HUMALOG Mix50 100 units/ml Suspension for injection in cartridge / KwikPen pre-filled pen Ref.[8013] Active ingredients: Insulin lispro

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands

Product name and form

Humalog Mix50 100 units/ml, suspension for injection in cartridge.

Humalog Mix50 100 units/ml KwikPen, suspension for injection in a pre-filled pen.

Pharmaceutical Form

Suspension for injection.

White suspension.

Qualitative and quantitative composition

Each ml contains 100 units insulin lispro* (equivalent to 3.5mg).

Humalog Mix50 consists of 50% insulin lispro solution and 50% insulin lispro protamine 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
m-Cresol
Phenol
Glycerol
Dibasic sodium phosphate 7H2O
Zinc oxide
Water for injections
Hydrochloric acid and sodium hydroxide may be used to adjust pH

Pack sizes and marketing

Cartridge

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.

KwikPen

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.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ, Utrecht, The Netherlands

Marketing authorization dates and numbers

EU/1/96/007/006
EU/1/96/007/025
EU/1/96/007/035
EU/1/96/007/036

Date of first authorisation: 30th April 1996
Date of last renewal: 30th April 2006

Drugs

Drug Countries
HUMALOG Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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