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NovoMix® 30 FlexPen®

Insulin aspart (rys)

Consumer Medicine Information

What is in this leaflet pancreas does not produce enough Ask your doctor or pharmacist if
insulin to control your blood sugar you have any questions about
(glucose) level. Extra insulin is why NovoMix® 30 FlexPen® has
Before you use NovoMix® 30 therefore needed. been prescribed for you.
FlexPen®.....................................1
There are two types of diabetes
How to use NovoMix 30 ® mellitus: Before you use
FlexPen®.....................................2 Type 1 diabetes – also called NovoMix® 30 FlexPen®
While you are using NovoMix® juvenile onset diabetes
30 FlexPen®................................4 Type 2 diabetes – also called When you must not use it
maturity onset diabetes Do not use the medicine if:
Things to be careful of ..............4
Patients with type 1 diabetes always 1 you have an allergy to:
Side effects .................................4 require insulin to control their blood • any medicine containing
sugar levels. insulin
After using NovoMix® 30
FlexPen®.....................................5 Some patients with type 2 diabetes • any of the ingredients listed in
may also require insulin after initial the ‘Ingredients’ section of this
Product description ..................5 treatment with diet, exercise and leaflet.
tablets. Some of the symptoms of an
Further information .................6
NovoMix® 30 lowers your blood allergic reaction may include:
Instructions For Use .................7 sugar level after injection. When • redness, swelling, rash and
This leaflet answers some common injected under your skin, NovoMix® itching at the injection site;
questions about NovoMix® 30 30 has a faster onset of action than
• rash, itching or hives on the
FlexPen®. It does not contain all soluble human insulin. It takes
effect within 10 to 20 minutes. The skin;
the available information. It does
maximum effect will occur between • shortness of breath;
not take the place of talking to
your doctor or pharmacist. 1-4 hours after injection and the • wheezing or difficulty
effect may last for up to 24 hours. breathing;
All medicines have risks and
benefits. Your doctor has weighed As with all insulins, the duration of • swelling of the face, lips,
the risks of you using NovoMix® action will vary according to the tongue or other parts of the
30 FlexPen® against the benefits dose, injection site, blood flow,
body.
they expect it will have for you. temperature and level of physical
activity. 2 you are experiencing a low
If you have any concerns about blood sugar level (a “hypo”)
NovoMix® 30 is a pre-mixed neutral
using this medicine, ask your when the dose is due.
suspension consisting of rapid-
doctor or pharmacist. acting insulin aspart (rys) (30%) and If you have a lot of hypos
Keep this leaflet with the long-acting protamine insulin aspart discuss appropriate treatment
medicine. You may need to read (rys) (70%). with your doctor.
it again.
FlexPen® is a pre-filled dial-a-dose If you are not sure whether you
insulin pen able to deliver from 1 to should start using this medicine,
What NovoMix® 30 is 60 units in increments of 1 unit: talk to your doctor.
used for NovoMix® 30 FlexPen® can be used Do not use this medicine after
alone, or together with other the expiry date printed on the
The insulin aspart (rys), or medicines, for treating diabetes. pack or if the packaging is torn
“NovoMix® 30”, in NovoMix® 30 or shows signs of tampering.
This medicine is not addictive.
FlexPen® is a mixture of rapid-
and long-acting insulin used to This medicine is available only with If it has expired or is damaged,
treat diabetes mellitus. Diabetes return it to your pharmacist for
a doctor’s prescription.
mellitus is a condition where your disposal.

