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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

NORADRENALINE (NOREPINEPHRINE) Solution for infusion (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

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

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 ...

Pharmaceutical form

Solution for infusion. Clear, colourless or slightly yellow solution. pH = 3.2-3.8 Osmolality: 260-320 mOsm/kg.

Therapeutic indications

Noradrenaline 0.08 mg/ml, solution for infusion is indicated in adults weighing over 50kg for the on-going treatment of hypotensive emergencies with escalating noradrenaline dose requirements.

Posology and method of administration

For intravenous use only. Noradrenaline 0.08mg/ml solution for infusion should not be used for initiating vasopressor treatment. It may be considered for use in patients already established on noradrenaline ...

Contraindications

Administration via peripheral cannula and/or peripheral vein. Hypersensitivity to noradrenaline or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Warning Noradrenaline is contraindicated in hypotensive patients in whom circulatory collapse is associated with hypovolaemia except as an emergency measure to maintain supply to the coronary and cerebral ...

Interaction with other medicinal products and other forms of interaction

Inadvisable combinations Volatile halogen anaesthetics: severe ventricular arrhythmia (increase in cardiac excitability). Imipramine antidepressants: paroxysmal hypertension with the possibility of arrhythmia ...

Pregnancy and lactation

Pregnancy Because of its indications, noradrenaline may be administered if necessary during pregnancy. However, pharmacodynamics properties of the substance have to be considered. Noradrenaline may impair ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

Psychiatric disorders: Anxiety. Nervous system disorders: Headache, tremor. Eyes disorders: Acute glaucoma (very frequent in patients anatomically predisposed with closing of the iridocorneal angle). ...

Overdose

In the event of overdose, the following may be observed: cutaneous vasoconstriction, bed sores, circulatory collapse, and hypertension. In the event of adverse reactions linked to an excessive dosage, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Adrenergic and dopaminergic agents ATC code: C01CA03 Noradrenaline provides a strong stimulation of alpha receptors in blood vessels at which these are counter-extracted. Noradrenaline ...

Pharmacokinetic properties

Two stereoisomers of noradrenaline exist, the biologically active L-isomer is the one present in Noradrenaline 0.08 mg/ml, solution for infusion. Absorption Subcutaneous: Poor. Oral: Noradrenaline is rapidly ...

Preclinical safety data

Most of the undesirable effects can be derived from sympathomimetic results from excessive stimulation of the sympathetic nervous system through the various adrenergic receptors. Noradrenaline may impair ...

List of excipients

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

Incompatibilities

This medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 18 months. After the first opening, the product should be used immediately.

Special precautions for storage

Do not store above 25°C. Store the vial in the outer carton to protect from light.

Nature and contents of container

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.

Special precautions for disposal and other handling

For single use only. Discard any unused contents. Noradrenaline 0.08 mg/ml, solution for infusion is already diluted and ready to use. It should be used without prior dilution .It should be used with a ...

Marketing authorization holder

LABORATOIRE AGUETTANT, 1, rue Alexander Fleming, 69007, LYON, FRANCE

Marketing authorization number(s)

14434/0017

Date of first authorization / renewal of the authorization

Date of first authorisation: 30/06/2015

Date of revision of the text

28/05/2018

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