Lilly HUMALOG Mix50/50 KwikPen User manual

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Instructions for Use
HUMALOG®Mix50/50™KwikPen®
50% insulin lispro protamine suspension and
50% insulin lispro injection (rDNA origin)
100 units/mL, 3 mL pen
Read the Instructions for Use before you start taking HUMALOG Mix50/50 and each time you get
another KwikPen.There may be new information. This information does not take the place of
talking to your healthcare provider about your medical condition or your treatment.
Do not share your HUMALOG Mix50/50 KwikPen with other people, even if the needle has
been changed. You may give other people a serious infection or get a serious infection
from them.
HUMALOG®Mix50/50™KwikPen®(“Pen”) is a disposable prefilled pen containing 300 units of
HUMALOG Mix50/50.You can give yourself more than 1 dose from the Pen. Each turn (click) of
the Dose Knob dials 1 unit of insulin. You can give from 1 to 60 units in a single injection. If your
dose is more than 60 units, you will need to give yourself more than 1injection. The
Plunger only moves a little with each injection, and you may not notice that it moves. The Plunger
will only reach the end of the cartridge when you have used all 300 units in the Pen.
This Pen is not recommended for use by the blind or visually impaired without the help of
someone trained to use the Pen.
Pen Needle Parts
(Needles Not Included)
Paper Tab
Dose Knob
Outer Needle
Shield Inner Needle Shield Needle

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How to recognize your HUMALOG Mix50/50 KwikPen
•Pen color: Dark blue
•Dose Knob: Dark blue
•Labels: White label with red stripe
Supplies you will need to give your injection
•HUMALOG Mix50/50 KwikPen
•KwikPen compatible Needle (Becton, Dickinson and Company Pen Needles recommended)
• Alcohol swab
•Gauze
Preparing your Pen
•Wash your hands with soap and water.
• Check your Pen to make sure you are taking the right type of insulin. This is especially
important if you use more than 1 type of insulin.
•Do not use your Pen past the expiration date printed on the Label or for more than 10 days
after you first start using the Pen.
•Always use a new needle for each injection to help prevent infections and blocked
needles. Do not reuse or share your needles with other people. You may give other
people a serious infection or get a serious infection from them.
Step 1:
•Pull the Pen Cap straight off.
-Do not remove the Pen Label.
•Wipe the Rubber Seal with an alcohol swab.
-Do not attach the Needle before mixing.
Step 2:
•Gently roll the Pen between your hands 10
times.
Step 3:
•Move the Pen up and down (invert) 10
times.
Mixing by rolling and inverting the Pen is
important to make sure you get the right
dose.

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Step 4:
•Check the liquid in the Pen.
HUMALOG Mix50/50 should look white and
cloudy after mixing. Do not use if it looks
clear or has any lumps or particles in it.
Step 5:
•Select a new Needle.
• Pull off the Paper Tab from the Outer
Needle Shield.
Step 6:
•Push the capped Needle straight onto the
Pen and twist the Needle on until it is tight.
Step 7:
• Pull off the Outer Needle Shield.Do not
throw it away.
•Pull off the Inner Needle Shield and throw it
away.
Keep
Outer
Needle Shield
Throw Away
Inner
Needle Shield

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Priming your Pen
Prime before each injection.
•Priming your Pen means removing the air from the Needle and Cartridge that may collect
during normal use and ensures that the Pen is working correctly.
•If you do not prime before each injection, you may get too much or too little insulin.
Step 8:
•
To prime your Pen, turn the Dose Knob to
select 2 units.
Step 9:
•Hold your Pen with the Needle pointing up.
Tap the Cartridge Holder gently to collect air
bubbles at the top.
Step 10:
•Continue holding your Pen with Needle
pointing up.Push the Dose Knob in until it
stops,and “0” is seen in the Dose Window.
Hold the Dose Knob in and count to 5
slowly.
•You should see insulin at the tip of the
Needle.
-If you do not see insulin, repeat priming
steps 8to 10, no more than 4 times.
-If you still do not see insulin, change
the Needle and repeat priming steps 8
to 10.
Small air bubbles are normal and will not affect
your dose.
Selecting your dose
•You can give from 1 to 60 units in a single injection.
•If your dose is more than 60 units, you will need to give more than oneinjection.
-If you need help with dividing up your dose the right way, ask your healthcare provider.
- Use a new Needle for each injection and repeat the priming step.

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Step 11:
• Turn the Dose Knob to select the number of
units you need to inject. The Dose Indicator
should line up with your dose.
-The Pen dials 1 unit at a time.
-The Dose Knob clicks as you turn it.
-Do not dial your dose by counting the
clicks . You may dial the wrong dose.
This may lead to you getting too much
insulin or not enough insulin.
-The dose can be corrected by turning
the Dose Knob in either direction until
the correct dose lines up with the Dose
Indicator.
-The even numbers (for example, 12)
are printed on the dial.
-The odd numbers, (for example,25)
after the number 1, are shown as full
lines.
•Always check the number in the Dose
Window to make sure you have dialed
the correct dose.
(Example: 12 units shown
in the Dose Window)
(Example: 25 units shown
in the Dose Window)
•The Pen will not let you dial more than the number of units left in the Pen.
•If you need to inject more than the number of units left in the Pen, you may either:
-inject the amount left in your Pen and then use a new Pen to give the rest of your dose, or
-get a new Pen and inject the full dose.
•It is normal to see a small amount of insulin left in the Pen that you can not inject.