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Before you start to use it • non-selective beta blockers – Tell your doctor about any other
used to treat high blood pressure medicines that you are taking.
Tell your doctor if you have and certain heart conditions This is very important. Your
allergies to any other medicines,
• ACE inhibitors - used to treat doctor will advise you if it is
foods, preservatives or dyes.
high blood pressure, certain alright to keep taking them or if
Tell your doctor if you have or heart conditions or elevated you should stop taking them.
have had any medical protein/albumin in the urine
conditions, especially the Your doctor and pharmacist
following: • salicylates e.g. aspirin - used to have more information on
relieve pain and lower fever medicines to be careful with or
• kidney problems
• anabolic steroids – used to avoid while using this medicine.
• liver problems promote growth
Tell your doctor if you are • glucocorticoids (except when How to use
pregnant or plan to become applied locally) – used to treat
pregnant. inflammatory conditions
NovoMix® 30 FlexPen®
Pregnancy may make managing • oral contraceptives (“the pill”) - Your doctor, diabetes education
your diabetes more difficult. used for birth control nurse or pharmacist will have
Insulin needs usually decrease
• thiazides - used to treat high shown you how to use your
during the first three months of
blood pressure or fluid retention medicine.
pregnancy and increase during the
last six months. Your doctor can (oedema) Carefully follow all the
discuss with you the risks and • thyroid hormones - used to treat directions.
benefits involved. malfunction of the thyroid gland They may differ from the
information contained in this
Tell your doctor if you are • sympathomimetics such as leaflet.
breast-feeding or plan to breast- salbutamol or terbutaline - used
feed. to treat asthma Any change in dose or type of
insulin should be made
Your doctor/pharmacist can • sulphonamides – used to treat cautiously and only under
discuss with you the risks and bacterial infections medical supervision.
benefits involved. If you change the type of insulin
Or other specific medicines
If you have not told your doctor including: that you use, you may have to use
about any of the above, tell them more or less than before. This
before you start using this • danazol - used to treat may happen with the first dose or
medicine. endometriosis, menorrhagia, over a period of time.
fibrocystic breast disease and
hereditary angioedema If you do not understand the
Taking other medicines instructions, ask your doctor or
• oxymetholone – used to treat
Tell your doctor if you are pharmacist for help.
certain blood disorders
taking any other medicines,
including any that you get • octreotide - used to treat How much to use
without a prescription from your gastrointestinal endocrine
tumours Your doctor will tell you how
pharmacy, supermarket or much of this medicine you need to
health food shop. • diazoxide - used to treat high use each day.
Some medicines and NovoMix® blood pressure
It is very important that you
30 may interfere with each other. • nicotinic acid - used to treat manage your diabetes carefully.
These include: high cholesterol levels in the Too much or too little insulin can
• oral hypoglycaemic medicines blood cause serious effects.
- used to treat type 2 diabetes • asparaginase - used to treat
• monoamine oxidase inhibitors leukaemia and lymph gland When to use it
(MAOI) - used for the tumours NovoMix® 30 is normally used
treatment of depression • quinine – used to treat malaria immediately (up to 10 minutes)
• alpha blockers - used to treat and relieve muscle cramps before your meal. When necessary
high blood pressure and to NovoMix® 30 may be used
relieve difficulty in passing • quinidine – used to treat heart immediately after the meal.
urine caused by an enlarged problems
prostate • growth hormone – used to treat
growth disorders

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How to use it • have too much or unexpected education nurse, or the closest
® exercise hospital.
• Inject NovoMix 30 under the
skin (subcutaneous injection) • delay eating meals or snacks If you do not respond to glucagon
as shown to you by your • eat too little food treatment, you will require medical
doctor or diabetes education • are ill attention.
nurse. Never inject
The first symptoms of mild to See your doctor if you keep
NovoMix® 30 into a vein or
moderate hypos can come on having hypo reactions, or if you
muscle.
suddenly. They may include: have ever become unconscious
• NovoMix® 30 may be injected after using insulin.
into your abdomen, thigh, • cold sweat, cool pale skin
buttock or upper arm. Your insulin dose may need to be
• fatigue, drowsiness, unusual changed.
• Remember to change your tiredness and weakness
injection site regularly as If a severe hypo is not treated, it
• nervousness, anxious feeling, can cause brain damage and even
shown to you by your doctor
or diabetes education nurse. tremor, rapid heart beat death.
• Take care not to drop or • confusion, difficulty
knock NovoMix® 30 concentrating If you miss a dose –
®
FlexPen . • excessive hunger Hyperglycaemia
• Do not use NovoMix® 30 in • vision changes If you forget your insulin dose,
insulin pumps. • headache, nausea test your blood sugar level as
Checking your NovoMix® 30 Always carry some sugary food or soon as possible.
FlexPen®: fruit juice with you. If you are not sure what to do,
Check your NovoMix® 30 If you experience any of these talk to your doctor, diabetes
FlexPen® before each symptoms of a hypo, immediately education nurse or pharmacist.
preparation and injection. Make eat some sugary food or have a
sure you are using the correct Do not use a double dose of your
sugary drink, e.g. lollies, biscuits or
type and strength of insulin. insulin.
fruit juice.
If it is almost time for your next
Do not use NovoMix® 30 Tell your relatives, friends, close dose, skip the dose you missed and
FlexPen® if the medicine workmates or carers that you use your next dose when you are
contains clumps of material or have diabetes. It is important that meant to.
solid white particles sticking to they recognise the signs and
the bottom or wall of the Otherwise, use it as soon as you
symptoms of a hypo. remember – don’t forget to eat
cartridge, giving a frosted
appearance. Make sure they know to give you some carbohydrate within 10
some sugary food or fruit juice for minutes of your injection – and
Read the instructions printed at mild to moderate symptoms of a then go back to using it as you
the end of this leaflet carefully in hypo. would normally.
order to prepare and handle
If you lose consciousness, make Your blood sugar levels may
your NovoMix® 30 FlexPen®
sure they know: become high (hyperglycaemia) if
correctly.
you:
• to turn you on your side and
How long to use it get medical help immediately. • miss doses of insulin or use
less insulin than you need
Do not stop using NovoMix® 30 • not to give you anything to eat • have uncontrolled diabetes
FlexPen® unless your doctor tells or drink.
you to. This is because you could choke. • exercise less than usual
• eat more carbohydrates than
An injection of the hormone
If you use too much glucagon may speed up recovery usual
(overdose) - from unconsciousness. This can be • are ill or stressed
Hypoglycaemia given by a relative, friend, workmate High blood sugar levels over a
Your blood sugar level may or carer who knows how to give it. long period of time can lead to too
become too low (you may If glucagon is used, eat some sugary much acid in the blood (diabetic
experience hypoglycaemia or a food or have a sugary drink as soon ketoacidosis).
“hypo”) if you: as you are conscious again. Contact your doctor
• accidentally use too much of If you do not feel better after this, immediately if your blood sugar
this medicine contact your doctor, diabetes

