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Inform female patients of reproductive potential that protonix may cause fetal harm and to inform their prescriber of a known or suspected pregnancy see use in specific populations .

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Pantoprazole was positive in the in vitro human lymphocyte chromosomal aberration assaysin one of two mouse micronucleus tests for clastogenic effectsand in the in vitro Chinese hamster ovarian cell/HGPRT forward mutation assay for mutagenic effectsEquivocal results were observed in the in vivo rat liver DNA covalent binding assayPantoprazole was negative in the in vitro Ames mutation assaythe in vitro unscheduled DNA synthesisUDSassay with rat hepatocytesthe in vitro AS52/GPT mammalian cell-forward gene mutation assaythe in vitro thymidine kinase mutation test with mouse lymphoma L5178Y cellsand the in vivo rat bone marrow cell chromosomal aberration assay.

Data on the safe and effective dosing for conditions other than those describedsee Indications and Usage1such as life-threatening upper gastrointestinal bleedsare not availableProtonix I.V40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.

Pantoprazole was positive in the in vitro human lymphocyte chromosomal aberration assaysin one of two mouse micronucleus tests for clastogenic effectsand in the in vitro Chinese hamster ovarian cell/HGPRT forward mutation assay for mutagenic effectsEquivocal results were observed in the in vivo rat liver DNA covalent binding assayPantoprazole was negative in the in vitro Ames mutation assaythe in vitro unscheduled DNA synthesisUDSassay with rat hepatocytesthe in vitro AS52/GPT mammalian cell-forward gene mutation assaythe in vitro thymidine kinase mutation test with mouse lymphoma L5178Y cellsand the in vivo rat bone marrow cell chromosomal aberration assay.

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