Negara: Selandia Baru
Bahasa: Inggris
Sumber: Medsafe (Medicines Safety Authority)
Insulin aspart 100 U/mL;
Novo Nordisk Pharmaceuticals Ltd
Insulin aspart 100 U/mL
100 U/mL
Solution for injection
Active: Insulin aspart 100 U/mL Excipient: Dibasic sodium phosphate dihydrate Glycerol Hydrochloric acid Metacresol Phenol Sodium chloride Sodium hydroxide Water for injection Zinc
Prescription
Novo Nordisk A/S
Treatment of diabetes mellitus
Package - Contents - Shelf Life: Cartridge, glass, 3ml with bromobutyl rubber piston and bromobutyl/polyisoprene disc closure in FlexTouch injector - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 1 months opened stored at or below 30°C protect from light 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze) - Cartridge, glass, 3ml with bromobutyl rubber piston and bromobutyl/polyisoprene disc closure in FlexTouch injector - 5 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 1 months opened stored at or below 30°C protect from light 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze) - Cartridge, glass, 3ml with bromobutyl rubber piston and bromobutyl/polyisoprene disc closure in FlexTouch injector - 10 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 1 months opened stored at or below 30°C protect from light 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze)
2012-10-02
1 of 15 NEW ZEALAND DATASHEET 1 PRODUCT NAME NovoRapid ® 10ml Vial NovoRapid ® Penfill ® 3ml NovoRapid ® FlexPen ® 3ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin Aspart 100 Units/ml Recombinant DNA origin: _Saccharomyces cerevisiae_ 3 PHARMACEUTICAL FORM NovoRapid is a sterile, clear, colourless, aqueous, neutral solution of insulin aspart (B28 Asp) 100 U/ml. NovoRapid is a solution for injection. Insulin aspart is produced by recombinant DNA technology using _Saccharomyces cerevisiae_. One unit of insulin aspart corresponds to 6 nmol, 0.035 mg salt-free anhydrous insulin aspart. Insulin aspart is a rapid-acting analogue of human insulin that rapidly lowers blood glucose. Insulin aspart is homologous with human insulin with the exception of a substitution of the amino acid proline by aspartic acid at position 28 on the B-chain. The unique structure of insulin aspart increases the rate of absorption from a subcutaneous injection site, giving a faster onset of action, an earlier peak effect and a shorter duration of action than soluble human insulin. Insulin aspart should be given immediately before a meal or, when necessary, after the start of a meal. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of diabetes mellitus. 4.2 Dose and method of administration NovoRapid has a faster onset and a shorter duration of action than soluble human insulin. Due to the faster onset of action, NovoRapid should generally be given immediately before a meal or when necessary, soon after the start of a meal. The dosage of insulin aspart is determined by the physician according to the patient’s individual needs. The individual insulin requirement is usually between 0.5 and 1.0 Units/kg/day in adults and children. In a meal-related treatment 50-70% of this requirement may be provided by NovoRapid and the remainder provided by an intermediate-acting or long-acting insulin given at least once a day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. due to obesity), and low Baca dokumen lengkapnya