PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 86101-048-43100 mL

** Enrofloxacin**

100 mg/mL Antimicrobial Injectable Solution

For Subcutaneous Use In Beef Cattle And Non-Lactating Dairy Cattle

** For Intramuscular Or Subcutaneous Use In Swine**

** Not For Use In Female Dairy Cattle20 Months Of Age Or OlderOr 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.

To assure responsible antimicrobial drug use, enrofloxacin should only be used as a second-line drug for colibacillosis in swine following consideration of other therapeutic options.

Approved by FDA under ANADA # 200-758

INDICATIONS:

**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.

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 http://www.fda.gov/reportanimalae

STORAGE CONDITIONS:

Protect from direct sunlight. Do not refrigerate or freeze. Store at 20° to 25°C (68°-77°F), excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Precipitation may occur due to cold temperature. To redissolve, warm and then shake the vial.

PRODUCT DESCRIPTION:

Enrofloxacin 100 mg/mL is a sterile, ready-to-use injectable antimicrobial solution that contains enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent.

Each ml of Enrofloxacin 100 mg/mL 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.

DOSAGE AND ADMINISTRATION:

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*

*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

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*

*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.

HOW SUPPLIED:

Enrofloxacin 100 mg/mL

100 mg/mL 100 mL Bottle

REFERENCES:

1. Hooper, D. C., Wolfson, J. S., Quinolone Antimicrobial Agents, 2nd ed, 59

• 75, 1993.

To report suspected adverse drug events, 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

Approved by FDA under ANADA # 200-758

Distributed by:
Felixvet Inc.,
1300 NW Briarcliff Parkway,
Suite 100, Kansas City, Missouri 64150

Made in India

Neutral Code No. PON/ DRUGS/17 26 4238

Rev. November 2024