Pompezo 40mg Lyophilized Powder for Solution for Injection or Infusion

Manufacturer
Mefar Ilac Sanayii A.S.(TURKEY)

Registraction Number
MAL24066011ACZ

Contents:
Pompezo 40mg is a lyophilized powder for solution for injection or infusion containing Esomeprazole Sodium. Each vial contains 42.5 mg of Esomeprazole Sodium, which is equivalent to 40 mg of Esomeprazole.
Indications:
Pompezo is indicated for:

• Gastric antisecretory treatment when the oral route is not possible.
• Gastroesophageal reflux disease (GERD) in patients with esophagitis and/or severe symptoms of reflux.
• Healing of gastric ulcers associated with NSAID therapy.
• Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk.
• Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.

1. Reconstitution: Reconstitute the lyophilized powder with the appropriate diluent to obtain a clear, colorless, or light-yellow solution.
2. Injection: For a 40 mg dose, administer 5 ml of the reconstituted solution (8 mg/ml) as an intravenous injection over at least 3 minutes. For a 20 mg dose, administer 2.5 ml of the reconstituted solution over at least 3 minutes1.
3. Infusion: For a 40 mg dose, administer the reconstituted solution as an intravenous infusion over 10 to 30 minutes. For a 20 mg dose, administer half of the reconstituted solution over 10 to 30 minutes1.
4. Unused Solution: Discard any unused solution.

• Gastric antisecretory treatment: 20-40 mg once daily.
• GERD with esophagitis: 40 mg once daily.
• Healing of gastric ulcers: 20 mg once daily.
• Prevention of ulcers: 20 mg once daily.
• Prevention of rebleeding: 80 mg as a bolus infusion over 30 minutes, followed by a continuous infusion of 8 mg/h for 72 hours.