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NOVORAPID Solution for injection in vial / Cartridge / Pre-filled pen (2019)

Active ingredients: Insulin aspart

Product Name and Form

NovoRapid 100 units/ml solution for injection in vial.
NovoRapid Penfill 100 units/ml solution for injection in cartridge.
NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen.
NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen.
NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen.
NovoRapid PumpCart 100 units/ml solution for injection in cartridge.

Pharmaceutical form

Solution for injection.

The solution is clear, colourless and aqueous.

Qualitative and Quantitative Composition

NovoRapid vial: 1 vial contains 10 ml equivalent to 1,000 units. 1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg).

NovoRapid Penfill: 1 cartridge contains 3 ml equivalent to 300 units. 1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg).

NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch: 1 pre-filled pen contains 3 ml equivalent to 300 units. 1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg).

NovoRapid PumpCart: 1 cartridge contains 1.6 ml equivalent to 160 units. 1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg).

* Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology. For the full list of excipients, see section 6.1.

Chemical substance
Description
Insulin aspart

The blood glucose lowering effect of insulin aspart 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. Insulin aspart produces a more rapid onset of action compared to soluble human insulin, together with a lower glucose concentration, as assessed within the first four hours after a meal. Insulin aspart has a shorter duration of action compared to soluble human insulin after subcutaneous injection.

List of excipients

Glycerol
Phenol
Metacresol
Zinc chloride
Disodium phosphate dihydrate
Sodium chloride
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and Marketing

NovoRapid vial: 10 ml solution in vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap.

Pack sizes of 1 or 5 vials of 10 ml or a multipack containing 5 packs of 1 × 10 ml vial. Not all pack sizes may be marketed.

NovoRapid Penfill: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).

Pack sizes of 5 and 10 cartridges. Not all pack sizes may be marketed.

NovoRapid FlexPen: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.

Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens.

Not all pack sizes may be marketed.

NovoRapid InnoLet: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained 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.

NovoRapid FlexTouch: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.

Pack sizes of 1 (with or without needles), 5 (without needles) or a multipack with 2 × 5 (without needles) pre-filled pens of 3 ml. Not all pack sizes may be marketed.

NovoRapid PumpCart: 1.6 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).

Pack size of 5 cartridges and a multipack containing 25 (5 packs of 5) cartridges. 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: 7 September 1999

Date of last renewal: 30 April 2009

Marketing authorization number:

NovoRapid vial:

EU/1/99/119/001
EU/1/99/119/008
EU/1/99/119/015

NovoRapid Penfill:

EU/1/99/119/003
EU/1/99/119/006

NovoRapid FlexPen:

EU/1/99/119/009
EU/1/99/119/010
EU/1/99/119/011
EU/1/99/119/017
EU/1/99/119/018

NovoRapid InnoLet:

EU/1/99/119/012
EU/1/99/119/013
EU/1/99/119/014

NovoRapid FlexTouch:

EU/1/99/119/019
EU/1/99/119/020
EU/1/99/119/021
EU/1/99/119/022
EU/1/99/119/023

NovoRapid PumpCart:

EU/1/99/119/024
EU/1/99/119/025