Novorapid Flexpen: What Is in This Leaflet Before You Use Novorapid Flexpen

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NovoRapid® FlexPen®

Insulin aspart (rys)


Consumer Medicine Information

What is in this leaflet mellitus is a condition where your


pancreas does not produce enough
insulin to control your blood sugar
Before you use
®
What NovoRapid is used for.. 1 (glucose) level. Extra insulin is NovoRapid® FlexPen®
therefore needed.
Before you use NovoRapid® When you must not use it
FlexPen® .................................... 1 There are two types of diabetes
mellitus: Do not use NovoRapid® if:
® ®
How to use NovoRapid FlexPen 1. you have an allergy to:
Type 1 diabetes – also called
.................................................... 2
juvenile onset diabetes  any medicine containing insulin
®
While you are using NovoRapid Type 2 diabetes – also called  any of the ingredients listed in
FlexPen® .................................... 4 the “Ingredients” section of this
maturity onset diabetes
leaflet.
Things to be careful of ............. 4 Patients with type 1 diabetes always
Some of the symptoms of an
require insulin to control their blood
Side effects ................................. 5 allergic reaction may include:
sugar levels.
 redness, swelling, rash and
After using NovoRapid® FlexPen® Some patients with type 2 diabetes
itching at the injection site
.................................................... 5 may also require insulin after initial
treatment with diet, exercise and  rash, itching or hives on the
Product Description ................. 5 tablets. skin
NovoRapid® lowers your blood sugar  shortness of breath
Further information ................. 6
level after injection. When injected  wheezing or difficulty
Instructions For Use ................. 7 under your skin, NovoRapid® has a breathing
faster onset of action than soluble  swelling of the face, lips,
This leaflet answers some common
human insulin. It takes effect within
questions about NovoRapid® tongue or other parts of the
10 to 20 minutes. Usually, the
FlexPen®. It does not contain all the body.
maximum effect will occur between
available information. It does not 2. you are experiencing a low
1-3 hours after injection and the
take the place of talking to your
effect may last for up to 5 hours. blood sugar level (a “hypo”)
doctor, diabetes education nurse or
pharmacist. As with all insulins, the duration of when the dose is due.
action will vary according to the If you have a lot of hypos discuss
All medicines have risks and
dose, injection site, blood flow, appropriate treatment with your
benefits. Your doctor has weighed
temperature and level of physical doctor.
the risks of you using NovoRapid®
activity. Due to its shorter duration
FlexPen® against the benefits they If you are not sure whether you
of action, NovoRapid® has a lower
expect it will have for you. should start using this medicine,
risk of causing nocturnal
If you have any concerns about hypoglycaemic episodes. talk to your doctor.
using this medicine, ask your FlexPen® is a pre-filled dial-a-dose Do not use this medicine after the
doctor, diabetes education nurse insulin pen able to deliver from 1 to expiry date printed on the pack or
or pharmacist. 60 units of NovoRapid® in if the packaging is torn or shows
Keep this leaflet with the medicine. increments of 1 unit. signs of tampering.
You may need to read it again. If it has expired or is damaged,
NovoRapid® is not addictive.
return it to your pharmacist for
NovoRapid® FlexPen® is available disposal.
What NovoRapid® is
only with a doctor’s prescription.
used for Before you start to use it
Ask your doctor, diabetes
The insulin aspart, or “NovoRapid®”, education nurse or pharmacist if Tell your doctor if you have
“NovoRapid®”, in NovoRapid® you have any questions about why allergies to any other medicines,
FlexPen® is a rapid-acting insulin NovoRapid® FlexPen® has been foods, preservatives or dyes.
used to treat diabetes mellitus in prescribed for you.
adults and children. Diabetes
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Tell your doctor if you have or treatment of diabetes fibrocystic breast disease and
have had any medical conditions,  monoamine oxidase inhibitors hereditary angioedema
especially the following: (MAOI) - used for the treatment  oxymetholone - used to treat
 kidney problems of depression certain blood disorders
 alpha-blocking agents - used for
 liver problems  diazoxide - used for the
the treatment of high blood
treatment of high blood pressure
 adrenal, pituitary or thyroid pressure and to relieve difficulty
gland problems. in passing urine caused by an  nicotinic acid - used for the
enlarged prostate treatment of high cholesterol
Tell your doctor if you are levels in the blood
pregnant or plan to become  non-selective beta-blocking
agents - used for the treatment of  asparaginase - used to treat
pregnant.
®
certain heart conditions and high leukaemia and lymph gland
NovoRapid can be used in blood pressure which may also tumours.
pregnancy. Pregnancy may make mask the symptoms of
managing your diabetes more hypoglycaemia and delay If you take the following medicines,
difficult. Insulin needs usually recovery from hypoglycaemia your blood sugar level may rise or
decrease during the first three fall:
 angiotensin converting enzyme
months of pregnancy and increase  octreotide - used to treat
(ACE) inhibitors - used for the
during the last six months. Your gastrointestinal endocrine
treatment of certain heart
doctor can discuss with you the risks tumours and enlargement of
conditions, high blood pressure
and benefits involved. parts of the body (e.g. hands,
or elevated protein/albumin in
Tell your doctor if you are breast- the urine feet, head) caused by abnormal
feeding or plan to breast-feed. growth hormone levels
 salicylates e.g. aspirin - used to
Your doctor or pharmacist can relieve pain and lower fever  lanreotide – used to treat
discuss with you the risks and enlargement of parts of the body
 anabolic steroids - used to (e.g. hands, feet, head) caused
benefits involved.
promote growth by abnormal hormone levels.
Inform your doctor as soon as
 sulfonamides - used to treat
possible if you experience signs of Tell your doctor about any other
bacterial infections
heart failure such as unusual medicines that you are taking.
shortness of breath or rapid  quinine - used for the prevention This is very important. Your doctor
increase in weight or localised of malaria and the relief of will advise you if it is all right to
swelling (oedema). muscle cramps keep taking them or if you should
Some patients with long-standing  quinidine - used for the control stop taking them.
type 2 diabetes mellitus and heart of heart problems.
Your doctor and pharmacist have
disease or previous stroke who are
If you take any of the medicines more information on medicines to be
treated with thiazolidinediones in
below, your blood sugar level may careful with or avoid while using this
combination with insulin may
rise (hyperglycaemia) medicine.
develop heart failure.
 glucocorticoids (except when
If you have not told your doctor
applied locally) - used to treat How to use NovoRapid®
about any of the above, tell them
inflammatory conditions
before you use NovoRapid®. FlexPen®
 oral contraceptives (“the pill”) -
Taking other medicines used for birth control Your doctor, diabetes education
Tell your doctor if you are  thiazides, frusemide or nurse or pharmacist will have
currently taking any other ethacrynic acid - used for the given you advice on how to use
medicines, including any that you treatment of high blood pressure your medicine. Carefully follow all
get without a prescription from or fluid retention (oedema) the directions.
your pharmacy, supermarket or They may differ from the
 thyroid hormones - used for the
health food shop. information contained in this leaflet.
treatment of malfunction of the
Some medicines and NovoRapid® thyroid gland Your doctor may also want you to
may interfere with each other and use another insulin such as
this may mean that your insulin dose  sympathomimetics - used for the
Protaphane® or Levemir®.
has to change. treatment of asthma
 growth hormone - used to treat Any change in dose or type of
If you take any of the medicines insulin should be made cautiously
listed below, your blood sugar may growth disorders
and only under medical
fall (hypoglycaemia):  danazol - used to treat supervision.
 other medicines used for the endometriosis, menorrhagia,

