Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Tresiba 100 units/mL solution for injection in pre-filled pen.
Tresiba 200 units/mL solution for injection in pre-filled pen.
Tresiba 100 units/mL solution for injection in cartridge.
| Pharmaceutical Form |
|---|
|
Tresiba 100 units/mL solution for injection in pre-filled pen: Solution for injection (FlexTouch). Tresiba 200 units/mL solution for injection in pre-filled pen: Solution for injection (FlexTouch). Tresiba 100 units/mL solution for injection in cartridge: Solution for injection (Penfill). Clear, colourless, neutral solution. |
Tresiba 100 units/mL solution for injection in pre-filled pen: One pre-filled pen contains 300 units of insulin degludec in 3 mL solution. 1 mL solution contains 100 units insulin degludec* (equivalent to 3.66 mg insulin degludec).
Tresiba 200 units/mL solution for injection in pre-filled pen:One pre-filled pen contains 600 units of insulin degludec in 3 mL solution. 1 mL solution contains 200 units insulin degludec (equivalent to 7.32 mg insulin degludec).
Tresiba 100 units/mL solution for injection in cartridge: One cartridge contains 300 units of insulin degludec in 3 mL solution. 1 mL solution contains 100 units insulin degludec* (equivalent to 3.66 mg insulin degludec).
* Produced in Saccharomyces cerevisiae by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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 |
Tresiba 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 pre-filled multidose disposable 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.
Tresiba 200 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 pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles) and multipack containing 6 (2 packs of 3) (without needles) pre-filled pens. Not all pack sizes may be marketed.
Tresiba 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
Tresiba 100 units/mL solution for injection in pre-filled pen:
EU/1/12/807/001
EU/1/12/807/002
EU/1/12/807/003
EU/1/12/807/004
EU/1/12/807/005
Tresiba 200 units/mL solution for injection in pre-filled pen:
EU/1/12/807/009
EU/1/12/807/006
EU/1/12/807/010
EU/1/12/807/012
EU/1/12/807/013
EU/1/12/807/015
EU/1/12/807/016
Tresiba 100 units/mL solution for injection in cartridge:
EU/1/12/807/007
EU/1/12/807/008
Date of first authorisation: 21 January 2013
Date of latest renewal: 21 September 2017
| Drug | Countries | |
|---|---|---|
| TRESIBA | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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