Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
Insulin human
Novo Nordisk A/S
A10AC01
insulin human (rDNA)
Drugs used in diabetes
Diabetes Mellitus
Treatment of diabetes mellitus.
Revision: 18
Authorised
2002-10-07
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER PROTAPHANE 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 PROTAPHANE IS AND WHAT IT IS USED FOR Protaphane is human insulin with a gradual onset and long duration of action. Protaphane 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 Protaphane helps to prevent complications from your diabetes. Protaphane will start to lower your blood sugar about 1½ hours after you inject it, and the effect will last for approximately 24 hours. Protaphane is often given in combination with fast-acting insulin preparations. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PROTAPHANE DO NOT USE PROTAPHANE ► 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 Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Protaphane 40 international units/ml suspension for injection in vial. Protaphane 100 international units/ml suspension for injection in vial. Protaphane Penfill 100 international units/ml suspension for injection in cartridge. Protaphane InnoLet 100 international units/ml suspension for injection in pre-filled pen. Protaphane FlexPen 100 international units/ml suspension for injection in pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Protaphane vial (40 international units/ml) 1 vial contains 10 ml equivalent to 400 international units. 1 ml suspension contains 40 international units isophane (NPH) insulin human* (equivalent to 1.4 mg). Protaphane vial (100 international units/ml) 1 vial contains 10 ml equivalent to 1,000 international units. 1 ml suspension contains 100 international units isophane (NPH) insulin human* (equivalent to 3.5 mg). Protaphane Penfill 1 cartridge contains 3 ml equivalent to 300 international units. 1 ml suspension contains 100 international units isophane (NPH) insulin human* (equivalent to 3.5 mg). Protaphane InnoLet/Protaphane FlexPen 1 pre-filled pen contains 3 ml equivalent to 300 international units. 1 ml suspension contains 100 international units isophane (NPH) insulin human* (equivalent to 3.5 mg). *Human insulin is produced in _Saccharomyces cerevisiae_ by recombinant DNA technology. Excipient with known effect: Protaphane contains less than 1 mmol sodium (23 mg) per dose, i.e. Protaphane 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 Protaphane 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 Protaphane dosing is individual and determined in accordance with the needs of the patient. The Přečtěte si celý dokument