Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for solution for Infusion

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Noradrenaline tartrate

Disponible depuis:

Wockhardt UK Limited

Code ATC:

C01CA; C01CA03

DCI (Dénomination commune internationale):

Noradrenaline tartrate

Dosage:

1 milligram(s)/millilitre

forme pharmaceutique:

Concentrate for solution for infusion

Mode d'administration:

For intravenous use

Unités en paquet:

ampoules of 2 ml in a pack 5 ampoules of 4 ml in a pack 5 vials of 20 ml in a pack

Type d'ordonnance:

Product subject to prescription which may not be renewed (A)

Groupe thérapeutique:

Adrenergic and dopaminergic agents

Domaine thérapeutique:

Adrenergic and dopaminergic agents; norepinephrine

indications thérapeutiques:

Noradrenaline (Norepinephrine) Concentrate is indicated for the emergency restoration of blood pressure in cases of acute hypotension

Statut de autorisation:

Not marketed

Date de l'autorisation:

2015-04-17

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
NORADRENALINE (NOREPINEPHRINE) 1 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
NORADRENALINE (AS NORADRENALINE TARTRATE)
WHAT IS IN THIS LEAFLET:
1. What Noradrenaline solution is and what it is used for
2. What you need to know before you use Noradrenaline solution
3. How to use Noradrenaline solution
4. Possible side effects
5. How to store Noradrenaline solution
6. Contents of the pack and other information
1. WHAT NORADRENALINE SOLUTION IS AND WHAT IT IS USED FOR
Noradrenaline is used in an emergency to increase blood pressure to
normal levels.
2. WHAT YOU NEED TO KNOW BEFORE YOU START TO USE NORADRENALINE
SOLUTION
YOU WILL NOT BE GIVEN NORADRENALINE IF

You are allergic to noradrenaline or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Noradrenaline if you:

have diabetes

suffer from high blood pressure

have an over-active thyroid

have low levels of oxygen in the blood

have high levels of carbon dioxide in the blood

have clots or obstructions in the blood vessels supplying the heart,
intestines, or other parts of the body

have low blood pressure following a heart attack

have a type of angina (chest pain) called Prinzmetal’s angina

are elderly

are hypotensive (have a low blood pressure) that has been caused by
hypovolaemia (low blood volume)

are taking some anaesthetics such as halothane or cyclopropane (this
mai increase the risk of irregular
heart beat).
OTHER MEDICINES AND NORADRENALINE
Tell your doctor or pharmacist if you are taking, or have recently
taken, any other medicines. A number of
medicines are known to increase the toxic effects of Noradrenaline,
such as:

monoamine oxidase inhibitors (antidepressants)

tricyclic antidepressants

linezolid (an antibiotic)

anaesthetics (especially anaesthetic gases)

adrenergic-serotoninergic medicines, e.g. used in the treatment of
asthma and heart conditions.
PREGNA

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for solution for
Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for solution for infusion contains 2 mg noradrenaline
tartrate equivalent to 1 mg noradrenaline base.
1 ampoule of 2 ml contains 4 mg noradrenaline tartrate equivalent to 2
mg noradrenaline base.
1 ampoule of 4 ml contains 8 mg noradrenaline tartrate equivalent to 4
mg noradrenaline base.
1 vial of 20 ml contains 40 mg noradrenaline tartrate equivalent to 20
mg noradrenaline base.
When diluted as recommended, each ml contains 80 micrograms
noradrenaline tartrate equivalent to 40 micrograms
noradrenaline base.
Excipients:
1 ampoule of 2 ml contains 0.29 mmol (or 6.6 mg) sodium.
1 ampoule of 4 ml contains 0.58 mmol (or 13.2 mg) sodium.
1 vial of 20 ml contains 2.90 mmol (or 66.1 mg) sodium
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
A clear, colourless or yellowish solution
pH: 3.0 – 4.5
Osmolality: 280 – 320 mosmol/Kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Noradrenaline (Norepinephrine) Concentrate is indicated for the
emergency restoration of blood pressure in cases of
acute hypotension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Route of Administration:_
For intravenous use only.
_Method of administration:_
Administer as a diluted solution via a central venous catheter.
The infusion should be at a controlled rate using either a syringe
pump or an infusion pump or a drip counter.
For dilution instructions see section 6.6.
_Dosage:_
Adults
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