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Novo Nordisk Insulin Pen 30 User's Manual

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1. Priming NovoMix 30 FlexPen prior to each injection Small amounts of air may collect in the needle and reservoir during normal use To avoid injection of air and ensure proper dosing Dial 2 units O Hold NovoMix 30 FlexPen with the needle pointing upwards and tap the reservoir gently with your finger a few times Holding NovoMix 30 FlexPen with the needle upwards press the push button all the way in A drop of insulin should appear at the needle tip If not repeat the procedure no more than 6 times If a drop of insulin still does not appear the device is defective and must not be used Setting the dose Q Check that the dose selector is set at zero Dial 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 When dialing back be careful not to push the push button as insulin will come out You cannot set a dose larger than the number of units left in the reservoir Residual scale ua Dosage indicator window Push button Making the injection Use the injection technique advised by your doctor Deliver the dose by pressing the push button all the way in Be careful only to push the push button when injecting After the injection the needle should remain under the skin for at least 6 seconds Keep the push button fully depressed until the needle is withdrawn from the skin This will ensure that
2. can cause temporary or permanent brain damage and death If you use less NovoMix 30 FlexPen than you should If you are ill with fever or if you eat much more than usual and repeatedly take less insulin than you need your blood sugar may become unusually high i e result in hyperglycaemia The symptoms of unusually high blood sugar levels will appear gradually They include increased urination thirst loss of appetite nausea vomiting drowsiness fatigue flushed dry skin dry mouth acetone breath What to do in case of hyperglycaemia If you recognise any of the symptoms mentioned above you should test your blood sugar level and your urine for ketones as soon as possible as the symptoms may indicate that you have a condition called ketoacidosis This condition is critical and if untreated may result in diabetic coma and death You should therefore seek medical advice immediately and possibly take some extra insulin Possible side effects Like all medicines NovoMix 30 FlexPen can have side effects NovoMix 30 FlexPen may cause hypoglycaemia of which the symptoms have been mentioned above Redness swelling and itching at the site of injection also called local allergic reactions may be experienced by some people Usually these symptoms disappear within a few weeks during continued use If the symptoms do not disappear spread to other parts of your body or if you suddenly feel sick i e if you sweat vomit ha
3. the full dose has been delivered NovoFine O Inner needle cap E Outer needle cap Needle Protective tap a Removing the needle Replace the outer needle cap and unscrew the needle Dispose of it carefully It is important that you use a new needle for each injection Health care professionals relatives and other carers should follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration Dispose of the used NovoMix 30 FlexPen carefully without the needle attached Maintenance Your NovoMix 30 FlexPen is designed to work accurately and safely It should be handled with care Avoid situations where NovoMix 30 FlexPen might be damaged You can clean the exterior of your NovoMix 30 FlexPen by wiping it with cotton wool moistened with alcohol Do not soak it in alcohol or wash or lubricate it as this may damage the mechanism
4. 30 FlexPen may be given soon after a meal If you have reduced kidney or liver function your doctor may lower your insulin dosage There is no clinical experience in children and adolescents under the age of 18 years You should not take NovoMix 30 FlexPen if e Your blood sugar is too low hypoglycaemia Follow the guidance for hypoglycaemia e You are allergic to insulin aspart or any of the other ingredients contained in NovoMix 30 FlexPen Take special care with NovoMix 30 FlexPen Never stop taking insulin if you are ill Your need for insulin may however be changed If you have an infection fever or an operation you may need to have more insulin than usual 8 9673 90 001 1 If you suffer from diarrhoea vomiting or eat less than usual you may also need less insulin than usual What precautions have to be taken before going abroad The time difference between countries may mean that you have to take your insulin and meals at different times than usual You should therefore consult your doctor if you are planning to go abroad Taking NovoMix 30 FlexPen with food and drink Alcohol including beer and wine may lead to hypoglycaemia too low blood sugar Therefore be careful when you drink alcohol and never drink alcohol on an empty stomach Pregnancy If you are pregnant or planning pregnancy you should see your doctor immediately to discuss your need for and type of insulin in order to c
