Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
NovoMix 50 Penfill 100 units/ml suspension for injection in cartridge.
NovoMix 50 FlexPen 100 units/ml suspension for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Suspension for injection. The suspension is cloudy, white and aqueous. |
NovoMix 50 Penfill: 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 50/50 (equivalent to 3.5 mg). 1 cartridge contains 3 ml equivalent to 300 units.
NovoMix 50 FlexPen: 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 50/50 (equivalent to 3.5 mg). 1 pre-filled pen contains 3 ml equivalent to 300 units.
* Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Insulin aspart |
The blood glucose lowering effect of insulin aspart is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver. Insulin aspart produces a more rapid onset of action compared to soluble human insulin, together with a lower glucose concentration, as assessed within the first four hours after a meal. Insulin aspart has a shorter duration of action compared to soluble human insulin after subcutaneous injection. |
| List of Excipients |
|---|
|
Glycerol |
NovoMix 50 Penfill:
3 ml suspension in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene). The cartridge contains a glass ball to facilitate resuspension.
Pack sizes of 1, 5 and 10 cartridges. Not all pack sizes may be marketed.
NovoMix 50 FlexPen:
3 ml suspension in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene. The cartridge contains a glass ball to facilitate resuspension.
Pack sizes of 1, 5 and 10 pre-filled pens. Not all pack sizes may be marketed.
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
NovoMix 50 Penfill:
EU/1/00/142/011
EU/1/00/142/012
EU/1/00/142/013
NovoMix 50 FlexPen:
EU/1/00/142/014
EU/1/00/142/015
EU/1/00/142/016
Date of first authorisation: 1 August 2000
Date of last renewal: 2 July 2010
| Drug | Countries | |
|---|---|---|
| NOVOMIX-50 | Estonia, Ireland, Israel, Lithuania, New Zealand, Poland, Romania, Tunisia |
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