Warnings and Precautions Specific for EXPAREL Sample Clauses

Warnings and Precautions Specific for EXPAREL. As there is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, EXPAREL should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity [See Overdosage (10)]. Caution should be taken to avoid accidental intravascular injection of EXPAREL. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amide-containing products. Using EXPAREL followed by other bupivacaine formulations has not been studied in clinical trials. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL [See Dosage and Administration (2.2) and Clinical Pharmacology (12.3)]. EXPAREL has not been evaluated for the following uses and, therefore, is not recommended for these types of analgesia or routes of administration. • epidural • intrathecal • regional nerve blocks • intravascular or intra-articular use EXPAREL has not been evaluated for use in the following patient population and, therefore, it is not recommended for administration to these groups. • patients younger than 18 years old • pregnant patients The ability of EXPAREL to achieve effective anesthesia has not been studied. Therefore, EXPAREL is not indicated for pre-incisional or pre-procedural loco-regional anesthetic techniques that require deep and complete sensory block in the area of administration.
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