HUMALOG 100 units/ml Solution for injection in vial / Cartridge / KwikPen - Junior KwikPen Ref.[8011] 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 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.

Qualitative and quantitative composition

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
Glycerol
Dibasic sodium phosphate 7H2O
Zinc oxide
Water for injections
Hydrochloric acid and sodium hydroxide maybe used to adjust pH

Pack sizes and marketing

Vial

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

Cartridge

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

KwikPen

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

Marketing authorization holder

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

Marketing authorization dates and numbers

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

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

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.