Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
insulin human (recombinant DNA)
Eli Lilly and Company
A10AD01
insulin human (recombinant DNA)
100IU/ml
suspension for injection
(1) glass vial 10ml
Prescription
Registered
2016-08-23
PA003IPXS00 HUMULIN ® (HU-MU-LIN) 70/30 USPI14NOV2013 PA003IPXS00 HUMULIN ® (HU-MU-LIN) 70/30 (70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% HUMAN INSULIN INJECTION [RDNA ORIGIN]) 1 INDICATIONS AND USAGE HUMULIN 70/30 is a fixed ratio premix recombinant human insulin formulation indicated to improve glycemic control in adult patients with diabetes mellitus. 2 DOSAGE AND ADMINISTRATION 2.1 IMPORTANT ADMINISTRATION INSTRUCTIONS Inspect HUMULIN 70/30 visually before use. It should not contain particulate matter and should appear uniformly cloudy after mixing. Do not use HUMULIN 70/30 if particulate matter is seen. Do not mix HUMULIN 70/30 with any other insulins or diluents. 2.2 ROUTE OF ADMINISTRATION HUMULIN 70/30 should only be administered subcutaneously. Administer in the subcutaneous tissue of the abdominal wall, thigh, upper arm, or buttocks. To reduce the risk of lipodystrophy, rotate the injection site within the same region from one injection to the next _[see Adverse Reactions (6)]_. Do not administer HUMULIN 70/30 intravenously or intramuscularly and do not use HUMULIN 70/30 in an insulin infusion pump. 2.3 DOSAGE INFORMATION Individualize and adjust the dosage of HUMULIN 70/30 based on the individual’s metabolic needs, blood glucose monitoring results and glycemic control goal. Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness _[see Warnings and Precautions (5.1, 5.2), and Use in Specific Populations _ _(8.6, 8.7)]_. The proportion of rapid acting and long acting insulin is fixed in a premixed insulin such as HUMULIN 70/30. Independent adjustment of the basal or prandial dose is not possible when using a premixed insulin. Physiological factors, disease states and concomitant drugs may impact the onset and duration of action of all insulins. HUMULIN 70/30 dose requirements may change with changes in level of physical activity, meal patterns (i Прочитать полный документ