MYKRONOR Solution for injection / infusion Ref.[50949] Active ingredients: Noradrenaline

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Laboratoire AGUETTANT, 1 Rue Alexander Fleming, 69007 LYON, France

Product name and form

Mykronor 5 micrograms/ml, solution for injection/infusion.

Pharmaceutical Form

Solution for injection/infusion.

Clearand colourless solution, practically free from visible particles.

pH: 3.7 to 4.1

Osmolality: 260-320 mOsm/kg.

Qualitative and quantitative composition

Each ml of solution for injection/infusion contains 10 micrograms of noradrenaline (norepinephrine) tartrate monohydrate, equivalent to 5 micrograms noradrenaline (norepinephrine) anhydrous.

Each 20 ml vial contains 200 micrograms of noradrenaline (norepinephrine) tartrate monohydrate, equivalent to 100 micrograms of noradrenaline (norepinephrine) anhydrous.

Each 50 ml vial contains 500 micrograms of noradrenaline (norepinephrine) tartrate monohydrate, equivalent to 250 micrograms of noradrenaline (norepinephrine) anhydrous.

Excipient with known effect:

This medicinal product contains sodium.

Each ml of solution for injection/infusion contains 3.54 mg equivalent to 0.15 mmol of sodium. Each 20 ml vial contains approximately 71 mg equivalent to 3 mmol of sodium.

Each 50 ml vial contains approximately 177 mg equivalent to 7.5 mmol of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Noradrenaline

Noradrenaline provides a strong stimulation of alpha receptors in blood vessels at which these are counter-extracted. Noradrenaline also has an effect on beta-1 receptors in the heart leading to a positive inotropic and initially positive chronotropic effect. The increase in blood pressure may cause a reflex reduction in heart rate.

List of Excipients

Sodium chloride
Disodium edetate
Hydrochloric acid (pH adjustment)
Water for injections

Pack sizes and marketing

20 ml or 50 ml clear type II glass vial closed with a chlorobutyl stopper and an aluminium cap. Box of 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratoire AGUETTANT, 1 Rue Alexander Fleming, 69007 LYON, France

Marketing authorization dates and numbers

PA1968/013/001

Date of first authorisation: 27th August 2021

Drugs

Drug Countries
MYKRONOR Ireland, Romania

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