Noradrenaline (Norepinephrine) 0.08 mg/mL solution for infusion

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Noradrenaline

Tillgänglig från:

Laboratoire AGUETTANT

ATC-kod:

C01CA; C01CA03

INN (International namn):

Noradrenaline

Dos:

0.08 milligram(s)/millilitre

Läkemedelsform:

Solution for infusion

Receptbelagda typ:

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

Terapiområde:

Adrenergic and dopaminergic agents; norepinephrine

Bemyndigande status:

Marketed

Tillstånd datum:

2016-02-05

Bipacksedel

106786
Package leaflet: Information for the user
NORADRENALINE
(NOREPINEPHRINE) 0.08 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
This medicine contains the active substance noradrenaline and acts as
a vasoconstrictor. This medicine is only indicated for adults.
This medicine is used in adults weighing over 50 kg for the treatment
of hypotensive emergencies that require an immediate increase in blood
pressure to
a normal level.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NORADRENALINE SOLUTION FOR
INFUSION
DO NOT USE NORADRENALINE SOLUTION FOR INFUSION:
- administered 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 cardiac rhythm disorders (your hea

Produktens egenskaper

Health Products Regulatory Authority
02 February 2023
CRN00CW1M
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Noradrenaline (Norepinephrine) 0.08 mg/mL solution for infusion
2 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.
Excipient with known effect:
Each mL of solution for infusion contains 3.5 mg equivalent to 0.2
mmol of sodium.
Each 50 mL vial contains approximately 177.3 mg equivalent to 7.7 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 (Norepinephrine) is indicated in adults weighing over
50kg for the treatment of hypotensive emergencies.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous use only.
Noradrenaline (Norepinephrine)
Noradrenaline (Norepinephrine) should only be administered as an
intravenous infusion via a central venous catheter to
minimize the risk of extravasation and subsequent tissue necrosis.
Noradrenaline (Norepinephrine) should be infused at a
controlled rate using an infusion pump or a syringe pump.
Noradrenaline (Norepinephrine) 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
monitoring. The patient should be monitored carefully for the duration
of noradrenaline (norepinephrine) therapy.
Posology
Initial dose:
The initial dose of noradrenaline base is usually between 0.05-0.15
micrograms/kg/min.
Maintenance dose range:
The recommended maintenance range of noradrenaline base is between
0.05-1.5 micrograms/kg/min.
Titrat