Enrofloxacin

Cattle (Single- Dose Therapy)

Enroflox 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy 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 may cause drug residues 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.

Enroflox® 100

Cattle (Single- Dose Therapy)

Enroflox 100 is indicated for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

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 may cause drug residues 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.

Enroflox® 100

Cattle (Multiple Day Therapy)

Enroflox 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef an non-lactating dairy 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 may cause drug residues 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.

Enroflox® 100

Cattle (Beef and Non-Lactating Dairy)

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle.

EnroPro™ 100

Cattle (Beef and Non-Lactating Dairy)

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Enrofloxacin

Cattle (beef and non-lactating dairy)

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

EnroMed™ 100

Cattle (beef and non-lactating dairy)

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

EnroMed™ 100

Cattle (replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age))

Conditionally approved for the treatment of clinical anaplasmosis associated with Anaplasma marginale in replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age). Not for use in any other class of dairy cattle or in veal calves.

Baytril® 100-CA1

Beef cattle, non-lactating dairy cattle

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

ENROFLOXACIN 100

Beef cattle, non-lactating dairy cattle

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

ENROFLOXACIN 100

Beef cattle and non-lactating dairy cattle

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle.

Tenotryl™

Beef cattle and non-lactating dairy cattle

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Tenotryl™

Enroflox 100 is indicated for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. Enroflox 100 is indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Animals intended for human consumption must not be slaughtered within five days of receiving a single-injection dose.

Enroflox® 100

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.

Baytril™ 100

For the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed

Baytril™ 100

As a treatment for canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine.

EnroPro™ Silver Otic

For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

Enroflox™ Injection for Dogs 2.27%

For the management of diseases associated with bacteria susceptible to enrofloxacin.

For use in animals only. In rare instances, use of this product in cats has been associated with Retinal Toxicity. Do not exceed 5 mg/kg of body weight per day in cats. Safety in breeding or pregnant cats has not been established. Keep out of reach of children. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra label use of this drug in food-producing animals. 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.

Baytril® Soft Chewable Tablets

Cattle - Single-Dose Therapy: Enrofloxacin 100 mg/ml is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis. Cattle - Multiple-Day Therapy: Enrofloxacin 100 mg/mL is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle. Swine: Enrofloxacin 100 mg/ml is indicated for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. Enrofloxacin 100 mg/mL is indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Enrofloxacin 100 mg/mL Antimicrobial Injectable Solution

Cattle - Single-Dose Therapy: Tenotryl™ is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis. Cattle - Multiple-Day Therapy: Tenotryl™ is indicated forthe treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle. Swine: Tenotryl™ is indicated for the treatment and controlof swine respiratory disease (SRD) associated with Actinobacilluspleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. Tenotryl™ is indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Tenotryl™ (enrofloxacin)100 mg/mL Antimicrobial Injectable Solution

Enrofloxacin and Silver Sulfadiazine Otic Emulsion is indicated as a treatment for canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine (see Microbiology section).

Enrofloxacin and Silver Sulfadiazine Otic Emulsion(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

Baytril (brand of enrofloxacin) Taste Tabs Antibacterial Tablets are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin. Baytril Antibacterial Tablets are indicated for use in dogs and cats.

Approved by FDA under NADA # 140-441 Elanco TM BaytrilTM (enrofloxacin) Taste TabsTM 22.7 mg, 68 mg, 136 mg Antibacterial Tablets For Dogs And Cats

INDICATIONS: Enroquin (enrofloxacin) Flavored Tablets are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin. Enroquin Flavored Tablets are indicated for use in dogs and cats.

Enroquin® (enrofloxacin)Flavored Tablets

Enrofloxacin flavored antibacterial tablets are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin. Enrofloxacin Flavored tablets are indicated for use in dogs and cats.

FDA application 200-737

Enroflox® Chewable Tablets (enrofloxacin) are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin. Enroflox Chewable Tablets are indicated for use in dogs and cats.

FDA application 200-720

Enrosite™ Silver Otic is indicated as a treatment for canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine (see Microbiology section).

VET one ® Enrosite™ Silver Otic(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. ► Federal law prohibits the extralabel use of this drug in food-producing animals. ◄

Enroquin® (enrofloxacin)

INDICATIONS: Enroquin® (enrofloxacin) Injectable Solution is indicated for the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

Enroquin® (enrofloxacin)

For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin

Federal law restricts this drug to use by or on the order of a licensed veterinarian

Enrofloxacin Antibacterial Injectable Solution

CONTRAINDICATIONS: Enrofloxacin is contraindicated in dogs known to be hypersensitive to quinolones. Based on the studies discussed under the section on Animal Safety Summary, the use of enrofloxacin is contraindicated in small and medium breeds of dogs during the rapid growth phase (between 2 and 8 months of age). The safe use of enrofloxacin has not been established in large and giant breeds during the rapid growth phase. Large breeds may be in this phase for up to one year of age and the giant breeds for up to 18 months. In clinical field trials utilizing a daily oral dose of 5.0 mg/kg, there were no reports of lameness or joint problems in any breed. However, controlled studies with histological examination of the articular cartilage have not been conducted in the large or giant breeds.

