Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
human insulin
Novo Nordisk A/S
A10AB01
human insulin (rDNA)
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus.
Revision: 17
Authorised
2002-10-07
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER ACTRAPID 40 IU/ML (INTERNATIONAL UNITS/ML) SOLUTION FOR INJECTION IN VIAL human insulin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor, pharmacist or nurse. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. 1. WHAT ACTRAPID IS AND WHAT IT IS USED FOR Actrapid is human insulin with a fast-acting effect. Actrapid is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with Actrapid helps to prevent complications from your diabetes. Actrapid will start to lower your blood sugar about half an hour after you inject it, and the effect will last for approximately 8 hours. Actrapid is often given in combination with intermediate-acting or long-acting insulin preparations. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ACTRAPID DO NOT USE ACTRAPID ► If you are allergic to human insulin or any of the other ingredients in this medicine, see section 6. ► If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very common side effects in section 4. ► In insulin infusion pumps. ► If the protective cap is loose or missing. Each vial has a protective, tamper-proof plastic cap. If it is not in perfect condition when you get the vial, return the vial to your supplier. ► If it has not been stored correctly or if it has been frozen, see section 5. ► If the insulin does not appear clear and colourless. If any of these apply, do not use Actr Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Actrapid 40 international units/ml solution for injection in vial. Actrapid 100 international units/ml solution for injection in vial. Actrapid Penfill 100 international units/ml solution for injection in cartridge. Actrapid InnoLet 100 international units/ml solution for injection in pre-filled pen. Actrapid FlexPen 100 international units/ml solution for injection in pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Actrapid vial (40 international units/ml) 1 vial contains 10 ml equivalent to 400 international units. 1 ml solution contains 40 international units insulin human* (equivalent to 1.4 mg). Actrapid vial (100 international units/ml) 1 vial contains 10 ml equivalent to 1,000 international units. 1 ml solution contains 100 international units insulin human* (equivalent to 3.5 mg). Actrapid Penfill 1 cartridge contains 3 ml equivalent to 300 international units. 1 ml solution contains 100 international units insulin human* (equivalent to 3.5 mg). Actrapid InnoLet/Actrapid FlexPen 1 pre-filled pen contains 3 ml equivalent to 300 international units. 1 ml solution contains 100 international units insulin human* (equivalent to 3.5 mg). *Human insulin is produced in _Saccharomyces cerevisiae_ by recombinant DNA technology. Excipient with known effect: Actrapid contains less than 1 mmol sodium (23 mg) per dose, i.e. Actrapid is essentially ‘sodium- free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear, colourless and aqueous. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Actrapid is indicated for treatment of diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The potency of human insulin is expressed in international units. 3 Actrapid dosing is individual and determined in accordance with the needs of the patient. It can be used alone or in combination with intermediate-acting or long-acting insulin before a meal or a Aqra d-dokument sħiħ