Lilly HumaPen Savvio User manual

Instructions for Use
Read and follow all of these instructions
carefully. If you do not follow these
instructions completely, you may get
too much or too little insulin.
Every time you inject:
• Use a new needle
• Prime to make sure the Pen is
ready to dose
• Make sure you got a full dose
(see page 18)
Also, read the
Information for
the Patient
insert enclosed in
your Pen box.
Pen Features
• A multiple dose, disposable insulin
delivery device (“insulin Pen”)
containing 3 mL (300 units) of U-100 insulin
• Delivers up to 60 units per dose
• Doses can be dialed by single units
Disposable Insulin Delivery Device
User Manual
PV 3734 AMP

2
Pen Parts ............................................................ 3
Important Notes .................................................. 4
Preparing the Pen ................................................ 6
Attaching the Needle .......................................... 8
Priming the Pen ....................................................10
Setting a Dose......................................................14
Injecting a Dose....................................................16
Following an Injection ..........................................18
Questions and Answers ........................................20
Table of Contents

3
Pen Parts
Dose Knob
Raised Notch
Raised Notch
Label Dose Window
Pen Cap
Outer Needle Shield Inner Needle Shield
Needle
Rubber Seal
Clear Cartridge Holder
Insulin Cartridge
Injection Button
Paper
Tab

4
Important Notes
•Read and follow all of these instructions carefully. If you
do not follow these instructions completely, you may get
too much or too little insulin.
•Use a new needle for each injection.
•
Be sure a needle is completely attached to the Pen
before priming, setting (dialing) the dose and
injecting your insulin.
•Prime every time.
• The Pen must be primed before each injection to make
sure the Pen is ready to dose. Performing the priming
step is important to confirm that insulin comes out when
you push the injection button, and to remove air that
may collect in the insulin cartridge during normal use.
See Section III. “Priming the Pen”, pages 10-13.
•If you do not prime, you may get too much or too
little insulin.
•Make sure you get a full dose.
•To make sure you get a full dose, you must push the
injection button all the way down until you see a
diamond (◆) or arrow (➞) in the center of the dose
window. See “Following an Injection”, page 18.
•The numbers on the clear cartridge holder give an estimate
of the amount of insulin remaining in the cartridge. Do not
use these numbers for measuring an insulin dose.
•Do not share your Pen.

5
•
•
•
•
•
•
•
•
•
•
•
Keep your Pen out of the reach of children.
Pens that have not been used should be stored in a refrigerator
but not in a freezer. Do not use a Pen if it has been frozen.
Refer to the
Information for the Patient insert for complete
storage instructions.
After a Pen is used for the first time, it should NOT be
refrigerated but should be kept at room temperature [below
86°F (30°C)] and away from direct heat and light.
An unrefrigerated Pen should be discarded according to the
time specified in the Information for the Patient insert, even if
it still contains insulin.
Never use a Pen after the expiration date stamped on the label.
Do not store your Pen with the needle attached. Doing so may
allow insulin to leak from the Pen and air bubbles to form in the
cartridge. Additionally, with suspension (cloudy) insulins,
crystals may clog the needle.
Always carry an extra Pen in case yours is lost or damaged.
Dispose of empty Pens as instructed by your Health Care
Professional and without the needle attached.
This Pen is not recommended for use by blind or visually
impaired persons without the assistance of a person trained in
the proper use of the product.
The directions regarding needle handling are not intended to
replace local, Health Care Professional or institutional policies.
Any changes in insulin should be made cautiously and only
under medical supervision.
Important Notes
(Continued)

6
I. Preparing the Pen
1. Before proceeding, refer to the Information for the
Patient
insert for instructions on checking the
appearance of your insulin.
2. Check the label on the Pen to be sure the Pen
contains the type of insulin that has been
prescribed for you.
3. Always wash your hands before preparing your
Pen for use.
4. Pull the Pen cap to remove.
Pen Cap