Enroquin® (enrofloxacin)

Enrofloxacin and Silver Sulfadiazine Otic Emulsion is contraindicated in dogs with suspected or known hypersensitivity to quinolones and/or sulfonamides.

Enrofloxacin and Silver Sulfadiazine Otic Emulsion(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

Enrosite™ Silver Otic is contraindicated in dogs with suspected or known hypersensitivity to quinolones and/or sulfonamides.

VET one ® Enrosite™ Silver Otic(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

CONTRAINDICATIONS: Enrofloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones.

Enroquin® (enrofloxacin)Flavored Tablets

For use in animals only. In rare instances, use of this product in cats has been associated with Retinal Toxicity. Do not exceed 5 mg/kg of body weight per day in cats. Safety in breeding or pregnant cats has not been established. 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 exposure. 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. Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by humans. Due to the flavoring contained in Enrofloxacin flavored antibacterial tablets, keep in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact ZyVet Animal Health Inc. at 1-877-779-9838. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

FDA application 200-737

WARNINGS: For use in animals only. In rare instances, use of this product in cats has been associated with Retinal Toxicity. Do not exceed 5 mg/kg of body weight per day in cats. Safety in breeding or pregnant cats has not been established. 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 exposure. 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. For customer service or to obtain product information, including Safety Data Sheet, call (866)933-2472. Keep Enroquin (enrofloxacin) Flavored Tablets in a secure location out of reach of dogs, cats, and other animals lo prevent accidental ingestion or overdose.

Enroquin® (enrofloxacin)Flavored Tablets

Not for use in humans. 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. CONTACT INFORMATION: To report suspected adverse drug experiences, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Elanco at 1-800-428-4441. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Elanco™ BaytrilTM 100

Not for use in humans. 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 ofuser photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Virbac AH, Inc. at 1-800-338-3659 or us.virbac.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Tenotryl™ (enrofloxacin)100 mg/mL Antimicrobial Injectable Solution

General Safety Study: In a target animal safety study, enrofloxacin/silver sulfadiazine otic was administered in both ears of 24 clinically normal beagle dogs at either recommended or exaggerated dosages: 10, 30 or 50 drops applied twice daily for 42 consecutive days. A control group of 8 beagle dogs was treated by administering 50 drops of vehicle in one ear twice daily for 42 consecutive days, with the contralateral ear untreated. Erythema was noted in all groups, including both treated and untreated ears in the controls, which resolved following termination of treatment. Oral Safety Study: In order to test safety in case of ingestion, enrofloxacin/silver sulfadiazine otic was administered, twice daily for 14 consecutive days, to the dorsum of the tongue and to the left buccal mucosa of 6 clinically normal dogs. No adverse local or systemic reactions were reported.

VET one ® Enrosite™ Silver Otic(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

HUMAN WARNINGS: Not for use in humans. 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. For customer service or to obtain product information, including a Safety Data Sheet, call 1-888-524-6332. For medical emergencies or to report adverse reactions, call 1-888-524-6332.

FDA application 200-598

For use in animals only. The use of this product in cats may result in Retinal Toxicity. 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 exposure. 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. For customer service, to obtain a copy of the Safety Data Sheet (SDS) or to report adverse reactions call Norbrook at 1-866-591-5777.

FDA application 200-513

WARNINGS: For use in animals only. The use of this product in cats may result in Retinal Toxicity. 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 exposure. 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. For customer service or to obtain product information, including Safety Data Sheet, call (866) 933-2472.

Enroquin® (enrofloxacin)

Not for use in humans. 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. For product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 1-800-428-4441.

Elanco™ Baytril® 100

Not for use in humans. 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. For customer service, to obtain a copy of the Safety Data Sheet (SDS) or to report adverse reactions, call Covetrus® North America at (855) 724-3461.

FDA application 200-495

Not for use in humans. 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. For customer service, adverse effects reporting, and/or a copy of the Safety Data Sheet (SDS), call 1-800-255-6368.

Enrofloxacin 100

Not for human use. 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 develops or persists following ocular or dermal exposures. Individuals with a history of hypersensitivity to quinolone compounds or antibacterials should avoid handling 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.

VET one ® Enrosite™ Silver Otic(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

RESIDUE WARNINGS: Cattle: Animals intende d 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 may cause drug residues 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 must not be slaughtered within 5 days of receiving a single-injection dose.

FDA application 200-598

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. ▶ Federal law prohibits the extralabel use of this drug in food-producing animals. ◀

Enroquin® (enrofloxacin)Flavored Tablets

NDC No. 17033-324-20 Antibacterial Injectable Solution 2.27% For Dogs Only

Enroquin® (enrofloxacin)

