Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
INSULIN HUMAN
Novo Nordisk A/S
100IU/ml IU/ML
Solution for Injection
2002-10-25
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Insulatard FlexPen 100 IU/ml Suspension for injection in a pre-filled pen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin human, (rDNA) (recombinant DNA origin produced in Saccharomyces cerevisiae). 1 ml contains 100 IU. 1 pre-filled pen contains 3 ml equivalent to 300 IU. Insulatard FlexPen is a suspension of isophane (NPH) insulin. One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin. For excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection Insulatard FlexPen is a cloudy, white, aqueous suspension of insulin human. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Dosage is individual and determined by the physician in accordance with the needs of the patient. The average range of total daily insulin requirement for maintenance therapy in type 1 diabetic patients lies between 0.5 and 1.0 IU/kg. However, in pre-pubertal children it usually varies from 0.7 to 1.0 IU/kg, but can be much lower during the period of partial remission. In insulin resistance, e.g. during puberty or due to obesity, the daily insulin requirement may be substantially higher. Initial dosages for type 2 diabetic patients are often lower, e.g. 0.3 to 0.6 IU/kg/day. In patients with diabetes mellitus optimised metabolic control effectively delays the onset and slows the progression of late diabetic complications. Optimised metabolic control, including glucose monitoring, is therefore recommended. In the elderly the primary aim of treatment may be symptom relief and avoidance of hypoglycaemic events. DOSAGE ADJUSTMENT Insulatard is a suspension of isophane (NPH) insulin. IRISH MEDICINES BOARD ___________________________ Lire le document complet