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Giving your injection
•Inject your insulin as your healthcare provider has shown you.
• Change (rotate) your injection site for each injection.
•Do not try to change your dose while injecting.
Step 12:
•Choose your injection site.
HUMALOG Mix50/50 is injected under the
skin (subcutaneously) of your stomach area,
buttocks, upper legs or upper arms.
• Wipe your skin with an alcohol swab, and let
your skin dry before you inject your dose.
Step 13:
•Insert the Needle into your skin.
• Push the Dose Knob all the way in.
•Continue to hold the Dose Knob in and
slowly count to 5 before removing the
Needle.
Do not try to inject your insulin by turning the
Dose Knob. You will not receive your insulin by
turning the Dose Knob.

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Step 14:
•Pull the Needle out of your skin.
A drop of insulin at the Needle tip is normal.
It will not affect your dose.
•Check the number in the Dose Window.
-If you see “0” in the Dose Window, you
have received the full amount you
dialed.
-If you do not see “0” in the Dose
Window, do not redial. Insert the Needle
into your skin and finish your injection.
-If you still do not think you received the
full amount you dialed for your injection,
do not start over or repeat the
injection. Monitor your blood glucose
as instructed by your healthcare
provider.
-If you normally need to give 2 injections
for your full dose, be sure to give your
second injection.
The Plunger only moves a little with each
injection, and you may not notice that it moves.
If you see blood after you take the Needle out
of your skin, press the injection site lightly with
a piece of gauze or an alcohol swab. Do not
rub the area.
After your injection
Step 15:
•Carefully replace the Outer Needle Shield.
Step 16:
•Unscrew the capped Needle and throw it
away (see Disposing of Pens and
Needles section).
•Do not store the Pen with the Needle
attached to prevent leaking, blocking the
Needle, and air from entering the Pen.

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Step 17:
•Replace the Pen Cap by lining up the Cap
Clip with the Dose Indicator and pushing
straight on.
Disposing of Pens and Needles
•Put your used needles in a FDA-cleared sharps disposal container right away after use.Do
not throw away (dispose of) loose needles in your household trash.
•If you do not have a FDA-cleared sharps disposal container, you may use a household
container that is:
-made of a heavy-duty plastic,
-can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come
out,
-upright and stable during use,
-leak-resistant, and
-properly labeled to warn of hazardous waste inside the container.
•When your sharps disposal container is almost full, you will need to follow your community
guidelines for the right way to dispose of your sharps disposal container. There may be state
or local laws about how you should throw away used needles and syringes.For more
information about safe sharps disposal, and for specific information about sharps disposal in
the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal
•Do not dispose of your used sharps disposal container in your household trash unless your
community guidelines permit this. Do not recycle your used sharps disposal container.
•The used Pen may be discarded in your household trash after you have removed the needle.
Storing your Pen
Unused Pens
•Store unused Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
•Do not freeze your insulin.Do not use if it has been frozen.
•Unused Pens may be used until the expiration date printed on the Label, if the Pen has been
kept in the refrigerator.
In-use Pen
•Store the Pen you are currently using at room temperature [up to 86°F (30°C)]. Keep away
from heat and light.
•Throw away the HUMALOG Mix50/50 Pen you are using after 10 days, even if it still has
insulin left in it.
General information about the safe and effective use of your Pen
•Keep your Pen and needles out of the reach of children.
•Do not use your Pen if any part looks broken or damaged.
•Always carry an extra Pen in case yours is lost or damaged.

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Troubleshooting
•If you can not remove the Pen Cap, gently twist the cap back and forth, and then pull the cap
straight off.
• If the Dose Knob is hard to push:
- Pushing the Dose Knob more slowly will make it easier to inject.
- Your Needle may be blocked. Put on a new Needle and prime the Pen.
-You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new
Pen.
If you have any questions or problems with your HUMALOG Mix50/50 KwikPen, contact Lilly at 1-
800-LillyRx (1-800-545-5979) or call your healthcare provider for help.For more information on
HUMALOG Mix50/50 KwikPen and insulin, go to www.humalog.com.
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www.humalog.com
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
HUMALOG®Mix50/50™ and HUMALOG®Mix50/50™ KwikPen®are trademarks of Eli Lilly and
Company.
Revised: January 6, 2017
Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA
Copyright ©2007, 2017, Eli Lilly and Company. All rights reserved.
HUMALOG Mix50/50 KwikPen meets the current dose accuracy and functional requirements of
ISO 11608-1:2014.
LOG5050KP-0002-IFU-20170106