Human insulin (rys)
Consumer Medicine Information
This leaflet answers some common questions about human insulin InnoLet®. It does not contain all the available information. It does not take the place of talking to your doctor, diabetes education nurse or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using human insulin against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor, diabetes education nurse or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
Human insulin is used to treat diabetes mellitus. Diabetes mellitus is a condition where your pancreas does not produce enough insulin to control your blood sugar (glucose) level. Extra insulin is therefore needed.
There are two types of diabetes mellitus:
Type 1 diabetes – also called juvenile onset diabetes
Type 2 diabetes – also called maturity onset diabetes
Patients with type 1 diabetes always require insulin to control their blood sugar levels.
Some patients with type 2 diabetes may also require insulin after initial treatment with diet, exercise and tablets.
Human insulin lowers your blood sugar level after injection. Each of the following human insulins is available in InnoLet ® , a 3mL compact pre-filled insulin pen able to deliver 1– 50 units in increments of 1 unit:
Protaphane ® is Isophane Insulin Injection, an intermediate-acting insulin. This means that it will start to lower your blood sugar level about one and a half hours after you inject it, and the effect will last for approximately 24 hours. Protaphane® is often used in combination with fast- or rapid-acting insulin products.
Mixtard® 30/70 is Biphasic Isophane Insulin Injection, a mixture of fast- and longer-acting insulins. Mixtard® 30/70 will start to lower your blood sugar level about half an hour after you inject, and the effect will last for approximately 24 hours.
As with all insulins, the duration of action will vary according to the type of insulin, the dose, injection site, blood flow, temperature and level of physical activity.
Human insulin is not addictive.
Human insulin is available only with a doctor’s prescription.
Ask your doctor if you have any questions about why human insulin InnoLet ® has been prescribed for you.
Do not use InnoLet® if:
Some of the symptoms of an allergic reaction may include:
If you have a lot of hypos discuss appropriate treatment with your doctor.
If you are not sure whether you should start using this medicine, talk to your doctor.
Do not inject Protaphane® or Mixtard® 30/70 into a vein.
Do not use Protaphane® or Mixtard® 30/70 to treat a condition known as diabetic ketoacidotic coma.
Do not use this medicine after the expiry date printed on the label and carton, or if the packaging is torn or shows signs of tampering or does not look quite right.
If it has expired or is damaged, return it to your pharmacist for disposal.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any medical conditions, especially the following:
Tell your doctor if you are pregnant or planning to become pregnant.
Pregnancy may make managing your diabetes more difficult. Insulin needs usually decrease during the first three months of pregnancy and increase during the last six months. Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you are breast-feeding or planning to breast-feed .
Your doctor or pharmacist can discuss with you the risks and benefits involved.
Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who are treated with thiazolidinediones in combination with insulin may develop heart failure.
If you have not told your doctor about any of the above, tell them before you use InnoLet®.
Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and human insulin may interfere with each other. These include:
Or other specific medicines including:
Tell your doctor about any other medicines that you are taking.
This is very important. Your doctor will advise you if it is alright to keep taking them or if you should stop taking them.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.
Your doctor, diabetes education nurse or pharmacist will have given you advice on how to use your medicine. Carefully follow all the directions.
They may differ from the information contained in this leaflet.
Any change in dose or type of insulin should be made cautiously and only under medical supervision.
If you change the type of insulin that you use, you may have to use more or less than before. This may happen with the first dose or over a period of time.
If you do not understand the instructions, ask your doctor, diabetes education nurse or pharmacist for help.
Your doctor or diabetes education nurse will tell you how much of this medicine you need to use.
It is very important that you manage your diabetes carefully. Too much or too little insulin can cause serious effects.
Your doctor or diabetes education nurse will tell you when and how often to inject the insulin. If you are using Mixtard® 30/70 InnoLet®, it is recommended that you eat a meal or a snack containing carbohydrate within 30 minutes of the injection.
Read the instructions printed at the end of this leaflet carefully in order to correctly prepare and handle your InnoLet®.
Do not stop using your insulin unless your doctor tells you to.
If you use too much (overdose) - Hypoglycaemia
Your blood sugar level may become too low (you may experience hypoglycaemia or a “hypo”) if you:
The first symptoms of mild to moderate hypos can come on suddenly. They may include:
Always carry some sugary food or fruit juice with you.
