Skip to content
PIL Logo

Tracrium Injection

Last Updated on eMC 09-Oct-2017 View changes  | Aspen Contact details

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Please click on the link to the left to view the PIL in PDF format.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: PL39699/0091, PL39699/0091, PL39699/0091.



Tracrium Injection

Package Leaflet: Information for the Patient

Tracrium 10 mg/ml Injection

atracurium besilate

Read all of this leaflet carefully before you start having 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, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Tracrium is and what it is used for
2. What you need to know before you have Tracrium
3. How to have Tracrium
4. Possible side effects
5. How to store Tracrium
6. Contents of the pack and other information

1. What Tracrium is and what it is used for

Tracrium contains a medicine called atracurium besilate. This belongs to a group of medicines called muscle relaxants.

Tracrium is used:

  • to relax muscles during operations on adults and children over 1 month of age
  • to help insert a tube into the windpipe (tracheal intubation), if a person needs help to breathe
  • to relax the muscles of adults in intensive care.

Ask your doctor if you would like more explanation about this medicine.

2. What you need to know before you have Tracrium

Do not have Tracrium if:

  • you are allergic to atracurium besilate, any other muscle relaxant or any of the other ingredients in Tracrium (listed in section 6)
  • you have reacted badly to an anaesthetic before.

Do not have Tracrium if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before you have Tracrium.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before having Tracrium if:

  • you have muscle weakness, tiredness or difficulty in co-ordinating your movements (myasthenia gravis)
  • you have a neuromuscular disease, such as a muscle wasting disease, paralysis, motor neurone disease or cerebral palsy
  • you have a severe electrolyte imbalance
  • you have a lower than normal volume of blood (hypovolaemia)
  • you have a burn which requires medical treatment
  • you have ever had an allergic reaction to any muscle relaxant which was given as part of an operation
  • you have a history of sensitivity to histamine. In particular, spasm of the airways may occur if you have a history of allergy or asthma.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before you are given Tracrium.

Other medicines and Tracrium

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because these medicines can affect how well Tracrium works or can cause side effects.

In particular tell your doctor, nurse or pharmacist if you are taking any of the following:

  • anaesthetics (used to reduce sensation and pain during surgical procedures)
  • antibiotics (used to treat infections)
  • medicines for heart conditions
  • medicines for high blood pressure
  • water tablets (diuretics), such as furosemide
  • medicines for fits (epilepsy), such as phenytoin or carbamazepine
  • medicines containing magnesium, such as those to treat indigestion and heart burn
  • drugs for Alzheimer’s disease (anticholinesterases e.g. donepezil)
  • medicines for mental illness, such as lithium
  • medicines for inflammation of the joints, such as chloroquine or D-penicillamine
  • steroids.

Pregnancy and breast-feeding

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 having this medicine.

Driving and using machines

It can be dangerous to drive or operate machinery too soon after having had an operation. Your doctor will tell you how long to wait before you can drive and use machinery.

3. How to have Tracrium

How your injection is given

You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.

Tracrium can be given:

  • as a single injection into your vein (intravenous bolus injection)
  • as a continuous infusion into your vein. This is where the drug is slowly given to you over a long period of time.

Your doctor will decide the way you are given the drug and the dose you will receive. It will depend on:

  • your body weight
  • the amount and duration of muscle relaxation required
  • your expected response to the medicine.

Children less than 1 month old should not have this medicine.

If you receive more Tracrium than you should

Tracrium will always be given under carefully controlled conditions. However, if you think that you have been given more than you should tell your doctor or nurse immediately.

4. Possible side effects

Like all medicines, Tracrium can cause side effects, although not everybody gets them. The following effects may happen with this medicine:

Allergic reactions

If you have an allergic reaction, tell your doctor or nurse straight away. The signs may include:

Common side effects (may affect up to 1 in 10 people)

  • decrease in blood pressure
  • reddening of your skin

Uncommon side effects (may affect up to 1 in 100 people)

  • wheezing or coughing

Rare side effects (may affect up to 1 in 1,000 people)

  • a lumpy skin rash or ‘hives’ anywhere on your body

Very Rare side effects (may affect up to 1 in 10,000 people)

  • sudden wheeziness, chest pain or chest tightness
  • swelling of your eyelids, face, lips, mouth or tongue
  • decrease in heart rate
  • shock, circulatory failure, cardiac arrest

Very rarely a severe allergic reaction can occur when given one or more anaesthetic agent.

Other side effects (unknown frequency) that you may experience are:

  • seizures
  • muscle disease (myopathy) or muscle weakness

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Tracrium

  • Keep out of the sight and reach of children
  • Do not use Tracrium after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month
  • Store between 2 and 8°C. Do not freeze
  • Keep in the outer carton in order to protect from light
  • When Tracrium is made up it should be used straight away. Any unused solution should be thrown away

6. Contents of the pack and other information

What Tracrium contains

  • The active substance is atracurium besilate
  • The other ingredients are benzene sulfonic acid and Water for Injections.

What Tracrium looks like and contents of the pack

Tracrium injection comes in boxes of 5 by 2.5 ml and 5 ml glass ampoules or 2 by 25 ml glass vials.

Each vial/ampoule contains 10 mg/ml of the active ingredient atracurium besilate.

Marketing authorisation holder and manufacturer

Marketing authorisation Holder:

Aspen Pharma Trading Limited
3016 Lake Drive
City West Business Campus
Dublin 24
Ireland
Service-Tel: 0800 008 7392 (+ 44 1748 828 391)

Manufacturer:

GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana 90
43056 San Polo di Torrile
Parma
Italy

Aspen Pharma Ireland Limited
One George’s Quay Plaza
Dublin 2
Ireland

Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Tracrium Injection

Reference number PL 39699/0091

This is a service provided by the Royal National Institute of Blind People

This leaflet was revised in August 2017

Tracrium is a trademark of the Aspen group.

© 2017 Aspen group of companies. All rights reserved

Company contact details

Aspen

Company image
Address

3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Medical Information Direct Line

0800 0087 392

Telephone

+ 44 1748 828 391

Medical Information e-mail

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

atracurium besilate

Legal categories

POM - Prescription Only Medicine

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue