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Baytril 100 Injectable
Baytril® (brand of enrofloxacin) Injectable Solution
Baytril® (brand of enrofloxacin) Injectable Solution


 
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Baytril® (brand of enrofloxacin) Injectable Solution

Item# Item Name Our Price Qty Add
71-014700 Baytril 100 Injectable 100 ML.
$79.99
71-018675 Baytril 100 Injectable 250 ML.
$169.99
71-040329 Baytril 100 Injectable 500 ML.
$312.99
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Features:
Baytril® 100 is a sterile, ready-to-use injectable antimicrobial solution that contains enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent. Therapeutic treatment with Baytril® 100 injectable solution may be administered as a single-dose or as a multiple-day therapy. Each milliliter of Baytril® 100 injectable solution contains 100 mg of enrofloxacin.





Extended Information:

(enrofloxacin) 100 mg/mL Antimicrobial Injectable Solution

Bayer Animal Health

For Subcutaneous Use In Cattle Only

Not For Use In Cattle Intended For Dairy Production Or In Calves To Be Processed For Veal

CAUTION:

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

Federal (U.S.A.) law prohibits the extra-label use of this drug in food producing animals.

PRODUCT DESCRIPTION:

Baytril® 100 is a sterile, ready-to-use injectable antimicrobial solution that contains enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent.

Therapeutic treatment with Baytril® 100 injectable solution may be administered as a single-dose or as a multiple-day therapy.

Each milliliter of Baytril® 100 injectable solution contains 100 mg of enrofloxacin. Excipients are L-arginine base 200 mg, n-butyl alcohol 30 mg, benzyl alcohol (as a preservative) 20 mg, and water for injection, q.s.

PHARMACOLOGY:

Microbiology: Enrofloxacin is bactericidal and exerts its antibacterial effect by inhibiting bacterial DNA gyrase (a type II topoisomerase) thereby preventing DNA supercoiling and replication, which leads to cell death.1 Enrofloxacin is active against gram-negative and gram-positive bacteria. Activity against Mycoplasma spp. has also been detected.

Enrofloxacin has demonstrated in vivo and in vitro activity against Mannheimia haemolytica, Pasteurella multocida, and Haemophilus somnus, the major pathogenic bacteria associated with bovine respiratory disease.

The Minimum Inhibitory Concentrations (MICs) of enrofloxacin were determined2 for isolates obtained from natural infections in cattle during 1994 and 1995 (see Table I).

Table I - MIC Values (µg/mL) of Enrofloxacin Against Bacteria and Mycoplasma Isolated from Natural Infections

ISOLATE

No. Isolates

MIC50**

MIC90**

Haemophilus somnus

104

0.015

0.03

Mycoplasma spp*

124

0.25

0.5

Mannheimia haemolytica

121

0.06

0.06

Pasteurella multocida

108

0.015

0.03

* The clinical significance of these in vitro data has not been demonstrated.

**The MIC for 50% and 90% of the isolates.

EFFICACY:

A total of 845 calves with naturally-occurring bovine respiratory disease (BRD) were treated with Baytril® 100 in eight field trials located in five cattle-feeding states. Response to treatment was compared to non-treated controls. Single-dose and multiple-day therapy regimens were evaluated. BRD and mortality were significantly reduced in enrofloxacin-treated calves. No adverse reactions were reported in treated animals.

INDICATIONS:

Baytril® 100 (enrofloxacin) injectable solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Haemophilus somnus.

WARNING:
Animals intended for human consumption must not be slaughtered within 28 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 pre-ruminating calves. Do not use in calves to be processed for veal.

HUMAN WARNINGS:

For use in animals only. Keep out of the 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.
PRECAUTIONS:
The effects of enrofloxacin on bovine reproductive performance, pregnancy, and lactation have not been adequately determined.

Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

Baytril® 100 contains different excipients than other Baytril® products. The safety and efficacy of this formulation in species other than cattle 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. No articular cartilage lesions were observed in the stifle joints of 23-day-old calves at 2 days and 9 days following treatment with enrofloxacin at doses up to 25 mg/kg for 15 consecutive days.

ADVERSE REACTIONS:
No adverse reactions were observed during clinical trials.
TOXICOLOGY:
The oral LD50 for laboratory rats was greater than 5000 mg/kg of body weight. Ninety-day feeding studies in dogs and rats revealed no observable adverse effects at treatment rates of 3 and 40 mg/kg respectively. Chronic studies in rats and mice revealed no observable adverse effects at 5.3 mg/kg and 323 mg/kg respectively. There was no evidence of carcinogenic effect in laboratory animal models. A two-generation rat reproduction study revealed no effect with 10 mg/kg treatments. No teratogenic effects were observed in rabbits at doses of 25 mg/kg or in rats at 50 mg/kg.
ANIMAL SAFETY:
Safety studies were conducted in feeder calves using single doses of 5, 15, and 25 mg/kg for 15 consecutive days and 50 mg/kg for 5 consecutive days. No clinical signs of toxicity were observed when a dose of 5 mg/kg was administered for 15 days. Clinical signs of depression, incoordination, and muscle fasciculation were observed in calves when doses of 15 or 25 mg/kg were administered for 10 to 15 days. Clinical signs of depression, inappetence, and incoordination were observed when a dose of 50 mg/kg had been administered for 3 days. No drug-related abnormalities in clinical pathology parameters were identified. No articular cartilage lesions were observed after examination of stifle joints from animals administered 25 mg/kg for 15 days.

A safety study was conducted in 23-day-old calves using doses of 5, 15, and 25 mg/kg for 15 consecutive days. No clinical signs of toxicity or changes in clinical pathology parameters were observed. No articular cartilage lesions were observed in the stifle joints at any dose level at 2 days and 9 days following 15 days of drug administration.

An injection site study conducted in feeder calves demonstrated that the formulation may induce transient reaction in the subcutaneous tissue and underlying muscle. No painful responses to administration were observed.

DOSAGE ADMINISTRATION:
Baytril® 100 injectable solution provides flexible dosages and durations of therapy. Baytril® 100 may be administered as a single dose for one day or for multiple days of therapy. Selection of the appropriate dose and duration of therapy should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response. Administered dose volume should not exceed 20 mL per injection site.

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

Multiple-Day Therapy: Administer daily, a subcutaneous dose of 2.5 - 5.0 mg/kg of body weight (1.1 - 2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on days 4 and 5 to animals which have shown clinical improvement but not total recovery.

Table II - Baytril®100 Dose and Treatment Schedule*

CATTLE WEIGHT
(lb)

Single-Dose Therapy
7.5 - 12.5 mg/kg
Dose Size (mL)

Multiple-Day Therapy
2.5 - 5.0 mg/kg
Dose Size (mL)

100

3.5 - 5.5

1.5 - 2.0

200

7.0 - 11.0

2.5 - 4.5

300

10.5 - 17.0

3.5 - 6.5

400

14.0 - 22.5

4.5 - 9.0

500

17.0 - 28.0

5.5 - 11.5

600

20.5 - 34.0

7.0 - 13.5

700

24.0 - 40.0

8.0 - 16.0

800

27.5 - 45.5

9.0 - 18.0

900

31.0 - 51.0

10.5 - 20.5

1000

34.0 - 56.5

11.5 - 22.5

1100

37.5 - 62.5

12.5 - 25.0

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

Note: Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

STORAGE CONDITIONS: Protect from direct sunlight. Do not refrigerate, freeze or store at or above 40°C (104°F). Precipitation may occur due to cold temperature. To redissolve, warm and then shake the vial.




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