Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands
Humalog 200 units/ml KwikPen, solution for injection in a pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless, aqueous solution. |
Each ml contains 200 units insulin lispro* (equivalent to 6.9 mg).
Each pre-filled pen contains 600 units of insulin lispro in 3 ml solution.
Each KwikPen delivers 1-60 units in steps of 1 unit.
* produced in E.coli by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Insulin lispro |
The primary activity of insulin lispro is the regulation of glucose metabolism. |
| List of Excipients |
|---|
|
m-Cresol |
Type I glass cartridges, sealed with halobutyl disc seals and plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges which contain 600 units insulin lispro (200 units/ml), are sealed in a disposable pen injector, called the “KwikPen”. Needles are not included.
1 pre-filled pen of 3 ml.
2 pre-filled pens of 3 ml.
5 pre-filled pens of 3 ml.
Multipacks containing 10 (2 packs of 5) pre-filled pens of 3 ml.
Not all packs may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands
EU/1/96/007/039
EU/1/96/007/040
EU/1/96/007/041
EU/1/96/007/042
Date of first authorisation: 30th April 1996
Date of last renewal: 30th April 2006
| Drug | Countries | |
|---|---|---|
| HUMALOG | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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