Dogs: Two of the 270 (0.7%) dogs treated with enrofloxacin flavored tablets at 5.0 mg/kg per day in the clinical field studies exhibited side effects, which were apparently drug-related. These two cases of vomition were self-limiting. Post-Approval Experience: The following adverse experiences, although rare, are based on voluntary post-approval adverse drug experience reporting. The categories of reactions are listed in decreasing order of frequency by body system. Gastrointestinal: anorexia, diarrhea, vomiting, elevated liver enzymes Neurologic: ataxia, seizures Behavioral: depression, lethargy, nervousness Cats: No drug-related side effects were reported in 124 cats treated with enrofloxacin flavored tablets at 5.0 mg/kg per day for 10 days in clinical field studies. Post-Approval Experience: The following adverse experiences, although rare, are based on voluntary post-approval adverse drug experience reporting. The categories of reactions are listed in decreasing order of frequency by body system. Ocular: Mydriasis, retinal degeneration (retinal atrophy, attenuated retinal vessels, and hyperreflective tapeta have been reported), loss of vision. Mydriasis may be an indication of impending or existing retinal changes. Gastrointestinal: vomiting, anorexia, elevated liver enzymes, diarrhea Neurologic: ataxia, seizures Behavioral: depression, lethargy, vocalization, aggression To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact ZyVet Animal Health Inc. at 1-877-779-9838. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

FDA application 200-737

Dogs: Two of the 270 (0.7%) dogs treated with Baytril (brand of enrofloxacin) Tablets at 5.0 mg/kg per day in the clinical field studies exhibited side effects, which were apparently drug-related. These two cases of vomition were self-limiting. Post-Approval Experience: The following adverse experiences, although rare, are based on voluntary post-approval adverse drug experience reporting. The categories of reactions are listed in decreasing order of frequency by body system. Gastrointestinal: anorexia, diarrhea, vomiting, elevated liver enzymes Neurologic: ataxia, seizures Behavioral: depression, lethargy, nervousness Cats: No drug-related side effects were reported in 124 cats treated with Baytril (brand of enrofloxacin) Tablets at 5.0 mg/kg per day for 10 days in clinical field studies. Post-Approval Experience: The following adverse experiences, although rare, are based on voluntary post-approval adverse drug experience reporting. The categories of reactions are listed in decreasing order of frequency by body system. Ocular: Mydriasis, retinal degeneration (retinal atrophy, attenuated retinal vessels, and hyperreflective tapeta have been reported), loss of vision. Mydriasis may be an indication of impending or existing retinal changes. Gastrointestinal: vomiting, anorexia, elevated liver enzymes, diarrhea Neurologic: ataxia, seizures Behavioral: depression, lethargy, vocalization, aggression CONTACT INFORMATION: To report adverse reactions, call 888-545-5973. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Approved by FDA under NADA # 140-441 Elanco TM BaytrilTM (enrofloxacin) Taste TabsTM 22.7 mg, 68 mg, 136 mg Antibacterial Tablets For Dogs And Cats

During clinical trials, 2 of 113 (1.7%) dogs exhibited reactions that may have resulted from treatment with enrofloxacin/silver sulfadiazine otic. Both cases displayed local hypersensitivity responses of the aural epithelium to some component within the enrofloxacin/silver sulfadiazine otic formulation. The reactions were characterized by acute inflammation of the ear canal and pinna. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Cronus Pharma LLC at 1-844-227-6687 or 1-844-2-CRONUS. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

VET one ® Enrosite™ Silver Otic(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

During clinical trials, 2 of 113 (1.7%) dogs exhibited reactions that may have resulted from treatment with Baytril Otic. Both cases displayed local hypersensitivity responses of the aural epithelium to some component within the Baytril Otic formulation. The reactions were characterized by acute inflammation of the ear canal and pinna. CONTACT INFORMATION: For product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 888-545-5973. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

BaytrilTM Otic (enrofloxacin/silver sulfadiazine) Antibacterial-Antimycotic Emulsion

No drug-related side effects were reported in 122 clinical cases treated with enrofloxacin injectable solution followed by enrofloxacin tablets at 5.0 mg/kg per day. CONTACT INFORMATION To report suspected adverse drug experiences, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Felix Pharmaceuticals Private Limited at 1-833-571-1525. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

NDC No: 86101-015-42 Enrofloxacin Antibacterial Injectable Solution 2.27% For Dogs Only

No drug-related side effects were reported in 122 clinical cases treated with an enrofloxacin injectable solution followed by enrofloxacin tablets at 5.0 mg/kg per day. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Norbrook at 1-866-591-5777. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

FDA application 200-513

No drug-related side effects were reported in 122 clinical cases treated with Baytril (enrofloxacin) Injectable Solution followed by Baytril Tablets at 5.0 mg/kg per day. CONTACT INFORMATION: For medical emergencies or to report adverse reactions, contact Elanco US Inc. at 888-545-5973. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

FDA application 140-913

ADVERSE REACTIONS: No adverse reactions were observed during clinical trials. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae.

QuellaxcinTM 100(enrofloxacin)

No adverse reactions were observed during clinical trials. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), call Covetrus® North America at (855) 724-3461. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1 -888-FDA-VETS or online at www.fda.gov/reportanimalae.

FDA application 200-495

No adverse reactions were observed during clinical trials. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Norbrook at 1-866-591-5777. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

FDA application 200-495

No adverse reactions were observed during clinical trials. To report suspected adverse drug experiences, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Elanco at 1-800-428-4441. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Elanco™ BaytrilTM 100

To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Sparhawk Laboratories, Inc. at 1-800-255-6368. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Enrofloxacin 100

No adverse reactions were observed during clinical trials. To report suspected adverse drug events, contact Cronus Pharma LLC at 1-844-227-6687. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

EnroPro TM 100(enrofloxacin)100 mg/mL Antimicrobial Injectable Solution

ADVERSE REACTIONS: No adverse reactions were observed during clinical trials. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

FDA application 200-598

No adverse reactions were observed during clinical trials.For additional information about adverse drug experience reportingfor animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae.

