Advocin 180 mg/ml Solution for Injection for Cattle

Advocin 180 mg/ml Solution for Injection for Cattle.

Presentation

Advocin 180 solution is a clear sterile aqueous formulation of danofloxacin mesylate that contains 180 mg danofloxacin per ml. The product is ready for immediate administration.

Each ml contains 2.5 mg phenol and 5 mg monothioglycerol as preservative.

Uses

Advocin 180 contains danofloxacin, a fluoroquinolone antimicrobial agent that possesses potent in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Escherichia coli, the bacterial pathogens most commonly associated with bovine respiratory disease, enteric disease and acute bovine mastitis.

Cattle and calves

Advocin 180 is specifically indicated for the treatment of bovine respiratory disease caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni and for the treatment of acute bovine mastitis caused by Escherichia coli sensitive to danofloxacin.

Neonatal calves

Advocin 180 is also indicated for the treatment of enteric infections caused by Escherichia coli sensitive to danofloxacin.

Dosage and administration

6 mg/kg body weight (1 ml/30 kg body weight) as a single injection by the subcutaneous or intravenous route.

If clinical signs of respiratory or enteric disease persist 48 hours after the first injection, an additional dose at 6 mg/kg body weight may be administered. It is recommended to treat animals in the early stages of disease and to evaluate the response to treatment within 48 hours.

For the treatment of acute bovine mastitis, Advocin 180 should be administered at 6 mg/kg body weight (1 ml/30kg body weight) as a single injection by the subcutaneous or intravenous route. The clinical signs should be monitored carefully and supportive therapy should be given as appropriate. If clinical signs of acute bovine mastitis persist 36-48 hours after the first injection, the antibiotic treatment should be reviewed. It is recommended to treat animals in the early stages of disease and to evaluate the response to treatment within 36-48 hours.

For treatment of cattle weighing more than 450 kg, divide the subcutaneous dose so that no more than 15 ml are injected at one site. When dosing a large number of animals from a single vial, the use of an automatic syringe is recommended to avoid excessive broaching of the rubber stopper.

Contra-indications, warnings, etc

Cattle must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 8 days from the last treatment.

Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from 4 days (96 hours) after the last treatment; i.e. at the eighth milking for cows milked twice daily.

Use of the product deviating from the instructions given above may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

For fluoroquinolones as a class, over-dosage at multiples of the recommended dose has been shown to induce erosion of articular cartilage. Care should be taken to dose accurately and Advocin 180 should be used with caution in animals with joint disease or cartilage growth disorders.

Subcutaneous injection of the product induces a moderate inflammatory response in the tissue around the injection site. The resultant lesions may persist for up to 30 days. At doses of three times the therapeutic dose (18 mg/kg bw), erythema of the nasal and ocular mucosae was induced and food intake was reduced.

Studies in laboratory animals have shown adverse effects on reproduction. At high doses in rats (100 to 200 mg/kg/day), increase in foetal delayed ossification and in dilation of the cerebral ventricles were observed. Dams given high doses produced fewer live pups per litter and pup weight and survival were adversely affected. The safety of the product has not been assessed in pregnant cows. The use of the product is not recommended for cows during pregnancy. The safety of the product has not been assessed in breeding bulls.

Persons with known hypersensitivity to quinolones should avoid any contact with the product.

Wash hands after use. In case of contact with the skin, wash off any product immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with clean water.

Do not eat, drink or smoke during application.

Pharmaceutical precautions

Store in the original packaging.

Do not freeze.

Use the product within 28 days of withdrawal of the first dose from the bottle. Any unused product or waste material should be disposed of in accordance with national requirements.

Keep out of the sight and reach of children.

For animal treatment only.

Legal category

POM-V

Packaging quantities

Multidose glass vials containing 50 ml or 100 ml. Not all pack sizes may be marketed.