Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen.
Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear colourless solution. |
Each ml contains 300 units insulin glargine* (equivalent to 10.91 mg).
SoloStar pen: Each pen contains 1.5 ml of solution for injection, equivalent to 450 units.
DoubleStar pen: Each pen contains 3 ml of solution for injection, equivalent to 900 units.
* Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Insulin glargine |
Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. After injection, the acidic solution is neutralised leading to formation of a precipitate from which small amounts of insulin glargine are continuously released. |
| List of Excipients |
|---|
|
Zinc chloride |
Cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed in a disposable pen injector. Each cartridge contains 1.5 ml solution.
Packs of 1, 3, 5 and 10 pens are available. Not all pack sizes may be marketed.
Needles are not included in the pack.
Cartridge (type 1 colourless glass) with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed in a disposable pen injector. Each cartridge contains 3 ml solution.
Packs of 1, 3, 6 (2 packs of 3), 9 (3 packs of 3) and 10 pens are available. Not all pack sizes may be marketed.
Needles are not included in the pack.
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
EU/1/00/133/033
EU/1/00/133/034
EU/1/00/133/035
EU/1/00/133/036
EU/1/00/133/037
EU/1/00/133/038
EU/1/00/133/039
EU/1/00/133/040
EU/1/00/133/041
Date of first authorisation: 27 June 2000
Date of latest renewal: 17 February 2015
| Drug | Countries | |
|---|---|---|
| TOUJEO | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Tunisia, Turkey, United Kingdom, United States, South Africa |
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