Baytril for Cattle - [Bacterial Antibiotic]

Baytril® 100 for Cattle is a sterile, ready-to-use injectable antimicrobial solution for treating bovine respiratory disease (BRD), that contains enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent./p>

First. Baytril 100 for Cattle is the first single-dose fluoroquinolone FDA-approved for the treatment of bovine respiratory disease (BRD) and the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD.

Four major BRD pathogens. Baytril 100 has bactericidal activity against the major bovine pathogens Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis.

Concentration-dependent. Baytril 100 is concentration-dependent, delivering effective therapeutic drug concentrations with a single dose.

Effective. In cattle, Baytril 100 reaches therapeutic drug concentrations at the site of infection in the lung in 1-2 hours.¹

Kills the bacteria. In vitro,* Baytril 100 kills 97% of BRD-causing bacteria in 1-2 hours.^*2 And the sooner bacteria are killed, the faster a calf will feel better and get back to work eating.

Easy syringability. Baytril 100 is syringable in cold weather3, making it an easily stored injectable solution (do not refrigerate; and protect from freezing and exposure to direct sunlight).

Beef & Dairy. Baytril 100 is approved for use in non-lactating dairy cattle, including dairy replacement heifers < 20 months of age.

Subcutaneous. Single-dose Baytril 100 is administered by a subcutaneous injection in compliance with BQA guidelines.

Available in three convenient sizes. Baytril 100 lets you select the bottle size that best fits your needs. Look for it in the 100 mL, 250 mL and 500 mL amber glass bottles.

Bactericidal. Baytril 100 has a mode of action that actually kills the bacteria causing infection by destroying bacterial DNA and preventing bacterial replication.

View Baytril 100 Drug Facts Sheet.

Baytril® 100 provides flexible dosages and durations of therapy

Baytril® 100 may be administered as a single dose for one day for treatment and control of BRD (cattle), for treatment and control of SRD or for control of colibacillosis (swine), or for multiple days for bRD teratment (cattle). Selection of the appropriate dose and duration of therapy for BRD treatment in cattle should be based on an assessment of the severity of the disease, pathogen susceptibility and clinical response.

Cattle:

Single-Dose Therapy (BRD Treatment): Administer, by subcutaneous injection, a single dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).

Multiple-Day Therapy (BRD Treatment): Administer daily, a subcutaneous dose of 2.5-5 mg/kg of body weight (1.1-2.3 mL/100 lb).

Treatment should be repeated at 24-hour interval for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Single-Dose Therapy (BRD Control): Administer, by Subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb)/

Examples of conditions that may contribute to calves being at high risk of developing BRD include, but are not limited to, the following:

• Transportation with animals from two or more farm origins.
• An extended transport time with few to no rest stops.
• An environmental temperature change of > 30°F during transportation.
• A > 30°F range in temperature fluctuation within a 24-hour period.
• Exposure to wet or cold weather conditions.
• Excessive shrink (more than would be expected with a normal load of cattle).
• Stressful arrival processing procedures (eg., castration or dehorning).
• Exposure within the prior 72 hours to animals showing clinical signs of BRD.

*Dose volumes have been rounded to the nearest 0.5 mL within the dose range.

Swine: Administer, either by intramiscular or subcutaneous (behind the ear) injection, a single dose of 7,5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5mL per injection site.

For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group. If no improvement is noted within 48 hours, the diagnosis should be reevaluated.

Dilution of Baytril® 100: Baytril® 100 may be diluted with sterile water prior to injection. The diluted product shoul dbe used within 24 hours. Store diluted solution in amber glass bottles between 4-40°C(36-104°F).

*For 1 mL dose volume from diluted solution

Use within 30 days of first puncture and puncture a maximum of 30 times with a needle or 4 times with a dosage delivery device. Any product remaining beyond these parameters shoul dbe discarded.

RESIDUE WARNINGS:

Cattle: Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle mayu cause drug residued in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Swine: Animals intended for human consumption mus tnot be slaughtered within 5 days of receiving a single-injection dose.

HUMAN WARNINGS:

Not for use in humans. Keep out of reach of children. Avoid cotnact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal cotnact, wash skin with soap and water. Consult a physician if irritation persists following ocular or dermal exposures. Individuals with a history if 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. For customer service or to obtain product information, including a Safety Data Sheet, Call 1-800-633-3796. For medical emergencies or to report adverse reactions, call 1-800-422-9874.

PRECAUTIONS: The effects of enrofloxacin on cattle or swine reproductive perdormance, pregnancy and lactation have not been adequately determined. The long-term effects on articular joint cartilage have not been determined in pigs above market weight. Subcutaneous injection in cattle and swine, or intramuscular injection in swine, can cause a transiet local tissue reaction that may result in trim loss of edible tissue at slaughter.

Baytril® 100 contains different excipients that other Baytril® products. The safety and efficay of this formulation in species other than cattle and swine have not been determined.

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 animals of various species. See Animal Safety section for additional information.