Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Lyumjev 100 units/mL solution for injection in vial.
Lyumjev 100 units/mL solution for injection in cartridge.
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen.
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless, aqueous solution. |
Each mL contains 100 units of insulin lispro* (equivalent to 3.5 mg).
Lyumjev 100 units/mL solution for injection in vial: Each vial contains 1000 units insulin lispro in 10 mL solution.
Lyumjev 100 units/mL solution for injection in cartridge: Each cartridge contains 300 units of insulin lispro in 3 mL solution.
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen: 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 in a single injection.
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen: 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 in a single injection.
* 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 |
|---|
|
Glycerol |
Lyumjev 100 units/mL solution for injection in vial:
Type I clear glass vials, sealed with halobutyl stoppers and secured with aluminium seals.
10 mL vial: Packs of 1 or 2 vials or 5 (5 packs of 1) vials.
Lyumjev 100 units/mL solution for injection in cartridge:
Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl plungers.
3 mL cartridge: Packs of 2, 5 or 10 cartridges.
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen:
Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl plungers.
The 3 mL cartridges are sealed in a disposable pen injector KwikPen
The medicinal product is packed in a white carton with dark blue bands and an image of the pen. The KwikPen is taupe, the dose knob is blue with raised edges.
3 mL KwikPen: Packs of 2 pre-filled pens, 5 pre-filled pens or a multipack of 10 (2 packs of 5) prefilled pens.
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen:
Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl plungers.
The 3 mL cartridges are sealed in a disposable pen injector Junior KwikPen .
The medicinal product is packed in a white carton with stripes of peach, light blue and dark blue bands and an image of the pen. The Junior KwikPen is taupe, the dose knob is peach with raised edges.
3 mL Junior KwikPen: Packs of 2 pre-filled pens, 5 pre-filled pens or a multipack of 10 (2 packs of 5) pre-filled pens.
Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
EU/1/20/1422/001
EU/1/20/1422/002
EU/1/20/1422/003
EU/1/20/1422/004
EU/1/20/1422/005
EU/1/20/1422/006
EU/1/20/1422/007
EU/1/20/1422/008
EU/1/20/1422/009
EU/1/20/1422/010
EU/1/20/1422/011
EU/1/20/1422/012
Date of first authorisation: 24 March 2020
| Drug | Countries | |
|---|---|---|
| LYUMJEV | Austria, Estonia, France, Croatia, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States |
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