国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin Glargine
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
Insulin Glargine
1Units Units; 5Units Units
Sanofi-Aventis Deutschland GmbH
1 MY/LAN VIAL/1220/CCDS V20 LANTUS VIAL PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Lantus 100 units/ml solution for injection in a vial 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units insulin glargine* (equivalent to 3.64 mg). Each vial contains 10 ml of solution for injection, equivalent to 1000 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. Clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. 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 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. _Paediatric population _ • Adolescents and children aged 2 years and older patients Safety and efficacy of Lantus have been established in adolescents and children aged 2 years and older (see section 5.1). The dose regimen (dose and timing) should be in 完全なドキュメントを読む