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)
1
2
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 b2°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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