Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Ryzodeg 100 units/mL solution for injection in pre-filled pen.
Ryzodeg 100 units/mL solution for injection in cartridge.
| Pharmaceutical Form |
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Ryzodeg 100 units/mL solution for injection in pre-filled pen: Solution for injection (FlexTouch). Ryzodeg 100 units/mL solution for injection in cartridge: Solution for injection (Penfill). Clear, colourless, neutral solution. |
1 mL solution contains 100 units insulin degludec/insulin aspart* in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart).
Ryzodeg 100 units/mL solution for injection in pre-filled pen: One pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Ryzodeg 100 units/mL solution for injection in cartridge: One cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
* 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. |
|
| Insulin degludec |
Insulin degludec binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin. The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver. |
| List of Excipients |
|---|
|
Glycerol |
Ryzodeg 100 units/mL solution for injection in pre-filled pen:
3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a multidose disposable pre-filled pen made of polypropylene.
Pack sizes of 1 (with or without needles), 5 (without needles) and multipack containing 10 (2 packs of 5) (without needles) pre-filled pens.
Not all pack sizes may be marketed.
Ryzodeg 100 units/mL solution for injection in cartridge:
3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) in a carton.
Pack sizes of 5 and 10 cartridges.
Not all pack sizes may be marketed.
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Ryzodeg 100 units/mL solution for injection in pre-filled pen:
EU/1/12/806/001
EU/1/12/806/002
EU/1/12/806/003
EU/1/12/806/004
EU/1/12/806/005
Ryzodeg 100 units/mL solution for injection in cartridge:
EU/1/12/806/007
EU/1/12/806/008
Date of first authorisation: 21 January 2013
Date of latest renewal: 21 September 2017
| Drug | Countries | |
|---|---|---|
| RYZODEG | Austria, Australia, Estonia, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, South Africa |
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