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level is high or you recognise any Always carry some sugary food or Things to be careful of
of the following symptoms. fruit juice with you.
Symptoms of mild to moderate If you experience any of the Be careful driving or operating
hyperglycaemia include: symptoms of a hypo, immediately machinery until you know how
• drowsy feeling eat some sugary food or have a the insulin affects you.
drink, e.g. lollies, biscuits or fruit
• flushed face Tell your doctor if you drink
juice. alcohol.
• thirst, loss of appetite
Tell your doctor if you have Alcohol may mask the symptoms
• fruity odour on the breath of hypos.
trouble recognising the symptoms
• blurred vision of hypos. Tell your doctor if you are ill.
• passing larger amounts of urine Under certain conditions, the early Illness, especially with nausea and
than usual warning signs of hypos can be vomiting, may cause your insulin
• getting up at night more often different or less obvious. Your needs to change. Even if you are
than usual to pass urine doctor may need to adjust your not eating, you still require insulin.
insulin dose. You and your doctor should design
• high levels of glucose and
Make sure that you tell every an insulin plan for those times
acetone in the urine
doctor, dentist, pharmacist or when you are sick.
Symptoms of severe other health care professional who Tell your doctor if you are
hyperglycaemia include: is treating you that you have exercising more than usual.
• heavy breathing diabetes and are using insulin. Exercise may lower your need for
• fast pulse Tell your doctor, diabetes this medicine. Exercise may also
speed up the effect of a dose of it,
• nausea, vomiting education nurse or pharmacist if
especially if the exercise involves
• dehydration you are travelling.
the area of the injection site (e.g.
Ask your doctor for a letter
• loss of consciousness explaining why you are taking
the leg should not be used for
Severe hyperglycaemia can lead to injection prior to jogging or
injecting devices with you. Each
unconsciousness and in extreme running).
country you visit will need to see
cases death if untreated. this letter, so you should take several Tell your doctor if your diet
Discuss any worries you may have copies. changes.
about this with your doctor or You may need to inject your insulin Changes in diet may cause your
pharmacist. and eat your meals at different times insulin needs to change.
because of time differences in and
between countries.
While you are using Side effects
You may not be able to get the same
NovoMix® 30 FlexPen® type of insulin in the country you are Tell your doctor, diabetes
visiting. education nurse or pharmacist
Things you must do
Your doctor, diabetes education as soon as possible if you do not
Measure your blood sugar level nurse or pharmacist can provide you feel well while you are using
regularly. with some helpful information. NovoMix® 30 FlexPen®.
Make sure all friends, relatives, This medicine helps most people
workmates or carers know that Things you must not do for whom it is prescribed, but it
you have diabetes. may have unwanted side effects in
If your child has diabetes it is Do not stop using your medicine a few people. All medicines can
important to tell their carers. unless your doctor tells you to. have side effects. Sometimes they
Keep using your insulin even if Do not use the medicine if you are serious, most of the time they
you feel well. think it has been frozen or are not. You may need medical
It helps to control your condition, exposed to excessive heat. treatment if you get some of the
but does not cure it. side effects.
It will not work as well.
Tell your doctor if you often Do not be alarmed by the
Do not use this medicine to treat following lists of side effects. You
have hypos (low blood sugar
any other complaints unless your
levels). may not experience any of them.
doctor tells you to.
Your doctor may need to adjust Ask your doctor, diabetes
your insulin dose. Do not give your medicine to
education nurse or pharmacist
anyone else, even if they have the
same condition as you.