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If you change the type of insulin that Check your NovoRapid® FlexPen® diabetes. It is important that they
you use, you may have to use more before each preparation and recognise the signs and symptoms
or less than before. This may happen injection. Make sure you are using of a hypo.
with the first dose or over a period of the correct type of insulin. Make sure they know to give you
time. some sugary food or fruit juice for
Do not use this medicine if it is
If you do not understand the thickened, coloured, or has solid mild to moderate symptoms of a
instructions, ask your doctor, bits in it. hypo.
diabetes education nurse or If you lose consciousness, make
pharmacist for help. Read the instructions printed at
the end of this leaflet carefully in sure they know:
order to prepare and handle your  to turn you on your side and get
How much to use NovoRapid® FlexPen® correctly. medical help immediately
Your doctor or diabetes education
nurse will tell you how much of this How long to use it  not to give you anything to eat
medicine you need to use. or drink.
Do not stop using NovoRapid® This is because you could choke.
It is very important that you manage FlexPen® unless your doctor tells
your diabetes carefully. Too much you to. An injection of the hormone
or too little insulin can cause serious glucagon may speed up recovery
effects. from unconsciousness. This can be
If you use too much given by a relative, friend, workmate
(overdose) - Hypoglycaemia or carer who knows how to give it.
When to use it
Your blood sugar level may become If glucagon is used, eat some sugary
NovoRapid® should normally be
too low (you may experience food or have a sugary drink as soon
used immediately (up to 10 minutes)
hypoglycaemia or a “hypo”) if you: as you are conscious again.
before your meal or carbohydrate
snack. When necessary NovoRapid®  accidentally use too much of If you do not feel better after this,
may be used immediately after the this medicine contact your doctor, diabetes
meal.  have too much or unexpected education nurse, or the closest
exercise hospital.
How to use it  delay eating meals or snacks If you do not respond to glucagon
 ®
Inject NovoRapid under the  eat too little food treatment, you will require medical
skin (subcutaneous injection) as  are ill. attention.
shown to you by your doctor or
The first symptoms of mild to See your doctor if you keep having
diabetes education nurse.
moderate hypos can come on hypo reactions, or if you have ever
 NovoRapid® may be injected become unconscious after using
suddenly. They may include:
into the abdomen, thighs, insulin.
buttocks or upper arms.  cold sweat, cool pale skin
Your insulin dose may need to be
 Remember to change your  fatigue, drowsiness, unusual changed.
injection site regularly as shown tiredness and weakness
to you by your doctor or If a severe hypo is not treated, it can
 nervousness, anxious feeling, cause brain damage and even death.
diabetes education nurse.
tremor, rapid heart beat
 In an emergency, the insulin
 confusion, difficulty If you miss a dose –
contained within NovoRapid®
FlexPen® is suitable for concentrating Hyperglycaemia
intravenous administration,  excessive hunger
under medical supervision only. If you forget your insulin dose, test
 vision changes your blood sugar level as soon as
For emergency use, the insulin
 headache, nausea. possible.
must first be withdrawn from
FlexPen® into a syringe. Always carry some sugary food or If you are not sure what to do, talk
Discard your FlexPen® after fruit juice with you. to your doctor, diabetes education
emergency use. If you experience any of these nurse or pharmacist.
 If you use NovoRapid® and symptoms of a hypo, immediately
another type of insulin, you Do not use a double dose of your
eat some sugary food or have a
must use a separate insulin insulin.
sugary drink e.g. lollies, biscuits or
delivery system for each type of fruit juice, and measure your blood If it is almost time for your next
insulin. sugar level. dose, skip the dose you missed and
use your next dose when you are
Checking your NovoRapid® Tell your relatives, friends, close meant to.
FlexPen® workmates or carers that you have

