Advocin for Cattle - (Danofloxacin Mesylate) Sterile Injectable Solution - 250mL (180 mg/mL) - [Respiratory Health]

Advocin for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica and Pasteurella multocida. Advocin™ provides one more treatment option for bovine respiratory disease (BRD). A 4-day withdrawal time provides increased flexibility to treat animals during the entire feeding period.

Key Benefits

• Fast-acting BRD therapy
• Reaches peak lung concentrations in one hour
• Four-day meat withdrawal the shortest available
• Offers the flexibility to treat animals during the entire feeding period

Indications

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica and Pasteurella multocida in beef cattle and for the control of BRD in beef cattle at high risk of developing BRD associated with Mannheimia haemolytica and Pasteurella multocida.

View Advocin Drug Facts Sheet.

Care should be taken to dose accurately. Administered dose volume should not exceed 15 mL per injection site.

Single-Dose Therapy (BRD Treatment and Control in Cattle at High Risk): Administer subcutaneously at 8 mg/kg of body weight (2 mL/100 lb) as a one-time injection.

Multi-Day Therapy (BRD Treatment): Administer subcutaneously at 6 mg/kg of body weight (1.5 mL/100 lb) with this treatment repeated once approximately 48 hours following the first injection.

*Administered dose volume should not exceed 15 mL per injection site.

Clinical field studies indicate that Advocin (danofloxacin injection) Sterile Injectable Solution is effective for the control of respiratory disease in beef cattle at high risk of developing BRD. Cattle at high risk of developing BRD typically experience one or more of the following risk factors:

• Commingling from multiple sale barns/sources• Extended transport times and shrink
• Exposure to wet or cold weather conditions or wide temperature swings
• Stressful arrival processing procedures (such as castration, dehorning, or branding)
• Recent weaning or poor vaccination history

Residue Warnings:

Animals intended for human consumption must not be slaughtered within 4 days from the last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Human Warnings:

For use in animals only. Keep out of reach of children. Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation persists following ocular or dermal exposures. Individuals with a history of hypersensitivity to quinolones should avoid this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight.

To report adverse reactions or to obtain a copy of the Safety Data Sheet (SDS), call 1-888-963-8471.

Precautions:

The effects of danofloxacin on bovine reproductive performance, pregnancy, and lactation have not been determined. Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

Quinolone-class drugs should be used with caution in animals with known or suspected central nervous system (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation, which may lead to convulsive seizures.

Quinolone-class drugs have been shown to produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature, rapidly growing animals of various species. Refer to Animal Safety for information specific to danofloxacin.

Adverse Reactions:

A hypersensitivity reaction was noted in 2 healthy calves treated with Advocin in a laboratory study. In one location of a multi-site field trial, one out of the 41 calves treated with 6 mg/kg q 48 hours showed lameness on Day 6 only. In this same field trial location one of 38 calves treated with 8 mg/kg once became lame 4 days after treatment and remained lame on the last day of the study (Day 10). Another calf in the same treatment group developed lameness on the last day of the study.

Effectiveness:

The effectiveness of 8 mg/kg administered once and the 6 mg/kg BW alternate day regimen was confirmed in 4 well-controlled studies of naturally acquired bacterial respiratory infections in feedlot age cattle. These studies were conducted under commercial conditions at 4 locations in North America. Bacterial pathogens isolated in the clinical field trial are provided in the Microbiology section.

The effectiveness of Advocin for the control of BRD in cattle at high risk of developing BRD associated with Mannheimia haemolytica and Pasteurella multocida was demonstrated in a multi-site study conducted in North America. The study enrolled a total of 1,480 commercial, crossbred-beef, Holstein and Holstein-cross steer calves at high risk of developing BRD associated with M. haemolytica and P. multocida. At enrollment, calves were randomly administered a one-time subcutaneous injection of either Advocin at a dosage rate of 8 mg/kg of body weight or an equivalent volume of sterile saline. Cattle were observed daily for clinical signs of BRD and were evaluated for clinical success on Day 10 post-treatment. The treatment success rate of Advocin-treated calves (86.0%) was statistically significantly (p=0.0068) greater than that of saline-treated calves (76.3%) (based on back-transformed least squares means). No adverse events associated with Advocin administration were reported in the study.

Storage:

Store at or below 30°C (86°F). Protect from light. Protect from freezing. The color is yellow to amber and does not affect potency. When using a draw-off spike or needle with bore diameter larger than 16 gauge, discard any product remaining in the vial immediately after use.

100 mL vial: Use this product within 28 days of the first puncture and puncture a maximum of 7 times. If more than 7 punctures are anticipated, the use of automatic injection equipment or a repeater syringe is recommended.

250 mL vial: Use this product within 28 days of the first puncture and puncture a maximum of 17 times. If more than 17 punctures are anticipated, the use of automatic injection equipment or a repeater syringe is recommended.