Tenotryl™ (enrofloxacin)100 mg/mL Antimicrobial Injectable Solution

No drug-related side effects were reported in 122 clinical cases treated with enrofloxacin injectable solution followed by enrofloxacin tablets at 5.0 mg/kg per day.

EnroPro TM 22.7(enrofloxacin)Antibacterial Injectable Solution 2.27%For Dogs Only

ADVERSE REACTIONS:

Enroquin® (enrofloxacin)Flavored Tablets

Cattle (Single- Dose Therapy)

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

Intramuscular, Subcutaneous

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 may cause drug residues 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.

Enroflox® 100

Cattle (Multiple Day Therapy)

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 intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Intramuscular, Subcutaneous

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 may cause drug residues 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.

Enroflox® 100

Cattle (Beef and Non-Lactating Dairy)

Multiple-day therapy: 2.5 to 5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) by subcutaneous injection. Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery. Administered dose volume should not exceed 20 mL per injection site.

Intramuscular, Subcutaneous

Baytril™ 100

Cattle (Beef and Non-Lactating Dairy)

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 intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Intramuscular, Subcutaneous

Enrofloxacin

Cattle (Beef and Non-Lactating Dairy)

Single-dose therapy: 7.5 to 12.5 mg/kg of body weight (3.4 to 5.7 mL/100 lb) by subcutaneous injection. Administered dose volume should not exceed 20 mL per injection site.

Intramuscular, Subcutaneous

Baytril™ 100

Cattle (Beef and Non-Lactating Dairy)

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).

Intramuscular, Subcutaneous

Enrofloxacin

Cattle (beef and non-lactating dairy)

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 intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Intramuscular, Subcutaneous, Injection

EnroMed™ 100

Cattle (beef and non-lactating dairy)

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).

Intramuscular, Subcutaneous, Injection

EnroMed™ 100

Cattle (replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age))

Administer as a single dose for treatment of clinical anaplasmosis. Administer, by subcutaneous injection, a single dose of 12.5 mg/kg of body weight (5.7 mL/100 lb). Administered dose volume should not exceed 20 mL per injection site.

Subcutaneous

Baytril® 100-CA1

Beef cattle, non-lactating dairy cattle

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 intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Subcutaneous, Intramuscular

ENROFLOXACIN 100

Beef cattle, non-lactating dairy cattle

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

Subcutaneous, Intramuscular

ENROFLOXACIN 100

Beef cattle and non-lactating dairy cattle

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 intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Intramuscular, Subcutaneous

Tenotryl™

Beef cattle and non-lactating dairy cattle

Administer, by subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 20 mL per injection site.

Intramuscular, Subcutaneous

Tenotryl™

Beef cattle and non-lactating dairy cattle

Administer, by subcutaneous injection, a single dose of 7.5 – 12.5 mg/kg of body weight (3.4 – 5.7 mL/100 lb).

Intramuscular, Subcutaneous

Tenotryl™

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition.

Oral

Enrofloxacin

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition. All tablet sizes are double scored for accurate dosing.

Oral

The use of enrofloxacin is contraindicated in small and medium breeds of dogs during the rapid growth phase (between 2 and 8 months of age). The safe use of enrofloxacin has not been established in large and giant breeds of dogs during the rapid growth phase. For use in animals only. Keep out of reach of children. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra label use of this drug in food-producing animals. 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.

Baytril® Soft Chewable Tablets

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. May be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs to a maximum of 30 days.

Oral

Enrofloxacin Flavored Tablets

Enrofloxacin Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. The initial Enrofloxacin Injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy.

Intramuscular

Enrofloxacin

Administer orally at 5 to 20 milligrams per kilogram (2.27 to 9.07 milligrams per pound) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.

Oral

Enrofloxacin Flavored Tablets

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.

Oral

EnroPro™

Administer intramuscularly (IM) as a single injection at the rate of 1 mL/9.1 kg (20 lb) to provide 2.5 mg/kg (1.13 mg/lb). The injectable dose should be followed by oral tablet treatment in 12 hours.

Intramuscular

Enroflox™ Injection for Dogs 2.27%

Administer 5 to 10 drops per treatment in dogs weighing 35 pounds or less and 10 to 15 drops per treatment in dogs weighing more than 35 pounds. Apply twice daily for a duration of up to 14 days.

Otic

EnroPro™ Silver Otic

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight as a single daily dose or divided into two (2) equal daily doses at twelve (12) hour intervals.

Oral

Enroflox® Chewable Tablets

5 to 10 drops for dogs weighing 35 pounds or less and 10 to 15 drops for dogs weighing more than 35 pounds; applied twice daily for up to 14 days.

Topical

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra- label use of this drug in food-producing animals.

Baytril™ Otic

2.5 milligrams intramuscularly per kilogram (1.13 milligrams per pound) of body weight as a single initial dose only.

Intramuscular

As a single, intramuscular, initial dose followed by use of tablets twice daily for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days.

Baytril™ Antibacterial Injectable Solution

5 to 20 milligrams per kilogram (2.27 to 9.07 milligrams per pound) of body weight.

