Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Actraphane 30 40 international units/ml suspension for injection in vial.
Actraphane 30 100 international units/ml suspension for injection in vial.
Actraphane 30 Penfill 100 international units/ml suspension for injection in cartridge.
Actraphane 30 InnoLet 100 international units/ml suspension for injection in pre-filled pen.
Actraphane 30 FlexPen 100 international units/ml suspension for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Suspension for injection. The suspension is cloudy, white and aqueous. |
Actraphane 30 vial (40 international units/ml): 1 vial contains 10 ml equivalent to 400 international units. 1 ml suspension contains 40 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 30/70 (equivalent to 1.4 mg).
Actraphane 30 vial (100 international units/ml): 1 vial contains 10 ml equivalent to 1,000 international units. 1 ml suspension contains 100 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 30/70 (equivalent to 3.5 mg).
Actraphane 30 Penfill: 1 cartridge contains 3 ml equivalent to 300 international units. 1 ml suspension contains 100 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 30/70 (equivalent to 3.5 mg).
Actraphane 30 InnoLet/Actraphane 30 FlexPen: 1 pre-filled pen contains 3 ml equivalent to 300 international units. 1 ml suspension contains 100 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 30/70 (equivalent to 3.5 mg).
* Human insulin is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Excipient with known effect: Actraphane 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. Actraphane 30 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 |
Actraphane 30 vial (40 international units/ml)/Actraphane 30 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 suspension.
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.
Actraphane 30 Penfill:
Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of suspension. The cartridge contains a glass ball to facilitate resuspension.
Pack sizes of 1, 5 and 10 cartridges. Not all pack sizes may be marketed.
Actraphane 30 InnoLet/Actraphane 30 FlexPen:
Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of suspension 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
Actraphane 30 vial (40 international units/ml):
EU/1/02/229/001
EU/1/02/229/002
EU/1/02/229/036
Actraphane 30 vial (100 international units/ml):
EU/1/02/229/003
EU/1/02/229/004
EU/1/02/229/037
Actraphane 30 Penfill:
EU/1/02/229/011
EU/1/02/229/012
EU/1/02/229/013
Actraphane 30 InnoLet:
EU/1/02/229/030
EU/1/02/229/031
EU/1/02/229/032
Actraphane 30 FlexPen:
EU/1/02/229/033
EU/1/02/229/034
EU/1/02/229/035
Date of first authorisation: 07 October 2002
Date of latest renewal: 18 September 2007
| Drug | Countries | |
|---|---|---|
| ACTRAPHANE | Austria, Germany, Estonia, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, South Africa |
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