Manufacturer
AstraZeneca Pharmaceutical Co. Ltd, China(CHINA)
Registraction Number
MAL20051460AZ
Contents:
• Each vial contains 40 mg of esomeprazole sodium (as the sodium salt).
• Excipients include less than 1 mmol of sodium and other inactive ingredients.
Indications:
• NEXIUM IV is indicated for the treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis in adults and pediatric patients older than one month when oral therapy is not possible or appropriate.
• It is also used for healing of gastric ulcers associated with NSAID therapy, prevention of gastric and duodenal ulcers in patients at risk, and prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.
Instructions:
• Reconstitution: Reconstitute each vial with Sterile Water for Injection.
• Administration:
o Injection: Administer 5 mL of the reconstituted solution (8 mg/mL) as an intravenous injection over at least 3 minutes.
o Infusion: Administer the reconstituted solution as an intravenous infusion over 10 to 30 minutes.
• Dosage:
o GERD with Erosive Esophagitis: 40 mg once daily.
o Healing of Gastric Ulcers: 20 mg once daily.
o Prevention of Gastric and Duodenal Ulcers: 20 mg once daily.
o Prevention of Rebleeding: 80 mg as a bolus infusion over 30 minutes, followed by a continuous intravenous infusion of 8 mg/h for 72 hours.
Malaysia
