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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bupivacaine Hydrochloride 5 mg/ml (0.5% w/v) Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bupivacaine Hydrochloride 5 mg/ml (0.5% w/v) Solution for Injection contains 5 mg bupivacaine hydrochloride per ml
(as monohydrate).
Each 5ml ampoule contains 25 mg bupivacaine hydrochloride.
Each 10ml ampoule contains 50 mg bupivacaine hydrochloride.
Each 20ml ampoule contains 100 mg bupivacaine hydrochloride.
For excipients see 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
o
Local Infiltration.
o
Peripheral Nerve Blocks.
o
Central Nerve Blocks (Epidural and Spinal Anaesthesia).
For local or regional anaesthesia and/or analgesia for surgical, diagnostic and obstetric procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
The following recommended bupivacaine doses (Table 1) serve as a guideline for an average adult with a body weight
of approximately 70 kg.
The dosage varies and depends upon the area(s) to be anaesthetised, the vascularity of the tissues, the number of
neuronal segments to be blocked, individual tolerance and the anaesthetic technique that is to be used.
The lowest dosage needed to provide effective anaesthesia and / or analgesia should always be administered.
The maximum dosage must always be determined by evaluating the size and physical status of the patient, and by
considering the usual rate of systemic absorption from a particular injection site. Based on body weight, the maximum
recommended dose of bupivacaine hydrochloride is 2 mg/kg, and up to a maximum of 150 mg within a 4-hour period.
The maximum recommended adult dose during a 24-hour period is 400 mg.
CHILDREN:
Bupivacaine hydrochl
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