Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin Detemir
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
Insulin Detemir
3 ml x 5 Units
Novo Nordisk Production SAS
LEVEMIR ® FLEXPEN ® 100 U/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN Insulin detemir 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ WHAT IS IN THIS LEAFLET 1. What Levemir ® is used for 2. How Levemir ® works 3. Before you use Levemir ® 4. How to use Levemir ® 5. While you are using it 6. Side effects 7. Storage and disposal of Levemir ® 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT LEVEMIR ® IS USED FOR Levemir ® 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 LEVEMIR ® WORKS Levemir ® is a modern insulin (insulin analogue) with a long-acting effect (up to 24 hours). Modern insulin products are improved versions of human insulin. In treatment of type 2 diabetes mellitus, Levemir ® may also be used in combination with oral antidiabetic medicines and/or with injectable antidiabetic products other than insulin. Levemir ® can also be used with meal-related rapid-acting insulin products. Compared to other insulin products, therapy with Levemir ® is associated with less weight gain. 3. BEFORE YOU USE LEVEMIR ® _- WHEN YOU MUST NOT USE IT _ _►_IF YOU ARE ALLERGIC (HYPERSENSITIVE) to insulin detemir or any of the other ingredients in Levemir ® (see section 8. _Product description_ ). ►IF YOU SUSPECT HYPOGLYCAEMIA (LOW BLOOD SUGAR) is starting (see section 4. _How to use Levemir_ _®_ ). ► 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_ _ _ _Levemir_ _®_ _)._ ► IF THE INSULIN DOES NOT APPEAR WATER 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 LEVEMIR ® FLEXPEN ® MUST N Прочитать полный документ
Levemir ® FlexPen ® Professional Leaflet STF-Aug-2021 site France_8-XXXX-XX-XXX-X Based on EU text: 20210406_EN_07209_LEV_42-5 1 LEVEMIR ® _ _ 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 detemir* (equivalent to 14.2 mg). 1 pre-filled pen contains 3 ml equivalent to 300 U. *Insulin detemir is produced by recombinant DNA technology in _Saccharomyces cerevisiae._ 1 unit (U) of insulin detemir corresponds to 1 international unit (IU) of human insulin. PHARMACEUTICAL FORM Clear, colourless, neutral 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 Levemir ® is a soluble, basal insulin analogue with a prolonged duration of effect (up to 24 hours). Compared to other insulin products, basal-bolus therapy with Levemir ® is not associated with weight gain. The lower risk of nocturnal hypoglycaemia compared to NPH (Neutral Protamine Hagedorn) insulin allows a more intensive titration towards target blood glucose levels for basal-bolus therapy. Levemir ® provides better glycaemic control as measured by Fasting Plasma Glucose (FPG) compared to NPH insulin treatment. Levemir ® can be used alone as the basal insulin or in combination with bolus insulin. It can also be used in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists. DOSAGE When Levemir ® is used in combination with oral antidiabetic medicinal products or when added to GLP-1 receptor agonists, it is recommended to use Levemir ® once daily, initially at a dose of 0.1–0.2 U/kg, or of 10 U IN ADULT PATIENTS. The dose of Levemir ® should be titrated based on the individual patient’s needs. When a GLP-1 receptor agonist is added to Levemir ® , it is recommended to reduce the dose of Levemir ® by 20% to minimise the risk of hypoglycaemia. Subsequently, dosage should be adjusted individually. For Прочитать полный документ