flunixin

For the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia.

Flunine™

For control of pyrexia associated with bovine respiratory disease, acute bovine mastitis, and endotoxemia. Also indicated for the control of inflammation in endotoxemia.

Do not use in calves to be processed for veal. Do not use in dry dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian

Flunixin Injection

For the control of pyrexia associated with bovine respiratory disease, endotoxemia, and acute bovine mastitis.

The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in calves to be processed for veal. Do not use in dry dairy cows.

Flunazine™

For control of pyrexia associated with acute bovine mastitis.

Do not use in calves to be processed for veal. Do not use in dry dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flunixin Meglumine Injection

Cattle (Beef and dairy)

For control of pyrexia associated with bovine respiratory disease, endotoxemia, and acute bovine mastitis. It is also indicated for the control of inflammation in endotoxemia.

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flu-Nix™

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, and control of BRD-associated pyrexia in beef and non lactating dairy cattle.

Resflor GOLD®

Cattle (Beef, Non-Lactating Dairy, Calves, Yearlings)

For the treatment of bacterial pneumonia associated with Pasteurella spp. and for the control of associated pyrexia in beef and non-lactating dairy cattle

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For intramuscular or subcutaneous use in beef and non-lactating dairy cattle, calves and yearlings. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows, bulls intended for breeding, and calves intended to be processed for veal. Do not use in animals showing hypersensitivity to either flunixin meglumine or oxytetracycline.

Hexasol® Injection

Cattle (beef cattle 2 months of age and older and dairy cattle. Not for use in beef and dairy bulls intended for breeding over 1 year of age, replacement dairy heifers over 20 months of age, dry dairy cows, dairy calves, or veal calves)

For the control of pyrexia associated with bovine respiratory disease and acute bovine mastitis, and the control of pain associated with foot rot.

Banamine® Transdermal

Beef and non-lactating dairy cattle

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

nixiFLOR™

For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.

Flunine™

For the alleviation of inflammation and pain associated with musculoskeletal disorders and the alleviation of visceral pain associated with colic.

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flunixin Injection

For alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.

Administer daily dose for up to 5 days by sprinkling on small amount of feed. The effect of this drug on pregnancy has not been determined. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Banamine® Granules

For the control of pyrexia associated with swine respiratory disease.

Swine must not be slaughtered for human consumption within 12 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Banamine®-S

INDICATIONS: Flunazine Equine Paste is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. ACTIVITY: Flunixin meglumine is a potent, nonnarcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test. Oral studies in the horse show onset of flunixin activity occurs within 2 hours of administration. Peak response occurs between 12 and 16 hours and duration of activity is 24 to 36 hours.

FDA application 200-581

INDICATIONS: Prevail Equine Paste is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. ACTIVITY: Flunixin meglumine is a potent, nonnarcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test. Oral studies in the horse show 1 onset of flunixin activity occurs within 2 hours of administration. Peak response occurs between 12 and 16 hours and duration of activity is 24 to 36 hours.

FDA application 200-581

Indications Horse: Flunixin Injection (flunixin meglumine injection) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. Cattle: Flunixin Injection (flunixin meglumine injection) is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. Flunixin Injection (flunixin meglumine injection) is also indicated for the control of inflammation in endotoxemia.

FDA application 200-061

Indications Horse: Flu-Nix™ (flunixin meglumine injection) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. Cattle: Flu-Nix™ (flunixin meglumine injection) is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. Flu-Nix™ (flunixin meglumine injection) is also indicated for the control of inflammation in endotoxemia.

FDA application 200-061

INDICATIONS Horse: Flunazine (flunixin meglumine injection) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. Cattle: Flunazine (flunixin meglumine injection) is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. Flunazine is also indicated for the control of inflammation in endotoxemia.

FDA application 200-387

INDICATIONS Horse: Vetameg (flunixin meglumine injection) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. Cattle: Vetameg (flunixin meglumine injection) is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. Vetameg is also indicated for the control of inflammation in endotoxemia.

