Pantoprazole 40 mg Powder for Solution for Injection

This medicine should be administered by a healthcare professional and under appropriate medical supervision.

Intravenous administration of Pantoprazole 40 mg Powder for Solution for Injection 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 Pantoprazole 40 mg Powder for Solution for Injection IV should be discontinued and 40 mg pantoprazole p.o. should be administered instead.

Posology

Gastric and duodenal ulcer, reflux oesophagitis

The recommended intravenous dose is one vial of Pantoprazole 40 mg Powder for Solution for Injection (40 mg pantoprazole) per day.

Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions

For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80 mg Pantoprazole 40 mg Powder for Solution for Injection. 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 Pantoprazole 40 mg Powder for Solution for Injection is sufficient to manage a decrease of acid output into the target range (< 10 mEq/h) within one hour in the majority of patients.

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 section 4.4).

Renal Impairment

No dose adjustment is necessary in patients with impaired renal function (see section 5.2).

Elderly

No dose adjustment is necessary in elderly patients (see section 5.2).

Paediatric population

The safety and efficacy of Pantoprazole 40 mg powder for solution for injection in children aged under 18 years have not been established. Therefore, Pantoprazole 40 mg powder for solution for injection is not recommended for use in patients below 18 years of age.

Currently available data are described in section 5.2 but no recommendation on a posology can be made.

Method of administration

A ready-to-use solution is prepared in 10 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection.

For instructions for preparation see section 6.6. 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 monohydrate 55 mg/ml (5 %) solution for injection.

After preparation the solution must be used within 12 hours.

The medicinal product should be administered intravenously over 2 - 15 minutes.