Gastrointestinal Drug Omeprazole Sodium for Injection 40mg 10ml Shinepharm

• Application: Internal Medicine
• Usage Mode: Injection
• Suitable for: Elderly, Children, Adult
• State: Liquid
• Shape: Oral Liquid
• Type: Organic Chemicals
• Model NO.: AMC13025-04
• Pharmaceutical Technology: Chemical Synthesis
• Function: Gastrointestinal Drug
• Standard Available: Bp, Cp
• Delivery Time: 30~60 Days
• OEM/ODM: Support
• Transport Package: 10′s/Box
• Specification: 40MG/10ML
• Trademark: Shinepharm
• Origin: China
• HS Code: 3004909099
• Production Capacity: 1000000 Boxes/Month

Product Description

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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