Introduction

Pfizer

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Advocin 2.5% Solution for Injection is a clear sterile aqueous formulation of danofloxacin mesylate that contains 25 mg danofloxacin per ml. The product is ready for immediate administration. Each ml contains 3.1 mg phenol as preservative.

Uses

Advocin 2.5% Solution for Injection contains danofloxacin as the mesylate salt, a broad-spectrum fluoroquinolone antimicrobial that is active against a wide range of Gram-negative and Gram-positive bacteria and mycoplasmas of veterinary importance. Advocin 2.5% Solution for Injection is very rapidly absorbed after intramuscular administration and has marked affinity for tissues of the lung and gastrointestinal tract.

Cattle

Advocin is specifically indicated for the treatment of bovine respiratory disease (shipping fever, pneumonia) caused by Mannheimia haemolytica and Pasteurella multocida and enteric infections caused by Escherichia coli and Salmonella spp. in cattle.

Pigs

Advocin is specifically indicated for the treatment of respiratory disease caused by Pasteurella multocida and Actinobacillus pleuropneumoniae in pigs, and the treatment of enteric disease caused by Escherischia coli in pigs.

Dosage and administration

Cattle

Administer Advocin 2.5% Solution for Injection by the intramuscular or intravenous routes at a dosage rate of 1.25 mg danofloxacin/kg bodyweight (1 ml/20 kg bodyweight). Three treatments should be given at 24 hour intervals. Treatment may be extended up to an additional two days for animals that have not fully recovered after the initial three treatments. For treatment of cattle weighing more than 400 kg, divide the intramuscular dose so that no more than 20 ml are injected per site.

Pigs

Administer Advocin 2.5% Solution for Injection by intramuscular injection at a dosage rate of 1.25 mg danofloxacin/kg bodyweight (1 ml/20 kg bodyweight). Three treatments should be given at 24 hour intervals. For treatment of pigs weighing more than 100kg, divide the dose so that no more than 5ml are injected per site.

Contra-indications, warnings, etc

Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from cows only from 48 hours after the last treatment; i.e. at the fourth milking for cows milked twice daily.

Animals must not be slaughtered for human consumption during treatment. Cattle may only be slaughtered for human consumption from 5 days after the last treatment and pigs from 3 days after the last treatment.

Wash hands after use.

Pharmaceutical precautions

Following withdrawal of the first dose, use the product within 4 weeks. Any unused product and empty containers should be disposed of in accordance with guidance from your local waste regulation authority. Avoid the introduction of contamination during use. Should any apparent growth or discolouration occur the product should be discarded immediately. Do not store above 30°C.

Keep out of reach of children.

For animal treatment only.

Further information

Advocin has demonstrated excellent in vitro and in vivo activity against M.haemolytica and P.multocida, E.coli and Salmonella spp. and A.pleuropneumoniae, the major pathogenic bacteria associated with bovine and porcine respiratory and enteric infections.

Advocin has also demonstrated efficacy against mycoplasma in vitro

Mycoplasma hyopneumoniae MIC90 = 0.06 μg/ml.

Mycoplasma bovis MIC90 = 0.5 μg/ml.

Advocin is rapidly absorbed from the site of injection and reaches a high concentration in lung tissues within one hour following initial treatment. Drug levels in these tissues are approximately four-fold those found in the plasma. Advocin exerts its activity by inhibiting the bacterial DNA gyrase enzyme which is involved in bacterial DNA replication. Inhibition of DNA gyrase is lethal to bacteria and danofloxacin has been shown to be rapidly bactericidal. Advocin is bacteriocidal by a concentration-dependent mechanism so that achievement of high peak plasma concentrations will achieve optimal performance.