Leading the way to safer medication
 Crosscheck  Recommender

ACTRAPID Solution for injection (2019)

Active ingredients: Insulin (human)

Product Name and Form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
Description

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
Glycerol
Metacresol
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark

Date of first authorisation: 07 October 2002

Date of latest renewal: 18 September 2007

Marketing authorization number:

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