Lilly HumatroPen 24 mg User manual

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INTRODUCTION
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.
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 rofessional.
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.
ABOUT PEN NEEDLE
IMPORTANT INFORMATION ABOUT THE HUMATROPEN 24 MG
CARE AND TORAGE FOR THE HUMATROPEN 24 MG
REPLACEMENT
Read these instructions carefully BEFORE using the HumatroPen®24 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.
1
SECTION Rea this section completely before you begin. Then,
move on to Section 2.
WH AT YOU NEE D TO K NOW A BO UT THE HU MATR OP EN ®24 MG
• Where you see in this manual, please pay special attention.
•DO NOT U E the Pen if any part of the Pen or Cartridge appears broken or damaged. Contact your
healthcare professional.
• Confirm that you have a 24 mg Humatrope Cartridge to match the HumatroPen 24 mg. If it does not
match DO NOT U E and contact your healthcare professional. This is important to ensure the correct
dose of Humatrope is given.
• DO NOT use the Humatrope Cartridge past the expiration date.
• Follow ection 2 ONLY to set up a new Cartridge before first use.
•ection 3 of this manual should be used for every injection.
•DO NOT transfer the contents of the Humatrope Cartridge to a syringe.
•DO NOT HARE the HumatroPen 24 mg or Pen Needles.
• The HumatroPen 24 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 o Needles can be used with the HumatroPen 24 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 your 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.
Must a new Needle be used or 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.
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
• oiled parts can be cleaned with a damp cloth. DO NOT U E alcohol or other cleaning agents.
• DO NOT OAK or immerse the Pen in liquid.
• DO NOT APPLY oil or any other lubricant.
Storage
• tore the HumatroPen 24 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 U E any prepared Cartridge after 28 days.
• Let the HumatroPen 24 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 TORE the Pen with the Needle attached.
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.
Please see the accompanying complete Humatrope
Patient In ormation Sheet . For additional
in ormation, call 1-800-545-5979 or visit www.humatrope.com
!
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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 U E
Be sure to follow the reconstitution (mixing) directions as described in the Humatrope Cartridge Kit.
Perform the New Cartridge etup only once at the beginning of each new Cartridge. For daily use, DO NOT
REPEAT this one-time-only New Cartridge etup. If you do, you may run out of Humatrope early.
HumatroPen®24 mg
Growth Hormone Delivery System
Injection Device for Use with Humatrope®[somatropin (rDNA origin ) for injection] Ca rtridges
24
mg
PEN USER MANUAL
Humatrope
24 mg Cartridge
(sold separately)
Screw
24 mg
Pe Body
I jectio
Butto
Pe
Cap Rubber
Seal
White
Tip
Fro t
Housi g
Dose
Wi dow
Dose
K ob
Outer Cap
I er Cap Paper Tab
Needle
PEN NEEDLE PARTS (PEN NEEDLES NOT INCLUDED)
2
SECTION Rea an follow the irections in this section only after
you have rea Section 1.
GETTING STARTED
HUMATROPEN 24 MG PARTS
• DO NOT REPEAT Cartridge Setup before each dose.
• Leave the Cartridge attached and DO NOT REMO E until the Cartridge is empty.
• Go to Section 3, Step 3, for instructions on how to inject the first dose.
• The Pen must e set up efore injecting the first dose from each new 24 mg Cartridge.
• Setting up the new Cartridge is important to remove large air u les that may e present after reconstitution (mixing).
• If a stream is not seen after several attempts, contact your healthcare professional or Lilly.
Dial 5.00 mg. • Point the Needle straight up.
• Push the Injection Button and hold for five seconds.
• Dial 0.20 mg and repeat these steps until you see a stream of liquid.
Remove the Paper Tab from the end
of the Outer Cap.
• Pull off the Outer Cap and the
Inner Cap.
• Keep the Outer Cap to remove the
Needle after the 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 24 mg Pen Body onto the
Cartridge until it is secure.
The Screw may not e out when you
get the Pen.
Look at the Injection Button and
the Front Housing to confirm it is
a 24 mg Pen.
If the Cartridge is not completely
attached, the Screw may not move
and an incorrect dose may e given.
NOTE
NOTE
NOTE
CHECK
!
Be sure to check the Cartridge:
•For 24 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
a24 mg Pen.
NOTE
CHECK
!
Push the Needle straight onto the
24 mg Cartridge and screw on
clockwise until secure.
Check that the num er on the Front
Housing matches the Cartridge
strength on the Cartridge la el.
If the Pen and Cartridge do not
match, contact your healthcare
professional.
DO NOT USE the Cartridge past the
expiration date.
DONOTUSE thePenif any partofthePen
or Cartridge appears roken or damaged.
Contact your healthcare professional.
