NovoMix 30 FlexPen
100 U/ml suspension for injection in a pre-filled pen
Insulin aspart
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or your pharmacist.
This side of the leaflet:
1. What NovoMix 30 is and what it is used for
2. Before you use NovoMix 30
3. How to use NovoMix 30
4. What to do in an emergency
5. Possible side effects
6. How to Store NovoMix 30
7 Further information
Overleaf: How to use your FlexPen
What NovoMix 30 is and what it is used for
NovoMix 30 is an insulin analogue to treat diabetes. It comes in a 3 ml pre-filled pen, called FlexPen - see overleaf for detailed instructions. NovoMix 30 is a mixture of rapid-acting insulin analogue (30%) and long-acting insulin analogue (70%). This means that it will start to lower your blood sugar 10-20 minutes after you take it, have a maximum effect between 1 and 4 hours and the effect will last for up to 24 hours. It may be used in combination with certain oral antidiabetic drugs.
Before you use NovoMix 30
Do not use NovoMix 30
If you are allergic (hypersensitive) to this insulin product or any of the other ingredients (see 7 Further information). Look out for the signs of allergy in 5 Possible side effects
If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar). See 4 What to do in an emergency for more about hypos.
Take special care with NovoMix 30
If you have trouble with your kidneys or liver, your doctor may decide to alter your insulin dose
If you are drinking alcohol (also beer, wine): watch for signs of a hypo and never drink alcohol on an empty stomach
If you are exercising more than usual or if you want to change your usual diet
If you are ill: carry on taking your insulin. Your need for insulin may change
If you have an infection, fever or have had an operation you may need more insulin than usual
If you suffer from diarrhoea, vomiting or eat less than usual you may need less insulin than usual
If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections. Consult your doctor if you are planning such travelling.
Using other medicines
Many medicines affect the way your glucose works in your body and this may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Please consult your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Your need for insulin may change if you also take: Oral antidiabetic medicinal products, monoamine oxidase (MAO) inhibitors, beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and glucocorticoids (except topical administration), oral contraceptives, thiazides, thyroid hormones, sympathomimetics, growth hormones, danazol, octreotide and sulphonamides.
Pregnancy and breast-feeding
If you are planning a pregnancy or if you are pregnant or breast-feeding: please contact your doctor for advice. There is limited clinical experience with insulin aspart in pregnancy.
Driving and using machines
If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react may be reduced during a hypo. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you should drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.
NovoMix 30 can be used in children and adolescents aged 10 years and above when premixed insulin is preferred. For children 6-9 years limited clinical data exists.
How to use NovoMix 30
Talk about your insulin needs with your doctor and nurse. Follow their advice carefully. This leaflet is a general guide.
When NovoMix 30 is used in combination with oral antidiabetic drugs the dosage should be adjusted. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Eat a meal or snack containing carbohydrates within 10 minutes of the injection. NovoMix 30 may also be given soon after the meal.
It is recommended that you measure your blood glucose regularly.
NovoMix 30 is for use by one person only.
Injecting the insulin
See overleaf for detailed instructions.
Before using NovoMix 30
Check the label to make sure it is the right type of insulin
Always use a new needle for each injection to prevent contamination.
NovoMix 30 should not be used
In insulin infusion pumps
If FlexPen is dropped, damaged or crushed, there is a risk of leakage of insulin
If it hasn’t been stored correctly or if it has been frozen (see 6 How to store NovoMix 30)
If the insulin is not uniformly white and cloudy when it’s mixed
If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
How to use this insulin
NovoMix 30 is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle.
Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms. Your insulin will work more quickly if you inject around the waist.
What to do in an emergency
If you get a hypo (hypoglycaemia)
A hypo means your blood sugar level is too low.
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Don’t take any insulin if you feel a hypo coming on. Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case it is needed.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and get medical help straight away. They must not give you any food or drink, as it could choke you.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death
If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted.
Using glucagon
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.
Causes of a hypo
You get a hypo if your blood sugar gets too low.
This might happen:
- If you take too much insulin
- If you eat too little or miss a meal
- If you exercise more than usual.
If your blood sugar gets too high
Your blood sugar may get too high (this is called hyperglycaemia).
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
If you get any of these signs, test your blood sugar level; test your urine for ketones if you can; then seek medical advice straight away.
These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.
Causes of hyperglycaemia
- Having forgotten to take your insulin
- Repeatedly taking less insulin than you need
- An infection or a fever
- Eating more than usual
- Less exercise than usual.
Possible side effects
Like all medicines, NovoMix 30 can cause side effects, although not everybody gets them.
The most common side effect is low blood sugar (hypoglycaemia). See the advice in 4 What to do in an emergency.
Side effects reported uncommonly
(less than 1 in 100)
Vision problems. When you first start your insulin treatment, it may disturb your vision, but the condition usually disappears.
Changes of the injection site (Lipodystrophy). If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.
Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.
Seek medical advice immediately:
- If signs of allergy spread to other parts of your body, or
- If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.
You may have a very rare serious allergic reaction to NovoMix 30 or one of its ingredients (called a systemic allergic reaction). See also the warning in 2 Before you use NovoMix 30.
Diabetic retinopathy. If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Ask your doctor about this.
Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally, this soon disappears.
Side effects reported rarely
(less than 1 in 1,000)
Painful neuropathy. If your blood glucose levels improve very fast, you may get nerve related pain - this is called acute painful neuropathy and is usually transient.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
How to store NovoMix 30
Keep out of the reach and sight of children.
Do not use NovoMix 30 after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
NovoMix 30 FlexPen that is not being used is to be stored in the refrigerator (2°C - 8°C), not in or to near the freezer section or cooling element. Do not freeze.
NovoMix 30 FlexPen that is being used or about to be used is not to be kept in the refrigerator. After removing NovoMix 30 FlexPen from the refrigerator it is recommended to mix the insulin as instructed for the first time use. See overleaf: Getting started. You can carry it with you and keep it at room temperature (not above 30°C) for up to 4 weeks, but any remainder must then be discarded.
Always keep the pen cap on your FlexPen when you’re not using it in order to protect it from light.
NovoMix 30 FlexPen must be protected from excessive heat and sunlight.
NovoMix 30 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What NovoMix 30 contains
The active substance is insulin aspart made by recombinant DNA technology in Saccharomyces cerevisiae (30% insulin aspart in a soluble fraction and 70% insulin aspart crystallised with protamine)
The other ingredients are glycerol, phenol, metacresol, zinc (as chloride), sodium chloride, disodium phosphate dihydrate, protamine sulphate, sodium hydroxide, hydrochloric acid and water for injections.
What NovoMix 30 looks like and contents of the pack
The suspension for injection comes as a white suspension in packs of 5 or 10 pre-filled pens of 3 ml (not all packs may be marketed).
1 ml contains 100 U (3.5 mg) of insulin aspart.
1 pre-filled pen contains 3 ml equivalent to 300 U.
Marketing Authorisation Holder
Manufacturer
The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
- If the second and third characters are W5, S6, P5, K7, R7 or ZF
is the manufacturer
- If the second and third characters are H7 or T6
is the manufacturer.
Now turn over for information on how to use your FlexPen.
This leaflet was last approved in 10/2009
Introduction
Please read the following instructions carefully before using your NovoMix 30 FlexPen.
Your 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 and tested to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. 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 differs from your FlexPen.
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 a medicinal swab. Do not soak it, wash or lubricate it as it may damage the pen.
Do not refill your FlexPen.
Preparing your NovoMix 30 FlexPen
Check the label to make sure that your FlexPen contains the correct type of insulin. Before your first injection with a new FlexPen you must resuspend the insulin:
A 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 Then 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.
For every following injection 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.
- Always check there are at least 12 units of insulin left in the cartridge to allow resuspension. If there are less than 12 units left, use a new FlexPen.
Attaching a needle
Disinfect the rubber membrane with a medicinal swab.
D Remove the protective tab from a new disposable needle.
Screw the needle straight and tightly onto your FlexPen.
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 to prevent contamination.
- Be careful not to bend or damage the needle before use.
- To reduce the risk of unexpected needle sticks, never put the inner needle cap back on when you have removed it from the needle.
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:
G Turn the dose selector to select 2 units.
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, the pen is defective, and you must use a new one.
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.
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.
- Do not use the residual scale to measure your dose of insulin.
Making the injection
Insert the needle into your skin. Use the injection technique shown by your doctor or 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.
M Lead the needle tip into the big outer needle cap without touching the big outer needle cap. 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.
- Caregivers should be most careful when handling used needles to avoid needle sticks.
- Dispose of the used FlexPen carefully without the needle attached.
- Do not share your FlexPen with anyone else.
NovoMix,
FlexPen,
NovoTwist
and NovoFine,
are trademarks owned by Novo Nordisk A/S Denmark
© 2010
Novo Nordisk A/S
8-9674-01-002-3
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