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Date: Friday, July 1, 2022 17:05

Release 3.57
Advocin 2.5% Solution for Injection
 
Species: Pigs, Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Danofloxacin Mesylate
Product:Advocin® 2.5% Solution for Injection
Product index: Advocin 2.5%
Cattle - milk: 48 hours
Cattle - meat: 5 days
Pig - meat: 3 days
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
Seek veterinary advice regarding use of appropriately sized needles and syringes when dosing small animals. An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes, e.g. piglets less than 2 kg body weight.
When dosing a large number of animals from a single bottle, the use of an aspirating needle is recommended to avoid excessive broaching of the stopper.
Official and local antimicrobial policies should be taken into account when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Withdrawal period
Cattle: Milk: 48 hours.
Meat: 5 days.
Pigs: Meat: 3 days.
Operator warnings
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 the sight and 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.
Legal category
Legal category: POM-V
Packaging quantities
Multidose glass vials containing 50 ml or 100 ml. Not all pack sizes may be marketed.
Marketing Authorisation Number
Vm 42058/4001
Significant changes
GTIN
GTIN description:50 ml:
GTIN:05013457072044
GTIN description:100 ml:
GTIN:05013457072020