TRACRIUM 10 Mg/Ml Solution for Inj/Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ATRACURIUM BESILATE

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

M03AC04

INN (International Name):

ATRACURIUM BESILATE

Dosage:

10 Mg/Ml

Pharmaceutical form:

Solution for Inj/Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other quaternary ammonium compounds

Authorization status:

Authorised

Authorization date:

2004-07-16

Patient Information leaflet

Package leaflet: Information for the patient
TRACRIUM
®
 10 MG/ML  
SOLUTION FOR INJECTION OR 
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, nurse or pharmacist.
· If you get any side effects, talk to your doctor, 
nurse or pharmacist. 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 use 
Tracrium 
3. How to use 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. 
Ask your doctor if you would like more 
explanation about this medicine.
2.  WHAT YOU NEED TO KNOW BEFORE YOU USE  
 TRACRIUM
DO NOT USE TRACRIUM IF:
· you are allergic to atracurium besilate, 
cisatracurium (another muscle relaxant) or 
any of the other ingredients in Tracrium (listed 
in Section 6) 
· you have reacted badly to an anaesthetic before.
Do not use Tracrium if any of the above apply 
to you. If you are not sure, talk to your doctor, 
nurse or pharmacist before you use Tracrium.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before 
using this medicine if:
· you are allergic to any other muscle relaxant
· 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 
neuron

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tracrium 10mg/ml, solution for injection or infusion, ampoules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10 mg of Atracurium Besilate.
Each 2.5 ml ampoule contains 25 mg of Atracurium Besilate.
Each 5 ml ampoule contains 50mg of Atracurium Besilate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
A clear, slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tracrium is a highly selective, competitive or non-depolarising neuromuscular blocking agent, which is used as an
adjunct to general anaesthesia to enable tracheal intubation to be performed and to relax skeletal muscles during
surgery or controlled ventilation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Injection:_
Tracrium is administered by intravenous injection. The dosage range for adults is 0.3 to 0.6 mg/kg (depending on the
duration of full block required) and will provide adequate relaxation for 15 to 35 minutes.
Endotracheal intubation can usually be accomplished within 90 seconds from the intravenous injection of 0.5 to 0.6
mg/kg.
Full block can be prolonged with supplementary doses of 0.1 to 0.2 mg/kg as required. Successive supplementary
dosing does not give rise to accumulation of neuromuscular blocking effect.
_Caesarean Section_:
Tracrium is suitable for maintenance of muscle relaxation during Caesarean section as it does not cross the placenta in
clinically significant amounts following recommended doses (0.3-0.6 mg/kg).
Spontaneous recovery from the end of full block occurs in about 35 minutes as measured by the restoration of the
tetanic response to 95% of normal neuromuscular function.
The neuromuscular block produced by Tracrium can be rapid