Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
INSULIN LISPRO (RDNA)
ZUELLIG PHARMA SDN BHD
INSULIN LISPRO (RDNA)
5 Pieces
ELI LILLY AND COMPANY
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ LYUMJEV KWIKPEN 3ML (100IU/ML), SOLUTION FOR INJECTION IN PRE-FILLED PEN Insulin lispro 1 WHAT IS IN THIS LEAFLET 1. What Lyumjev KwikPen is used for 2. How Lyumjev KwikPen works 3. Before you use Lyumjev KwikPen 4. How to use Lyumjev KwikPen 5. While you are using Lyumjev KwikPen 6. Side Effects 7. Storage and Disposal of Lyumjev KwikPen 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT LYUMJEV KWIKPEN IS USED FOR Lyumjev KwikPen is used to treat diabetes in adults. HOW LYUMJEV KWIKPEN WORKS Lyumjev KwikPen contains the active ingredient insulin lispro. It is a mealtime insulin that works more quickly than other medicine containing insulin lispro. Lyumjev contains ingredients that speed up absorption of insulin lispro into the body. Diabetes is a condition in which your body does not make enough insulin or does not use insulin effectively, which results in effects such as high levels of sugar in the blood. Lyumjev is an insulin medicine that is used in the treatment of diabetes and so controls blood sugar. Effective treatment of diabetes, with good control of blood sugar, prevents long-term complications from your diabetes. Treatment with Lyumjev helps to control blood sugar in the long term and prevent complications from your diabetes. Lyumjev has its maximum effect 1 to 3 hours after injection and the effect lasts for up to 5 hours. You should use Lyumjev at the start of the meal, or up to 20 minutes after starting the meal. Your doctor may tell you to use Lyumjev as well as a longer- or intermediate- acting insulin. Do not change your insulin unless your doctor tells you to. BEFORE YOU USE LYUMJEV KWIKPEN - _When you must not use it _ Do NOT use Lyumjev KwikPen • if you think your blood sugar is dropping (hypoglycaemia). Further on, this leaflet tells you how to deal with low blood sugar (see Section ‘If you use too much (overdose)’). • if you are allergic to insulin lispro or any of Læs hele dokumentet
1 1. NAME OF THE MEDICINAL PRODUCT Lyumjev KwikPen Injection 3mL (100 IU/mL), solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 100 units of insulin lispro* (equivalent to 3.5 mg). Lyumjev KwikPen Injection 3mL (100 IU/mL), solution for injection in pre-filled pen Each pre-filled pen contains 300 units of insulin lispro in 3 mL solution. Each KwikPen delivers 1-60 units in steps of 1 unit in a single injection. *produced in _E.coli_ by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Lyumjev is a mealtime insulin for subcutaneous injection and should be administered zero to two minutes before the start of the meal, with the option to administer up to 20 minutes after starting the meal (see section 5.1). The initial dose should take into account the type of diabetes, weight of the patient and their blood glucose levels. The early onset of action must be considered when prescribing Lyumjev (see section 5.1). Continued adjustment of the dose of Lyumjev should be based on the patient’s metabolic needs, blood glucose monitoring results, and glycaemic control goal. Dose adjustments may be needed, when switching from another insulin, with changes in physical activity, changes in concomitant medicinal products, changes in meal patterns (i.e., amount and type of food, timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycaemia or hyperglycaemia (see sections 4.4 and 4.5). _Switching from another mealtime insulin medicinal product _ _ _ If converting from another mealtime insulin to Lyumjev, the change can be done on a unit-to-unit basis. The potency of insulin analogues, including Lyumjev, is expressed in units. One (1) unit of 2 Lyumjev corresponds to 1 Læs hele dokumentet