PANTOPRAZOLE AUXILTO POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL [SIN17568P]

Product Info

PANTOPRAZOLE AUXILTO POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL

[SIN17568P]

Indication

4.1 Indications
Short-term use for symptomatic improvement and healing of gastrointestinal diseases which required a reduction in acid secretion:

– Duodenal ulcer
– Gastric ulcer
– Moderate and severe reflux esophagitis

Dosing

4.2 Posology and method of administration
The intravenous administration of Pantoprazole i.v. is recommended only if oral application is not appropriate.

Posology
Duodenal ulcer, gastric ulcer, moderate and severe reflux esophagitis
The recommended intravenous dose is one vial of 40mg Pantoprazole per day. As soon as oral therapy is possible, treatment with pantoprazole i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead.

This medicine should be administered by a healthcare professional and under appropriate medical supervision. Intravenous administration of pantoprazole is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days.

Special populations
Pediatric patients
The experience in children is limited. Pantoprazole 40 mg powder for solution for injection is not recommended for use in patients below 18 years of age.

Impaired hepatic function
A daily dose of pantoprazole 20 mg should not be exceeded in patients with severe liver impairment (See section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Impaired renal function
No dose adjustment is necessary in patients with impaired renal function.

Elderly patients
Generally, no dose adjustment is necessary in elderly patients. However, the daily dose of 40 mg should not be exceeded in treatment of gastric or duodenal ulcer.

Method of administration
Pantoprazole should be administered intravenously after reconstitution, or reconstitution and dilution. A ready-to-use solution is prepared by injecting 10ml of physiological sodium chloride solution for injection. The prepared solution may be administered directly or may be administered after mixing it with 100 ml physiological sodium chloride solution for injection or 5% glucose solution for injection.

After preparation, the solution must be used within 12 hours.

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

General instruction
Keep the vial in the outer carton in order to protect from light.
As soon as oral therapy is possible, treatment with pantoprazole i.v. should be discontinued and 40 mg pantoprazole p.o. (by mouth) should be administered instead.

Contraindications

4.3 Contraindications
Pantoprazole i.v. should not be used in cases of known hypersensitivity to any of the constituents.