Skip to content
This is a text only leaflet, designed for the visually impaired. Please visit our electronic Medicines Compendium (eMC) website to view the original document which may contain images or tables.

You may be able to get this leaflet in large print, Braille or as an audio CD, call the RNIB Medicine Leaflet line on 0800 198 5000 for more information.

The product codes for this leaflet are: PL30306/0273 , PL30306/0273

 

Atracurium 10mg/ml Solution for Injection/Infusion

Company Details

Actavis UK Ltd


Whiddon ValleyBarnstapleDevonEX32 8NS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:medinfo@actavis.co.uk
[view all information leaflets from this company]

PATIENT INFORMATION LEAFLET

Atracurium 10mg/ml

Solution for Injection/Infusion

Atracurium besilate

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, pharmacist or nurse.
  • This medicine has been prescribed for you only. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
  • The full name of this medicine is Atracurium 10mg/ml Solution for Injection/Infusion but within the leaflet it will be referred to as Atracurium.

What is in this leaflet

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

Go to top of the page

1 What Atracurium is and what it is used for

Atracurium belongs to a group of medicines called muscle relaxants. It is used to relax muscles during surgery.

Atracurium is used:

  • during surgery, other procedures and in intensive care
  • during general anaesthesia to ease tracheal intubation (a tube into the windpipe) and controlled ventilation.
Go to top of the page

2 What you need to know before you use Atracurium

Do not use Atracurium

  • if you allergic (hypersensitive) to atracurium, cisatracurium or benzenesulfonic acid.

Warnings and Precautions

Talk to your doctor before using Atracurium . Tell your doctor if you have:

  • a disease that affects the muscles and/or their nervous control (neuromuscular disease such as myasthenia gravis or Eaton-Lambert syndrome)
  • an electrolyte imbalance (changes to the body’s normal levels of certain chemicals)
  • cancer that has spread to different parts of body (carinomatosis)
  • allergy to any other muscle relaxant
  • a recent burn that has required medical attention
  • a history of asthma, hay fever or allergies that give you a rash, itching or shortness of breath (histamine hypersensitivity)
  • heart diseases and low blood pressure

Other medicines and Atracurium

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

This is especially important with the following medicines as they may interact with Atracurium :

  • antibiotics (e.g. aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin, clindamycin and vancomycin)
  • antiarrhythmic medicines (used to control the rhythm of the heart e.g. lidocaine, procainamide, quinidine)
  • diuretics (water tablets) (e.g. furosemide, thiazides and mannitol)
  • medicines used to control blood pressure, angina or other heart problems (e.g. propranolol, oxprenolol, diltiazem, nicardipine, nifedipine and verapamil)
  • antiepileptic medicines (e.g. carbamazepine, phenytoin)
  • drugs used to treat rheumatism (e.g. chloroquine, D-penicillamine)
  • steroids
  • trimetaphan, hexamethonium (used to lower blood pressure during surgery)
  • dantrolene (a muscle relaxant)
  • acetazolamide (treatment of glaucoma)
  • magnesium sulphate
  • ketamine (an anaesthetic drug)
  • lithium, chlorpromazine (treatment of mental illness)
  • quinine (treatment of malaria or leg cramps)
  • medicines used in the treatment of Alzheimer’s disease (anticholinesterases e.g. donepezil)

It may still be all right for you to be given Atracurium and your doctor will be able to decide what is suitable for you.

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 using this medicine

There is no adequate data on the use of atracurium besilate during pregnancy. Atracurium should only be administered during pregnancy after careful risk-benefit assessment. The use of the recommended dose in caesarean section showed no harmful effects on the newborn infants. Therefore Atracurium is also suitable for maintenance of muscle relaxation during caesarean section.

It is not known whether atracurium besilate passes into breast milk.

As precaution you should restart breast-feeding 24 hours after administration of Atracurium , when the effect of the medicine has worn off.

Driving and using machines

You should not drive, operate machinery or work in exposed situations soon after having had an operation. The time factor should be decided individually by the physician.