5. O WA novo nordisk 100 U ml NovoMix 30 FlexPen Suspension for injection in a pre filled pen The active substance in NovoMix 30 FlexPen is insulin aspart produced biosynthetically i e by use of recombinant DNA technology NovoMix 30 contains 30 insulin aspart in a soluble fraction and 70 insulin aspart crystallised with protamine NovoMix 30 FlexPen also contains the following other ingredients Mannitol Phenol Metacresol Zinc as chloride Sodium chloride Disodium phosphate dihydrate Protamine sulphate Sodium hydroxide Hydrochloric acid and Water for injections Produced by Novo Nordisk A S DK 2880 Bagsvaerd Denmark What NovoMix 30 FlexPen is and what it is used for NovoMix 30 FlexPen is a white suspension for subcutaneous injection in 3 ml pre filled pens NovoMix 30 FlexPen is an antidiabetic agent which lowers your blood sugar after injection When injected under your skin subcutaneously the onset of action will occur within 10 20 minutes of injection the maximum effect between 1 4 hours and the effect will last for up to 24 hours Therapeutic indications NovoMix 30 FlexPen is used for the treatment of patients with diabetes mellitus a disease where your pancreas does not produce enough insulin to control your blood sugar level Extra insulin is therefore needed Before you use NovoMix 30 FlexPen NovoMix 30 FlexPen should be given immediately before a meal When necessary NovoMix
6. ated protein albumin in the urine salicylates e g acetylsalicylic acid a substance present in many medicinal products used to relieve pain and lower fever anabolic steroids and glucocorticoids used to treat inflammatory conditions except topical administration oral contraceptives used for birth control thiazides used for the treatment of high blood pressure or oedema thyroid hormones used for the treatment of malfunction of the thyroid gland sympathomimetics used for the treatment of asthma danazol used for the treatment of some female hormonal disorders octreotide used in special endocrine conditions and sulphonamides antibiotic Please inform your doctor or pharmacist if you are taking or have recently taken any other medicine even those not prescribed How to use NovoMix 30 FlexPen To avoid the risk of passing on diseases NovoMix 30 FlexPen is for use by one person only Do not use NovoMix 30 FlexPen if it does not appear uniformly white and cloudy after shaking NovoMix 30 FlexPen should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridges giving a frosted appearance Remove air from the pen before each injection until a drop of insulin appears at the tip of the needle Do not use NovoMix 30 FlexPen if you need to make more than 6 airshots before the first injection When you are using NovoMix 30 FlexPen you should remove and di
7. om 1 to 60 units in increments of 1 unit NovoFine needles of 8 mm or shorter in length are designed to be used with FlexPen Look for an on the needle box The stands for shortcap Please read the following instructions carefully before using your NovoMIx 30 FlexPen Getting started Check that your NovoMix 30 FlexPen contains the correct type of insulin Take off the cap O Before using NovoMix 30 FlexPen the first time Roll NovoMix 30 FlexPen between your palms 10 times Thereafter turn the pen up and down between position 1 and 2 10 times so that the glass ball moves from one end of the reservoir to the other The rolling and turning procedure must be repeated at least once more until the liquid appears uniformly white and cloudy Inject immediately Before each injection Turn NovoMix 30 FlexPen up and down between position 1 and 2 10 times so that the glass ball moves from one end of the reservoir to the other The turning procedure must be performed until the liquid appears uniformly white and cloudy Inject immediately To ensure even mixing there must be at least 12 units of insulin left in the reservoir If there are less than 12 units left do not use NovoMix 30 FlexPen O Remove the protective tab from a NovoFine short cap needle and screw the needle tightly onto NovoMix 30 FlexPen Pull off the outer and inner needle caps Do not discard the outer needle cap Cap Residual scale window 12 units