Oral

Baytril™ Antibacterial Tablets

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. All tablet sizes are double scored for accurate dosing.

Oral

For use in animals only. In rare instances, use of this product in cats has been associated with Retinal Toxicity. Do not exceed 5 mg/kg of body weight per day in cats. Safety in breeding or pregnant cats has not been established. Keep out of reach of children. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra label use of this drug in food-producing animals. 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.

Baytril® Soft Chewable Tablets

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days.

Oral

Enrofloxacin

Administer orally at 5 milligrams per kilogram (2.27 milligrams per pound) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.

Oral

Enrofloxacin Flavored Tablets

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.

Oral

EnroPro™

Administer orally at a rate to provide 5 mg/kg (2.27 mg/lb) of body weight as a single, daily dose, or divided into two equal doses at 12-hour intervals

Oral

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals

Enrofloxacin Flavored Tablets

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight as a single daily dose or divided into two (2) equal daily doses at twelve (12) hour intervals.

Oral

Enroflox® Chewable Tablets

5 milligrams per kilogram (2.27 milligrams per pound) of body weight.

Oral

Baytril™ Antibacterial Tablets

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). 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.

Intramuscular, Subcutaneous

Baytril™ 100

Administer, either by intramuscular 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 5 mL per injection site. For the control of colibacillosis, administrations 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.

Intramuscular, Subcutaneous

Animals intended for human consumption must not be slaughtered within five days of receiving a single-injection dose.

Enroflox® 100

Administer, either by intramuscular 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 5 mL per injection site.

Intramuscular, Subcutaneous, Injection

EnroMed™ 100

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).

Intramuscular, Subcutaneous

Baytril™ 100

Enrofloxacin 100 mg/mL provides flexible dosages and durations of therapy. Enrofloxacin 100 mg/mL 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 treatment (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 intervals 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 (e.g., castration or dehorning). Exposure within the prior 72 hours to animals showing clinical signs of BRD. Administered dose volume should not exceed 20 mL per injection site. Table 1 - Enrofloxacin 100 mg/mL Dose and Treatment Schedule for Cattle* Weight(lb) Treatment Control Single-Dose Therapy 7.5-12.5 mg/kg Dose Volume (mL) Multiple-Day Therapy 2.5-5.0 mg/kg DoseVolume(mL) Single-Dose Therapy 7.5 mg/kg Dose Volume (mL) 100 3.5 - 5.5 1.5 - 2.0 3.5 200 7.0 - 11.0 2.5 - 4.5 7.0 300 10.5 - 17.0 3.5 - 6.5 10.5 400 14.0 - 22.5 4.5 - 9.0 14.0 500 17.0 - 28.5 5.5 - 11.5 17.0 600 20.5 - 34.0 7.0 - 13.5 20.5 700 24.0 - 39.5 8.0 - 16.0 24.0 800 27.5 - 45.5 9.0 - 18.0 27.5 900 31.0 - 51.0 10.0 - 20.5 31.0 1000 34.0 - 57.0 11.0 - 23.0 34.0 1100 37.5 - 62.5 12.5 - 25.0 37.5 *Dose volumes have been rounded to the nearest 0.5 mL within the dose range. Swine: Administer, either by intramuscular 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 5 mL 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. Table 2- Enrofloxacin 100 mg/mL Dose Schedule for Swine Weight (lb) Dose Volume (mL) 15 0.5 30 1.0 50 1.7 100 3.4 150 5.1 200 6.8 250 8.5 Dilution of Enrofloxacin 100 mg/mL: Enrofloxacin 100 mg/mL may be diluted with sterile water prior to injection. The diluted product should be used within 24 hours. Store diluted solution in amber glass bottles between 4-40°C (36-104°F). Table 3 – Dilution Schedule* Swine Weight mL of Enrofloxacin 100 mg/mL mL of sterile water Number of doses 10 lb 34 mL 66 mL 100 15 lb 51 mL 49 mL 100 20 lb 68 mL 32 mL 100 25 lb 85 mL 15 mL 100 *For 1 mL dose volume from diluted solution Use within 30 days of first puncture and puncture a maximum of 30 times. If more than 30 punctures are anticipated, the use of multi-dosing equipment is recommended. 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.

