outer Cap to remove the
Needle after your injection.
Use the White Tip of the Cartridge to
push the Screw back.
Push the White Tip of a reconstituted
Cartridge into the Pen Body. Screw
the 6 mg Pen Body onto the Cartridge
until it is secure.
The screw may not be out when you
get the Pen.
Look at the Injection Button and the
Front Housing to confirm it is a 6 mg
Pen.
If the Cartridge is not completely
attached, the Screw may not move and
an incorrect dose may be given.
DO NOT USE the Pen if any part of the Pen
or Cartridge appears broken or damaged.
Contact your healthcare professional.
Check that the number on the Front
Housing matches the Cartridge
strength on the Cartridge label.
If the Pen and Cartridge do not match,
contact your healthcare professional.
!
NOTE
NOTE
NOTE
CHECK
!
Be sure to check the Cartridge:
• For 6 mg Cartridge Label
• For expiration date
• Contents should be clear and free
of particles
Pull off the Pen Cap. Look at the Injection Button and
the Front Housing to confirm it is
a 6 mg Pen.
NOTE
CHECK
!
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0344
NOTE
STEP 1 - CHECK THE PEN
STEP 2 - ATTACH THE NEEDLE
STEP 3 - DIAL AND INJECT THE DOSE
STEP 4 - REMOVE AND DISPOSE OF THE NEEDLE
STEP 5 - STORE PEN AND CARTRIDGE FOR NEXT USE
3
SECTION
DAILY USE
Store the HumatroPen 6 mg properly. (See “Care and Storage for the HumatroPen 6 mg” in Section 1 of this
user manual for more information.)
When it is time for your next routine dose, go to Section 3, and repeat Steps 1-5.
• DO NOT STORE the Pen with a Needle attached to prevent air from entering the Cartridge.
• DO NOT REMOVE this Cartridge from the Pen until the Cartridge is empty or needs to be replaced to avoid the possibility
of an inaccurate dose.
• Remove the Paper Tab from the end
of the Outer Cap.
Holding the Needle by the outer
cap push the Needle straight
onto the 6 mg Cartridge and
screw on clockwise until secure
• Pull off the Outer Cap and the Inner
Cap.
• Keep the Outer Cap to remove the
Needle after the injection.
Hidden Needle Cover is available separately from the HumatroPen 6 mg Kit. Refer to the Hidden Needle Cover user manual for
instructions.
DO NOT USE the Pen if any part of
the Pen or Cartridge appears broken
or damaged. Contact your healthcare
professional. Check that the number on the Front
Housing matches the Cartridge
strength on the Cartridge label. If
the Pen and Cartridge do not match,
contact your healthcare professional.
NOTE
Be sure to check the Cartridge:
• For 6 mg Cartridge Label
• For expiration date
• Contents should be clear and free
of particles
Pull off the Pen Cap. Look at the Injection Button and
the Front Housing to confirm it is
a 6 mg Pen.
NOTE
CHECK
!
Turn the Dose Knob to desired dose. Insert the Needle as directed by your
healthcare professional.
Place your thumb on the Injection
Button, then slowly and firmly push
the Injection Button until it stops
moving.
Maintain pressure on the Injection
Button for five seconds, then remove
the Needle from the skin.
Check to make sure you see a 0.00
in the Dose Window to confirm you
received the complete dose.
0.25 mg shown in the drawing above.
If you dial past the desired dose, you can
correct the dose by dialing backwards.
EXAMPLE
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
you DID NOT receive.
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).
NOTE
Carefully replace the Outer Cap
as instructed by your healthcare
professional.
While holding the cartridge in one hand
unscrew the capped Needle by turning
counter-clockwise. Discard the Needle as
directed by your healthcare professional.
Replace the Pen Cap.
4
SECTION
COMMONLY ASKED QUESTIONS
1. Do I need to perform the New Cartridge Setup before every dose?
• No. The New Cartridge Setup is done 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 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. The
small amount of product used in the New Cartridge Setup will not affect the supply of Humatrope.
2. What should I do if the Cartridge Label and Pen do not match?
• DO NOT USE the Pen if the Cartridge strength on the Humatrope Cartridge label does not match the
number on the Pen’s Front Housing.
• Contact your healthcare professional for assistance or to obtain a replacement.
3. 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 or Lilly at 1-888-545-5972.
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. DO NOT STORE the Pen
with a Needle attached.
• Perform the New Cartridge Setup to remove air bubbles from the Cartridge.
• Small air bubbles are normal. They will not harm you nor affect the dose.
5. Why doesn’t 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.
6. What should I do if I can’t 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.
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. 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 your Pen gets dirty with Humatrope,
food, drink or other materials.
8. Why doesn’t 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
you DID NOT receive. 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).
9. Why do I see Humatrope leaking from the Needle after I have finished the injection?
• It is normal for a single drop to remain on the tip of the Needle after the injection is complete. If you see
more than one drop:
- You may not have received your full dose. DO NOT INJECT another dose. Consult with your healthcare
professional for assistance.
- To prevent this, for your next dose, firmly push and hold the Injection Button in and slowly count to
five before removing the needle from the skin (see Section 3, Step 3).
10. How can I tell when the injection is complete?
• 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
- 0.00 is in the center of the Dose Window.
11. What do I do if I dial past my prescribed dose?
• If you dial a dose higher than your prescribed dose, just dial the knob back to your prescribed dose without
pushing in on the Injection Button.
Packaged by:
Lilly Pharma Fertigung und Distribution
GmbH & Co. KG
35387 Giessen, Germany
Manufactured by Eli Lilly and Company
Pharmaceutical Delivery Systems
Lilly Corporate Center,
Indianapolis, IN 46285, USA
HumatroPen and the H Block designs are trademarks of Eli Lilly and Company.
Humatrope is a registered trademark of Eli Lilly and Company.
The HumatroPen 6 mg is for use with Humatrope 6 mg Cartridges only.
© 2012 Eli Lilly and Company. All rights reserved.
User Manual Revision Date: 29 June 2012
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Authorized Representative in the EU:
Eli Lilly and Company Ltd.
Erl Wood Manor, Windlesham, Surrey
GU20 6PH, UK
For assistance or further information, write to:
Eli Lilly Canada Inc.
3650 Danforth Avenue
Toronto, ON
M1N 2E8
Now that you have done the one-time-only New Cartridge
Setup, follow Section 3 for all of your injections.
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