You should be accompanied on your way home and you should not drink alcoholic drinks.

Go to top of the page

3 How to use Atracurium

Atracurium should only be used by a physician.

Dosage

Atracurium is used during procedures that require that the patient is fully anaesthetised (unconscious), or heavily sedated.

The dosing will be worked out by the doctor. Atracurium must be given only by injection directly into a vein (intravenous use). Atracurium must not be injected into a muscle.

Use in children:

The use of Atracurium is not recommended in neonates (children under the age of one month). In the case of necessary treatment in newborn or premature newborn the dose has to be significantly lowered.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Information for medical or healthcare professionals is provided at the end of this leaflet.

Go to top of the page

4 Possible side effects

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

The frequency of possible side effects listed below is defined using the following convention:

Very common: affects more than 1 user in 10

Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000

Rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 user in 10,000

Not known: frequency cannot be estimated from the available data

Common:

  • tachycardia (rapid hearbeat)
  • temporary hypotension (low blood pressure)
  • wheezing
  • bronchospasm (asthma-like symptoms)
  • skin flushing
  • urticaria (nettle rash)

Very rare:

  • myasthenia and/or myopathy (weak or non-working muscles)
  • severe allergic reactions including shock, circulatory failure and heart attack in patients receiving atracurium with one or more anaesthetic drugs
  • seizures (fits) when taken with other drugs in at-risk patients
  • laryngospasm (spasm of the vocal cords)

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.

Go to top of the page

5 How to store Atracurium

Keep this medicine out of the sight and reach of children.

Do not use Atracurium after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Storage conditions

Store in a refrigerator (2°C – 8°C). Keep the ampoules in the outer carton.

Shelf life after opening the ampoule

The solution has to be used immediately after opening the ampoule.

When Atracurium is diluted in compatible solutions, the resultant solutions will be stable in daylight for 4 to 24 hours at temperatures of up to 30°C, depending on the type of diluent (see Dilution instructions in section ‘The following information is intended for medical or healthcare professionals only’ at the end of this leaflet). 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, unless dilution has taken place in controlled and validated aseptic conditions.

Prior to administration a healthcare professional should inspect the product visually and discard any product where the usual appearance of the product has changed or if the container is damaged. Only clear solutions practically free from particles should be used.

The product is for single use only. Any unused solution should be discarded.

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

Go to top of the page

6 Contents of the pack and other information

What Atracurium contains:

The active substance is atracurium besilate.

1 ml solution contains 10mg atracurium besilate.

One ampoule with 2.5 ml solution contains 25mg atracurium besilate.

One ampoule with 5 ml solution contains 50mg atracurium besilate.

One ampoule with 25 ml solution contains 250mg atracurium besilate

The other ingredients are: Benzensulphonic acid, Water for injection.

What Atracurium looks like and contents of the pack

Solution for injection and Concentrate for solution for infusion

Clear and colourless solution

Box of 1 ampoule with 2.5 ml

Box of 5 ampoules with 2.5 ml

Box of 10 ampoules with 2.5 ml

Box of 5x5 ampoules with 2.5 ml

Box of 5x10 ampoules with 2.5 ml

Box of 1 ampoule with 5 ml

Box of 5 ampoules with 5 ml

Box of 10 ampoules with 5 ml

Box of 5x5 ampoules with 5 ml

Box of 5x10 ampoules with 5 ml

Box of 1 ampoule with 25 ml

Box of 2 ampoules with 25 ml

Box of 5 ampoules with 25 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Actavis Group PTC ehf
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland

Manufacturers:

Actavis Deutschland GmbH & Co. KG
Willy-Brandt-Allee 2
81829 München
Germany
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Go to top of the page

This leaflet was last revised in October 2013

If you would like a leaflet with larger text, please contact 01271 311257.

Actavis
Barnstaple
EX32 8NS
UK

AAAF6972


Text size normal Text size at 110% Text size at 120%

CHANGE FORMAT

 

USEFUL INFO

 

QUICK LINKS