PANTOSALA POWDER FOR SOLUTION FOR INJECTION 40 MG/VIAL [SIN14860P]

Product Info

PANTOSALA POWDER FOR SOLUTION FOR INJECTION 40 MG/VIAL

[SIN14860P]

4.1 Therapeutic indications
PANTOSALA 40 mg is indicated in adults for treatment of short-term use for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:

• Moderate to severe reflux oesophagitis.

• Gastric and duodenal ulcer.

4.2 Posology and method of administration

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.

Posology
Gastric and duodenal ulcer, moderate and severe reflux oesophagitis
The recommended intravenous dose is one vial of PANTOSALA 40 mg (40 mg pantoprazole) per day.
As soon as oral therapy is possible, treatment with pantoprazole i.v. should be discontinued and pantoprazole p. o. should be administered instead.

Special populations
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 until further data become available.

Hepatic impairment
In patients with severe liver impairment the daily dose has to be reduced to 20 mg pantoprazole. (See section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
The daily dose of 40 mg pantoprazole should not be exceeded in patients with impaired kidney function (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly patients
The daily dose of 40 mg pantoprazole should not be exceeded in elderly patients.

Method of administration
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 50 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.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications
Pantoprazole i.v. should generally not be used in cases of known hypersensitivity to one of the constituents of pantoprazole i.v.
Pantoprazole, like other PPIs, should not be co-administered with atazanavir (See section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).