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Dogs A total of 320 dogs, ranging in age from 8 weeks to 19 years, were included in a field study safety analysis. Adverse reactions reported in dogs treated with cefovecin sodium and the active control are summarized in Table 2. Table 2: Number of Dogs* with Adverse Reactions Reported During the Field Study with Cefovecin Sodium * Some dogs may have experienced more than one adverse reaction or more than one occurrence of the same adverse reaction during the study. Mild to moderate elevations in serum gamma glutamyl transferase or serum alanine aminotransferase were noted post-treatment in several of the CEFOVECIN-treated dogs. No clinical abnormalities were noted with these findings. One cefovecin sodium-treated dog in a separate field study experienced diarrhea post-treatment lasting four weeks. The diarrhea resolved. Cats A total of 291 cats, ranging in age from 2.4 months (one cat) to 21 years, were included in the field study safety analysis. Adverse reactions reported in cats treated with cefovecin sodium and the active control are summarized in Table 3. Table 3: Number of Cats* with Adverse Reactions Reported During the Field Study with Cefovecin Sodium. * Some cats may have experienced more than one adverse reaction or more than one occurrence of the same adverse reaction during the study. Four cefovecin sodium cases had mildly elevated post-study ALT (one case was elevated pre-study). No clinical abnormalities were noted with these findings. Twenty-four cefovecin sodium cases had normal pre-study BUN values and elevated post-study BUN values (37 – 39 mg/dL post-study). There were 6 cefovecin sodium cases with normal pre- and mildly to moderately elevated post-study creatinine values. Two of these cases also had an elevated post-study BUN. No clinical abnormalities were noted with these findings. One cefovecin sodium-treated cat in a separate field study experienced diarrhea post-treatment lasting 42 days. The diarrhea resolved. FOREIGN MARKET EXPERIENCE: The following adverse events were reported voluntarily during post-approval use of the product in dogs and cats in foreign markets: death, tremors/ataxia, seizures, anaphylaxis, acute pulmonary edema, facial edema, injection site reactions (alopecia, scabs, necrosis, and erythema), hemolytic anemia, salivation, pruritus, lethargy, vomiting, diarrhea, and inappetance This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may also report side effects to the FDA at 1-800-FDA-1088.