Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Insulatard 40 international units/ml suspension for injection in vial.
Insulatard 100 international units/ml suspension for injection in vial.
Insulatard Penfill 100 international units/ml suspension for injection in cartridge.
Insulatard InnoLet 100 international units/ml suspension for injection in pre-filled pen.
Insulatard FlexPen 100 international units/ml suspension for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Suspension for injection. The suspension is cloudy, white and aqueous. |
Insulatard vial (40 international units/ml): 1 vial contains 10 ml equivalent to 400 international units. 1 ml suspension contains 40 international units isophane (NPH) insulin human* (equivalent to 1.4 mg).
Insulatard vial (100 international units/ml): 1 vial contains 10 ml equivalent to 1,000 international units. 1 ml suspension contains 100 international units isophane (NPH) insulin human* (equivalent to 3.5 mg).
Insulatard Penfill: 1 cartridge contains 3 ml equivalent to 300 international units. 1 ml suspension contains 100 international units isophane (NPH) insulin human* (equivalent to 3.5 mg).
Insulatard InnoLet/Insulatard FlexPen: 1 pre-filled pen contains 3 ml equivalent to 300 international units. 1 ml suspension contains 100 international units isophane (NPH) insulin human* (equivalent to 3.5 mg).
* Human insulin is produced in Saccharomyces cerevisiae by recombinant DNA technology.
Excipient with known effect:
Insulatard contains less than 1 mmol sodium (23 mg) per dose, i.e. Insulatard is essentially ‘sodiumfree’.
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 |
Insulatard vial (40 international units/ml)/Insulatard 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.
Insulatard 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.
Insulatard InnoLet/Insulatard 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
Insulatard vial (40 international units/ml):
EU/1/02/233/001
EU/1/02/233/002
EU/1/02/233/016
Insulatard vial (100 international units/ml):
EU/1/02/233/003
EU/1/02/233/004
EU/1/02/233/017
Insulatard Penfill:
EU/1/02/233/005
EU/1/02/233/006
EU/1/02/233/007
Insulatard InnoLet:
EU/1/02/233/010
EU/1/02/233/011
EU/1/02/233/012
Insulatard FlexPen:
EU/1/02/233/013
EU/1/02/233/014
EU/1/02/233/015
Date of first authorisation: 07 October 2002
Date of latest renewal: 18 September 2007
| Drug | Countries | |
|---|---|---|
| INSULATARD | Austria, Cyprus, Germany, Estonia, Spain, France, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom |
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