Properties:
• Danofloxacin is a synthetic fluoroquinolone antimicrobial agent with potent in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Escherichia coli, the bacterial pathogens most commonly associated with bovine respiratory disease (BRD), enteric disease, and acute bovine mastitis.
• The antimicrobial activity of Danofloxacin is based on the inhibition of bacterial DNA gyrase and topoisomerase IV.
• Danofloxacin inhibits the second step of the enzymatic process by preventing the re-ligation of cleaved DNA strands. Like other fluoroquinolones, it forms a stable complex with DNA and the enzyme, thereby inhibiting DNA replication and transcription.
• Danofloxacin exhibits bactericidal activity against both actively dividing bacteria and bacteria in the stationary phase of growth.
INDICATIONS:
In cattle
• Treatment of bovine respiratory disease caused by Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.
• Treatment of acute bovine mastitis caused by Escherichia coli.
In neonatal calves
• Treatment of enteric infections caused by Escherichia coli.
TARGET SPECIES:
Cattle (including neonatal calves) , Pigs
Dosage & Administration:
| Target species | Dose (Danofloxacin base) | Equivalent volume of a 180 mg/mL injection |
|---|---|---|
| Cattle | 6 mg/kg SC, repeat after 48 h or 8 mg/kg SC once | 1 mL/30 kg (6 mg/kg) or 1 mL/22.5 kg (8 mg/kg) |
| Calves | 6 mg/kg SC, repeat after 48 h (where approved) | 1 mL/30 kg |
| Pigs | 2.5 mg/kg IM once daily for 3 days | 1 mL/72 kg |
WARNINGS:
• Use of fluoroquinolones should be based on susceptibility testing and should take into account official and local antimicrobial use policies.
• Fluoroquinolones should be reserved for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
• Efficacy against Gram-positive organisms has not been established.
• As a class, fluoroquinolones have been shown, at multiples of the recommended dose, to induce erosion of articular cartilage. Therefore, care should be taken to administer the correct dose, and the product should be used with caution in animals with joint disease or disorders of cartilage development.
• Use of the product in a manner that deviates from the instructions provided in the SPC may increase the prevalence of bacteria resistant to fluoroquinolones and reduce the effectiveness of treatment with other quinolones due to potential cross-resistance.
• Do not use in cases where the causative pathogen is known to be resistant to other fluoroquinolones because of the potential for cross-resistance.
Contra-indications:
• Do not use in animals with known hypersensitivity to Danofloxacin, other (fluoro)quinolones, or any of the excipients.
Adverse Reactions:
• In very rare cases, immediate or delayed anaphylactic reactions may occur following administration.
• Subcutaneous administration may induce a moderate inflammatory reaction at the injection site.
• Injection-site lesions may persist for up to 30 days.
Withdrawal Time:
• Meat and offal: 8 days
• Milk: 4 days
Storage conditions:
• Keep out of the sight and reach of children and pets.
• Store in a cool, dry place, protected from direct sunlight.
• Dispose of unused product, waste materials, and empty containers in accordance with national regulations for veterinary medicinal products.
• Do not reuse empty containers.
Presentation:
• 100 mL glass vial.
