NORADRENALINE (NOREPINEPHRINE) Solution for infusion (2018)
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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
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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