| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | Injection |
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Indications:
Omeprazole for intravenous use is indicated as an alternative to oral therapy for the following indications i.e.
• Treatment of duodenal ulcers
• Prevention of relapse of duodenal ulcers
• Treatment of gastric ulcers
• Prevention of relapse of gastric ulcers
• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease
• Treatment of NSAID-associated gastric and duodenal ulcers
• Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
• Treatment of reflux oesophagitis
• Long-term management of patients with healed reflux oesophagitis
• Treatment of symptomatic gastro-oesophageal reflux disease
• Treatment of Zollinger-Ellison syndrome
Dosage and Administration:
In patients where the use of oral medicinal products is inappropriate, Omeprazole IV 40 mg once daily is recommended. In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily.
Omeprazole is to be administered in an intravenous infusion for 20-30 minutes.
Storage instructions:
Do not store above 25°C. Keep vials in the outer carton in order to protect from light.
| Testing terms | Standards | Results |
| Character | White or almost white mass or powder | White friable mass |
| pH | Should be 10.1-11.1 | 10.9 |
| Related substances | Impurity I:NMT 1.0% Single impurity:NMT 1.0% Total impurities:NMT 1.5%. |
0.015% 0.016% 0.04% |
| Water | NMT 7.0% | 0.44% |
| Sterility | Should be complied with requirements | Complies |
| Visible particles | Should be complied with requirements | Complies |
| Insoluble particles |
≥10μm:NMT 6000 PC/Vial ≥25μm:NMT 600 PC/Vial |
Complies Complies |
| Bacterial endotoxin | The content of endotoxin in ondansetron should be less than 2 EU per mg | Complies |
| Weight variayion | ±10% | Complies |
| Assay | 93.0%-107.0% | 98.2% |
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