Novo Nordisk NovoPen 3 PenMate, NovoPen 3, NovoPen 3 Demi, NovoPen Junior Instruction Manual
NDA 19-938/S-037
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NovoPen®3
®
PenMate
Instruction Manual
For use with the
following NovoPen
devices:
NovoPen
NovoPen
or NovoPen® Junior
Read this carefully before you use
NovoPen®3 PenMate® with
NovoPen®3, NovoPen® 3 Demi, or
NovoPen® Junior
®
®
3,
3 Demi,
®
insulin delivery
NNPI submission date: 5/17/05
NDA 19-938/S-037
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NNPI submission date: 5/17/05
NDA 19-938/S-037
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NNPI submission date: 5/17/05
NDA 19-938/S-037
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NNPI submission date: 5/17/05
NDA 19-938/S-037
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INTRODUCTION
NovoPen
®
3 PenMate® helps to give an injection without seeing a needle and is
designed for use with the following Novo Nordisk 3 mL PenFill® cartridge
compatible insulin delivery devices: NovoPen® 3, NovoPen® 3 Demi, or
NovoPen® Junior (hereafter referred to as “NovoPen devices”). When the
NovoPen 3 PenMate is used with one of the NovoPen devices mentioned above,
it is called “NovoPen 3 PenMate system”. With NovoPen 3 PenMate system, you
don’t see a needle when you give an injection.
If you use NovoPen 3 PenMate with NovoPen 3, you can dial doses from 2
to 70 units in one unit steps.
If you use NovoPen 3 PenMate with NovoPen 3 Demi or NovoPen Junior,
you can dial doses from 1 to 35 units in half (½) unit steps.
NovoPen 3 PenMate should only be used in combination with the following
products that are compatible and recommended by Novo Nordisk.
NovoPen 3 PenMate system is designed to be used with:
NovoPen 3
NovoPen 3 Demi
NovoPen Junior
Novo Nordisk 3 mL PenFill insulin cartridges (PenFill cartridges)
NovoFine® disposable needles
NovoFine disposable needles are for single-use only.
NovoPen 3 PenMate system design allows you to use the same recommended
injection technique as the NovoPen devices.
This booklet contains instructions for using, storing and cleaning NovoPen 3
PenMate system. Please read the instructions carefully. You should read these
instructions even if you have used NovoPen devices, or NovoPen devices with
the NovoPen 3 PenMate before. The two previous pages provide illustrations of
NovoPen 3 and the NovoPen 3 PenMate. The diagrams in this booklet are
shown using NovoPen 3 and NovoPen 3 PenMate. NovoPen 3 Demi and
NovoPen Junior are different versions of NovoPen 3, but the NovoPen devices
all work with NovoPen 3 PenMate in the same way.
Always check that the PenFill cartridge you use contains the correct type of
insulin.
If you use more than one type of insulin in PenFill cartridges, you should use a
separate NovoPen 3 PenMate system for each type of insulin to avoid giving an
injection with the wrong type of insulin.
If you have any questions about your NovoPen 3 PenMate, NovoPen 3 PenMate
system, or your NovoPen devices, please call Novo Nordisk Inc. at
1-800-727-6500.
NNPI submission date: 5/17/05
NDA 19-938/S-037
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Please complete and return the NovoPen 3 PenMate Warranty Card for full
warranty protection.
NNPI submission date: 5/17/05
NDA 19-938/S-037
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HOW TO USE THIS BOOKLET
This booklet gives you step-bystep instructions for using
NovoPen 3 PenMate system.
Begin by reviewing the illustration of
the parts of the NovoPen devices,
NovoPen 3 PenMate, Novo Nordisk
3 mL PenFill insulin cartridge, and
NovoFine disposable needle. The
inside front cover opens out while
you read the rest of the booklet.
Most pages contain a diagram (using
NovoPen 3 and NovoPen 3
PenMate) on the right with numbered
instructions to the left of the diagram.
