Land: Nieuw-Zeeland
Taal: Engels
Bron: 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
Syringe, 3mL glass cartridge, 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: Syringe, 3mL glass cartridge - 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
2002-02-26
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 Lees het volledige document