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4NDC: 7664-435-581000in 1 BOTTLE; Type 0: Not a Combination Product. Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date 1NDC: 7664-474-5990in 1 BOTTLE; Type 0: Not a Combination Product.The fixed-combination preparation containing metformin and rosiglitazone has not been specifically studied in patients previously receiving metformin monotherapy; however, clinical trials have evaluated rosiglitazone 4 or 8 mg once daily as add-on therapy in patients who had inadequate glycemic control with metformin 2.

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It may be necessary to discontinue therapy with metformin and administer insulin if patient is exposed to stress fever, trauma, or infection May impair vitamin B12 or calcium intake/absorption; monitor B12 serum concentrations periodically with long-term therapy.

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Properly conducted randomised trials are required, as well as a large enough database to exclude rare unanticipated adverse outcomes, such as birth defects.

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