Product Name:  Covenia [cefovecin] Injection For Dogs & Cats, 10 ml Vial

Description: 

CONVENIA Injection For Dogs & Cats

cefovecin sodium

Antimicrobial for Subcutaneous Injection in Dogs and Cats Only

CONVENIA is indicated for the treatment of skin infections (secondary superficial pyoderma, abscesses, and wounds) in dogs caused by susceptible strains of Staphylococcus intermedius and Streptococcus canis (Group G). CONVENIA is indicated for the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida.  Convenia is the first antibiotic for dogs and cats that ensures a course of treatment in a single injection.  One dose of Covenia provides up to 14 days of safe and effective antibiotic treatment for the most common skin infections.

Convenia is well-tolerated, and its safety has been demonstrated in juvenile and adult dogs and cats.

DOSAGE AND ADMINISTRATION:

Dogs

CONVENIA should be administered as a single subcutaneous injection of 3.6 mg/lb (8 mg/kg) body weight. A second subcutaneous injection of 3.6 mg/lb (8 mg/kg) may be administered if response to therapy is not complete. The decision for a second injection for any individual dog should take into consideration such factors as progress toward clinical resolution, the susceptibility of the causative organisms, and the integrity of the dog's host-defense mechanisms. Therapeutic drug concentrations after the first injection are maintained for 7 days for S. intermedius infections and for 14 days for S. canis (Group G) infections. Maximum treatment should not exceed 2 injections.

Cats

CONVENIA should be administered as a single, one-time subcutaneous injection at a dose of 3.6 mg/lb (8 mg/kg) body weight. After an injection of CONVENIA, therapeutic concentrations are maintained for approximately 7 days for Pasteurella multocida infections.

General Dosing Information

A sample of the lesion should be obtained for culture and susceptibility testing prior to beginning antimicrobial therapy. Once results become available, continue with appropriate therapy. If acceptable response to treatment is not observed, or if no improvement is seen within 3 to 4 days, then the diagnosis should be re-evaluated and appropriate alternative therapy considered.

CONVENIA may persist in the body for up to 65 days. The effect of remaining concentrations of cefovecin on any subsequent antimicrobial therapies has not been determined. Fluoroquinolone and aminoglycoside antimicrobials have been reported to be compatible with cephalosporin antimicrobial agents.^1,2,3

Dose Table for CONVENIA at 8 mg/kg Body Weight.

PREPARATION OF SOLUTION FOR INJECTION: To deliver the appropriate dose, aseptically reconstitute CONVENIA with 10 mL sterile water for injection. Shake and allow vial to sit until all material is visually dissolved. The resulting solution contains cefovecin sodium equivalent to 80 mg/mL cefovecin. CONVENIA is light sensitive. The vial should be stored in the original carton and refrigerated when not in use. Use the entire contents of the vial within 56 days of reconstitution.

CONTRAINDICATIONS: CONVENIA is contraindicated in dogs and cats with known allergy to cefovecin or to β-lactam (penicillins and cephalosporins) group antimicrobials. Anaphylaxis has been reported with the use of this product in foreign market experience. If an allergic reaction or anaphylaxis occurs, CONVENIA should not be administered again and appropriate therapy should be instituted. Anaphylaxis may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamine, corticosteroids, and airway management, as clinically indicated. Adverse reactions may require prolonged treatment due to the prolonged systemic drug clearance (65 days).

WARNINGS: Not for use in humans. Keep this and all drugs out of reach of children. Consult a physician in case of accidental human exposure. For subcutaneous use in dogs and cats only. Antimicrobial drugs, including penicillins and cephalosporins, can cause allergic reactions in sensitized individuals. To minimize the possibility of allergic reactions, those handling such antimicrobials, including cefovecin, are advised to avoid direct contact of the product with the skin and mucous membranes.

PRECAUTIONS: Prescribing antibacterial drugs in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to treated animals and may increase the risk of the development of drug-resistant animal pathogens.

The safe use of CONVENIA in dogs or cats less than 4 months of age (see Animal Safety) and in breeding or lactating animals has not been determined. Safety has not been established for IM or IV administration. The long-term effects on injection sites have not been determined. CONVENIA is slowly eliminated from the body, approximately 65 days is needed to eliminate 97% of the administered dose from the body. Animals experiencing an adverse reaction may need to be monitored for this duration.

CONVENIA has been shown in an experimental in vitro system to result in an increase in free concentrations of carprofen, furosemide, doxycycline, and ketoconazole. Concurrent use of these or other drugs that have a high degree of protein-binding (e.g. NSAIDs, propofol, cardiac, anticonvulsant, and behavioral medications) may compete with cefovecin-binding and cause adverse reactions.

Positive direct Coombs' test results and false positive reactions for glucose in the urine have been reported during treatment with some cephalosporin antimicrobials. Cephalosporin antimicrobials may also cause falsely elevated urine protein determinations. Some antimicrobials, including cephalosporins, can cause lowered albumin values due to interference with certain testing methods.

Occasionally, cephalosporins and NSAIDs have been associated with myelotoxicity, thereby creating a toxic neutropenia⁴. Other hematological reactions seen with cephalosporins include neutropenia, anemia, hypoprothrombinemia, thrombocytopenia, prolonged prothrombin time (PT) and partial thromboplastin time (PTT), platelet dysfunction and transient increases in serum aminotransferases.

ADVERSE REACTIONS:

Dogs: Lethargy, anorexia/decreased appeptite, vomiting, diarrhea, blood in feces, dehydration, flatulence, increase borborygmi

Cats:  Vomiting, diarrhea, anorexia/decreased appetite, lethargy, hyper/acting strange, inappropriate urination

Storage:  Store the powder and the reconstituted product in the original carton, refrigerated at 2° to 8° C (36° to 46° F). Use the entire contents of the vial within 28 days of reconstitution. PROTECT FROM LIGHT. After each use it is important to return the unused portion back to the refrigerator in the original carton. As with other cephalosporins, the color of the solution may vary from clear to amber at reconstitution and may darken over time. If stored as recommended, solution color does not adversely affect potency.