Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Sanofi-Aventis Deutschland GmbH, D-65926, Frankfurt am Main, Germany
Apidra 100 Units/ml solution for injection in a vial.
Apidra 100 Units/ml solution for injection in a cartridge.
Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen.
| Pharmaceutical Form |
|---|
|
Apidra 100 Units/ml solution for injection in a vial: Solution for injection in a vial. Apidra 100 Units/ml solution for injection in a cartridge: Solution for injection in a cartridge. Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen: Solution for injection in a pre-filled pen. Clear, colourless, aqueous solution. |
Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Apidra 100 Units/ml solution for injection in a vial: Each vial contains 10 ml of solution for injection, equivalent to 1000 Units.
Apidra 100 Units/ml solution for injection in a cartridge: Each cartridge contains 3 ml of solution for injection, equivalent to 300 Units.
Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen: Each pen contains 3 ml of solution for injection, equivalent to 300 Units.
Insulin glulisine is produced by recombinant DNA technology in Escherichia coli.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Insulin glulisine |
Insulin glulisine is a recombinant human insulin analogue that is equipotent to regular human insulin. Insulin glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin. |
| List of Excipients |
|---|
|
Metacresol |
Apidra 100 Units/ml solution for injection in a vial: 10 ml solution in a vial (type I colourless glass) with a stopper (flanged aluminium overseal, elastomeric chlorobutyl rubber) and a polypropylene tear-off cap. Packs of 1, 2, 4 and 5 vials are available.
Not all pack sizes may be marketed.
Apidra 100 Units/ml solution for injection in a cartridge: 3 ml solution in a cartridge (type I colourless glass) with a plunger (elastomeric bromobutyl rubber) and a flanged cap (aluminium) with a stopper (elastomeric bromobutyl rubber). Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges are available.
Not all pack sizes may be marketed.
Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen: 3 ml solution in a cartridge (colourless glass) with a plunger (elastomeric bromobutyl rubber) and a flanged cap (aluminium) with a stopper (elastomeric bromobutyl rubber). The cartridge is sealed in a disposable pre-filled pen. Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pens are available.
Not all pack sizes may be marketed.
Sanofi-Aventis Deutschland GmbH, D-65926, Frankfurt am Main, Germany
Apidra 100 Units/ml solution for injection in a vial: EU/1/04/285/001-004
Apidra 100 Units/ml solution for injection in a cartridge: EU/1/04/285/005-012
Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen: EU/1/04/285/029-036
Date of first authorisation: 27 September 2004
Date of latest renewal: 20 August 2009
| Drug | Countries | |
|---|---|---|
| APIDRA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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