§ 520.1782 Pimobendan solution.
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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
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Specifications.(a) Each milliliter of solution contains 1.5 milligrams (mg) pimobendan.
Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter.
Conditions of use in dogsAmount.i.e.,(c) —(1) Administer orally at a total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight. The total daily dose should be divided into two equal portions administered approximately 12 hours apart ( morning and evening).
Indications for use.e.g.,(2) For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure ( furosemide, etc.) as appropriate on a case-by-case basis.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[89 FR 42357, May 15, 2024]
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