Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark
Actrapid 40 international units/ml solution for injection in vial.
Actrapid 100 international units/ml solution for injection in vial.
Actrapid Penfill 100 international units/ml solution for injection in cartridge.
Actrapid InnoLet 100 international units/ml solution for injection in pre-filled pen.
Actrapid FlexPen 100 international units/ml solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection. The solution is clear, colourless and aqueous. |
Actrapid vial (40 international units/ml): 1 vial contains 10 ml equivalent to 400 international units. 1 ml solution contains 40 international units insulin human* (equivalent to 1.4 mg).
Actrapid vial (100 international units/ml): 1 vial contains 10 ml equivalent to 1,000 international units. 1 ml solution contains 100 international units insulin human* (equivalent to 3.5 mg).
Actrapid Penfill: 1 cartridge contains 3 ml equivalent to 300 international units. 1 ml solution contains 100 international units insulin human* (equivalent to 3.5 mg).
Actrapid InnoLet/Actrapid FlexPen: 1 pre-filled pen contains 3 ml equivalent to 300 international units. 1 ml solution contains 100 international units insulin human* (equivalent to 3.5 mg).
* Human insulin is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Excipient with known effect: Actrapid contains less than 1 mmol sodium (23 mg) per dose, i.e. Actrapid is essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Insulin (human) |
The blood glucose lowering effect of insulin 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. |
| List of Excipients |
|---|
|
Zinc chloride |
Actrapid vial (40 international units/ml)/Actrapid vial (100 international units/ml): Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of solution.
Pack sizes of 1 and 5 vials of 10 ml or a multipack of 5 packs of 1 × 10 ml vial. Not all pack sizes may be marketed.
Actrapid Penfill: Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of solution.
Pack sizes of 1, 5 and 10 cartridges. Not all pack sizes may be marketed.
Actrapid InnoLet/Actrapid FlexPen: Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of solution in a pre-filled multidose disposable pen made of polypropylene.
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
Actrapid vial (40 international units/ml):
EU/1/02/230/001
EU/1/02/230/002
EU/1/02/230/016
Actrapid vial (100 international units/ml):
EU/1/02/230/003
EU/1/02/230/004
EU/1/02/230/017
Actrapid Penfill:
EU/1/02/230/005
EU/1/02/230/006
EU/1/02/230/007
Actrapid InnoLet:
EU/1/02/230/010
EU/1/02/230/011
EU/1/02/230/012
Actrapid FlexPen:
EU/1/02/230/013
EU/1/02/230/014
EU/1/02/230/015
Date of first authorisation: 07 October 2002
Date of latest renewal: 18 September 2007
| Drug | Countries | |
|---|---|---|
| ACTRAPID | Austria, Australia, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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