Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
INSULIN LISPRO
ELI LILLY (SINGAPORE) PTE LTD
A10AB04
100 iu/ml
INJECTION
INSULIN LISPRO 100 iu/ml
SUBCUTANEOUS
Prescription Only
Eli Lilly and Company (for Vial)
ACTIVE
1997-11-08
Page 1 of 15 1. NAME OF THE MEDICINAL PRODUCT Humalog Injection 100 iu/ml (vial) Humalog KwikPen 100 units/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg). Vial Each vial contains 1000 units insulin lispro in 10 ml solution. KwikPen Each KwikPen 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. Humalog is a sterile, clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Vial For the treatment of patients with diabetes mellitus for the control of hyperglycemia. KwikPen 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 dosage should be determined by the physician, according to the requirement of the patient. Page 2 of 15 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 sulphonylure Les hele dokumentet
Page 1 of 15 1. NAME OF THE MEDICINAL PRODUCT Humalog Injection 100 iu/ml (vial) Humalog KwikPen 100 units/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg). Vial Each vial contains 1000 units insulin lispro in 10 ml solution. KwikPen Each KwikPen 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. Humalog is a sterile, clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Vial For the treatment of patients with diabetes mellitus for the control of hyperglycemia. KwikPen 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 dosage should be determined by the physician, according to the requirement of the patient. Page 2 of 15 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 sulphonylure Les hele dokumentet