NORADRENALINE (NOREPINEPHRINE) Solution for infusion Ref.[7928] Active ingredients: Noradrenaline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: LABORATOIRE AGUETTANT, 1, rue Alexander Fleming, 69007, LYON, FRANCE

Product name and form

NORADRENALINE (NOREPINEPHRINE) 0.08 mg/ml, solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, colourless or slightly yellow solution.

pH = 3.2-3.8

Osmolality: 260-320 mOsm/kg.

Qualitative and quantitative composition

Each ml of solution for infusion contains 0.16 mg Noradrenaline tartrate, equivalent to 0.08 mg Noradrenaline base.

Each 50 ml vial contains 8 mg Noradrenaline tartrate, equivalent to 4 mg Noradrenaline base.

Excipients:

Each ml of solution for infusion contains 3.546 mg equivalent to 0.1542 mmol of sodium.

Each 50 ml vial contains approximately 177.3 mg equivalent to 7.71 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 dihydrate
Hydrochloric acid or Sodium hydroxide (pH adjustment)
Water for injections

Pack sizes and marketing

Clear glass vial closed with a type I bromobutyl stopper and an aluminum cap containing 50 ml of solution for infusion in pack size of 1, 10, and 25 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

14434/0017

Date of first authorisation: 30/06/2015

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.