KIRSTY™ SOLUTION FOR INJECTION IN VIAL 100 UNITS/ML

Biocon Sdn. Bhd. (MALAYSIA)🇸🇬 Health Sciences Authority

Approval Date: Sep 20, 2023
Approval ID: aadf69766b448233
Company: Biocon Sdn. Bhd. (MALAYSIA)
Type: Therapeutic

Approval Details

Approval Id: aadf69766b448233
Drug Name: KIRSTY™ SOLUTION FOR INJECTION IN VIAL 100 UNITS/ML
Product Name: KIRSTY™ SOLUTION FOR INJECTION IN VIAL 100 UNITS/ML
Approval Number: SIN16867P
Approval Date: 2023-09-20
Registrant: CEDAR PHARMACEUTICALS PTE. LTD.
Licence Holder: CEDAR PHARMACEUTICALS PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SOLUTION
Dosage: 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 to 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 2 years 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). 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.
Route Of Administration: INTRAVENOUS, SUBCUTANEOUS
Indication Info: Therapeutic indications Kirsty® is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Contraindications: Contraindications Hypersensitivity to the active substance or to any of the excipients listed in List of excipients section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Atc Code: A10AB05
Atc Item Name: insulin aspart
Pharma Manufacturer Name: ZUELLIG PHARMA PTE. LTD.

Active Ingredients

Insulin aspart (rDNA origin)

100 U/ml

Insulin aspart (rDNA origin)

100 U/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Sep 20, 2023

Approval ID

aadf69766b448233

Type

Therapeutic

Back to HSA Approvals