Important additional information is
given below the diagram.
We suggest that you read the text
and look at the diagrams to make
sure that you understand each step
thoroughly.
Also included is an illustration
showing a side-by-side comparison
of the NovoPen devices and the
NovoPen 3 PenMate. This illustration
allows you to see which part of the
NovoPen devices the NovoPen 3
PenMate replaces.
The main differences between
the NovoPen devices and the
NovoPen 3 PenMate system are
as follows:
• The PenFill cartridge holder
and the Pen cap of the
NovoPen devices are
replaced by the NovoPen 3
PenMate.
• With the NovoPen 3
PenMate system, you do
not see a needle when you
give an injection.
Look at the illustration inside the front cover for the names of the
different parts of NovoPen devices and NovoPen 3 PenMate. You can
unfold the illustration to help you while you follow the instructions.
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NNPI submission date: 5/17/05
NDA 19-938/S-037
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TABLE OF CONTENTS
SECTION 1:
Assembly of the NovoPen 3 PenMate system................................................4
SECTION 2:
Air shot before each injection..........................................................................9
SECTION 3:
Choosing your dose.........................................................................................10
SECTION 4:
Giving the injection...........................................................................................12
SECTION 5:
Mechanical function check of NovoPen 3 PenMate system .........................17
SECTION 6:
For subsequent injections ...............................................................................18
SECTION 7:
What to do if the 3 mL PenFill cartridge is nearly empty ..............................19
SECTION 8:
Changing 3mL PenFill cartridge......................................................................20
SECTION 9:
Function check..................................................................................................21
IMPORTANT ......................................................................................................22
WHAT TO DO IF.................................................................................................25
MAINTENANCE .................................................................................................27
WARRANTY.......................................................................................................28
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NDA 19-938/S-037
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SECTION 1 Assembly of the NovoPen 3 PenMate system
Assembly of the NovoPen 3 PenMate
system
1 Take the NovoPen 3 out of its
case by pressing the top of the
Pen cap, or take NovoPen 3
Demi or NovoPen Junior out of
the soft carrying case.
2 Gently twist the Pen cap until it
separates from the barrel.
3 Pull the Pen cap straight up to
remove it.
4 Unscrew and remove the PenFill
holder from the barrel.
You will not use the Pen cap and
PenFill holder with the NovoPen
3 PenMate system but you
should store them in case you
want to use the NovoPen device
without the NovoPen 3 PenMate
in the future.
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SECTION 1 (cont.)
5 Press the push button all the way
in until you see zero (0) in the
dose indicator window. The zero
should be lined up with the stripe
next to the dose indicator
window.
6 The end of the piston rod should
be flat against the end of the
reset mechanism before inserting
a new 3 mL PenFill cartridge.
The piston rod should not be
sticking out.
If the piston rod is sticking out:
Turn the end of the reset
mechanism in a clockwise
direction until the piston rod is no
longer sticking out. Never push
the piston rod back in.
You should never reset the piston
rod until it is time to remove the
empty PenFill cartridge and insert a
new 3 mL PenFill cartridge.
If the reset mechanism locks, it is
usually due to improper technique.
Gently turn the reset mechanism
side to side until it unlocks. Then
call the toll free number 1-800-7276500 so we may go over your
technique with you.
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NDA 19-938/S-037
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SECTION 1 (cont.)
7 To remove the PenFill cartridge
from its wrapper, push the PenFill
cartridge through the foil side of
the packaging.
Before use, check that the new
PenFill cartridge does not have
puncture holes in the rubber
stopper. If the rubber stopper
has holes in it, do not use the
cartridge.
8 If you use a suspension insulin
(white and cloudy), such as
Novolin
®
N, Novolin® 70/30, or
NovoLog® Mix 70/30, make sure
to mix the insulin in the cartridge
before use. You will find
instructions in the 3 mL PenFill
cartridge “Information For The
Patient” leaflet on how to prepare
the insulin.