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to answer any questions you may This list includes very serious side Disposal
have. effects. You may need urgent
Dispose of used needles safely
The most common side effect medical attention or hospitalisation.
into a yellow plastic sharps
when using insulin is low blood These side effects are very rare.
container.
sugar levels (a hypo). Tell your doctor if you notice
If your doctor tells you to stop
Tell your doctor if you notice anything that is making you feel
using this medicine or the expiry
any of the following and they unwell. date has passed, ask your
worry you: Other side effects not listed above pharmacist what to do with any
• hypos (mild to moderate) may also occur in some people. medicine that is left over.
• redness, swelling or itching at Ask your doctor or pharmacist to
the injection site. Usually answer any questions you have.
Product description
these symptoms disappear
within a few weeks during
continued use. If you have
After using NovoMix® What it looks like
serious or continuing reactions, 30 FlexPen® NovoMix® 30 is a white, cloudy
you may need to stop using suspension for subcutaneous
® injection. NovoMix® 30 FlexPen®,
NovoMix 30 and use another Storage is a 3mL pre-filled glass cartridge
insulin. contained in a dial-a-dose insulin
Store NovoMix® 30 FlexPen® that
• a depression or thickening of pen.
are not being used between 2°C
the skin around the injection and 8°C in a refrigerator (not in
site (lipodystrophy) or too near the freezer section or Ingredients
• when you first start your cooling element). NovoMix® 30 contains soluble
insulin treatment you may get Resuspend the insulin in your insulin aspart (rys) and protamine-
visual problems or swollen NovoMix® 30 FlexPen® – whether crystallised insulin aspart (rys) 100
hands and feet it is to be used immediately or units per mL (100 U/mL) as the
This list includes the more whether it is to be carried as a active ingredient, in the ratio of
spare – upon removing it from the 30:70.
common side effects of your
refrigerator. The abbreviation “rys” indicates
medicine. They are usually mild
and short-lived. Do not keep the NovoMix 30 ® the method of genetic engineering
FlexPen® that you are using, or used to manufacture the insulin
If any of the following happen, that you are carrying as a spare, aspart.
tell your doctor immediately or in a refrigerator. You can use it up NovoMix® 30 FlexPen® also
go to Accident and Emergency to 4 weeks at or below 30°C after contains the following inactive
at your nearest hospital: taking it out of the refrigerator. ingredients: glycerol, phenol,
More severe symptoms of low Discard NovoMix® 30 FlexPen® meta-cresol, zinc chloride, sodium
blood sugar levels, including: after 4 weeks even if there is still chloride, dibasic sodium phosphate
• disorientation some medicine left in it. dihydrate, protamine sulfate,
The medicine in your NovoMix® sodium hydroxide, hydrochloric
• seizures, fits or convulsions
30 FlexPen® must not be frozen, acid and water for injections.
• loss of consciousness.
or exposed to heat or direct
If a severe hypo is not treated, it sunlight. Protect the medicine in Sponsor
can cause brain damage and death. NovoMix® 30 FlexPen® from light NovoMix® 30 FlexPen® is
by keeping the cap on when not in supplied in Australia by:
Tell your doctor immediately or
use.
go to Accident and Emergency Novo Nordisk Pharmaceuticals
at your nearest hospital if you Never use NovoMix® 30 FlexPen® Pty. Ltd.
notice any of the following: after the expiry date printed on A.B.N. 40 002 879 996
• skin rashes over a large part of the label and carton. Level 3
the body Never use NovoMix® 30 FlexPen® 21 Solent Circuit
• shortness of breath, wheezing if the NovoMix® 30 does not Baulkham Hills NSW 2153
• swelling of the face, lips or appear white and uniformly NovoMix® 30 FlexPen® is
tongue cloudy after shaking. supplied in New Zealand by:
• fast pulse Keep out of the reach of children. Novo Nordisk Pharmaceuticals
• sweating Ltd.

