Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Neutral insulin, human, pyr 100 IU/mL;
Novo Nordisk Pharmaceuticals Ltd
Neutral insulin, human, pyr 100 IU/mL
100 IU/mL
Solution for injection
Active: Neutral insulin, human, pyr 100 IU/mL Excipient: Glycerol Hydrochloric acid Metacresol Sodium hydroxide Water for injection Zinc
Cartridge, 3.0mL, 5 dose units
Prescription
Prescription
Novo Nordisk A/S
Treatment of diabetes mellitus. Furthermore indicated for the initial stabilisation of diabetes, during treatment of diabetic ketoacidosis and the hyperosmolar non ketotic syndrome, and during stress situations such as severe infections and major surgery in diabetic patients.
Package - Contents - Shelf Life: Cartridge, 3.0mL - 5 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 weeks opened stored at or below 25°C
1985-04-15
Page 1 of 6 NEW ZEALAND CONSUMER MEDICINE INFORMATION ACTRAPID ® PENFILL ® 100 IU/ML SOLUTION FOR INJECTION IN CARTRIDGE Insulin human (rDNA) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING YOUR INSULIN – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor, nurse or your pharmacist. – This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. – If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or your pharmacist. 1. WHAT ACTRAPID ® IS AND WHAT IT IS USED FOR ACTRAPID ® IS HUMAN INSULIN USED TO TREAT DIABETES. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of your blood sugar. Actrapid ® is a fast-acting insulin. This means that it will start to lower your blood sugar about ½ hour after you take it, and the effect will last for approximately 8 hours. Actrapid ® is often given in combination with longer-acting insulin products. 2. BEFORE YOU USE ACTRAPID ® DO NOT USE ACTRAPID ® ► IN INSULIN INFUSION PUMPS. ► IF YOU ARE ALLERGIC (HYPERSENSITIVE) to human insulin or any of the other ingredients in Actrapid ® (see 7 FURTHER INFORMATION). ► IF YOU SUSPECT HYPOGLYCAEMIA (low blood sugar) is starting (see 4. WHAT TO DO IN AN EMERGENCY). ► IF THE CARTRIDGE OR THE DEVICE CONTAINING CARTRIDGE IS DROPPED, DAMAGED OR CRUSHED . ► IF IT HAS NOT BEEN STORED CORRECTLY or been frozen (see 6.HOW TO STORE ACTRAPID ® ). ► IF THE INSULIN DOES NOT APPEAR CLEAR AND COLOURLESS. BEFORE USING ACTRAPID ® ► CHECK THE LABEL TO MAKE SURE it is the right type of insulin. ► ALWAYS CHECK the cartridge, including the rubber stopper. Do not use it if any damage is seen or if there is a gap between the rubber stopper and the white label band. Take it back to your supplier. See your delivery system manual for further instructions. ► ALWAYS USE Lue koko asiakirja
1 NEW ZEALAND DATASHEET 1 PRODUCT NAME ACTRAPID ® 100 IU/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin human, rDNA (produced by recombinant DNA technology in _Saccharomyces _ _cerevisiae_). Neutral insulin 100 IU/ml 3 PHARMACEUTICAL FORM ACTRAPID is a clear colourless solution containing 100% neutral human insulin. It is available in 3 ml Penfill ® cartridges made of glass, with a plunger (bromobutyl) and a stopper (bromobutyl/polyisoprene) in a carton, or in 10 ml glass vials closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap in a carton. One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin. The Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of diabetes mellitus. Furthermore, indicated for the initial stabilisation of diabetes, during treatment of diabetic ketoacidosis and the hyperosmolar non ketotic syndrome, and during stress situations such as severe infections and major surgery in diabetic patients. 4.2 Dose and method of administration ACTRAPID is a-short-acting insulin and is often used in combination with intermediate- or long acting insulins. Dosage is individual and determined by the physician in accordance with the needs of the patient. The individual insulin requirement is usually between 0.5 and 1.0 IU/kg/day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty in the young or due to obesity) and lower in patients with residual, endogenous insulin production. In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications. Close blood glucose monitoring is recommended. An injection should be followed by a meal or snack containing carbohydrates within 30 minutes. _ _ Concomitant illness, especially infections and feverish conditions, usually increases the patient’s insulin requirement. Concomitant diseases in the kidney, liver Lue koko asiakirja