Maa: Armenia
Kieli: englanti
Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
insulin human (recombinant DNA)
Novo Nordisk A/S
insulin human (recombinant DNA)
100IU/ml
suspension for injection
Prescription
8-0191-00-096-1 Regulatory Operations Insert: 2010-125x295-001 Current 1.0 I10 vial Professionel COLOUR: PMS 280C 100 IU/ml MIXTARD® 30 Suspension for injection in vial. QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin human, rDNA (produced by recombinant DNA technology in_ Saccharomyces cerevisiae_). 1 ml contains 100 IU of insulin human. 1 vial contains 10 ml equivalent to 1,000 IU. One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin. Mixtard® is a mixture of dissolved insulin and isophane (NPH) insulin. Mixtard® 30 consists of 30% dissolved insulin and 70% isophane insulin. PHARMACEUTICAL FORM Suspension for injection in vial. Cloudy, white, aqueous suspension. THERAPEUTIC INDICATIONS Treatment of diabetes mellitus. POSOLOGY AND METHOD OF ADMINISTRATION Mixtard® is a dual-acting insulin. It is a biphasic formulation containing both fast-acting and long-acting insulin. Premixed insulin products are usually given once or twice daily when a rapid initial effect together with a more prolonged effect is desired. DOSAGE Dosage is individual and determined in accordance with the needs of the patient. The individual insulin requirement is usually between 0.3 and 1.0 IU/kg/day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production. An injection should be followed within 30 minutes by a meal or snack containing carbohydrates. DOSAGE ADJUSTMENT Concomitant illness, especially infections and feverish conditions, usually increases the patient’s insulin requirement. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose. Adjustment of dosage may also be necessary if patients change physical activity or their usual diet. Dosage adjustment may be necessary when transferring patients from one insulin preparation to another. ADMINISTRATION For subcutaneous use. Insulin suspensions are n Lue koko asiakirja