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NOTE
STEP 1 - CHECK THE PEN
STEP 2 - ATTACH THE NEEDLE
STEP 3 - DIAL AND INJECT THE DO E
STEP 4 - REMOVE AND DI PO E OF THE NEEDLE
STEP 5 - TORE PEN AND CARTRIDGE FOR NEXT U E
3
SECTION Now that you have one the one-time-only New Cartri ge
Setup, follow Section 3 for all of the injections.
DAILY USE
tore the HumatroPen 24 mg properly. ( ee “Care and torage for the HumatroPen 24 mg” in ection 1 of this
user manual for more information.)
When it is time for the next routine dose, go to ection 3, and repeat teps 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 e replaced to avoid the possi ility
of an inaccurate dose.
Remove the Paper Tab from the end
of the Outer Cap.
Push the Needle straight onto the
24 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 availa le separately from the HumatroPen 24 mg Cartridge 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 roken
or damaged. Contact your healthcare
professional. Check that the num er on the Front
HousingmatchestheCartridgestrength
on the Cartridge la el. If the Pen and
Cartridge do not match, contact your
healthcare professional.
NOTE
Be sure to check the Cartridge:
• For 24 mg Cartridge label
• For expiration date
• Contents should be clear and free
of particles
DO NOT U E the Cartridge past
the expiration date.
Pull off the Pen Cap. Look at the Injection Button and
the Front Housing to confirm it is
a 24 mg Pen.
NOTE
CHECK
!
Turn the Dose Knob to desired dose.
1.00 mg shown in the drawing a ove.
Ifyoudialpastthedesireddose,youcan
correct the dose y dialing ackwards.
NOTE
NOTE
Carefully replace the Outer Cap
as instructed by your healthcare
professional.
Remove the capped Needle by turning
counter-clockwise.Throwawayasdirected
byyourhealthcare professional.
Replace the Pen Cap.
4
SECTION
COMMONLY ASKED QUESTIONS
1.Do I need to per orm the New Cartridge Setup be ore every dose?
•No. The New Cartridge etup 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.
•If you repeat the New Cartridge etup before each routine dose, you may run out of Humatrope early. The
small amount of product used in the New Cartridge etup will not affect the supply of Humatrope.
2.What should I do i 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. This is important to ensure the correct dose of Humatrope is given.
•Contact your healthcare professional for assistance or to obtain a replacement.
3. What should I do i the Humatrope is not clear a ter 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.
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 etup to remove air bubbles from the Cartridge.
•A small air bubble is normal. It will not cause any harm nor affect the dose.
5. Why doesn’t the Screw move out when there is no Cartridge attached to the Pen?
•The crew 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 crew into the Pen Body when replacing a Cartridge.
•Once a Cartridge is attached, the crew will move out when the Injection Button is pushed.
6. What should I do i 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 di icult 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.
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
that WA NOT delivered. 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
ection 2, tep A, and continue with New Cartridge etup ( ection 2).
9. Why do I see Humatrope leaking rom the Needle a ter I have inished 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:
-The full dose may not have been delivered. DO NOT INJECT another dose. Consult with your healthcare
professional for assistance.
-To prevent this, for the next dose, firmly push and hold the Injection Button in and slowly count to five
(see ection 3, tep 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.
Made for Eli Lilly and Company
Pharma euti al Deli ver y Systems
Lilly Corporate Center
Indianap oli s, IN 46285, USA
Auth orized Representative in the EU:
Eli Lil ly an d Compan y Ltd.
Erl Wood Man or, Wind lesham, Surrey
GU20 6PH, UK
Humatrope®, HumatroPen® 24 mg and the
H Blo k design are registered trademarks
of Eli Lilly and Company.
The HumatroPen 24 mg is for use with
Humatrope 24 mg Cartridges only.
© 2009, Eli Lilly and Company.
All rights reserved.
PV 6520 AMP
Insert the Needle as directed by your
healthcare professional.
Place your thumb on the Injection
Button, thenslowlyand firmlypushthe
Injection Button until it stops moving.
ContinuetoholdtheInjectionButtonfor
five seconds, then remove the Needle
from the skin.
Check to make sure you see a 0.00
in the Dose Window to confirm the
complete dose was received.
5seconds
Itispossi letosetadoselargerthanthe
amountofHumatropeleftintheCartridge.
At the end of the injection, the num er
inthe DoseWindowshould e0.00.If it
is not, this is the amount of Humatrope
that WAS NOT delivered.
Consultwithyourhealthcareprofessional
onhow to handle a partialdose.Remove
theNeedleandempty Cartridge.
For the next daily use attach a new
Cartridge as shown in Section 2, Step A,
and continue with New Cartridge Setup
(Section2).
NOTE
0344
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