국가: 이스라엘
언어: 영어
출처: Ministry of Health
INSULIN GLARGINE
SANOFI ISRAEL LTD
N/A
SOLUTION FOR INJECTION
INSULIN GLARGINE 100 U/ML
S.C
Required
SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY
Treatment of adult and pediatric patients, 6 years and over, with type 1 diabetes mellitus or adults patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia.
2021-12-31
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1 _LAN‐SPC‐20.0 _ 1. NAME OF THE MEDICINAL PRODUCT LANTUS 100 UNITS/ML solution for injection in a vial LANTUS 100 UNITS/ML solution for injection in a pre-filled pen SoloStar 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units of insulin glargine* (equivalent to 3.64 mg). Lantus 100 units/ml solution for injection in a vial Each vial contains 10 ml of solution for injection, equivalent to 1000 units. Lantus 100 units/ml solution for injection in a pre-filled pen SoloStar Each cartridge or pen contains 3 ml of solution for injection, equivalent to 300 units. *Insulin glargine is produced by recombinant DNA technology in Escherichia coli . For a 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 adult and paediatric patients 6 years and over with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycaemia. 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. 2 Hepatic impairment In patients with hepatic impairment, i 전체 문서 읽기