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Otherwise, use it as soon as you While you are using Your doctor, diabetes education
remember – don’t forget to eat some nurse or pharmacist can provide you
carbohydrate within 10 minutes of NovoRapid® FlexPen® with some helpful information.
your injection – and then go back to
using it as you would normally. Things you must do Things you must not do
Your blood sugar levels may become Measure your blood sugar level
high (hyperglycaemia) if you: regularly. Do not stop using your medicine
unless your doctor tells you to.
 miss doses of insulin or use less Make sure all friends, relatives,
insulin than you need workmates or carers know that Do not use the medicine if you
you have diabetes. think it has been frozen or exposed
 have uncontrolled diabetes
If your child has diabetes it is to excessive heat.
 exercise less than usual important to tell their carers. It will not work as well.
 eat more carbohydrates than
Keep using your insulin even if Do not use this medicine to treat
usual you feel well. any other complaints unless your
 are ill or stressed. It helps to control your condition, doctor tells you to.
High blood sugar levels over a long but does not cure it.
period of time can lead to too much Do not give your medicine to
Tell your doctor if you often have anyone else, even if they have the
acid in the blood (diabetic
hypos (low blood sugar levels). same condition as you.
ketoacidosis).
Your doctor may need to adjust your
Contact your doctor immediately insulin dose. Do not share needles or pens.
if your blood sugar level is high or
you recognise any of the following Always carry some sugary food or
symptoms. fruit juice with you. Things to be careful of
If you experience any of the
Symptoms of mild to moderate Be careful driving or operating
symptoms of a hypo, immediately
hyperglycaemia include: machinery until you know how the
eat some sugary food or have a drink
 drowsy feeling e.g. lollies, biscuits or fruit juice. insulin affects you.
 flushed face Tell your doctor if you have
If your blood sugar is low or high
 thirst, loss of appetite your concentration and ability to
trouble recognising the symptoms
react might be affected, and therefore
 fruity odour on the breath of hypos.
also your ability to drive or operate a
 blurred vision Under certain conditions, the early
machine. Bear in mind that you
warning signs of hypos can be
 passing larger amounts of urine different or less obvious. Your
could endanger yourself or others.
than usual doctor may need to adjust your Please ask your doctor whether you
can drive a car:
 getting up at night more often insulin dose.
than usual to pass urine  if you have frequent hypos
Make sure that you tell every
 high levels of glucose and doctor, dentist, pharmacist or  if you find it hard to recognise
acetone in the urine. other health care professional who hypoglycaemia.
is treating you that you have Tell your doctor if you drink
Symptoms of severe hyperglycaemia
diabetes and are using insulin. alcohol.
include:
Tell your doctor, diabetes Alcohol may mask the symptoms of
 heavy breathing hypos. If you drink alcohol, your
education nurse or pharmacist if
 fast pulse you are travelling.
need for insulin may change as your
 nausea, vomiting blood sugar level may either rise or
Ask them for a letter explaining why
fall. Careful monitoring is
 dehydration you are taking injecting devices with
recommended.
you. Each country you visit will
 loss of consciousness.
need to see this letter, so you should Tell your doctor if you are ill.
Severe hyperglycaemia can lead to take several copies. Illness, especially with nausea and
unconsciousness and in extreme
You may need to inject your insulin vomiting, may cause your insulin
cases death if untreated.
and eat your meals at different times needs to change. Even if you are not
Discuss any worries you may have because of time differences in and eating, you still require insulin. You
about this with your doctor, diabetes between countries. and your doctor should design an
education nurse or pharmacist. insulin plan for those times when
You may not be able to get the same you are sick.
type of insulin in the country you are
visiting. Tell your doctor if you are
exercising more than usual.

