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This medicine should be administered by a healthcare professional and under appropriate medical supervision.
Intravenous administration is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days. Therefore, as soon as oral therapy is possible, treatment with PANTONIL i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead.
Posology: Gastric and duodenal ulcer, mild and severe gastroesophageal reflux: The recommended intravenous dose is one vial of PANTONIL (40 mg pantoprazole) per day.
Short-term maintenance of haemostasis and prevention of recurrence in patients with acute hemorrhagic gastric or duodenal ulcer: In patients with acute haemorrhagic gastric or duodenal ulcer, 80 mg should be administered as bolus infusion for 2-15 minutes followed by continuous intravenous infusion at 8 mg/hr for 3 days (72 hours).
Zollinger-Ellison-Syndrome and other pathological hyper secretory conditions: For the long-term management of Zollinger-Ellison-Syndrome and other pathological hyper secretory conditions patients should start their treatment with a daily dose of 80 mg PANTONIL. Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control.
In case a rapid acid control is required, a starting dose of 2 x 80 mg PANTONIL is sufficient to manage a decrease of acid output into the target range (<10 mEq/h) within one hour in the majority of patients.
Oral treatment should be started as soon as clinically confirmed.
Method of administration: PANTONIL is administered as i.v. injection.
A ready-to-use solution is prepared in 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. The prepared solution may be administered directly or may be administered after mixing it with 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 55 mg/ml (5%) solution for injection.
The medicinal product should be administered intravenously over 2-15 minutes.
PANTONIL should not be mixed with other substances than the specified solvents.
After preparation the solution must be used within 12 hours.
Additional information on special populations: Patients with renal impairment: No dose adjustment is necessary in patients with impaired renal function.
Patients with hepatic impairment: A daily dose of 20 mg pantoprazole (half a vial of 40 mg pantoprazole) should not be exceeded in patients with severe liver impairment (see Precautions). Also liver enzymes should be monitored during PANTONIL treatment. Treatment with PANTONIL should be discontinued when liver enzymes are raised.
Paediatric population: The safety and efficacy of PANTONIL 40 mg lyophilized powder for solution for injection in children aged under 18 years have not been established. Therefore, Protium 40 mg powder for solution for injection PANTONIL is not recommended for use in patients below 18 years of age.
Elderly: No dose adjustment is necessary in elderly patients.
