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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atracurium Besilate 10 mg/ml Solution for Injection, vial.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Atracurium besilate 10 mg/ml (equivalent to atracurium 7.5 mg/ml)
25 ml of solution contains 250 mg atracurium besilate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
A clear colourless or faint yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atracurium Besilate Injection is indicated as an adjunct to general anaesthesia during surgery to relax skeletal muscles,
and to facilitate endotracheal intubation and mechanical ventilation. It is also indicated to facilitate mechanical
ventilation in intensive care unit (ICU) patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Use as an adjunct to general anaesthesia
Atracurium Besilate Injection should only be administered by intravenous injection.
Do not give Atracurium Besilate Injection intramuscularly since this may result in tissue irritation and there are no
clinical data to support this route of administration.
To avoid distress to the patient, Atracurium Besilate Injection should not be administered before unconsciousness has
been induced. Atracurium Besilate Injection should not be mixed in the same syringe, or administered simultaneously
through the same needle, with alkaline solutions (e.g. barbiturate solutions).
In common with all neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the
use of Atracurium Besilate Injection in order to individualise dosage requirements.
Initial bolus doses for intubation
An initial atracurium besilate dose of 0.3 to 0.6 mg/kg (depending on the duration of full block required), given as an
intravenous bolus injection, is recomm
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