Pantoprazole 40mg Lyophilized Powder for Injection (I.M./I.V.)


Pantoprazole 40mg Lyophilized Powder for Injection (I.M./I.V.)

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    Each vial contains:
    40mg Pantoprazole (equivalent to 44.18mg Pantoprazole Sodium Monohydrate)
    The excipients are Edetate Disodium and Sodium hydroxide

    1vial + 10 mL diluent / tray / box

    Indication & Dosage

    – Reflux oesophagitis.
    – Gastric and duodenal ulcer.
    – Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.

    Dosage and 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. 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 injection should be discontinued and 40 mg pantoprazole p.o. should be administered instead.

    Recommended dose:
    Gastric and duodenal ulcer, reflux oesophagitis – The recommended intravenous dose is one vial of Pantoprazole (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 Pantoprazol Azevedos. 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 Pantoprazol Azevedos is sufficient to
    manage a decrease of acid output into the target range (<10mEq/h) within one hour in the majority of patients. Special populations Paediatric patients - The experience in children is limited. Therefore, Pantoprazole is not recommended for use in patients below 18 years of age until further data become available. 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. Renal Impairment - No dose adjustment is necessary in patients with impaired renal function. Elderly - No dose adjustment is necessary 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. 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. The product is to be used immediately after reconstitution or dilution. The medicinal product should be administered intravenously over 2 - 15 minutes. The contents of the vial are for single use only.


    Imported by:
    8F RBMT Bldg., 5th Avenue corner C3 Road,
    East Grace Park, Caloocan City

    Manufactured by:
    Henan, China


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