Once the PenFill cartridge is
punctured (in use), it should be
stored at room temperature
below 86° F (30° C). Stored at this
temperature, the in-use PenFill
cartridge can be used for the
amount of days listed in the 3 mL
PenFill cartridge “Information For
The Patient” leaflet for the type of
insulin you are using.
If you use more than one type of insulin in PenFill cartridges, use a separate
NovoPen 3 PenMate system for each type of insulin to avoid giving an injection
with the wrong type of insulin.
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SECTION 1 (cont.)
9 Take NovoPen 3 PenMate out of
its case.
Pull off the cap and put it to one
side.
10 Put the PenFill cartridge into the
NovoPen 3 PenMate. The
threaded plastic cap goes in first.
If you use a suspension insulin
(white and cloudy), make sure to
mix the insulin in the cartridge
before you put it into the
NovoPen 3 PenMate. You will
find the instructions in the 3 mL
PenFill cartridge “Information For
The Patient” leaflet on how to mix
the insulin.
11 Tightly screw the barrel of the
NovoPen device into the
NovoPen 3 PenMate and you
have NovoPen 3 PenMate
system.
Make sure that the dose indicator
window on the mechanical
section is aligned with the yellow
push button on NovoPen 3 PenMate.
Each 3 mL PenFill cartridge contains 300 units of insulin. Make sure you are
using the correct type of insulin. The name of the insulin is on the glass part
of the PenFill cartridge.
PenFill cartridge is for single-person use only. DO NOT SHARE the PenFill
cartridge with anyone else even if you attach a new disposable needle for
each injection. Sharing the PenFill cartridge can spread disease.
Use only a new 3 mL PenFill cartridge when loading the NovoPen 3
PenMate. Never load a partially filled PenFill cartridge.
Never try to refill a used PenFill cartridge.
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SECTION 1 (cont.)
12 Clean the front rubber stopper on
the PenFill cartridge with an
alcohol swab.
You must wipe the front rubber
stopper with an alcohol swab
before each injection, even if you
are using the same PenFill
cartridge.
13 Remove the protective tab from
the NovoFine disposable needle.
Screw the NovoFine disposable
needle firmly onto the threaded
plastic cap of the PenFill
cartridge until it is tight.
Pull off the outer and inner
needle caps.
For users of a suspension
insulin (white and cloudy),
always remix the insulin in the
PenFill cartridge before each
injection.
You will find instructions on how
to remix the suspension insulin in
the PenFill cartridge in the 3 mL
PenFill cartridge “Information For
The Patient” leaflet.
Never place a NovoFine disposable needle on your NovoPen 3 PenMate
system until you are ready to do an air shot and give an injection. If the
NovoFine needle is left on, some insulin may leak out from the PenFill
cartridge. This may cause a change in the concentration (strength) of a
suspension insulin (white and cloudy).
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SECTION 2 Air shot before each injection
Air shot before each injection
14 Small amounts of air may be
present in the needle and/or
PenFill cartridge. To avoid
injecting air bubbles and to make
sure of correct dosing, you must
perform an air shot before
each injection.
• Check that the dial-a-dose
selector is set to zero.
• Dial 2 units.
• Hold the NovoPen 3 PenMate
system with the NovoFine needle
pointing up and tap gently near
the window of NovoPen 3
PenMate with your finger a few
times.
• Press the push button at the end
of the barrel all the way in.
A drop of insulin should appear at
the needle tip.
If no insulin appears, repeat the
above steps until a drop of insulin
If you dialed more than 2 units,
DO NOT turn the dial-a-dose
selector back to zero (0). If you
do, the extra insulin will squirt out
of the needle. You may complete
the air shot with the number of
units you have dialed or refer to
the instructions on how to reset
the dose to zero in Section 3
“Choosing your dose”, step 17.
appears. There may still be some
small air bubble(s) in the PenFill
cartridge after this, but they will not
affect your dose and they will not be
injected.
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NNPI submission date: 5/17/05
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