APIDRA Solution for injection Ref.[9168] Active ingredients: Insulin glulisine

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Sanofi-Aventis Deutschland GmbH, D-65926, Frankfurt am Main, Germany

Product name and form

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.

Qualitative and quantitative composition

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
Sodium chloride
Trometamol
Polysorbate 20
Hydrochloric acid, concentrated
Sodium hydroxide
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Sanofi-Aventis Deutschland GmbH, D-65926, Frankfurt am Main, Germany

Marketing authorization dates and numbers

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

Drugs

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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