Actrapid ® Penfill ® 3mL
Contents
1. 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 How much to use 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 When to use it Your doctor or diabetes education nurse will tell you when and how often to inject the insulin If you are using Actrapid Mixtard 30 70 or Mixtard 50 50 it is recommended that you eat a meal or a snack containing carbohydrate within 30 minutes of the injection How to use it Penfill cartridges are designed to be used with Novo Nordisk insulin delivery devices such as NovoPen and NovoFine or NovoTwist needles Make sure you are using the correct type and strength of insulin Carefully follow the instructions on how to use your Penfill in the Novo Nordisk insulin delivery device If you use more than one type of Penfill more than one type of insulin you must use a separate insulin delivery device for each type2. e disorientation e seizures fits or convulsions e loss of consciousness 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 e skin rashes over a large part of the body e shortness of breath wheezing e swelling of the face lips or tongue e fast pulse e sweating 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 After using human insulin Penfill Storage Penfill 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 Penfill from light by keeping the cartridges in the carton when not in use The Penfill that you are using in your device or that you are carrying as a spare does not need to be kept in a refrigerator You can use it for up to 4 weeks after taking it out of the refrigerator if it is kept below 25 C Discard Penfill after 4 weeks even if there is still some insulin left in it Penfill must not be frozen or exposed to excessive heat or
3. Protaphane Mixtard 30 70 or Mixtard 50 50 into a vein Do not use Protaphane Mixtard 30 70 or Mixtard 50 50 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 Before you start to use it 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 e kidney problems e liver problems e adrenal pituitary or thyroid gland problems 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
4. as possible if you do not feel well while you are using human insulin This medicine 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 e hypos mild to moderate e redness swelling or itching at the injection site Usually these symptoms disappear within a few weeks during continued use If you have serious or continuing reactions you may need to stop using your current insulin and use another insulin e a depression or thickening of the skin around the injection site lipodystrophy e when you first start your insulin treatment you may get visual problems or swollen hands and feet 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
5. of Penfill Do not use the insulin level indicator on the device to measure your dose of insulin You should inject human insulin under the skin subcutaneous injection as shown to you by your doctor or diabetes education nurse In an emergency the insulin contained within Actrapid Penfill is suitable for intramuscular administration under medical guidance In an emergency the insulin contained within Actrapid Penfill is also suitable for intravenous administration but only if administered by a physician For emergency use the insulin must first be withdrawn from Penfill into a syringe Discard your Penfill after emergency use In an emergency the insulins contained within Protaphane Mixtard 30 70 and Mixtard 50 50 Penfill are suitable for intramuscular administration under medical guidance For emergency use the resuspended insulin must first be withdrawn from Penfill into a syringe Discard your Penfill after emergency use Do not use Penfill in insulin pumps e Take care not to drop or knock the device that contains Penfill Checking your _human_ insulin Penfill Check your Penfill before each preparation and injection to make sure you are using the correct type and strength of insulin Disinfect the rubber membrane with a medicinal swab Do not use your Actrapid Penfill unless the insulin appears clear and colourless Do not use it if the in
6. 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 hel
7. your used needle safely into a yellow plastic sharps container after each injection If you are using Actrapid or Mixtard insulins it is recommended that you eat a meal or a snack containing carbohydrate within 30 minutes of the injection Do not share needles insulin cartridges or insulin delivery devices How long to use it Do not stop using human 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 e accidentally use too much of this medicine e have too much or unexpected exercise e delay eating meals or snacks e eat too little food e areill The first symptoms of mild to moderate hypos can come on suddenly They may include e cold sweat cool pale skin e fatigue drowsiness unusual tiredness and weakness e nervousness anxious feeling tremor rapid heart beat e confusion difficulty concentrating e excessive hunger e vision changes e headache nausea 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 sympto
8. Actrapid Penfill Protaphane Penfill Mixtard 30 70 Penfill Mixtard 50 50 Penfill Human insulin rys Consumer Medicine Information What is in this leaflet What is in this leaflet 1 What human insulin is used for EET EEE REA E 1 Before you use human insulin Penil siusnisasniiikauni 1 How to use human insulin Penti inniinn 3 While you are using human insulin Penfill ccseseseeeees 5 Side effects scssssessssssssssssses 6 After using human insulin Meri Lill gt i sisned aenssucisndanstetucrncanive 6 Product description 0 7 Further information 7 This leaflet answers some common questions about human insulin Penfill 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 medicine leaflet with the You may need to read it again What human insulin is used for 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 theref
