SOLIQUA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 100UNITSML + 33MCGML

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Aktif bileşen:

Insulin glargine; Lixisenatide

Mevcut itibaren:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC kodu:

A10AE54

Farmasötik formu:

INJECTION, SOLUTION

Kompozisyon:

Insulin glargine 100 Units/ml; Lixisenatide 33μg/mL

Uygulama yolu:

SUBCUTANEOUS

Reçete türü:

Prescription Only

Tarafından üretildi:

Sanofi-Aventis Deutschland GmbH

Yetkilendirme durumu:

ACTIVE

Yetkilendirme tarihi:

2018-09-20

Ürün özellikleri

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