8. ontrol your diabetes and thereby avoid hyperglycaemia too high blood sugar and hypoglycaemia too low blood sugar as these conditions could harm your baby There is limited clinical experience with insulin aspart in pregnancy Breast feeding Breast feeding while you are taking insulin does not put your baby at risk Your insulin dosage and diet may however need to be adjusted Driving and using machines Your ability to concentrate or react may be reduced if you have hypoglycaemia 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 You should contact your doctor about the advisability of driving if you have e Frequent episodes of hypoglycaemia e Reduced or absent warning signs of hypoglycaemia Using other medicines Your insulin need may change if you take other medicines You should therefore consult your doctor if you are currently taking any of the listed medicines or medicines which you are not sure of Oral hypoglycaemic agents used for the treatment of non insulin dependent Type 2 diabetes mellitus monoamine oxidase MAO inhibitors used for the treatment of depression non selective beta blocking agents used for the treatment of certain heart conditions and high blood pressure angiotensin converting enzyme ACE inhibitors used for the treatment of certain heart conditions high blood pressure or elev
9. spose of the needle after each injection If you do not remove it temperature changes may cause liquid to leak out of the needle and the concentration may change Take care not to drop or knock the pen Do not use the residual scale to measure your dose of insulin Do not refill NovoMix 30 FlexPen Do not use NovoMix 30 FlexPen in insulin pumps If you switch from another insulin to biphasic insulin aspart your dosage may have to be adjusted by your doctor How to handle this insulin FlexPen pre filled insulin pens should only be used in combination with products that are compatible therewith and allow the pre filled pens to function safely and effectively How to take this insulin Before injection make sure that you have got the type and strength of insulin prescribed NovoMix 30 FlexPen is for injection under the skin subcutaneously NovoMix 30 FlexPen should never be injected into a vein The insulin may be injected in the abdomen thigh upper arm or buttock It is recommended that you eat a meal or snack containing carbohydrate within 10 minutes of the injection and measure your blood sugar level regularly When necessary NovoMix 30 FlexPen may be given soon after a meal If you use more NovoMix 30 FlexPen than you should If you take too much insulin miss a meal or exercise more than usual your blood sugar may become too low i e hypoglycaemia The first symptoms of hypoglycaemia can come on suddenly The
10. ve difficulties in breathing have rapid heart beat feel dizzy you should consult your doctor immediately as these reactions may be due to systemic allergic reactions which are rare but may be serious Your skin may thicken or pit if the injection site is not rotated When you first start your insulin treatment you may suffer from visual disturbances or swelling of the extremities If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist Storing NovoMix 30 FlexPen Store NovoMix 30 FlexPen which you are not using at 2 C 8 C in a refrigerator not too near the freezer compartment Do not freeze NovoMix 30 FlexPen that you are using must not be kept in a refrigerator NovoMix 30 FlexPen can be used or carried with you as a spare for up to 4 weeks not above 30 C after which it must be discarded In order to protect from light keep the cap on when NovoMix 30 FlexPen is not in use Keep out of the reach and sight of children Do not use after the expiry date stated on the label and carton Do not use NovoMix 30 FlexPen if it does not appear uniformly white and cloudy after shaking NovoMix FlexPen NovoFine and amp are trademarks owned by Novo Nordisk A S Denmark December 2001 O Novo Nordisk A S a 2880 Bagsvaerd Denmark novo nordisk NovoMix 30 FlexPen Introduction NovoMix 30 FlexPen is a unique dial a dose insulin pen You can dial doses fr
11. y may include cold sweats cool pale skin fatigue nervousness or tremor anxious feeling unusual tiredness and weakness confusion difficulty in concentration drowsiness excessive hunger temporary vision changes headache nausea and palpitation What to do in case of hypoglycaemia If you experience any of the symptoms mentioned above you should immediately take sugar or a Sugar containing product So always carry sugar lumps sweets biscuits or fruit juice with you Tell your relatives friends and close colleagues that you have diabetes and how they can help you if you get a severe hypoglycaemic reaction They must know that they should not give you anything to eat or drink if you are unconscious as you could choke If you are unconscious you should be turned on your side and your relatives friends or colleagues should get medical help immediately You may recover from unconsciousness more quickly if you are given an injection of the hormone glucagon by a person who has been instructed in how to use it If glucagon is injected you should also be given sugar a product containing sugar or glucose by mouth as soon as you are conscious again If you do not respond to glucagon treatment you will have to be treated in a hospital See your doctor if you have had repeated hypoglycaemic reactions or one reaction that led to unconsciousness as your insulin dose may need to be changed If severe hypoglycaemia is not treated it

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