9. a neutral solution of human insulin rys 100 IU mL Also contains glycerol meta cresol zinc chloride water for injections Hydrochloric acid and sodium hydroxide are used to adjust the pH 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 Mixtard 50 50 is a pre mixed neutral suspension of human insulin rys 100 IU mL consisting of neutral insulin injection 50 and isophane insulin injection 50 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 Sponsor Penfill is supplied in Australia by Novo Nordisk Pharmaceuticals Pty Ltd Level 3 21 Solent Circuit Baulkham Hills NSW 2153 This leaflet was prepared on 30 August 2012 Australian Registration Number
10. 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 Penfill Taking other medicines 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 e oral hypoglycaemic agents used to treat type 2 diabetes e monoamine oxidase inhibitors MAOI used to treat depression e non selective beta blockers used to treat certain heart conditions and high blood pressure e alpha blockers used to treat high blood pressure and to relieve difficulty in passing urine caused by an enlarged prostate e angiotensin converting enzyme ACE inhibitors used to treat certain heart conditions high blood pressure or elevated protein albumin in the urine Or salicylates e g aspirin used to relieve pain and lower fever anabolic steroids used to promote growth glucocorticoids except when applied locally used to treat inflammatory conditions oral contraceptives the pill used for birth control thiazides frusemide or ethacrynic acid used to treat high blood pressure or fluid retention oedema thyroid hormones used to treat malfunction of the thyroid gland sympat
11. homimetics used to treat asthma sulphonamides used to treat bacterial infections other specific medicines including danazol used to treat certain female conditions oxymetholone used to treat certain blood disorders octreotide used to treat gastrointestinal endocrine tumours and enlargement of parts of the body e g hands feet head caused by abnormal growth hormone levels lanreotide used to treat enlargement of parts of the body e g hands feet head caused by abnormal growth hormone levels diazoxide used to treat high blood pressure nicotinic acid used to treat high cholesterol levels in the blood asparaginase used to treat leukaemia and lymph gland tumours quinine used to treat malaria and relieve muscle cramps quinidine used to treat heart problems growth hormone used to treat growth disorders Novo Nordisk Human Insulin Penfill InshPfcemil 1 docx Page 2 of 7 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 How to use human insulin Penfill Your doctor diabetes education nurse or pharmacist will have given you advice on how to use your medicine Carefully follow all the directions
12. insulin delivery device turn the delivery device upside down at least 10 times with the cartridge inside it Do this again before each subsequent injection 5 Complete the remaining stages of injection without delay Checking for insulin flow riming Always check your Novo Nordisk insulin delivery device for insulin flow priming before each injection as described in the device user manual The priming procedure may highlight a malfunction with your insulin delivery device Priming also removes any air bubbles and helps indicate whether or not a needle is broken Only dial up your required dose after you see a drop of insulin at the needle tip After priming if you need to put the insulin delivery device down make sure the needle does not touch anything Injecting a dose Choose a site for injection Inject the medicine into the abdomen thighs upper arms or buttocks Your insulin will work more quickly if you inject into the abdomen Change the injection site so that the same position is not used more often than once a month This will reduce the chance of local skin reactions developing Pinch the skin between two fingers push the needle into the raised skin and inject the full dose of insulin under the skin Slowly count to 6 before pulling the needle out Apply gentle pressure over the injection site for several seconds Do not rub the area After injecting Dispose of
13. light Never use insulin 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 Actrapid Penfill if the solution is not clear and colourless Never use Protaphane Mixtard 30 70 or Mixtard 50 50 Penfill if the suspension does not become white and uniformly cloudy after shaking Keep out of the reach of children Disposal Dispose of your needles 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 Novo Nordisk Human Insulin Penfill InshPfcemil 1 docx Page 6 of 7 pharmacist what to do with any medicine that is left over Product description What it looks like A coloured band is located on the Penfill cartridge The colour of the band is specific for the insulin preparation Actrapid is a clear colourless solution for subcutaneous injection Actrapid Penfill 3mL is a glass cartridge Protaphane Mixtard 30 70 and Mixtard 50 50 are white cloudy suspensions for subcutaneous injection Protaphane Mixtard 30 70 and Mixtard 50 50 Penfill 3mL are glass cartridges Ingredients Human insulin rys is characterised by being identical to natural human insulin The ce 33 abbreviation rys indicates the method of genetic engineering used to manufacture the insulin Actrapid is
