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ReBalance®

(sulfadiazine and pyrimethamine)

USES

Indicated for the treatment of horses with equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

See full prescribing information for complete dosing and administration instructions.

Item #Product NameSupplied
30024711ReBalance® Antiprotozoal Oral Suspension1 qt. bottle

PRODUCT INFORMATION

Active Ingredient(s): sulfadiazine pyrimethamine

IMPORTANT SAFETY INFORMATION:

Prior to treatment with ReBalance® Antiprotozoal Oral Suspension, EPM should be distinguished from other diseases that may cause ataxia in horses. Injuries or lameness may also complicate the evaluation of an animal with EPM. In most instances, ataxia due to EPM is asymmetrical and affects the front and/or the hind limbs.

Treatment may cause generalized bone marrow suppression, anemia, leukopenia, neutropenia and thrombocytopenia. A complete blood count (CBC) should be performed monthly to monitor horses for development of these conditions. The administration of the drug may need to be discontinued and/or treatments for bone marrow suppression initiated.

Other, less frequent side effects included decreased appetite, loose stools, and mild colic. In most cases, the gastrointestinal signs were self-limiting and did not require discontinuation of treatment.

Worsened neurologic deficits (treatment crisis) may be observed during a period beginning with the first few days of treatment with ReBalance and ranging out to 5 weeks. This neurologic deficit exacerbation may be the result of an inflammatory reaction to the dying parasites in the CNS tissue.

The safe use of ReBalance® Antiprotozoal Oral Suspension in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated. The safety of ReBalance® with concomitant therapies in horses has not been evaluated.

ReBalance® is not for use in horses with known hypersensitivity to sulfonamide drugs or pyrimethamine. Refer to the prescribing information for complete details.

NADA#141-240

WARNINGS:

For use in horses only. Do not use in horses intended for human consumption. Not for human use. Keep out of the reach of children.

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