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Exercise may lower your need for  when you first start your insulin Do not keep the NovoRapid®
this medicine. Exercise may also treatment you may get visual FlexPen® that you are using, or
speed up the effect of a dose of it, problems or swollen hands and feet that you are carrying as a spare, in
especially if the exercise involves the a refrigerator. You can use it up to
area of the injection site (e.g. the leg This list includes the more common 4 weeks below 30C after taking it
should not be used for injection prior side effects of your medicine. They out of the refrigerator. Discard
to jogging or running). are usually mild and short-lived. NovoRapid® FlexPen® after 4
weeks even if there is still some
Tell your doctor if your diet If any of the following happen, tell
NovoRapid® left in it.
changes. your doctor immediately or go to
Changes in diet may cause your Accident and Emergency at your The NovoRapid® in NovoRapid®
insulin needs to change. nearest hospital: FlexPen® must not be frozen, or
More severe symptoms of low blood exposed to excessive heat or light.
sugar levels, including: Protect the NovoRapid® in
Side effects NovoRapid® FlexPen® from light
 disorientation
by keeping the pen cap on when
Tell your doctor, diabetes  seizures, fits or convulsions not in use.
education nurse or pharmacist as  loss of consciousness.
soon as possible if you do not feel Never use NovoRapid® FlexPen®
If a severe hypo is not treated, it can after the expiry date printed on
well while you are using
cause brain damage and death. the label and carton.
NovoRapid® FlexPen®.
This medicine helps most people for Tell your doctor immediately or go Never use NovoRapid® FlexPen® if
whom it is prescribed, but it may to Accident and Emergency at the solution is not clear and
have unwanted side effects in a few your nearest hospital if you notice colourless.
people. All medicines can have side any of the following:
Keep out of the reach of children.
effects. Sometimes they are serious,  skin rashes over a large part of
most of the time they are not. You the body
may need medical treatment if you Disposal
 shortness of breath, wheezing
get some of the side effects. Dispose of used needles safely into
 swelling of the face, lips or
Do not be alarmed by the following tongue a yellow plastic sharps container.
lists of side effects. You may not  fast pulse If your doctor tells you to stop using
experience any of them. this medicine or the expiry date has
 sweating.
Ask your doctor, diabetes passed, ask your pharmacist what to
This list includes very serious side do with any medicine that is left
education nurse or pharmacist to
effects. You may need urgent over.
answer any questions you may
medical attention or hospitalisation.
have.
These side effects are very rare.
The most common side effect when Product Description
using insulin is low blood sugar Tell your doctor if you notice
anything that is making you feel
levels (a hypo). What it looks like
unwell.
Tell your doctor if you notice any Other side effects not listed above NovoRapid® is a clear, colourless
of the following and they worry may also occur in some people. solution for subcutaneous injection.
you: NovoRapid® FlexPen® is a 3mL pre-
Ask your doctor, diabetes filled glass cartridge contained in a
 hypos (mild to moderate)
education nurse or pharmacist to dial-a-dose insulin pen.
 pain, redness, hives, bruising, answer any questions you have.
swelling or itching at the
Ingredients
injection site. Usually these ®
symptoms disappear within a few After using NovoRapid NovoRapid® contains insulin aspart
weeks during continued use. If FlexPen® (rys) 100 units per mL (100 U/mL)
you have serious or continuing as the active ingredient. The
abbreviation “rys” indicates the
reactions, you may need to stop Storage
method of genetic engineering used
using NovoRapid® and use to manufacture the insulin aspart.
Store NovoRapid® FlexPen® that
another insulin.
are not being used between 2C NovoRapid® also contains the
 a depression or thickening of the and 8C in a refrigerator (not in or following inactive ingredients:
skin around the injection site too near the freezer section or glycerol, phenol, metacresol, zinc
(lipodystrophy). cooling element). chloride, sodium chloride, dibasic
sodium phosphate dihydrate, sodium

