- atracurium besilate
POM: Prescription only medicine
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.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 04515/0099.
Atracurium Besilate 10 mg/ml Solution for Injection - Ampoule
PACKAGE LEAFLET: INFORMATION FOR THE USER
Atracurium Besilate 10 mg/ml Solution for Injection
The active substance is atracurium besilate
Read all of this leaflet carefully before you start using this medicine.
In this leaflet:
1. What Atracurium Besilate Solution for Injection is and what it is used for
2. What you need to know before you use Atracurium Besilate Solution for Injection
3. How to use Atracurium Besilate Solution for Injection
4. Possible side effects
5. How to store Atracurium Besilate Solution for Injection
6. Contents of the pack and other information
1. WHAT ATRACURIUM BESILATE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Atracurium Besilate Solution for Injection is a medicine which acts as a muscle relaxant.
Atracurium Besilate Solution for Injection is used during surgery to relax muscles and to assist with inserting a breathing tube and with artificial breathing. It is also used to help with artificial breathing in patients in intensive care.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ATRACURIUM BESILATE SOLUTION FOR INJECTION
Do not use Atracurium Besilate Solution for Injection
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Atracurium Besilate Solution for Injection if you
Using other medicines
Please tell your doctor , pharmacist or nurse if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Some medicines are known to interact with atracurium besilate, tell your doctor if you are taking any of the following:
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 for advice before taking this medicine.
Atracurium besilate should not be used during the first three months of pregnancy. It will not be used during the second and third trimesters unless your doctor advises that it is necessary.
Atracurium besilate can be used during a caesarean section.
Your baby would be closely monitored if you breast-feed within 24 hours of being given atracurium besilate.
Driving and using machines
Do not drive or use machines within 24 hours of being given atracurium besilate.
3. HOW TO USE ATRACURIUM BESILATE SOLUTION FOR INJECTION
Atracurium besilate is used during procedures which require you to be anaesthetised (unconscious) or heavily sedated. The amount given to you will depend upon the length of time you will be unconscious or heavily sedated and your body weight.
An initial dose of this medicine will be given to you of approximately 0.3 – 0.6 mg/kg of body weight, followed by a reduced dose at specific intervals. This standard dose will be given to children and adults. The rate this medicine is administered may vary depending on your age and if you suffer from any heart problems. You will be monitored during use with this medicine, and the dose will be adjusted if necessary.
Atracurium besilate will be given to you by an injection into a vein.
Children less than 1 month old should not have this medicine.
If you are given more Atracurium Besilate Solution for Injection than you should be given
Atracurium besilate will only be used by doctors who are appropriately skilled in its administration. As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or a healthcare professional immediately if you have any concerns.
If you have any further questions on the use of this product, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Atracurium Besilate Solution for Injection can cause side effects, although not everybody gets them.
If any of the following happen, tell the doctor immediately:
The above are rare or very rare serious side effects. You may need urgent medical attention.
If you experience any of the following tell your doctor as soon as possible:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ATRACURIUM BESILATE SOLUTION FOR INJECTION
Keep out of the sight and reach of children.
Do not use Atracurium Besilate Solution for Injection after the expiry date which is stated on the ampoule label and carton.
The ampoules should be stored in a refrigerator (2 – 8°C) but not frozen.
The ampoules should be kept in the outer carton (in order to protect from light).
6. CONTENTS OF THE PACK AND FURTHER INFORMATION
What Atracurium Besilate Solution for Injection contains
The active substance is atracurium besilate
The other ingredients are benzenesulphonic acid and Water for Injections
What Atracurium Besilate Solution for Injection looks like and contents of the pack
This medicinal product is a solution for injection (a solution which can be given as an injection). It is a clear, colourless or faint yellow solution. Each millilitre (ml) of solution contains 10 milligrams (mg) of atracurium besilate.
This medicine is presented in glass containers (ampoules). The 2.5 ml and 5 ml ampoule are available in packs of 5. Not all presentations may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in 02/2019
Ref: gxAT 2_0
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