NovoMix 30 Penfill
100 U/ml suspension for injection in a cartridge
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, diabetes 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, diabetes nurse or your pharmacist.
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 cartridge, called Penfill, which fits into a delivery system.
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 diabetes 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.
Before using NovoMix 30
Check the label to make sure it is the right type of insulin
Always check the cartridge, including the rubber plunger (stopper). Don’t use it if any damage is seen or if there is a gap between the rubber plunger and the white label band. Take it back to your supplier. See your delivery system manual for further instructions
Disinfect the rubber membrane with a medicinal swab
Always use a new needle for each injection to prevent contamination.
NovoMix 30 should not be used
In insulin infusion pumps
If the cartridge or the device containing the cartridge 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.
NovoMix 30 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles. If you are treated
with NovoMix 30 Penfill and another insulin Penfill cartridge, you must use one insulin delivery system for each type of insulin. Do not refill NovoMix 30 Penfill cartridges.
As a precautionary measure, always carry a spare Penfill cartridge in case your Penfill cartridge is lost or damaged.
Resuspension of the insulin
Before you put the cartridge into the insulin delivery system:
The first time you use NovoMix 30 Penfill roll the cartridge between your palms 10 times - it is important that the cartridge is kept horizontal (see picture A). Move the cartridge up and down between positions a and b (see picture B) 10 times so that the glass ball moves from one end of the cartridge to the other. Repeat the rolling and moving procedures (see pictures A and B until the liquid does appears uniformly white and cloudy. Resuspension is easier when the insulin has reached room temperature. Complete the other stages of injection without delay
For every following injection move the delivery system with the cartridge inside up and down between a and b (see picture B) at least 10 times until the liquid appears uniformly white and cloudy. Complete the other stages of injection without delay.
Check there are at least 12 units of insulin left in the cartridge to allow even resuspension. If there are less than 12 units left, use a new one.
How to inject this insulin
Inject the insulin under the skin. Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual
Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered
After each injection be sure to remove and discard the needle and store NovoMix without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.
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 diabetes 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, diabetes 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 Penfill that is not being used is to be stored in the refrigerator (2°C - 8°C), not in or too near the freezer section or cooling element. Do not freeze.
NovoMix 30 Penfill that is being used or about to be used is not to be kept in the refrigerator. After removing NovoMix 30 Penfill from the refrigerator it is recommended to mix the insulin as instructed for the first time use. See 3 How to use NovoMix 30. 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 cartridge in the outer carton when you’re not using it in order to protect it from light.
NovoMix 30 Penfill 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 cartridges of 3 ml (not all packs may be marketed).
1 ml contains 100 U (3.5 mg) of insulin aspart.
1 cartridge 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.
This leaflet was last approved in 10/2009
NovoMix
, Penfill and NovoFineare trademarks owned by Novo Nordisk A/S, Denmark
© 2004/2009
Novo Nordisk A/S
8-0940-01-001-4
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