Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
Insulin glargine
SANOFI-AVENTIS SINGAPORE PTE. LTD.
A10AE04
100 iu/ml
INJECTION, SOLUTION
Insulin glargine 100 iu/ml
SUBCUTANEOUS
Prescription Only
SANOFI-AVENTIS DEUTSCHLAND GMBH
ACTIVE
2008-03-18
1 1.4.3 Proposed clean PI Lantus SoloStar 1. NAME OF THE MEDICINAL PRODUCT Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units insulin glargine (equivalent to 3.64 mg). Each pen contains 3 ml of solution for injection, equivalent to 300 units. Insulin glargine is produced by recombinant DNA technology in _Escherichia coli_. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in a pre-filled pen SoloStar. Lantus is a clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Lantus should be administered once daily at any time but at the same time each day. The Lantus dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to Lantus and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). Special population _Elderly population (_ _≥65 years old)_ In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements. _Renal impairment_ In patients with renal impairment, insulin requirements may be diminished due to reduced insulin Przeczytaj cały dokument
1 SG/ L AN SOLO/1120/CCDS V20 1. NAME OF THE MEDICINAL PRODUCT Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units insulin glargine*(equivalent to 3.64 mg). Each pen contains 3 ml of solution for injection, equivalent to 300 units. *Insulin glargine is produced by recombinant DNA technology in _Escherichia coli_ . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in a pre-filled pen SoloStar. Lantus is a clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Lantus should be administered once daily at any time but at the same time each day. The Lantus dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to Lantus and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). _Special population _ _Elderly population (≥65 years old) _ In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements. _Renal impairment _ In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism. _Hepatic impairment _ In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. _Children _ In children, efficacy and safety of Lantus have only been demonstrated when given in the evening. Due to limited experience, the efficacy and safety o Przeczytaj cały dokument