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

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Noradrenaline tartrate

Mevcut itibaren:

Pinewood Laboratories Ltd,

ATC kodu:

C01CA; C01CA03

INN (International Adı):

Noradrenaline tartrate

Doz:

1 milligram(s)/millilitre

Farmasötik formu:

Concentrate for solution for infusion

Terapötik alanı:

Adrenergic and dopaminergic agents; norepinephrine

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2015-04-17

Bilgilendirme broşürü

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
may 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.
PR

Ürün özellikleri

Health Products Regulatory Authority
08 January 2021
CRN009L7N
Page 1 of 6
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
_Initial rate of infusion:_
Health Products Regulatory Authority
08 January 2021
CRN009L7N
Page 2 of 6
When diluted as recommended in section 6.6 (the concentration of the
prepared infusion is 40 mg/litre noradrenaline base (80
mg/litre noradrenaline tartrate)) the initial rate of infusion, at a
body weight of 70 kg, should b