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Each vial contains sterile sodium Pantoprazole equivalent to Pantoprazole 40 mg
Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific action
on the proton pumps of the parietal cells. Pantoprazole is converted to its active form in the acidic environment in the parietal
cells where its inhibits the H+, K+-ATPase enzyme, i.e. the final stage in the production of hydrochloric acid in the stomach.
The inhibition is dose-dependent and affects both receptor inhibitors, treatment with pantoprazole causes a reduced acidity in
the stomach and thereby an increase in gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible.
Since pantoprazole binds to the enzyme distal to the cell receptor level, the substance can affect hydrochloric acid secretion
independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the
product is given orally or intravenously.
Duodenal ulcer, gastric ulcer, moderate and severe forms of inflammation of reflux esophagitis.
DOSAGE AND ADMINISTRATION
Adults : 40 mg IV daily. It should be administered for over 2 – 15 minutes.
As soon as oral therapy is possible, treatment with PANTOZ injection should be discontinued and should be replaced with oral
Daily dose should not exceed 40 mg in elderly patients or patients with impaired renal function.
Administration : inject solution of sodium chloride 0.9 % or dextrose 5 % into the vial containing dry powder of pantoprazole.
The contents of the vial is for single use only.
Overdosage case in human is unknown. In the case of overdosage with clinical signs of intoxication, the usual rules of
intoxication therapy apply.
Patients with hypersensitivity to pantoprazole.
WARNINGS AND PRECAUTIONS
PANTOZ IV is not indicated for mild gastrointestinal complaint such as nervous dyspepsia. Before treatment, any possibility of
malignancy of gastric ulcer or malignant disease of the esophagus should be excluded because the treatment of PANTOZ IV
may alleviate the symptoms of malignant ulcer and can delay diagnosis. The intravenous administration of Pantoprazole IV is
recommended only if oral application is not appropriate. Diagnosis of reflux esophagitis should be confirmed by endoscopy. In
patients with severe liver impairment the daily dose has to be reduced to 20 mg pantoprazole. Furthermore, in these patients
the liver enzymes should be monitored during pantoprazole IV therapy. In case of a rise of the liver enzymes pantoprazole IV
should be discontinued.
Clinical experience in pregnant women is limited. There is no information on the excretion of pantoprazole into breast milk.
Pregnancy and lactation : pantoprazole should only be used when the benefit to the mother is considered greater than the
potential risk to the foetus/baby.
To date, there has been no experience with treatment in children.