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hydroxide, hydrochloric acid and
water for injections.

Sponsor
NovoRapid® FlexPen® is supplied in
Australia by:
Novo Nordisk Pharmaceuticals Pty.
Ltd.
Level 3
21 Solent Circuit
Baulkham Hills NSW 2153
Australia

® ®
NovoRapid FlexPen is supplied in
New Zealand by:
Novo Nordisk Pharmaceuticals
Ltd.
58 Richard Pearse Drive
Airport Oaks
Mangere
New Zealand

NovoRapid®, FlexPen®, NovoFine®,


Protaphane®, Levemir® and
®
NovoCare are registered trademarks
of Novo Nordisk A/S.

This leaflet was prepared on 13


June 2017.

Australian Registration Number:


AUST R 133445

© 2017
Novo Nordisk A/S

Further information
For further information call the
NovoCare® Customer Care Centre
on 1800 668 626 (Australia) or 0800
733 737 (NZ).
www.novonordisk.com.au
www.novonordisk.co.nz

You can also get more information


about diabetes and insulin from
Diabetes Australia and Diabetes New
Zealand:
 freecall helpline 1300 136 588
(Australia)
 www.diabetesaustralia.com.au
 www.diabetes.org.nz

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NovoRapid® FlexPen®
Insulin aspart (rys)

Instructions For Use


Introduction
Please read the following instructions carefully before using your NovoRapid® FlexPen®. If you do
not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or
too low blood sugar levels.
Your NovoRapid® FlexPen® is a pre-filled, dial-a-dose insulin pen. You can select doses from 1 to 60 units
in increments of 1 unit. FlexPen® is designed to be used with NovoFine® disposable needles up to a length
of 8mm.
As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen® is lost or
damaged.

