Cisatracurium

Cisatracurium is an intermediate-duration, non-depolarising neuromuscular blocking agent for intravenous administration. Cisatracurium is indicated for use during surgical and other procedures and in intensive care in adults and children aged 1 month and over.

Cisatracurium can be used as an adjunct to general anaesthesia, or sedation in the Intensive Care Unit (ICU) to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation.

0 Page 3 of 37 Pr Cisatracurium Besylate Injection Single-Dose Solution for injection (preservative-free) (2 mg/mL) Pr Cisatracurium Besylate Injection Multi-Dose Solution for injection (preserved) (2 mg/mL) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Non-medicinal Ingredients intravenous Solution for injection / 2 mg/mL (preservative-free), 5 mL single-dose vial benzenesulfonic acid and water for injection For a complete listing see DOSAGE FORMS, COMPOSITION AND PACKAGING section.

intravenous Solution for injection / 2 mg/mL (preserved), 10 mL multiple- dose vial benzyl alcohol, benzenesulfonic acid and water for injection For a complete listing see DOSAGE FORMS, COMPOSITION AND PACKAGING section. Cisatracurium Besylate Injection Multi-Dose, 10 mL multiple-dose vials contain benzyl alcohol, not for use in neonates.

See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS. INDICATIONS AND CLINICAL USE Cisatracurium Besylate Injection Single-Dose and Cisatracurium Besylate Injection Multi-Dose are non-depolarizing skeletal neuromuscular blocking agent with an intermediate onset and duration of action indicated as an adjunct to general anesthesia, to facilitate non-emergency endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

1 INDICATIONS AND USAGE Cisatracurium besylate injection is indicated: • as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age • to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU • to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older Limitations of Use Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.

Cisatracurium besylate injection is a nondepolarizing neuromuscular blocker indicated: as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age (1) to provide skeletal muscle relaxation during surgery in adults and in pediatric patients 2 to 12 years of age as a bolus or infusion maintenance (1) for mechanical ventilation in the ICU in adults (1) Limitations of Use: Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.