Gastrointestinal Drug 40mg 10ml Omeprazole Sodium for Injection

Product Details
Customization: Available
Application: Internal Medicine
Usage Mode: For oral administration
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  • Gastrointestinal Drug 40mg 10ml Omeprazole Sodium for Injection
  • Gastrointestinal Drug 40mg 10ml Omeprazole Sodium for Injection
  • Gastrointestinal Drug 40mg 10ml Omeprazole Sodium for Injection
  • Gastrointestinal Drug 40mg 10ml Omeprazole Sodium for Injection
  • Gastrointestinal Drug 40mg 10ml Omeprazole Sodium for Injection
  • Gastrointestinal Drug 40mg 10ml Omeprazole Sodium for Injection
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Basic Info.

Model NO.
AMC13025-04
Suitable for
Elderly, Children, Adult
State
Powder
Shape
Injection
Type
Biological Products
Pharmaceutical Technology
Chemical Synthesis
OEM/ODM
Support
Standard Available
Bp, Cp
Model No.
Amc13025-04
Function
Injection
Transport Package
40mg/10ml
Specification
40MG/10ML
Trademark
Shinepharm
Origin
China
HS Code
3004909099
Production Capacity
500000 Boxes/ Month

Product Description

Gastrointestinal Drug 40mg 10ml Omeprazole Sodium for Injection

Gastrointestinal Drug 40mg 10ml Omeprazole Sodium for Injection
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%

Gastrointestinal Drug 40mg 10ml Omeprazole Sodium for Injection


Gastrointestinal Drug 40mg 10ml Omeprazole Sodium for InjectionGastrointestinal Drug 40mg 10ml Omeprazole Sodium for Injection

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