Pantoprazole sodium for injection
Indicatios:
Reflux oesophagitis.
Gastric and duodenal ulcer.
Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
Dosage and administration：
Posology
Intravenous administration of Pantoprazole is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days.
Recommended dose
The recommended intravenous dose is one vial of Pantoprazole (40 mg pantoprazole) per day.
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.
A daily dose of 20 mg Pantoprazole should not be exceeded in patients with severe liver impairment.
Method of administration
This medicine should be administered by a healthcare professional and under appropriate medical supervision.
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 55 mg/ml (5 %) solution for injection.
After preparation the solution must be used within 6 hours.
The medicinal product should be administered intravenously over 2 - 15 minutes.
Contraindications:
Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the excipients.
Precautions:
In presence of alarm symptoms
l In the presence of any alarm symptom (e. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with pantoprazole may alleviate symptoms and delay diagnosis.
Hepatic Impairment
Co-administration with atazanavir
Gastrointestinal infections caused by bacteria
Hypomagnesaemia
Bone fractures
Subacute cutaneous lupus erythematosus (SCLE)
Drug interactions:
Effect of pantoprazole on the absorption of other medicinal products
l Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may reduce the absorption of drugs with a gastric pH dependent bioavailability, e.g some azole antifungals as ketoconazole, itraconazole, posaconazole and other medicine as erlotinib.
HIV medications (atazanavir)
Coumarin anticoagulants (phenprocoumon or warfarin)
Methotrexate
Storage:
Keep the vial not reconstituted in the outer carton.
Do not store above 30 °C.
Store in the original package in order to protect from light