Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
Lantus 100 units/ml solution for injection in a vial.
Lantus 100 units/ml solution for injection in a cartridge.
Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear colourless solution. |
Each ml contains 100 units insulin glargine* (equivalent to 3.64 mg).
Lantus 100 units/ml solution for injection in a vial: Each vial contains 5 ml of solution for injection, equivalent to 500 units, or 10 ml of solution for injection, equivalent to 1000 units.
Lantus 100 units/ml solution for injection in a cartridge, Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen: Each cartridge or pen contains 3 ml of solution for injection, equivalent to 300 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 |
|---|
|
5 ml vial, cartridge, SoloStar pre-filled pen: Zinc chloride 10 ml vial: Zinc chloride |
5 ml vial: Type 1 colourless glass vial with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene) containing 5 ml of solution.
Packs of 1, 2, 5 and 10 vials.
10 ml vial: Type 1 colourless glass vial with a flanged cap (aluminium), a stopper (type 1, laminate of polyisoprene and bromobutyl rubber) and a tear-off cap (polypropylene) containing 10 ml of solution.
Pack of 1 vial.
Not all pack sizes may be marketed.
Type 1 colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber) containing 3 ml of solution.
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges.
Not all pack sizes may be marketed.
Type 1 colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber) containing 3 ml of solution.
The cartridge is sealed in a disposable pen injector. Needles are not included in the pack.
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 SoloStar pre-filled pens.
Not all pack sizes may be marketed.
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
EU/1/00/134/001-004
EU/1/00/134/005-007
EU/1/00/134/012
EU/1/00/134/013-017
EU/1/00/134/030-037
Date of first authorisation: 9 June 2000
Date of latest renewal: 17 February 2015
| Drug | Countries | |
|---|---|---|
| LANTUS | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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