Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands
Humalog 100 units/ml, solution for injection in vial.
Humalog 100 units/ml, solution for injection in cartridge.
Humalog 100 units/ml KwikPen, solution for injection in a pre-filled pen.
Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless, aqueous solution. |
Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg).
Vial: Each vial contains 1000 units insulin lispro in 10 ml solution.
Cartridge: Each cartridge contains 300 units of insulin lispro in 3 ml solution.
KwikPen: Each pre-filled pen contains 300 units of insulin lispro in 3 ml solution. Each KwikPen delivers 1-60 units in steps of 1 unit.
Junior KwikPen: Each pre-filled pen contains 300 units of insulin lispro in 3 ml solution. Each Junior KwikPen delivers 0.5-30 units in steps of 0.5 units.
* produced in E.coli by recombinant DNA technology.
For a 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 |
The solution is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the vial stoppers.
10 ml Vial: Packs of 1 or 2 or a multipack of 5 (5 packs of 1). Not all packs may be marketed
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads, and are secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the cartridge plungers, and/or the glass cartridges.
3 ml Cartridge: Packs of 5 or 10. Not all packs may be marketed
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads and are 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 are sealed in a disposable pen injector, called the “KwikPen”. Needles are not included.
3 ml KwikPen: Packs of 5 or a multipack of 10 (2 packs of 5). Not all packs may be marketed.
Junior KwikPen
Type I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutyl plunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 ml cartridges are sealed in a disposable pen injector, called the “Junior KwikPen”. Needles are not included.
3 ml Junior KwikPen: Packs of 1, 5 or a multipack of 10 (2 packs of 5). Not all packs may be marketed
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands
EU/1/96/007/002
EU/1/96/007/004
EU/1/96/007/020
EU/1/96/007/021
EU/1/96/007/023
EU/1/96/007/031
EU/1/96/007/032
EU/1/96/007/043
EU/1/96/007/044
EU/1/96/007/045
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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