국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
INSULIN LISPRO (RDNA)
ZUELLIG PHARMA SDN BHD
INSULIN LISPRO (RDNA)
5Pieces Pieces
LILLY FRANCE
HUMALOG KWIKPEN INJECTION 3 ML (100 IU/ML) Insulin lispro 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Humalog KwikPen is used for 2. How Humalog KwikPen works 3. Before you use Humalog KwikPen 4. How to use Humalog KwikPen 5. While you are using Humalog KwikPen 6. Side effects 7. Storage and Disposal of Humalog KwikPen 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT HUMALOG KWIKPEN IS USED FOR Humalog KwikPen is used to treat diabetes. It works more quickly than normal human insulin because the insulin molecule has been changed slightly. HOW HUMALOG KWIKPEN WORKS You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally use Humalog within 15 minutes of a meal. Your doctor may tell you to use Humalog KwikPen as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin. Humalog is suitable for use in adults and children. BEFORE YOU USE HUMALOG KWIKPEN - _When you must not use it _ Do not use Humalog KwikPen: - If you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section ‘If you use too much (overdose)’). - If you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of Humalog KwikPen (see Section ‘Product Description’). - _Before you start to use it_ - If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about 전체 문서 읽기
Humalog KP PI_EUSPC 03Sep2020_21June2021 1. NAME OF THE MEDICINAL PRODUCT Humalog KwikPen Injection 3ml (100 IU/ML), solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg). 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. *produced in _E.coli _ by recombinant DNA technology. For a 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 For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be determined by the physician, according to the requirement of the patient. Humalog may be given shortly before meals. When necessary Humalog can be given soon after meals. Humalog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with soluble insulin. This rapid onset of activity allows a Humalog injection (or, in the case of administration by continuous subcutaneous infusion, a Humalog bolus) to be given very close to mealtime. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. The faster onset of action compared to soluble human insulin is maintained regardless of injection site. As with all insulin preparations, the duration of action of Humalog is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humalog can be used in conjunction with a longer-acting insulin or oral sulphonylurea agents, on the advice of a physician. _Special populations _ _Renal impairment _ Insulin requirements may be reduced in the presence of renal impairment 전체 문서 읽기