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NORADRENALINE (NOREPINEPHRINE) 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): NORADRENALINE TARTRATE

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4. Possible side effects

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience:

Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for Solution for Infusion
Noradrenaline (as noradrenaline tartrate)

• sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat
(which may cause difficulty in swallowing or breathing), feeling that you are going to faint.
• pain and/or swelling at the injection site

Read all of this leaflet carefully before you start using this medicine because it contains
important imformation for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.See section 4.

Tell your doctor as soon as possible if you experience
• slow heart rate
• abnormal heart rhythm
• breathing difficulties
• anxiety
• headaches
• cold extremities
• pain in the extremities

The name of this medicinal product is Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for
Solution for Infusion but it will be referred to as Noradrenaline (Norepinephrine) Concentrate
throughout this leaflet.

Your doctor will monitor your blood pressure and blood volume.

What is in this leaflet:
1. What Noradrenaline (Norepinephrine) Concentrate is and what it is used for
2. What you need to know before you are given Noradrenaline (Norepinephrine) Concentrate
3. How you are given Noradrenaline (Norepinephrine) Concentrate
4. Possible side effects
5. How to store Noradrenaline (Norepinephrine) Concentrate
6. Contents of the pack and other information

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.

Reporting of side effects

You can also report side effects directly via the Yellow Card Scheme.
Website www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Noradrenaline (Norepinephrine) Concentrate
Keep this medicine out of the sight and reach of children

1. What Noradrenaline (Norepinephrine) Concentrate is and what it is used for

Do not store above 25°C
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry
date refers to the last day of that month.

Noradrenaline (Norepinephrine) Concentrate for Solution for Infusion is used in an emergency to
increase blood pressure to normal levels.

From a microbiological point of view, the product should be used immediately after dilution.

2. What you need to know before you are given Noradrenaline (Norepinephrine) Concentrate

Do not use this medicine if the solution is brown in colour.

Do not take Noradrenaline (Norepinephrine) Concentrate

Do not throw away any medicines via wastewater. Ask your pharmacists how to throw away
medicines you no longer use. These measures will help protect the environment.

• if you are allergic to noradrenaline preparations or to any of the other ingredients of this medicine
(listed in section 6).

6. Contents of the pack and other information

Tell your doctor if any of the above applies to you before this medicine is used.

Warnings and precautions

What Noradrenaline (Norepinephrine) contains

Talk to your doctor or pharmacist before taking Noradrenaline (Norepinephrine) Concentrate
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

The active substance is noradrenaline (as noradrenaline tartrate).
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.
The other ingredients are:
• sodium chloride
• sodium hydroxide (for pH adjustment)
• hydrochloric acid (for pH adjustment)
• Water for Injections.

What Noradrenaline (Norepinephrine) Concentrate looks like and contents of the pack:

Other medicines and Noradrenaline

This medicinal product is presented as a concentrate for solution for infusion. The solution is a clear
colourless or yellowish solution.

Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other
medicines.

It may be supplied in packs of 5 x 2 ml ampoules or 5 x 4 ml ampoules.

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.

Marketing Authorisation Holder
Hospira UK Limited
Queensway
Leamington Spa
CV31 3RW

Manufacturers

Pregnancy, breast-feeding and fertility

Hospira S.p.A.
Via Fosse Ardeatine 2
20060 Liscate - Milan
Italy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine. Noradrenaline
(Norepinephrine) Concentrate may harm the unborn baby. Your doctor will decide if you should be
given Noradrenaline (Norepinephrine) Concentrate.

Hospira UK Limited
Queensway, Leamington Spa
Warwickshire, CV31 3RW
United Kingdom

Noradrenaline (Norepinephrine) Concentrate contains sodium
The 2 ml ampoule contains 6.7 mg sodium, and the 4 ml ampoule contains 13.3 mg sodium.
Take into consideration if you are on a low-sodium diet.

