Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands
Humalog Mix25 100 units/ml, suspension for injection in vial.
Humalog Mix25 100 units/ml, suspension for injection in cartridge.
Humalog Mix25 100 units/ml KwikPen, suspension for injection in a pre-filled pen.
| Pharmaceutical Form |
|---|
|
Suspension for injection. White suspension. |
Each ml contains 100 units insulin lispro* (equivalent to 3.5mg).
Humalog Mix25 consists of 25% insulin lispro solution and 75% insulin lispro protamine suspension.
Vial: Each vial contains 1000 units of insulin lispro in 10 ml suspension.
Cartridge: Each cartridge contains 300 units of insulin lispro in 3 ml suspension.
KwikPen: Each pre-filled pen contains 300 units of insulin lispro in 3 ml suspension. Each KwikPen delivers 1-60 units in steps of 1 unit.
* 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 |
|---|
|
Protamine sulphate |
The suspension is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with aluminium seals. Dimeticone or silicone emulsion may have been used to treat the vial stoppers.
10 ml Vial: Pack of 1. Not all packs may be marketed.
The suspension is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may have been used to treat the cartridge plunger, and/or the glass cartridge.
3 ml Cartridge: Packs of 5 or 10. Not all packs may be marketed.
The suspension is contained in type I flint glass cartridges, sealed with halobutyl disc seals and plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may have been 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.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands
EU/1/96/007/005
EU/1/96/007/008
EU/1/96/007/024
EU/1/96/007/033
EU/1/96/007/034
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, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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