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58 Richard Pearse Drive
Airport Oaks
Mangere
New Zealand
Australian Registration Number:
AUST R 143166

This leaflet was prepared on 22


April 2008.
NovoMix®, FlexPen® and
®
NovoFine are registered
trademarks of Novo Nordisk A/S.
© 2001/2008

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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NovoMix® 30 FlexPen®
Insulin aspart (rys)

Instructions For Use

Introduction

Please read the following instructions carefully before using your NovoMix® 30 FlexPen®.

Your NovoMix® 30 FlexPen® is a unique, 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® 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.

The colour of the pen in the illustrations may differ from your FlexPen®.

Your NovoMix® 30 FlexPen®


Pen cap

Rubber 12 Glass Cartridge Residual Pointer Dose Push-


membrane units ball scale selector button

Needle (example)
Big outer Inner Needle Protective
needle cap needle cap tab

Maintenance
®
Your FlexPen is designed to work accurately and safely. It must be handled with care. If it is dropped
or crushed, there is a risk of damage and leakage of insulin.
®
You can clean the exterior of your FlexPen by wiping it with an alcohol swab. Do not soak it, wash or
lubricate it as this may damage the pen.
®
Do not refill your FlexPen .

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Preparing your NovoMix® 30 FlexPen®
®
Check the label to make sure that your FlexPen contains the correct type of insulin. Before
®
every injection with a FlexPen you must resuspend the insulin.

® ®
A The first use of a new NovoMix 30 FlexPen :

Let the insulin reach room temperature before you use it.

This makes it easier to resuspend.

Pull off the pen cap.

B Roll the pen between your palms ten times – it is important that the pen is kept horizontal.

C Move the pen up and down ten times between the two positions as shown, so the glass ball moves
from one end of the cartridge to the other.

Repeat rolling and moving the pen until the liquid appears uniformly white and cloudy (resuspended).

For every subsequent injection:

Always check there are at least 12 units of insulin left in the cartridge to allow resuspension. If there
®
are fewer than 12 units left, use a new FlexPen .

Move the pen up and down between the two positions at least ten times until the liquid appears
uniformly white and cloudy.

After you have resuspended the insulin, complete all the following steps of injection without delay.

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Attaching a needle

Disinfect the rubber membrane with an alcohol swab.

®
D Remove the protective tab from a NovoFine needle.

®
Screw the needle onto your FlexPen so that it is straight and secure.

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

F Pull off the inner needle cap and dispose of it.

• Always use a new needle for each injection.

• Be careful not to bend or damage the needle before use.

• To reduce the risk of needlestick injury, never put the inner needle cap back on once you
have removed it from the needle.

Checking the insulin flow

It is important to prime your FlexPen® prior to every injection. The priming procedure may
highlight a malfunction with FlexPen®. Priming also removes any air bubbles and would help indicate
whether or not a needle is blocked. If problems are encountered during priming, use an alternative
insulin delivery system, DO NOT USE YOUR FLEXPEN®, and contact your diabetes education nurse
and/or Novo Nordisk.

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To prime your FlexPen®:

G Turn the dose selector to select 2 units.

2 units-
select ed

®
H 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.

I 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 six times.

If a drop of insulin still does not appear, your FlexPen® has failed to prime, and you must use a new
one.

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Selecting your dose

Check that the dose selector is set at 0.

J Turn the dose selector to select the number of units you need to inject. Do not use the residual scale
to measure your dose of insulin.

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.

5 units
select ed

24 unit s
select ed

Injecting the insulin

Insert the needle into your skin. Use the injection technique shown by your doctor or diabetes
education nurse.

K Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful
only to push the push-button when injecting. Turning the dose selector will not inject insulin.

L Keep the push-button fully depressed after the injection until the needle has been withdrawn from
the skin. The needle must remain under the skin for at least six seconds. This will ensure that the full
dose has been injected.

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M Guide the needle into the big outer needle cap without touching the big outer needle cap, as shown.
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.

• Always remove the needle after each injection and store your FlexPen® without the needle
attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.

• Health care professionals, relatives and other carers should follow general precautionary
measures for removal and disposal of needles, to eliminate the risk of needlestick injury.

• Dispose of your used FlexPen® carefully without the needle attached.

• Do not share your FlexPen® with anyone else.

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