Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin Aspart
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
Insulin Aspart
3ml x 5 Units; 3ml x 5 Units
NOVO NORDISK A/S
NOVORAPID ® FLEXPEN ® 100 U/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN Insulin aspart 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ WHAT IS IN THIS LEAFLET 1. What NovoRapid ® is used for 2. How NovoRapid ® works 3. Before you use NovoRapid ® 4. How to use NovoRapid ® 5. While you are using it 6. Side effects 7. Storage and Disposal of NovoRapid ® 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT NOVORAPID ® IS USED FOR NovoRapid ® is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of your blood sugar. 2. HOW NOVORAPID ® WORKS NovoRapid ® is a rapid-acting modern insulin (insulin analogue). Modern insulin products are improved versions of human insulin. NovoRapid ® will start to lower your blood sugar 10–20 minutes after you take it, a maximum effect occurs between 1 and 3 hours and the effect lasts for 3–5 hours. Due to this short action, NovoRapid ® should normally be used in combination with intermediate-acting or long-acting insulin preparations. Moreover NovoRapid ® can be used for continuous infusion in a pump system. 3. BEFORE YOU USE NOVORAPID ® _- WHEN YOU MUST NOT USE IT _ _ _ ► IF YOU ARE ALLERGIC (HYPERSENSITIVE) to insulin aspart or any of the other ingredients in NovoRapid ® (see section 8. _Product _ _Description_ ). ► IF YOU SUSPECT HYPOGLYCAEMIA (LOW BLOOD SUGAR) is starting (see section 4. _How to use NovoRapid_ _®_ ). ► IF FLEXPEN ® IS DROPPED, DAMAGED OR CRUSHED. ► IF IT HAS NOT BEEN STORED CORRECTLY or if it has been frozen (see section 7. _Storage _ _and _ _Disposal _ _of _ _NovoRapid_ _®_ ). ► IF THE INSULIN DOES NOT APPEAR CLEAR AND COLOURLESS. _- BEFORE YOU START TO USE IT _ ►CHECK THE LABEL TO MAKE SURE it is the right type of insulin. ►ALWAYS USE A NEW NEEDLE for each injection to prevent contamination. ►NEEDLES AND NOVORAPID ® FLEXPEN ® MUST NOT Lire le document complet
NovoRapid ® FlexPen ® Professional Leaflet STF-Mar-2018_site Denmark 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 in children and Lire le document complet