SUBCUTANEOUS, INTRAMUSCULAR

Enrofloxacin 100 mg/mL Antimicrobial Injectable Solution

DOSAGE AND ADMINISTRATION: Quellaxcin™ 100 provides flexible dosages and durations of therapy. Quellaxcin™ 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 treatment (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 intervals 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 (e.g., castration or dehorning). Exposure within the prior 72 hours to animals showing clinical signs of BRD. Administered dose volume should not exceed 20 mL per injection site. Table 1 – Quellaxcin™ 100 100 Dose and Treatment Schedule for Cattle* *Dose volumes have been rounded to the nearest 0.5 mL within the dose range. Weight (lb) Treatment Control Single-Dose Therapy 7.5 - 12.5 mg/kg Dose Volume (mL) Multiple-Day Therapy 2.5 - 5.0 mg/kg Dose Volume (mL) Single-Dose Therapy 7.5 mg/kg Dose Volume (mL) 100 3.5 - 5.5 1.5 - 2.0 3.5 200 7.0 - 11.0 2.5 - 4.5 7.0 300 10.5 - 17.0 3.5 - 6.5 10.5 400 14.0 - 22.5 4.5 - 9.0 14.0 500 17.0 - 28.5 5.5 - 11.5 17.0 600 20.5 - 34.0 7.0 - 13.5 20.5 700 24.0 - 39.5 8.0 - 16.0 24.0 800 27.5 - 45.5 9.0 - 18.0 27.5 900 31.0 - 51.0 10.0 - 20.5 31.0 1000 34.0 - 57.0 11.0 - 23.0 34.0 1100 37.5 - 62.5 12.5 - 25.0 37.5 Swine: Administer, either by intramuscular 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 5 mL 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. Table 2 - Quellaxcin™ 100 Dose Schedule for Swine Weight (lb) Dose Volume (mL) 15 0.5 30 1.0 50 1.7 100 3.4 150 5.1 200 6.8 250 8.5 Dilution of Quellaxcin™100: Quellaxcin™ 100 may be diluted with sterile water prior to injection. Discard any diluted product remaining in the vial immediately after use. Table 3 – Dilution Schedule* Swine Weight mL of Quellaxcin™ 100 mL of Sterile Water Number of Doses 10 lb 34 mL 66 mL 100 15 lb 51 mL 49 mL 100 20 lb 68 mL 32 mL 100 25 lb 85 mL 15 mL 100 * For 1 mL dose volume from diluted solution Use within 28 days of first puncture and puncture a maximum of 25 times with a needle or 5 times with a dosage delivery device.

SUBCUTANEOUS, INTRAMUSCULAR

QuellaxcinTM 100(enrofloxacin)

DOSAGE AND ADMINISTRATION: EnroMed™ 100 provides flexible dosages and durations of therapy. EnroMed™ 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 treatment (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 intervals 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 (e.g., castration or dehorning). Exposure within the prior 72 hours to animals showing clinical signs of BRD. Administered dose volume should not exceed 20 mL per injection site. Table 1 –EnroMed™ 100 100 Dose and Treatment Schedule for Cattle * *Dose volumes have been rounded to the nearest 0.5 mL within the dose range. Weight (lb) Treatment Control Single-Dose Therapy 7.5 - 12.5 mg/kg Dose Volume (mL) Multiple-Day Therapy 2.5 - 5.0 mg/kg Dose Volume (mL) Single-Dose Therapy 7.5 mg/kg Dose Volume (mL) 100 3.5 - 5.5 1.5 - 2.0 3.5 200 7.0 - 11.0 2.5 - 4.5 7.0 300 10.5 - 17.0 3.5 - 6.5 10.5 400 14.0 - 22.5 4.5 - 9.0 14.0 500 17.0 - 28.5 5.5 - 11.5 17.0 600 20.5 - 34.0 7.0 - 13.5 20.5 700 24.0 - 39.5 8.0 - 16.0 24.0 800 27.5 - 45.5 9.0 - 18.0 27.5 900 31.0 - 51.0 10.0 - 20.5 31.0 1000 34.0 - 57.0 11.0 - 23.0 34.0 1100 37.5 - 62.5 12.5 - 25.0 37.5 Swine: Administer, either by intramuscular 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 5 mL 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. Table 2 - EnroMed™ 100 Dose Schedule for Swine Weight (lb) Dose Volume (mL) 15 0.5 30 1.0 50 1.7 100 3.4 150 5.1 200 6.8 250 8.5 Use within 28 days of first puncture and puncture a maximum of 25 times with a needle or 5 times with a dosage delivery device. Dilution of EnroMed™100: EnroMed™ 100 may be diluted with sterile water prior to injection. Discard any diluted product remaining in the vial immediately after use. Table 3 – Dilution Schedule* Swine Weight mL of EnroMed™100 mL of Sterile Water Number of Doses 10 lb 34 mL 66 mL 100 15 lb 51 mL 49 mL 100 20 lb 68 mL 32 mL 100 25 lb 85 mL 15 mL 100 * For 1 mL dose volume from diluted solution

SUBCUTANEOUS, INTRAMUSCULAR

FDA application 200-598

Tenotryl™ provides flexible dosages and durations of therapy. Tenotryl™ 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 treatment (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 intervals 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 (e.g., castration or dehorning). • Exposure within the prior 72 hours to animals showing clinical signs of BRD. Administered dose volume should not exceed 20 mL per injection site. Swine: Administer, either by intramuscular 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 5 mL per injection site. For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are presenting at least 2% of the animals in the group. If no improvement is noted within 48 hours, the diagnosis should be reevaluated. Dilution of Tenotryl: Tenotryl™ may be diluted with sterile water prior to injection. The diluted product should be used within 24 hours. Store diluted solution in amber glass bottles between 5°C - 40°C (41°F – 104°F), excursions are not permitted. Use within 30 days of first puncture and puncture a maximum of 30times with a 16-gauge needle or smaller, or 4 times with a draw-off spike 4.75 mm or smaller. Any product remaining beyond these parameters should be discarded.