7
5. If your insulin is a suspension
(cloudy):
a. Roll the Pen back and
forth 10 times then
perform step b.
b. Gently turn the Pen up
and down 10 times until
the insulin is evenly
mixed.
Note: Suspension (cloudy)
insulin cartridges contain
a small glass bead to assist in mixing.
6. Use an alcohol swab to wipe
the rubber seal on the end of
the Pen.
I. Preparing the Pen
(Continued)
Glass
Bead
Glass
Bead

8
This device is suitable for use with Becton Dickinson
and Company’s insulin pen needles.
1. Always use a new needle for each injection. Do
not push injection button without a needle
attached. Storing the Pen with the needle
attached may allow insulin to leak from the Pen
and air bubbles to form in the cartridge.
2. Remove the paper tab from
the outer needle shield.
3. Attach the capped needle
onto the end of the Pen by
turning it clockwise until
tight.
II. Attaching the Needle
Outer Needle
Shield
Paper Tab

9
II. Attaching the Needle
(Continued)
4. Hold the Pen with the needle
pointing up and remove the
outer needle shield. Keep it
to use during needle
removal.
5. Remove the inner needle shield and discard.
Outer Needle
Shield (Keep)
Inner Needle
Shield
(Discard)

10
•The Pen must be primed before each injection to
make sure the Pen is ready to dose. Performing the
priming step is important to confirm that insulin
comes out when you push the injection button, and to
remove air that may collect in the insulin cartridge
during normal use.
•If you do not prime, you may get too much or too
little insulin.
•Always use a new needle for each injection.
1. Make sure the arrow is in the
center of the dose window as
shown.
2. If you do not see the
arrow in the center of
the dose window,
push in the injection
button fully and turn
the dose knob until the arrow is seen in the center
of the dose window.
III. Priming the Pen
Correct

11
3. With the arrow in the center
of the dose window, pull the
dose knob out in the direction
of the arrow until a “0”is
seen in the dose window.
4. Turn the dose knob clockwise
until the number “2”is seen
in the dose window. If the
number you have dialed is too
high, simply turn the dose knob
backward until the number 2
is seen in the dose window.
III. Priming the Pen
(Continued)

12
5. Hold your Pen with the
needle pointing up. Tap the
clear cartridge holder gently
with your finger so any air
bubbles collect near the top.
Using your thumb, if
possible, push in the
injection button completely. Keep pressing and
continue to hold the injection button firmly while
counting slowly to 5. You should see either a
drop or a stream of insulin come out of the tip of
the needle.
If insulin does not come out of the tip of the
needle, repeat steps 1 through 5. If after several
attempts insulin does not come out of the tip of
the needle, change the needle and repeat the
priming steps.
III. Priming the Pen
(Continued)

13
6. At the completion of the
priming step, a diamond (◆)
must be seen in the center of
the dose window. If a
diamond (◆) is not seen in
the center of the dose
window, continue
pushing on the
injection button until
you see a diamond (◆)
in the center of the
dose window.
Note: A small air bubble may remain in the cartridge
after the completion of the priming step. If you have
properly primed the Pen, this small air bubble will
not affect your insulin dose.
7. Now you are ready to set your dose. See next
page.
III. Priming the Pen
(Continued)
Correct

14
•Always use a new needle for each injection.
Storing the Pen with the needle attached may
allow insulin to leak from the Pen and air
bubbles to form in the cartridge.
•Caution: Do not push in the injection button while
setting your dose. Failure to follow these
instructions carefully may result in getting too
much or too little insulin. If you accidentally push
the injection button while setting your dose, you
must prime the pen again before injecting your
dose. See Section III. “Priming the Pen”,
pages 10-13.
1. A diamond must be seen in the center of the dose
window before setting your dose.
If you do not see a
diamond in the center
of the dose window,
the pen has not been
primed correctly and
you are not ready to set your dose. Before continuing,
repeat the priming steps.
IV. Setting a Dose
Correct