14. ms 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 e to turn you on your side and get medical help immediately e not to give you anything to eat or drink 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 Novo Nordisk Human Insulin Penfill InshPfcemil 1 docx Page 4 of 7 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 miss a dose Hyperglycamia 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 u
15. ore 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 Penfill a 3mL glass cartridge designed to be used with Novo Nordisk insulin delivery devices such as NovoPen Actrapid is Neutral Insulin Injection a fast acting insulin This means that it will start to lower your blood sugar level about half an hour after you inject it and the effect will last for approximately 8 hours Actrapid is often used in combination with longer acting insulin products 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 and Mixtard 50 50 are Biphasic Isophane Insulin Injection and each is a mixture of fast and longer acting insulins Mixtard 30 70 and Mixtard 50 50 will start to lower your blood sugar le
16. pful information Things you must not do 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 Penfill 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 Things to be careful of Be careful driving or operating machinery until you know how the insulin affects you Novo Nordisk Human Insulin Penfill InshPfcemil 1 docx Page 5 of 7 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 this medicine 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 Side effects Tell your doctor diabetes education nurse or pharmacist as soon
17. s Actrapid Penfill 3mL AUST R 169623 Protaphane Penfill 3mL AUST R 169635 Mixtard 30 70 Penfill 3mL AUST R 169629 Mixtard 50 50 Penfill 3mL AUST R 169630 Penfill NovoFine NovoTwist NovoPen Actrapid Protaphane Mixtard and NovoCare are registered trademarks of Novo Nordisk A S 2012 Further information For further information call the NovoCare Customer Care Centre on 1800 668 626 www novonordisk com au You can also get more information about diabetes and insulin from Diabetes Australia e freecall helpline 1300 136 588 www diabetesaustralia com au Novo Nordisk Human Insulin Penfill InshPfcemil 1 docx Page 7 of 7
18. se 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 e miss doses of insulin or use less insulin than you need e have uncontrolled diabetes e exercise less than usual e eat more carbohydrates than usual e are ill or stressed 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 e drowsy feeling e flushed face e thirst loss of appetite e fruity odour on the breath e blurred vision e passing larger amounts of urine than usual e getting up at night more often than usual to pass urine e high levels of glucose and acetone in the urine Symptoms of hyperglycaemia include severe e heavy breathing e fast pulse e nausea vomiting e dehydration e loss of consciousness 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 While you are using human insulin Penfill Things you must do Measure your blood sugar level regularly Make sure all friends relatives workmates or carers know
19. sulin appears thickened or has bits in it Do not use your Protaphane Mixtard 30 70 or Mixtard 50 50 Penfill if the insulin is no longer a cloudy white suspension after shaking or if it has bits in it Always check your Penfill including the rubber plunger stopper Do not use your Penfill if any damage is seen or if there is a gap between the plunger and the white label band If these observations are noted return your Penfill to your pharmacist See the insulin delivery device user manual for further instructions Preparing a dose 1 Wash your hands IMPORTANT If your Penfill contains cloudy insulin please read and follow points 2 5 carefully 2 On the Penfill cartridge is a coloured band Do not start an injection with a Penfill cartridge you have emptied beyond the coloured band The glass ball must have adequate space to resuspend the insulin Resuspending is easier when the insulin has reached room temperature 3 Before you put Penfill into the Novo Nordisk insulin delivery device move it up and down between positions a and b see picture below so that the glass ball in the cartridge moves from Novo Nordisk Human Insulin Penfill InshPfcemil 1 docx Page 3 of 7 one end to the other at least 20 times The movement must always be repeated until the liquid appears uniformly white and cloudy resuspended 4 If Penfill is already inside the Novo Nordisk
20. vel 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 Actrapid is also used by doctors to treat some people with diabetes in emergency situations 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 Penfill has been prescribed for you Before you use human insulin Penfill When you must not use it Do not use Penfill if 1 you have an allergy to e any medicine containing insulin e any of the ingredients listed in the Ingredients section of this leaflet Some of the symptoms of an allergic reaction may include Novo Nordisk Human Insulin Penfill InshPfcemil 1 docx Page of 7 e redness swelling rash and itching at the injection site e rash itching or hives on the skin e shortness of breath e wheezing or difficulty breathing e swelling of the face lips tongue or other parts of the body 2 you are experiencing a low blood sugar level a hypo when the dose is due 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
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