Rx Item-Pantoprzole 40Mg Tab 90 By Aurobindo Pharma Gen Protonix

PROTONIX I.V.- pantoprazole sodium injection, powder, for solution
Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

1 INDICATIONS AND USAGE

1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis
PROTONIX I.V. for Injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.

Safety and efficacy of PROTONIX I.V. for Injection as a treatment of patients with GERD and a history of erosive esophagitis for more than 10 days have not been demonstrated.

1.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome


PROTONIX I.V. for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome in adults.

2 DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permit.

Parenteral routes of administration other than intravenous are not recommended.

PROTONIX I.V. for Injection may be administered intravenously through a dedicated line or through a Y-site. The intravenous line should be flushed before and after administration of PROTONIX I.V. for Injection with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP. When administered through a Y-site, PROTONIX I.V. for Injection is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.

Midazolam HCl has been shown to be incompatible with Y-site administration of PROTONIX I.V. for Injection. PROTONIX I.V. for Injection may not be compatible with products containing zinc. When PROTONIX I.V. for Injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.
DOSAGE FORMS AND STRENGTHS

PROTONIX I.V. (pantoprazole sodium) for Injection is supplied as a freeze-dried powder containing 40 mg of pantoprazole per vial.

Pantoprzole 40Mg Tab 90 By Aur
Item No.:RX342568/m NDC No.65862056090 6586256090 65862-560-90 UPC No.:365862560902 3-65862-56090-2 365862-560902 NDC No. 65862-0560-90 UPC/GTIN No. 3-65862-56090-2 MPN 56090

Pantoprzole 40Mg Tab 90 By Aur
Item No.:RX342568/m NDC No.65862056090 6586256090 65862-560-90 UPC No.:365862560902 3-65862-56090-2 365862-560902 NDC No. 65862-0560-90 UPC/GTIN No. 3-65862-56090-2 MPN 56090

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Pantoprzole 40Mg Tab 90 By Aurobindo Pha
BRAND: PANTOPRAZOLE NDC: 65862-0560-90,65862056090 UPC: 3-65862-56090-2,365862560902

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