国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin Aspart
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
Insulin Aspart
3ml x 5 Units
Novo Nordisk Production SAS
NOVOMIX ® 30 FLEXPEN ® 100 U/ML SUSPENSION FOR INJECTION IN A PRE-FILLED PEN Insulin aspart (30% soluble insulin aspart and 70% insulin aspart crystallised with protamine) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ WHAT IS IN THIS LEAFLET 1. What NovoMix ® 30 is used for 2. How NovoMix ® 30 works 3. Before you use NovoMix ® 30 4. How to use NovoMix ® 30 5. While you are using it 6. Side effects 7. Storage and disposal of NovoMix ® 30 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT NOVOMIX ® 30 IS USED FOR NovoMix ® 30 is used to treat patients with diabetes mellitus (diabetes) requiring insulin. Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. 2. HOW NOVOMIX ® 30 WORKS NovoMix ® 30 is a modern insulin (insulin analogue) with both a rapid- acting and an intermediate-acting effect, in the ratio 30/70. Modern insulin products are improved versions of human insulin. NovoMix ® 30 will start to lower your blood sugar 10-20 minutes after you take it, a maximum effect occurs between 1 and 4 hours after the injection and the effect will last for up to 24 hours. In treatment of type 2 diabetes mellitus, NovoMix ® 30 may be used in combination with tablets for diabetes and/or with injectable antidiabetic products. 3. BEFORE YOU USE NOVOMIX ® 30 - _WHEN YOU MUST NOT USE IT _ _ _ ► IF YOU ARE ALLERGIC (HYPERSENSITIVE) to insulin aspart or any of the other ingredients in NovoMix ® 30 (see section 8. _Product description_ ). ► IF YOU SUSPECT HYPOGLYCAEMIA (low blood sugar) is starting (see section 4. _How to use NovoMix_ _®_ _ _ _30_ ). ►IN INSULIN INFUSION PUMPS. ►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 _ _NovoMix_ _®_ _ 30_ ). ► IF THE RESUSPENDED INSULIN DOES NOT APPEAR UNIFORMLY WHITE AND CLOUDY. ►IF AFTER RE-SUSPENSION CLUMPS of material are present or if sol 完全なドキュメントを読む
NovoMix ® 30 FlexPen ® Professional leaflet STF-Mar-2021_site France 8-XXXX-XX-XXX-1 1 NOVOMIX ® 30 FlexPen ® 100 U/ml Suspension for injection in a pre-filled pen. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of the suspension contains 100 U of soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 30/70 (equivalent to 3.5 mg). 1 pre-filled pen contains 3 ml equivalent to 300 U. *Insulin aspart produced by recombinant DNA technology in _Saccharomyces cerevisiae._ PHARMACEUTICAL FORM: White suspension for injection in a pre-filled pen. FlexPen ® . THERAPEUTIC INDICATIONS: Treatment of patients with diabetes mellitus requiring insulin. POSOLOGY NovoMix ® 30 dosing is individual and determined in accordance with the needs of the patient. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control. In patients with type 2 diabetes, NovoMix ® 30 can be given as monotherapy. NovoMix ® 30 can also be given in combination with oral antidiabetic drugs and/or GLP-1 receptor agonists. HOW TO START Insulin naïve patients: For patients with type 2 diabetes, the recommended starting dose of NovoMix ® 30 is 6 U at breakfast and 6 U at dinner (evening meal). However, it can also be initiated once daily with 12 U at dinner (evening meal). HOW TO SWITCH When transferring a patient from biphasic human insulin to NovoMix ® 30, start with the same dose and regimen. Then titrate according to individual needs (see _The following titration guideline_ ). As with all insulin products, close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see _Transfer from other insulin products_ ). HOW TO INTENSIFY NovoMix ® 30 can be intensified from once daily to twice daily. When using NovoMix ® 30 once daily, it is generally recommended to move to twice daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses (50:50). From NovoMix ® 30 twice daily to thrice daily: the morning dose can be split 完全なドキュメントを読む