Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Insulin human
Novo Nordisk A/S
A10AD01
insulin human (rDNA)
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus.
Revision: 19
Authorised
2002-10-07
53 B. PACKAGE LEAFLET 54 PACKAGE LEAFLET: INFORMATION FOR THE USER ACTRAPHANE 30 40 IU/ML (INTERNATIONAL UNITS/ML) SUSPENSION 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 ACTRAPHANE IS AND WHAT IT IS USED FOR Actraphane is human insulin with both a fast-acting and a long-acting effect. Actraphane 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 Actraphane helps to prevent complications from your diabetes. Actraphane will start to lower your blood sugar about 30 minutes after you inject it, and the effect will last for approximately 24 hours. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ACTRAPHANE DO NOT USE ACTRAPHANE ► 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 resuspended insulin does not appear uniformly white and cloudy. If any of these apply, do not use Actraphane. Talk to your doctor, pharmacist Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Actraphane 30 40 international units/ml suspension for injection in vial. Actraphane 30 100 international units/ml suspension for injection in vial. Actraphane 30 Penfill 100 international units/ml suspension for injection in cartridge. Actraphane 30 InnoLet 100 international units/ml suspension for injection in pre-filled pen. Actraphane 30 FlexPen 100 international units/ml suspension for injection in pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Actraphane 30 vial (40 intern ational units/ml) 1 vial contains 10 ml equivalent to 400 international units. 1 ml suspension contains 40 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 30/70 (equivalent to 1.4 mg). Actraphane 30 vial (100 inter national units/ml) 1 vial contains 10 ml equivalent to 1,000 international units. 1 ml suspension contains 100 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 30/70 (equivalent to 3.5 mg). Actraphane 30 Penfill 1 cartridge contains 3 ml equivalent to 300 international units. 1 ml suspension contains 100 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 30/70 (equivalent to 3.5 mg). Actraphane 30 InnoLet/Actrap hane 30 FlexPen 1 pre-filled pen contains 3 ml equivalent to 300 international units. 1 ml suspension contains 100 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 30/70 (equivalent to 3.5 mg). *Human insulin is produced in _Saccharomyces cerevisiae_ by recombinant DNA technology. Excipient with known effect: Actraphane 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. Actraphane 30 is essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. The suspension is cloudy, white and aqueous. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Actraphane is indicated for treatment of diabetes mellitus. 3 4.2 PO Прочетете целия документ