If you experience any of these symptoms of a hypo, immediately eat some sugary food or have a sugary drink e.g. lollies, biscuits or fruit juice.
Do not inject any insulin if you feel a hypo coming on.
Tell your relatives, friends, close workmates or carers that you have diabetes. It is important that they recognise the signs and symptoms of a hypo.
Make sure they know to give you some sugary food or fruit juice for mild to moderate symptoms of a hypo.
If you lose consciousness, make sure they know:
This is because you could choke.
An injection of the hormone glucagon may speed up recovery from unconsciousness. This can be given by a relative, friend, workmate or carer who knows how to give it.
If glucagon is used, eat some sugary food or have a sugary drink as soon as you are conscious again.
If you do not feel better after this, contact your doctor, diabetes education nurse, or the closest hospital.
If you do not respond to glucagon treatment, you will require medical attention.
See your doctor if you keep having hypo reactions, or if you have ever become unconscious after using insulin.
Your insulin dose may need to be changed.
If a severe hypo is not treated, it can cause convulsions, brain damage and even death.
If you forget to inject your insulin dose, test your blood sugar level as soon as possible.
If you are not sure what to do, talk to your doctor, diabetes education nurse or pharmacist.
Do not use a double dose of your insulin.
If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to.
Otherwise, use it as soon as you remember and then go back to using it as you would normally.
Your blood sugar levels may become high (hyperglycaemia) if you:
High blood sugar levels over a long period of time can lead to too much acid in the blood (diabetic ketoacidosis).
Contact your doctor immediately if your blood sugar level is high or you recognise any of the following symptoms.
Symptoms of mild to moderate hyperglycaemia include:
Symptoms of severe hyperglycaemia include:
Severe hyperglycaemia can lead to unconsciousness and in extreme cases death if untreated.
Discuss any worries you may have about this with your doctor, diabetes education nurse or pharmacist.
Measure your blood sugar level regularly.
Make sure all friends, relatives, workmates or carers know that you have diabetes. If your child has diabetes it is important to tell their carers.
Keep using your insulin even if you feel well. It helps to control your condition, but does not cure it.
Tell your doctor if you often have hypos (low blood sugar levels). Your doctor may need to adjust your insulin dose.
Always carry some sugary food or fruit juice with you. If you experience any of the symptoms of a hypo, immediately eat some sugary food or have a sugary drink e.g. lollies, biscuits or fruit juice.
Tell your doctor if you have trouble recognising the symptoms of hypos. Under certain conditions, the early warning signs of hypos can be different or less obvious. Your doctor may need to adjust your insulin dose.
Make sure that you tell every doctor, dentist, pharmacist or other health care professional who is treating you that you have diabetes and are using insulin.
Tell your doctor, diabetes education nurse or pharmacist if you are travelling. Ask them for a letter explaining why you are taking injecting devices with you. Each country you visit will need to see this letter, so you should take several copies.
You may need to inject your insulin and eat your meals at different times because of time differences in and between countries.
You may not be able to get the same type of insulin in the country you are visiting.
Your doctor, diabetes education nurse or pharmacist can provide you with some helpful information.
Do not stop using your medicine unless your doctor tells you to.
Do not use the medicine if you think it has been frozen or exposed to excessive heat.
It will not work as well.
Do not refill your InnoLet®.
Do not use this medicine to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Be careful driving or operating machinery until you know how the insulin affects you.
Tell your doctor if you drink alcohol. Alcohol may mask the symptoms of hypos.
Tell your doctor if you are ill. Illness, especially with nausea and vomiting, may cause your insulin needs to change. Even if you are not eating, you still require insulin. You and your doctor should design an insulin plan for those times when you are sick.
Tell your doctor if you are exercising more than usual. Exercise may lower your need for insulin. Exercise may also speed up the effect of a dose of it, especially if the exercise involves the area of the injection site (e.g. the leg should not be used for injection prior to jogging or running).
Tell your doctor if your diet changes. Changes in diet may cause your insulin needs to change.
Tell your doctor, diabetes education nurse or pharmacist as soon as possible if you do not feel well while you are using human insulin.
Insulin helps most people for whom it is prescribed, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor, diabetes education nurse or pharmacist to answer any questions you may have.
