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NovoMix® 30 is a modern insulin (insulin analogue) with both a rapid-acting and an intermediateacting effect, in the ratio 30/70. Modern insulin products are improved versions of human insulin. NovoMix® 30 is used to reduce the high blood sugar level in adults, adolescents and children aged 10 years and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. NovoMix® 30 will start to lower your blood sugar 10–20 minutes after you inject it, the maximum effect occurs between 1 and 4 hours after the injection, and the effect lasts for up to 24 hours. In treatment of type 2 diabetes mellitus, NovoMix® 30 may be used in combination with tablets for diabetes and/or with injectable antidiabetic products. How to use Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure. NovoMix® 30 is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, NovoMix® 30 can be given soon after a meal. See How and where to inject, below for information. Do not change your insulin unless your doctor tells you to. 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. When NovoMix® 30 is used in combination with tablets for diabetes and/or with injectable antidiabetic products your dose may have to be adjusted by your doctor. Warnings and precautions Do not use NovoMix® 30 If you are allergic to insulin aspart or any of the other ingredients in this medicine If you suspect hypoglycaemia (low blood sugar) is starting, see a) In insulin infusion pumps. If FlexPen® is dropped, damaged or crushed. If it has not been stored correctly or if it has been frozen If the resuspended insulin does not appear uniformly white, cloudy and aqueous. If after resuspension, clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge. If any of these apply, do not use NovoMix® 30. Talk to your doctor, nurse or pharmacist for advice. 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. Needles and NovoMix® 30 FlexPen® must not be shared. NovoMix® 30 FlexPen® is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method. Warnings and precautions Some conditions and activities can affect your need for insulin. Consult your doctor: If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands. If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level. If you are ill, carry on taking your insulin and consult your doctor. If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof. Side Effects Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people. Low blood sugar may occur if you: Inject too much insulin. Eat too little or miss a meal. Exercise more than usual. Drink alcohol Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating. Storage Information Always keep the pen cap on your FlexPen® when you are not using it, in order to protect it from light. NovoMix® 30 must be protected from excessive heat and light. Before opening: NovoMix® 30 FlexPen® that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze. Drug Interactions Your blood sugar level may fall (hypoglycaemia) if you take: Other medicines for the treatment of diabetes Monoamine oxidase inhibitors (MAOI) (used to treat depression) Beta-blockers (used to treat high blood pressure) Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure) Salicylates (used to relieve pain and lower fever) Anabolic steroids (such as testosterone) Sulfonamides (used to treat infections). Your blood sugar level may rise (hyperglycaemia) if you take: Oral contraceptives (birth control pills) Thiazides (used to treat high blood pressure or excessive fluid retention) Glucocorticoids (such as ‘cortisone’ used to treat inflammation) Thyroid hormones (used to treat thyroid gland disorders) Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat asthma) Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes) Danazol (medicine acting on ovulation). Ingredients The active substance is insulin aspart. The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulfate, hydrochloric acid, sodium hydroxide and water for injections.
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