Land: Indonesien
Sprog: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
INSULIN GLARGINE, LIXISENATIDE
AVENTIS PHARMA - Indonesia
INSULIN GLARGINE, LIXISENATIDE
100 IU/ML /33 MCG/ML
LARUTAN INJEKSI
DUS, 3 PREFILLED PEN @ 3 ML
SANOFI-AVENTIS DEUTSCHLAND GMBH - Federal Republic of Germany
2019-08-28
1 of 21 SOLIQUA _Insulin glargine and lixisenatide _ Solution for injection 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 in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product (sulfonylurea, glinid, DPP-4 inhibitors or gliptins, and Sodium-glucose co-transporter 2 ( _SGLT2_ ) _inhibitors_ or gliflozin) or with basal insulin (see section 4.4 and 5.1 for available data on the different combinations). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DISETUJUI OLEH BPOM 12/06/19 EREG10002211800006 2 of 21 Soli Læs hele dokumentet