15
2. Turn the dose knob clockwise
until the arrow (➞) is seen in the
center of the dose window and
the notches on the Pen and dose
knob are in line.
3.
With the arrow (➞) in the center
of the dose window, pull the
dose knob out in the direction
of the arrow until a “0”is seen
in the dose window. A dose
cannot be dialed until the dose
knob is pulled out.
4. Turn the dose knob clockwise
until your dose is seen in the
dose window. If the dose you
have dialed is too high, simply
turn the dose knob backward
until the correct dose is seen in
the dose window.
5. If you cannot dial a full dose, see the “Questions and
Answers”section, Question 5, at the end of this
manual.
IV. Setting a Dose
(Continued)

16
V. Injecting a Dose
•
•Caution: Do not attempt to change the dose after
you begin to push in the injection button. Failure to
follow these instructions carefully may result in
getting too much or too little insulin.
•may increase while you are injecting your insulin
dose. If you cannot completely push in the injection
button, refer to the “Questions and Answers”
section, Question 7, at the end of this manual.
•Do not inject a dose unless the pen is primed,
just before injection, or you may get too much
or too little insulin.
•If you have set (dialed) a dose and pushed in the
injection button without a needle attached or if no
insulin comes out of the needle, see the “Questions
and Answers”section, Questions 1 and 2.
1. Wash hands. Prepare the skin and use the
injection technique recommended by your Health
Care Professional.
Always use a new needle for each injection.
Storing the Pen with the needle attached may
allow insulin to leak from the Pen and air
bubbles to form in the cartridge.
The effort needed to push in the injection button

17
V. Injecting a Dose
(Continued)
Insert the needle into your skin.
Inject the insulin by using your
thumb, if possible, to push in
the injection button completely.
3.
2.
Keep pressing and continue to
hold the injection button firmly
while counting slowly to 5.
4.
When the injection is
done, a diamond (◆)
or arrow (
➞ ) must be
seen in the center of
the dose window. This
means your full dose
has been delivered.
If you do not see the
diamond or arrow in
the center of the dose
window, you did not get a full dose. Contact your
Health Care Professional for additional instruction.
Correct
Correct

18
VI. Following an Injection
1. Make sure you got a full
dose by checking that the
injection button has been
completely pushed in and
you can see a diamond (◆)
or arrow (➞) in the center
of the dose window. If you
do not see the diamond (◆) or arrow (➞) in the
center of the dose window, you have not received
a full dose. Contact your Health Care Professional
for additional instructions.
2. Carefully replace the outer
needle shield as instructed
by your Health Care
Professional.
220
180
140
100
60
20

19
3. Remove the capped needle
by turning it counterclockwise
and throw it away. Place the
used needle in a puncture-
resistant disposable container
and properly dispose of it
as directed by your Health
Care Professional.
4. Replace the cap on the Pen.
5. The Pen that you are using should NOT be
refrigerated but kept at a room temperature
below 86°F (30°C) and away from direct heat and
light. It should be discarded according to the
time specified in the
Information for the Patient
insert, even if it still contains insulin.
Do not store or dispose of the Pen with a needle
attached. Storing the Pen with the needle attached
may allow insulin to leak from the Pen and air
bubbles to form in the cartridge.
220
180
140
100
60
20
VI. Following an Injection
(Continued)

20
1. Dose dialed
and injection
button
pushed in
without a
needle
attached.
Problem Action
2. Insulin does
not come out
of the needle.
To obtain an accurate dose you
must:
1) Attach a new needle.
2) Push in the injection button
completely (even if a “0”is seen
in the window) until a diamond
(◆) or arrow (➞) is seen in the
center of the dose window.
3) Prime the Pen.
To obtain an accurate dose you
must:
1) Attach a new needle.
2) Push in the injection button
completely (even if a “0”is seen
in the window) until a diamond
(◆) or arrow (➞) is seen in the
center of the dose window.
3) Prime the Pen. See Section III.
“Priming the Pen”, pages 10-13.
Questions and Answers