Страна: Тайвань
мова: китайська
Джерело: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
INSULIN ASPART
台灣諾和諾德藥品股份有限公司 台北市敦化南路二段216號7樓-1 (23528693)
A10AD05
注射劑
INSULIN ASPART (6820800109) approx.MG
支裝
菌 疫
限由醫師使用
NOVO NORDISK A/S HALLAS ALLE, DK-4400 KALUNDBORG, DENMARK DK
insulin aspart
糖尿病
註銷日期: 2016/03/01; 註銷理由: 自請註銷; 有效日期: 2016/01/12; 英文品名: NovoMix 50 Penfill
已註銷
2011-01-12
1 1. NAME OF THE MEDICINAL PRODUCT NovoMix 50 Penfill 100 U/ml suspension for injection in cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of the suspension contains 100 U soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 50/50 (equivalent to 3.5 mg). 1 cartridge contains 3 ml equivalent to 300 U. *Insulin aspart is produced by recombinant DNA technology in _Saccharomyces cerevisiae_ . For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection in cartridge. Penfill. White suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The potency of insulin analogues, including insulin aspart, is expressed in units (U), whereas the potency of human insulin is expressed in international units (IU). NovoMix 50 dosing is individual and determined in accordance with the needs of the patient. Blood glucose monitoring and insulin dose adjustments are recommended to archive optimal glycaemic control. The individual insulin requirement is usually between 0.5 and 1.0 U/kg/day _ _ in adult patients and this may be fully or partially supplied with NovoMix 50. The daily insulin requirement may be higher in patients with insulin resistance (e.g. due to obesity), and lower in patients with residual endogenous insulin production. In patients with type 2 diabetes, _ _ NovoMix 50 can be given as monotherapy or in combination with metformin, when the blood glucose is inadequately controlled with metformin alone. _ _ Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. In patients with diabetes mellitus optimised metabolic control effectively delays the onset and slows the progression of diabetic late complications. Optimised metabolic control, including glucose monitoring, is therefore recommended. Special populations As with all insulin medicinal products, in elderly patients ( Прочитайте повний документ