KIRSTY™ SOLUTION FOR INJECTION IN VIAL 100 UNITS/ML

INJECTION, SOLUTION

**Posology and method of administration** **Posology** The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units. Kirsty dosing is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate acting or long acting insulin. Moreover, Kirsty vial can be used for continuous subcutaneous insulin infusion (CSII) in pump systems. Kirsty vial can also be used if intravenous administration of insulin aspart, by physicians or other healthcare staff, is applicable. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control. The individual insulin requirement in adults and children is usually between 0.5 and 1.0 unit/kg/day. In a basal bolus treatment regimen 50 70% of this requirement may be provided by Kirsty and the remainder by intermediate acting or long acting insulin. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. **Special populations** _Elderly (≥ 65 years old)_ Kirsty can be used in elderly patients. In elderly patients, glucose monitoring should be intensified, and the insulin aspart dose adjusted on an individual basis. _Renal impairment_ Renal impairment may reduce the patient’s insulin requirements. In patients with renal impairment, glucose monitoring should be intensified, and the insulin aspart dose adjusted on an individual basis. _Hepatic impairment_ Hepatic impairment may reduce the patient’s insulin requirements. In patients with hepatic impairment, glucose monitoring should be intensified, and the insulin aspart dose adjusted on an individual basis. _Paediatric population_ Kirsty can be used in children and adolescents aged 1 year and above in preference to soluble human insulin when a rapid onset of action might be beneficial, for example, in the timing of the injections in relation to meals (see **Pharmacodynamic Properties** and **Pharmacokinetics Properties** section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The safety and efficacy of Kirsty in children below 1 year of age have not been established. No data are available. _Transfer from other insulin medicinal products_ When transferring from other insulin medicinal products, adjustment of the Kirsty dose and the dose of the basal insulin may be necessary. Kirsty has a faster onset and a shorter duration of action than soluble human insulin. When injected subcutaneously into the abdominal wall, the onset of action will occur within 10 to 20 minutes of injection. The maximum effect is exerted between 1 and 3 hours after the injection. The duration of action is 3 to 5 hours. Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see **Special warnings and precautions for use** section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) **.** **Method of administration** Insulin aspart is a rapid acting insulin analogue. Kirsty is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see **Special warnings and precautions for use and Undesirable effects** sections – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Subcutaneous injection in the abdominal wall ensures a faster absorption than other injection sites. Compared to soluble human insulin the faster onset of action of Kirsty is maintained regardless of the injection site. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. Due to the faster onset of action, Kirsty should generally be given immediately before a meal. When necessary Kirsty can be given soon after a meal. _Kirsty 100 units/ml solution for injection in vial_ _Continuous subcutaneous insulin infusion (CSII)_ Kirsty may be used for CSII in pump systems suitable for insulin infusion. CSII should be administered in the abdominal wall. Infusion sites should be rotated. When used with an insulin infusion pump, Kirsty should not be mixed with any other insulin medicinal products. Patients using CSII should be comprehensively instructed in the use of the pump system and use the correct reservoir and tubing for the pump (see **Special precautions for disposal and other handling** section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The infusion set (tubing and cannula) should be changed in accordance with the instructions in the product information supplied with the infusion set. Patients administering Kirsty by CSII must have an alternative insulin delivery method available in case of pump system failure. _Intravenous use_ If necessary, Kirsty can be administered intravenously which should be carried out by physicians or other healthcare professionals. For intravenous use, infusion systems with Kirsty 100 units/ml at concentrations from 0.05 unit/ml to 1.0 unit/ml insulin aspart in the solutions for infusion sodium chloride 9 mg/ml (0.9%), 5% glucose or 10% glucose including 40 mmol/l potassium chloride using polypropylene infusion bags, are stable at room temperature for 24 hours. Although stable over time, a certain amount of insulin will be initially adsorbed to the material of the infusion bag. Monitoring of blood glucose is necessary during insulin infusion. Administration with a syringe Kirsty vials are for use with insulin syringes with the corresponding unit scale. See also **Special precautions for disposal and other handling** section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. For detailed user instructions, please refer to the package leaflet.