Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Insulin glargine; Lixisenatide
SANOFI-AVENTIS SINGAPORE PTE. LTD.
A10AE54
INJECTION, SOLUTION
Insulin glargine 100 Units/ml; Lixisenatide 33μg/mL
SUBCUTANEOUS
Prescription Only
Sanofi-Aventis Deutschland GmbH
ACTIVE
2018-09-20
SG/SOL50/0923/EU SmPC Dec2022+ SL statement 1 1. NAME OF THE MEDICINAL PRODUCT Soliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Soliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Soliqua 100 units/ml + 50 microgram/ml solution for injection in a pre-filled pen Each pre-filled pen contains 300 units of insulin glargine* and 150 micrograms lixisenatide in 3 ml solution. Each ml contains 100 units of insulin glargine and 50 micrograms lixisenatide. Each dose step contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide Soliqua 100units/ml + 33 microgram/ml solution for injection in a pre-filled pen Each pre-filled pen contains 300 units of insulin glargine and 100 micrograms Lixisenatide in 3 ml solution. Each ml contains 100 units of insulin glargine and 33 micrograms lixisenatide. Each dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide *Insulin glargine is produced by recombinant DNA technology in _Escherichia coli_ . The dose window on the pen shows the number of dose steps. Excipient(s) with known effects: Each ml contains 2.7 milligrams of metacresol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). SoloStar Clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Soliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors. (For study results with respect to effect on glycaemic control, and the populations studied, see section 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Soliqua is available in two pre-filled pens, providing different dosing options, i.e. Soliqua (10-40) pen, Soliqua (30-60) pen respectively. The differentiation between the pen strengths is based on the dose range of the pen. • Soliqu Read the complete document