Glyset R PensetDescriptionGlyset R (Insulin Aspart rDNA) is a sterile, clear solution of Insulin Aspart human insulin analogue forsubcutaneous injection/infusion or intravenous injection. Glyset R is a blood glucose lowering agentwith an earlier onset of action. Glyset R produces a more rapid onset of action compared to solublehuman insulin. Insulin Aspart is homologous with regular human insulin with the exception of a singlesubstitution of the amino acid Proline by aspartic acid in position B28, and is produced by recombinantDNA technology.IndicationsGlyset R is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.Instructions to be given to the patientBefore injecting this Insulin:1. According to the instruction given with ConviPen, insert the Glyset cartridge into the pen correctly &equip the needle2. In case of Glyset Mix, gently turn the pen upside down for 8-10 times until the insulin in the cartridgebecomes uniformly mixed suspension3. Remove the needle cap, discharge air bubbles in the catridge4. Adjust the dosage button to get correct dose & inject to the specific site5. In order to avoid cross contamination, do not let the needle touch anything during the process ofpreparation.For detail description, please see the Patient Instruction Leaflet provided with ConviPen.Dosage & AdministrationGlyset R has a faster onset and a shorter duration of action than soluble human insulin. Due to thefaster onset of action, Glyset R should generally be given immediately before a meal. When necessaryGlyset R may be given soon after a meal.Dosage of Glyset R is individual and determined on the basis of the physician's advice in accordancewith the needs of the patient. It should normally be used in combination with long-acting insulin givenat least once a day.The individual insulin requirement is usually between 0.5 and 1.0 IU/kg/day in adults and children over2 years of age. In a meal-related treatment 50-70% of this requirement may be provided by Glyset Rand the remainder by long-acting insulin. Adjustment of dosage may also be necessary if patientsundertake increased physical activity or change their usual diet. Exercise taken immediately after ameal may increase the risk of hypoglycaemia.Subcutaneous InjectionGlyset R should be administered by subcutaneous injection in the abdominal region, buttocks, thigh,or upper arm. Because Glyset R has a more rapid onset and a shorter duration of activity than humanregular insulin, it should be injected immediately (within 5-10 minutes) before a mealContinuous Subcutaneous Insulin Infusion (CSII) by External PumpGlyset R can also be infused subcutaneously by an external insulin pump. The initial programming ofthe external insulin infusion pump should be based on the total daily insulin dose of the previousregimen. Approximately 50% of the total dose is usually given as meal-related boluses of Glyset R andthe remainder is given as a basal infusion. When used with an infusion pump Glyset R should not bemixed with any other insulin.Intravenous UseGlyset R can be administered intravenously under medical supervision for glycemic control with closemonitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. Forintravenous use, Glyset R should be used at concentrations from 0.05 IU/mL to 1.0 IU/mL insulinaspart in infusion systems using polypropylene infusion bags. Glyset R has been shown to be stable ininfusion fluids such as 0.9% sodium chloride.Side EffectsSide effects of Insulin Aspart are hypoglycemia, allergic reactions, injection site reaction,lipodystrophy, pruritus and rash.PrecautionsDose adjustment and monitoring: Blood glucose should be monitored in all patients treated withinsulin. Insulin regimens should be modified cautiously and only under medical supervisionUse in Pregnancy & LactationPregnancy: Pregnancy category B.Lactation: There are no restrictions on treatment with Glyset R during lactation. Insulin treatment of thenursing mother should not affect the baby. However, dosage may need to be adjusted.Drug InteractionA number of drugs affect glucose metabolism and may require dose adjustment.The following substances may reduce the Insulin as well as Insulin Aspart requirements:Oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates,fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates and sulfonamideantibiotics.The following substances may increase the Insulin as well as Insulin Aspart requirements:Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone and danazol.Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood glucoselowering effect of insulin.Over DoseA specific overdose for insulin cannot be defined, however, hypoglycaemia may develop oversequential stages if too high doses relative to the patient’s requirement are administered.Mild ..