Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
INSULIN ASPART; Insulin Degludec
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
INSULIN ASPART; Insulin Degludec
1 Pre-Filled Syringes; 5 Pre-Filled Syringes
NOVO NORDISK A/S
RYZODEG ® FlexTouch ® 100 UNITS/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN _ _ _ _ _ Consumer Medication Information Leaflet (RiMUP) _ insulin degludec/insulin aspart_ _ 1 WHAT IS IN THIS LEAFLET 1. What Ryzodeg ® is used for 2. How Ryzodeg ® works 3. Before you use Ryzodeg ® 4. How to use Ryzodeg ® 5. While you are using it 6. Side effects 7. Storage and disposal of Ryzodeg ® 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT RYZODEG ® IS USED FOR Ryzodeg ® is used to treat diabetes mellitus in adults, adolescents and children from the age of 2 years. Ryzodeg ® helps your body reduce your blood sugar level. 2. HOW RYZODEG ® WORKS Ryzodeg ® contains two types of insulin: Basal insulin called insulin degludec – this has a long blood- sugar-lowering effect. Rapid-acting insulin called insulin aspart – this lowers your blood sugar soon after you inject it. 3. BEFORE YOU USE RYZODEG ® _ _ _- WHEN YOU MUST NOT USE IT _ ► If you are allergic to insulin degludec, insulin aspart 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 Ryzodeg ® . 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_ Side 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 _Thiazolidinediones_ below. Eye disorder – fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disorder. If you experience eye problems, talk to your doctor. Ensuring you use the right type of insulin – always Leggi il documento completo
Ryzodeg ® FlexTouch ® 100 U/ml Professional Leaflet STF-Dec-2020 8-9564-00-009-1 Based on EU text: 20200618_EN_06949_RYZ_12-3 1 of 22 1. NAME OF THE MEDICINAL PRODUCT RYZODEG ® FlexTouch ® 100 units/ml Solution for injection in pre-filled pen. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 100 units insulin degludec/insulin aspart* in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart). One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 ml solution. *Produced in _Saccharomyces cerevisiae _by recombinant DNA technology. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless, neutral solution. 4. CLINICAL PARTICULARES 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Ryzodeg ® is a soluble insulin product consisting of the basal insulin degludec and the rapid-acting prandial insulin aspart. The potency of insulin analogues, including Ryzodeg ® , is expressed in units. One (1) unit of this insulin corresponds to 1 international unit of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir or 1 unit of biphasic insulin aspart. Ryzodeg ® is to be dosed in accordance with the individual patient’s needs. Dose-adjustments are recommended to be based on fasting plasma glucose measurements. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. _Patients with type 2 diabetes mellitus_ Ryzodeg ® can be administered once or twice daily with the main meal(s) alone, in combination with oral antidiabetic medicinal products, and in combination with bolus insulin (see section 5.1). When using Ryzodeg ® once-daily, changing to twice daily should be considered when higher doses are needed, e.g. to avoid hypoglycaemia. Split the dose based on individual patient’s ne Leggi il documento completo