SOLIQUA

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

INSULIN GLARGINE, LIXISENATIDE

Tersedia dari:

AVENTIS PHARMA - Indonesia

INN (Nama Internasional):

INSULIN GLARGINE, LIXISENATIDE

Dosis:

100 IU/ML /33 MCG/ML

Bentuk farmasi:

LARUTAN INJEKSI

Unit dalam paket:

DUS, 3 PREFILLED PEN @ 3 ML

Diproduksi oleh:

SANOFI-AVENTIS DEUTSCHLAND GMBH - Federal Republic of Germany

Tanggal Otorisasi:

2019-08-28

Karakteristik produk

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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
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Soli