Tuesday, 09-25-2018
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COMENAZOL


Composition:
Each vial contains:
Pantoprazol sodium equivalent to …40 mg Pantoprazol 
Excipients q.s to ……………………………….........1 vial

Each ampoule contains:
Sodium Chloride ....................................................0,09g 
Water for injection q.s to …………………………....10 ml

Dosage form:  Lyophilized Powder for Injection 

Packaging:   Box of 1 vial and 1 ampoule 

Indications:  
- Short-Term Treatment of erosive esophagitis associated With gastroesophageal reflux disease 
- Maintenance of healing of erosive esophagitis
- Pathological hypersecretory conditions Including Zollinger-Ellison syndrome

Dosage and Administration: 
• Administration:
- Intravenous injection: Inject 10 mL of physiological sodium chloride solution into the vial containing the dry substance. The resulting potency of the solution is 4 mg/mL of pantoprazole, and can be administered by slow injection over 2 to 5 minutes.
- Intravenous infusion: Prepare the 40 mg intravenous injection infusion by diluted with 100 mL 0.9% Sodium Chloride Injection or 100 mL of 5% Dextrose Injection. The resulting potency of the diluted solution is 0.4 mg/mL of pantoprazole, and can be administered by infusion over 15 minutes.
- After preparation, the reconstituted (ready-to-use) solution for intravenous injection or infusion should be used within 12 hours of initial puncture of the stopper.
- Use a half-volume injection if just need 20 mg Pantoprazol, the retire volume should be removed.

• Dosage:
- REFLUX ESOPHAGITIS: 40 mg pantoprazole once per day. 
- Pediatrics: The safety and effectiveness of pantoprazole in children have not yet been established
- In patients with severe liver disease: decrease dose or use between day. The daily dose is not exceed 20 mg pantoprazole.
- In patients with severe renal impairment: No dosage adjustment is necessary.

Contraindications: Please read carefully the leaflet before using.

Storage: Store at dry place, temperatures not exceeding 25°C, protected from light. 

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