NORADRENALINE (NOREPINEPHRINE)

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

NORADRENALINE TARTRATE

Tillgänglig från:

Laboratoire AGUETTANT

ATC-kod:

C01CA03

INN (International namn):

NORADRENALINE TARTRATE

Dos:

0.25 Mg/Ml

Läkemedelsform:

Solution for Infusion

Receptbelagda typ:

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

Terapiområde:

norepinephrine

Bemyndigande status:

Not Marketed

Tillstånd datum:

2016-02-05

Bipacksedel

Package leaflet : Information for the user
NORADRENALINE
(NOREPINEPHRINE) 0.25 MG/ML, SOLUTION FOR INFUSION
Noradrenaline / Norepinephrine
Referred to as Noradrenaline Solution for infusion in this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Noradrenaline Solution for infusion is and what it is used for
2. What you need to know before you use Noradrenaline Solution for
infusion
3. How to use Noradrenaline Solution for infusion
4. Possible side effects
5. How to store Noradrenaline Solution for infusion
6. Contents of the pack and other information
1. WHAT NORADRENALINE SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
Noradrenaline Solution for infusion is a medicine that belongs to the
group of adrenergic and dopaminergic agents.
Noradrenaline Solution for infusion is indicated in adults weighing
over 50 kg for the on-going treatment of hypotensive emergencies with
escalating
noradrenaline dose requirements.
The product is for adults only.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NORADRENALINE SOLUTION FOR
INFUSION
DO NOT USE NORADRENALINE SOLUTION FOR INFUSION:
- administred via peripheral cannula and/or peripheral vein.
- 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 nurse before using Noradrenaline Solution for
infusion:
- if you have major left ventricular dysfunction (a heart condition),
- if you have recently had myocardial infarction (a heart attack),
- if you have card

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Noradrenaline (norepinephrine) 0.25 mg/mL, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 0.5 mg Noradrenaline
tartrate, equivalent to 0.25 mg Noradrenaline base.
Each 50 ml vial contains 25 mg Noradrenaline tartrate, equivalent to
12.5 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.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless or slightly yellow solution
pH = 3.2 – 3.8
Osmolality: 260 - 320 mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Noradrenaline 0.25mg/ml, solution for injection is indicated in adults
weighing over 50kg for the on-going treatment of
hypotensive emergencies with escalating noradrenaline dose
requirements.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous use only.
Noradrenaline 0.25mg/ml, solution for injection should not be used for
initiating vasopressor treatment. It may be
considered for use in patients already established on noradrenaline
therapy whose dose requirements are clinically
confirmed to be escalating, such that Noradrenaline 0.25mg/ml,
solution for injection may be commenced at a flow rate
of 2 ml/h.
Noradrenaline should only be administered as an intravenous infusion
via a central venous catheter to minimize the risk
of extravasation and subsequent tissue necrosis.
Noradrenaline 0.25mg/ml, solution for injection should be infused at a
controlled rate using a syringe driver pump.
Noradrenaline (Norepinephrine) 0.25 mg/ml, solution for infusion
should not be diluted before use: it is supplied ready
to use. It should not be mixed with other medicines.
Blood pressure control:
Blood pressure should be monitored carefully for the duration of
therapy, and preferably controlled by arterial blood
pressure monitorin