NovoRapid® Dose Needle (example)


FlexPen® Residual scale selector Push-
Pen cap Big outer Needle
Cartridge Pointer button needle cap

Inner needle cap Paper tab

Caring for your pen


Your FlexPen® must be handled with care. If it is dropped, damaged or crushed, there is a risk of insulin
leakage. This may cause inaccurate dosing, which can lead to too high or too low blood sugar levels.
You can clean the exterior of your FlexPen® by wiping it with a medicinal swab. Do not soak it, wash or
lubricate it as this may damage the pen.
Do not refill your FlexPen®.
Preparing your NovoRapid® FlexPen®
Check the name and coloured label of your pen to make sure that it contains the correct type of
insulin. This is especially important if you inject more than one type of insulin. If you inject the wrong type
of insulin, your blood sugar level may get too high or too low.
A
Pull off the pen cap.
A

B
Remove the paper tab from a newdisposable needle.
Screw the needle straight and tightly onto your FlexPen®.
B

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C
Pull off the big outer needle cap and keep it for later.
C

D
Pull off the inner needle cap and dispose of it. Never try to put the inner needle cap back on the needle.
You may stick yourself with the needle.
D

Always use a new needle for each injection. This reduces the risk of contamination, infection,
leakage of insulin, blocked needles and inaccurate dosing.
Be careful not to bend or damage the needle before use.

Checking the insulin flow


Prior to each injection small amounts of air may collect in the cartridge during normal use. To avoid
injection of air and ensure proper dosing:
E
Turn the dose selector to select 2 units.
E

2 units
selected

F
Hold your FlexPen® with the needle pointing upwards and tap the cartridge gently with your finger a few
times to make any air bubbles collect at the top of the cartridge.
F

G
Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0.
A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no
more than 6 times.
If a drop of insulin still does not appear, your FlexPen® is defective, and you must use a new one.
G

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Always make sure that a drop appears at the needle tip before you inject. This makes sure that the
insulin flows. If no drop appears, you will not inject any insulin, even though the dose selector may
move. This may indicate a blocked or damaged needle.
Always check the flow before you inject. If you do not check the flow, you may get too little insulin
or no insulin at all. This may lead to too high blood sugar levels.

Selecting your dose


Check that the dose selector is set at 0.
H
Turn the dose selector to select the number of units you need to inject. The dose can be corrected either up
or down by turning the dose selector in either direction until the correct dose lines up with the pointer.
When turning the dose selector, be careful not to push the push-button as insulin will come out.
You cannot select a dose larger than the number of units left in the cartridge.
H

5 units
selected

24 units
selected

Always use the dose selector and the pointer to see how many units you have selected
before injecting the insulin.
Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level
may get too high or too low. Do not use the residual scale, it only shows approximately
how much insulin is left in your pen.

Making the injection


Insert the needle into your skin. Use the injection technique shown by your doctor or diabetes
education nurse.
I
Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful to only
push the push-button when injecting. Turning the dose selector will not inject insulin.
I

J
Keep the push-button fully depressed and let the needle remain under the skin for at least 6 seconds. This
will make sure you get the full dose.
Withdraw the needle from the skin, then release the pressure on the push-button.
Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops before it
returns to 0, the full dose has not been delivered, which may result in too high blood sugar levels.

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J

K
Guide the needle into the big outer needle cap without touching it. When the needle is covered, carefully
push the big outer needle cap completely on and then unscrew the needle. Dispose of it carefully and put
the pen cap back on.
K

Always remove the needle after each injection and store your FlexPen® without the needle
attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and
inaccurate dosing.

Further important information


Caregivers must be very careful when handling used needles, to reduce the risk of needle sticks
and cross-infection.
Dispose of your used FlexPen® carefully without the needle attached.
Never share your pen or needles with other people. It might lead to cross-infection.
Never share your pen with other people. Your medicine might be harmful to their health.
Always keep your pen and needles out of sight and reach of others, especially children.

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