Hospira Enterprises B.V.
Ranstad 22-11
1316 BN Almere
The Netherlands

3. How you are given Noradrenaline (Norepinephrine) Concentrate
Noradrenaline (Norepinephrine) Concentrate will be given to you in hospital by a doctor or nurse. It
is first diluted and then infused into a vein.

This medicinal product is authorised in the Member States of the EEA under the following
names:

The recommended dose of Noradrenaline (Norepinephrine) Concentrate will depend on your
medical condition. The usual dose is between 0.4 and 0.8 mg per hour. Your doctor will determine
the correct dose for you. After the initial dose your doctor will assess your response and adjust the
dose accordingly.

Austria, Finland and Sweden:

Noradrenalin Hospira

France:

Noradrénaline Hospira

The Netherlands:

Noradrenaline Hospira

It is unlikely that you will receive too much or too little of this medicine, as this medicine will be given
to you in hospital. However, talk to your doctor or nurse if you have any concerns.

Spain:

Noradrenalina Hospira

United Kingdom:

Noradrenaline (Norepinephrine)

Symptoms of overdose are severe high blood pressure, slow heartbeat, violent headache, light
sensitivity, pain in the chest, pale colour, intense sweating and vomiting.

This leaflet was last revised in 03/2014

If you are given more or forget to take Noradrenaline (Norepinephrine) Concentrate:

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

Dilution instructions

The following information is intended for healthcare professionals only:

Dilute before use with glucose 5% solution or sodium chloride 9 mg/ml (0.9%) with glucose 5% solution.

For intravenous use.

The infusion should be at a controlled rate using either a syringe pump or an infusion pump or a
drip counter.

Either add 2 ml of concentrate to 48 ml glucose 5% solution (or sodium chloride 9 mg/ml (0.9%) with
glucose 5% solution) for administration by syringe pump, or add 20 ml of concentrate to 480 ml glucose
5% solution (or sodium chloride 9 mg/ml (0.9%) with glucose 5% solution) for administration by drip
counter. In both cases the final concentration of the infusion solution is 40 mg/litre noradrenaline base
(which is equivalent to 80 mg/litre noradrenaline tartrate). Dilutions other than 40 mg/litre noradrenaline
base may also be used. If dilutions other than 40 mg/litre noradrenaline base are used, check the
infusion rate calculation carefully before starting treatment.

Incompatibilities

The product is compatible with PVC infusion bags.

Infusion solutions containing noradrenaline tartrate have been reported to be incompatible with the
following substances: alkalis and oxidising agents, barbiturates, chlorpheniramine, chlorothiazide,
nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin.

Any unused product or waste material should be disposed of in accordance with local requirements.

Dilute before use.
Administer as a diluted solution via a central venous catheter.

Shelf life after dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C when diluted to
4 mg/litre and 40 mg/litre noradrenaline base in sodium chloride 9 mg/ml (0.9%) solution or glucose 5%
solution. However, from a microbiological point of view, the product should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2 to 8°C.

Q77074

X######X

Component Specification

Q77074

X######X

Requester

Item number:

Q77074

Request number:

AS4020

Country:

UK

OI template:
Amalia version:
Mulgrave version:

LII015
3
N/A

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

150 x 420 mm
(1 x sheet)
Amps
Liscate
40 g/m2
150 x 210 mm
Yes
No

Version 1
Technician:
Date:

JH
12/Mar/14

Version 2
Technician:
Date:

JH
18/Mar/14

Version 3
Technician:
Date:

BE
24/Mar/14

Version 4
Technician:
Date:

XX
dd/mmm/yy

Pharma code:
Pharma code length:
Supplier Code:

32 (IIIIX)
7.5 mm
XX

Version 5
Technician:
Date:

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dd/mmm/yy

Version 6
Technician:
Date:

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dd/mmm/yy

Version 7
Technician:
Date:

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Version 8
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Date:

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Version 9
Technician:
Date:

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dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

Colours
Black:

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: Q64513
Latest QP Release Date:

Signed:
Date:

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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