Země: Arménie
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
insulin aspart
Novo Nordisk A/S
A10AB05
insulin aspart
100U/ml
solution for s/c or i/v injection
(5) pre-filled pens 3ml
Prescription
Registered
2018-06-27
NovoRapid ® FlexPen ® Professional Leaflet STF-Mar-2018_site Denmark_8-9670-00-014-1 1 NOVORAPID ® FlexPen ® 100 U/ml solution for injection in pre-filled pen. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of the solution contains 100 U of insulin aspart* (equivalent to 3.5 mg). 1 pre-filled pen contains 3 ml equivalent to 300 U. *Insulin aspart is produced by recombinant DNA technology in _Saccharomyces cerevisiae._ PHARMACEUTICAL FORM Clear, colourless, aqueous solution for injection in pre-filled pen. FlexPen ® . THERAPEUTIC INDICATIONS Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. POSOLOGY NovoRapid ® is a rapid-acting insulin analogue. NovoRapid ® dosage 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 given at least once a day. Blood glucose monitoring and insulin dose adjustment are recommended to achieve optimal glycaemic control. The individual insulin requirement in adults and children is usually between 0.5 and 1.0 U/kg/day. In a basal- bolus treatment regimen, 50–70% of this requirement may be provided by NovoRapid ® and the remainder by intermediate-acting or long-acting insulin. Adjustment of dosage may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. 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. When necessary NovoRapid ® can be given soon after a meal. Due to the shorter duration, NovoRapid ® has a lower risk of causing nocturnal hypoglycaemic episodes. SPECIAL POPULATIONS As with all insulin products, in elderly patients and patients with renal or hepatic impairment, glucose monitoring should be intensified and the insulin aspart dosage adjusted on an individual basis. PAEDIATRIC POPULATION NovoRapid ® can be used Přečtěte si celý dokument
1 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 2 1. NAME OF THE MEDICINAL PRODUCT NovoRapid 100 units/ml solution for injection in vial NovoRapid Penfill 100 units/ml solution for injection in cartridge NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen NovoRapid PumpCart 100 units/ml solution for injection in cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NovoRapid vial 1 vial contains 10 ml equivalent to 1,000 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). NovoRapid Penfill 1 cartridge contains 3 ml equivalent to 300 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch 1 pre-filled pen contains 3 ml equivalent to 300 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). NovoRapid PumpCart 1 cartridge contains 1.6 ml equivalent to 160 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). *Insulin aspart is produced in _Saccharomyces cerevisiae _by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear, colourless and aqueous. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. 4.2 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. NovoRapid 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. 3 3 Moreover NovoRapid vial and NovoRapid PumpCart can be used for continuous subcutaneous insulin infusion (CSII) i Přečtěte si celý dokument