Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin Degludec
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
Insulin Degludec
1 Pre-Filled Syringes; 5 Pre-Filled Syringes
NOVO NORDISK A/S
TRESIBA ® FLEXTOUCH ® SOLUTION FOR INJECTION _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ Insulin Degludec (100U/ml & 200 U/ml) 1 WHAT IS IN THIS LEAFLET 1. What Tresiba ® is used for 2. How Tresiba ® works 3. Before you use Tresiba ® 4. How to use Tresiba ® 5. While you are using it 6. Side effects 7. Storage and disposal of Tresiba ® 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number 1. WHAT TRESIBA ® IS USED FOR It is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Tresiba ® helps your body reduce your blood sugar level. 2. HOW TRESIBA ® WORKS Tresiba ® is a long-acting basal insulin called insulin degludec. It is used for once-daily dosing. On occasions when you cannot follow your regular dosing schedule, you can change the time of dosing because Tresiba ® has a long blood sugar-lowering effect. In type 2 diabetes mellitus, Tresiba ® may be used in combination with tablets for diabetes or with injectable antidiabetic products other than insulin. In type 1 diabetes mellitus, Tresiba ® must always be used in combination with meal-related rapid-acting insulin products. 3. BEFORE YOU USE TRESIBA ® _ _ _- WHEN YOU MUST NOT USE IT _ If you are allergic to insulin degludec or any of the other ingredients of this medicine (listed in section 8). _- BEFORE YOU START TO USE IT _ Talk to your doctor, pharmacist or nurse before using Tresiba ® . Be especially aware of the following: Low blood sugar (hypoglycaemia) – if your blood sugar is too low, follow the guidance for low blood sugar in section 6 S_ide effects_. High blood sugar (hyperglycaemia) – if your blood sugar is too high, follow the guidance for high blood sugar in section 6 S_ide effects_. Switching from other insulin products – the insulin dose may need to be changed if you switch from another type, brand or manufacturer of insulin. Talk to your doctor. Thiazolidinediones used together with insulin, see _Thiazolidine Đọc toàn bộ tài liệu
Tresiba ® FlexTouch ® 100 U/ml Professional leaflet EN-Mar-2021 8-9560-00-010-1 Based on EU text: 20200928_EN_07216_TRE_15-3 1 of 23 TRESIBA ® FlexTouch ® 100 units/ml Solution for injection in pre-filled pen. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 100 units insulin degludec* (equivalent to 3.66 mg insulin degludec). One pre-filled pen contains 300 units of insulin degludec in 3 ml solution. *Produced in _Saccharomyces cerevisiae_ by recombinant DNA technology. For the full list of excipients, see _List of excipients._ PHARMACEUTICAL FORM Solution for injection. Clear, colourless, neutral solution. THERAPEUTIC INDICATIONS Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Tresiba ® is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day. The potency of insulin analogues, including insulin degludec, is expressed in units (U). One (1) unit (U) of insulin degludec corresponds to 1 international unit (IU) of human insulin, 1 unit of insulin glargine (100 units/ml) or 1 unit of insulin detemir. In patients with type 2 diabetes mellitus, Tresiba ® can be administered alone or in any combination with oral antidiabetic medicinal products, GLP-1 receptor agonists and bolus insulin (see _Pharmacodynamic _ _properties_). In type 1 diabetes mellitus, Tresiba ® must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements. Tresiba ® is to be dosed in accordance with the individual patient’s needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose (FPG). As with all insulin products, adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. _ _ _Tresiba_ _®_ _ 100 units/ml and Tresiba_ _®_ _ 200 units/ml _ Tresiba ® is available in two strengths. For both, the needed dose is dial Đọc toàn bộ tài liệu