SUBCUTANEOUS, INTRAMUSCULAR

Tenotryl™ (enrofloxacin)100 mg/mL Antimicrobial Injectable Solution

Dogs: Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition. If dogs do not consume Enrofloxacin Flavored Tablets willingly when offered by hand, then alternatively the tablet(s) may be offered in the food or hand- administered (pilled) as with other oral tablet medications. Weight of Dog Once Daily Dosing Chart 5.0 mg/kg 10.0 mg/kg 15.0 mg/kg 20.0 mg/kg 9.1 kg (20 lb) 2 x 22.7 mg tablets 1 x 22.7 mg plus 1 x 68 mg tablets 1 x 136 mg tablet 1 x 136 mg plus 2 x 22.7 mg tablets 27.2 kg (60 lb) 1 x 136 mg tablets 2 x 136 mg tablets 3 x 136 mg tablets 4 x 136 mg tablets All tablet sizes are double scored for accurate dosing. Cats: Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. In cats, Enrofloxacin Flavored Tablets should be pilled. After adminsitration, watch the animal closely to be certain the entire dose has been consumed. Weight of Cat Once Daily Dosing Chart (5 mg/kg/day) 5 lb (2.27 kg) 1/2 x 22.7 mg tablet 10 lb (4.5 kg) 1 x 22.7 mg tablet 15 lb (6.8 kg) 1 and 1/2 x 22.7 mg tablets or 1/2 x 68 mg tablet All tablet sizes are double scored for accurate dosing. Dogs & Cats: The duration of treatment should be selected based on clinical evidence. Generally, administration of Enrofloxacin Flavored Tablets should continue for at least 2-3 days beyond cessation of clinical signs. For severe and/or complicated infections, more prolonged therapy, up to 30 days, may be required. If no improvement is seen within five days, the diagnosis should be re-evaluated and a different course of therapy considered. The lower limit of the dose range in dogs and the daily dose for cats was based on efficacy studies in dogs and cats where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology were used to establish the upper limit of the dose range for dogs and treatment duration for dogs and cats.

ORAL

FDA application 200-680

Dogs: Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition. All tablet sizes are double scored for accurate dosing. Weight of Dog Once Daily Dosing Chart 5.0 mg/kg 10.0 mg/kg 15.0 mg/kg 20.0 mg/kg 9.1 kg (20 lb) 2 x 22.7 mg tablets 1 x 22.7 mg plus 1 x 68 mg tablets 1 x 136 mg tablet 1 x 136 mg plus 2 x 22.7 mg tablets 27.2 kg (60 lb) 1 x 136 mg tablet 2 x 136 mg tablets 3 x 136 mg tablets 4 x 136 mg tablets Cats: Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. All tablet sizes are double scored for accurate dosing. Weight of Cat Once Daily Dosing Chart (5 mg/kg/day) 5 lb (2.27 kg) 1/2 x 22.7 mg tablet 10 lb (4.5 kg) 1 x 22.7 mg tablet 15 lb (6.8 kg) 1 and 1/2 x 22.7 mg tablets or 1/2 x 68 mg tablet Palatability: Most dogs will consume Baytril Taste Tabs Tablets willingly when offered by hand. Alternatively the tablet(s) may be offered in food or hand-administered (pilled) as with other oral tablet medications. In cats, Baytril Taste Tabs Tablets should be pilled. After administration, watch the animal closely to be certain the entire dose has been consumed. Dogs & Cats: The duration of treatment should be selected based on clinical evidence. Generally, administration of Baytril Tablets should continue for at least 2-3 days beyond cessation of clinical signs. For severe and/or complicated infections, more prolonged therapy, up to 30 days, may be required. If no improvement is seen within five days, the diagnosis should be reevaluated and a different course of therapy considered. The lower limit of the dose range in dogs and the daily dose for cats was based on efficacy studies in dogs and cats where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology were used to establish the upper limit of the dose range for dogs and treatment duration for dogs and cats.

ORAL

Approved by FDA under NADA # 140-441 Elanco TM BaytrilTM (enrofloxacin) Taste TabsTM 22.7 mg, 68 mg, 136 mg Antibacterial Tablets For Dogs And Cats

Dogs: Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition. Weight of Dog Once Daily Dosing Chart 5.0 mg/kg 10.0 mg/kg 15.0 mg/kg 20.0 mg/kg 9.1 kg (20 lb) 2 x 22.7 mg tablets 1 x 22.7 mg plus 1 x 68 mg tablets 1 x 136 mg tablet 1 x 136 mg plus 2 x 22.7 mg tablets 27.2 kg (60 lb) 1 x 136 mg tablet 2 x 136 mg tablets 3 x 136 mg tablets 4 x 136 mg tablets All tablet sizes are double scored for accurate dosing. Cats: Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. Weight of Cat Once Daily Dosing Chart (5 mg/kg/day) 5 lb (2.27 kg) 1/2 x 22.7 mg tablet 10 lb (4.5 kg) 1 x 22.7 mg tablet 15 lb (6.8 kg) 1 and 1/2 x 22.7 mg tablets or 1/2 x 68 mg tablet All tablet sizes are double scored for accurate dosing. Palatability: Enrofloxacin flavored tablets may be offered to dogs by hand. Alternatively the tablets may be offered in food or hand-administered (pilled) as with other oral tablet medications. In cats, enrofloxacin flavored tablets should be pilled. After administration, watch the animal closely to be certain the entire dose has been consumed. Dogs & Cats: The duration of treatment should be selected based on clinical evidence. Generally, administration of enrofloxacin tablets should continue for at least 2-3 days beyond cessation of clinical signs. For severe and/or complicated infections, more prolonged therapy, up to 30 days, may be required. If no improvement is seen within five days, the diagnosis should be re-evaluated and a different course of therapy considered. The lower limit of the dose range in dogs and the daily dose for cats was based on efficacy studies in dogs and cats where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology were used to establish the upper limit of the dose range for dogs and treatment duration for dogs and cats.