The most common side effect when using insulin is low blood sugar levels (a hypo).
Tell your doctor if you notice any of the following and they worry you:
This list includes the more common side effects of your medicine. They are usually mild and short-lived.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital :
More severe symptoms of low blood sugar levels, including:
If a severe hypo is not treated, it can cause brain damage and death.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following :
This list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.
Ask your doctor, diabetes education nurse or pharmacist to answer any questions you have.
InnoLet® that are not being used should be stored between 2°C and 8°C in the refrigerator (away from the cooling element). Protect the insulin in InnoLet ® from light by keeping the insulin pen in the carton when not in use.
The InnoLet® that you are using, or that you are carrying as a spare, does not need to be kept in a refrigerator. You can use it up to 4 weeks after taking it out of the refrigerator if it is kept below 25°C. Discard InnoLet ® after 4 weeks even if there is still some insulin left in it.
InnoLet® must not be frozen, or exposed to excessive heat or light.
Never use InnoLet® after the expiry date printed on the label and carton after ‘Expiry.’
The expiry date refers to the last day of that month.
Never use Protaphane® or Mixtard® 30/70 InnoLet® if the suspension does not become uniformly white and cloudy after resuspending.
Keep out of the reach of children.
Dispose of your used InnoLet® safely into a yellow plastic sharps container.
If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Protaphane® and Mixtard® 30/70 are white, cloudy suspensions for subcutaneous injection. Protaphane® and Mixtard® 30/70 InnoLet® are 3mL glass cartridges contained in an insulin pen.
Human insulin (rys) is characterised by being identical to natural human insulin. The abbreviation “rys” indicates the method of genetic engineering used to manufacture the insulin.
Protaphane ® is a neutral suspension of isophane human insulin (rys) 100 IU/mL. Also contains: glycerol, meta-cresol, phenol, dibasic sodium phosphate dihydrate, zinc chloride, protamine sulfate, water for injections. Hydrochloric acid and sodium hydroxide are used to adjust the pH.
Mixtard ® 30/70 is a pre-mixed neutral suspension of human insulin (rys) 100 IU/mL, consisting of neutral insulin injection (30%) and isophane insulin injection (70%). Also contains: glycerol, meta-cresol, phenol, dibasic sodium phosphate dihydrate, zinc chloride, protamine sulfate, water for injections. Hydrochloric acid and sodium hydroxide are used to adjust the pH.
InnoLet® is supplied in Australia by:
Novo Nordisk Pharmaceuticals Pty Ltd
21 Solent Circuit
Baulkham Hills NSW 2153
This leaflet was prepared on 30 August 2012.
Australian Registration Numbers:
AUST R 169633
Mixtard® 30/70 InnoLet®:
AUST R 169628
InnoLet®, NovoFine®, NovoTwist®, Protaphane®, Mixtard® and NovoCare® are registered trademarks of Novo Nordisk A/S
For further information call the NovoCare® Customer Care Centre on 1800 668 626.
You can also get more information about diabetes and insulin from Diabetes Australia:
Human insulin InnoLet® is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit. InnoLet® is designed to be used with NovoFine® or NovoTwist® disposable needles of 8mm or shorter length.
As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet® is lost or damaged.
Check the label to make sure that your InnoLetCheck the label to make sure contains the correct type of insulin. Take off the pen cap (as shown by the arrow).
Resuspending is easier when the insulin has reached room temperature.
Before every injection:
It is important to prime your InnoLet® prior to every injection. The priming procedure may highlight a malfunction with your InnoLet®. Priming also helps to remove 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 INNOLET®, and contact your diabetes education nurse and/or Novo Nordisk.
To avoid injection of air and ensure proper dosing:
You cannot set a dose larger than the number of units left in the cartridge.
Use a new needle for each injection.
Remove the needle after each injection and store InnoLet® without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.
Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.
Dispose of your used human insulin InnoLet® carefully with the needle removed.
Your human insulin InnoLet® is designed to work accurately and safely. It must be handled with care.
Do not refill your InnoLet®.
You can clean your human insulin InnoLet® by wiping it with a medicinal swab. Do not soak it, wash or lubricate it. This may damage the mechanism.
Published by MIMS November 2012