ORAL

FDA application 200-737

EnroProTM 22.7 Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. EnroProTM 22.7 Injectable Solution may be administered as follows: Weight of Animal EnroProTM 22.7 Injectable Solution* 2.5 mg/kg 9.1 kg (20 lb) 1.00 mL 27.2 kg (60 lb) 3.00 mL *The initial EnroPro TM 22.7 Injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy. The lower limit of the dose range was based on efficacy studies in dogs where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology studies were used to establish the upper limit of the dose range and treatment duration.

INTRAMUSCULAR

EnroPro TM 22.7(enrofloxacin)Antibacterial Injectable Solution 2.27%For Dogs Only

DOSAGE AND ADMINISTRATION: Enroquin Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. Enroquin Injectable Solution may be administered as follows: Weight of Animal Enroquin Injectable SolutionThe initial Enroquin injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy. 2.5 mg/kg 9.1 kg (20 lb) 1.00 mL 27.2 kg (60 lb) 3.00 mL The lower limit of the dose range was based on efficacy studies in dogs where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology studies were used to establish the upper limit of the dose range and treatment duration.

INTRAMUSCULAR

Enroquin® (enrofloxacin)

Enrofloxacin Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. Enrofloxacin Injectable Solution may be administered as follows: Weight of Animal Enrofloxacin Injectable Solution* 2.5 mg/kg 9.1 kg (20 lb) 1.00 mL 27.2 kg (60 lb) 3.00 mL * The initial enrofloxacin injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy. The lower limit of the dose range was based on efficacy studies in dogs where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology studies were used to establish the upper limit of the dose range and treatment duration.

INTRAMUSCULAR

NDC No. 11695-6999-1 Enrofloxacin Antibacterial Injectable Solution 2.27% For Dogs Only

Enrosite Injection for Dogs may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. Enrosite Injection for Dogs may be administered as follows: *The initial Enrosite Injection for Dogs administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy. Weight Of Animal Enrosite ™ Injection for Dogs* 2.5 mg/kg 9.1 kg (20 lb) 1.00 mL 27.2 kg (60 lb) 3.00 mL The lower limit of the dose range was based on efficacy studies in dogs where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology studies were used to establish the upper limit of the dose range and treatment duration.

INTRAMUSCULAR

FDA application 200-513

Enroflox Injection for Dogs may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. Enroflox Injection for Dogs may be administered as follows: *The initial Enroflox Injection for Dogs administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy. Weight Of Animal Enroflox ® Injection for Dogs* 2.5 mg/kg 9.1 kg (20 lb) 1.00 mL 27.2 kg (60 lb) 3.00 mL The lower limit of the dose range was based on efficacy studies in dogs where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology studies were used to establish the upper limit of the dose range and treatment duration.

INTRAMUSCULAR

FDA application 200-513

Baytril Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of Baytril Tablet therapy. Baytril Injectable Solution may be administered as follows: *The initial Baytril Injectable administration should be followed 12 hours later by initiation of Baytril Tablet therapy. Weight of Animal Baytril Injectable Solution* 2.5 mg/kg 9.1 kg (20 lb) 1.00 mL 27.2 kg (60 lb) 3.00 mL The lower limit of the dose range was based on efficacy studies in dogs where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology studies were used to establish the upper limit of the dose range and treatment duration.

INTRAMUSCULAR

FDA application 140-913

Shake well before each use. Tilt head so that the affected ear is presented in an upward orientation. Administer a sufficient quantity of Enrofloxacin and Silver Sulfadiazine Otic Emulsion to coat the aural lesions and the external auditory canal. As a general guide, administer 5-10 drops per treatment in dogs weighing 35 lbs. or less and 10-15 drops per treatment in dogs weighing more than 35 lbs. Following treatment, gently massage the ear so as to ensure complete and uniform distribution of the medication throughout the external ear canal. Apply twice daily for a duration of up to 14 days.

AURICULAR (OTIC)

Enrofloxacin and Silver Sulfadiazine Otic Emulsion(enrofloxacin/silver sulfadiazine)Antibacterial-Antimycotic Emulsion

Enrofloxacin 100 Injection provides flexible dosages and durations of therapy. Enrofloxacin 100 Injection 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 treatment (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.

SUBCUTANEOUS, INTRAMUSCULAR

FDA application 200-495

Administer 2.5 mg/kg as a single dose, followed by initiation of enrofloxacin tablet therapy

Intramuscular

Federal law restricts this drug to use by or on the order of a licensed veterinarian

Enrofloxacin Antibacterial Injectable Solution

DOSAGE AND ADMINISTRATION:

ORAL

Enroquin® (enrofloxacin)Flavored Tablets