FDA application 200-387

INDICATIONS: Banamine Transdermal pour-on is indicated for the control of pyrexia associated with bovine respiratory disease and acute bovine mastitis, and the control of pain associated with foot rot in beef cattle 2 months of age and older and dairy cattle. Not for use in beef and dairy bulls intended for breeding over 1 year of age, replacement dairy heifers over 20 months of age, dry dairy cows, dairy calves, or veal calves.

Banamine® Transdermal(flunixin transdermal solution)

Only for Intravenous use in Beef and Dairy Cattle. Not for Use in Dry Dairy Cows and Veal Calves. For Intravenous and Intramuscular Use in Horses. Read accompanying directions for use. Approved by FDA under ANADA # 200-061 ®Registered trademark of Huvepharma, Inc. Manufactured for Huvepharma, Inc. Peachtree City, GA 30269 Rev. 05-2022 F-2847-05

FDA application 200-061

INDICATIONS Horse: BANAMINE (flunixin meglumine injection) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.

Banamine® (flunixin meglumine injection)

INDICATION: RESFLOR GOLD® is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

Resflor GOLD®

nixiFLOR™ is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

nixiFLOR™(florfenicol and flunixin meglumine)Antimicrobial/Non-Steroidal Anti-Inflammatory Drug

Only for Intravenous Use in Beef and Dairy Cattle. Not for Use in Dry Dairy Cows and Veal Calves. For Intravenous and Intramuscular use in Horses. Before using this drug, read package outsert for complete product information.

FDA application 200-061

Only for Intravenous use in Beef and Dairy Cattle. Not for Use in Dry Dairy Cows and Veal Calves. For Intravenous and Intramuscular Use in Horses. Read accompanying directions for use.

FDA application 200-061

Only for Intravenous Use in Beef and Dairy Cattle. Not for Use in Dry Dairy Cows and Veal Calves. For Intravenous and Intramuscular Use in Horses.

FDA application 200-061

INDICATIONS BANAMINE Paste is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.

Banamine® (flunixin meglumine paste)

INDICATION Flunazine-S (flunixin meglumine injection) is indicated for the control of pyrexia associated with swine respiratory disease.

FDA application 200-489

For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse

For oral use in horses only. Treatment should not exceed 5 consecutive days. The effect of flunixin meglumine on pregnancy has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian

Flunazine®

For the control of pyrexia associated with swine respiratory disease.

Not for use in breeding swine. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flunixin Injection - S

CLINICAL PHARMACOLOGY: Flunixin meglumine is a nonsteroidal, anti-inflammatory drug. It is a weak acid (pKa=5.82)1 which exhibits a high degree of plasma protein binding (approximately 99%).2 However, free (unbound) drug appears to readily partition into body tissues (Vss predictions range from 297 to 782 mL/kg).2-5 In cattle, elimination occurs primarily through biliary excretion. Flunixin persists in inflammatory tissues6 and is associated with anti-inflammatory properties which extend well beyond the period associated with detectable plasma drug concentrations.4,6 Therefore, prediction of drug concentrations based upon the estimated plasma terminal elimination half-life will likely underestimate both the duration of drug action and the concentration of drug remaining at the site of activity. Pharmacokinetic properties of flunixin transdermal solution in cattle administered at a dose of 2.5 mg/kg, are summarized in Table 1, comparing results between animals that were allowed to self- and allo-lick vs. animals that were prevented from licking. Animals that were allowed to self- or allo-lick had lower rate and extent of absorption when compared to the animals prevented from licking. However, no dose adjustment is needed to account for the effect of licking because the substantial evidence of effectiveness was demonstrated in animals that were allowed to lick. Table 1. Average (+/- standard deviation [SD]) PK parameters after a single administration of flunixin transdermal solution at a dose of 2.5 mg/kg in cattle that were either allowed to lick or prevented from allo- and self-licking (n = 24/group). PK parameter Non-licking Licking Mean ± SD Mean ± SD Cmax: Maximum observed plasma concentration Tmax: Time at which Cmax was observed AUC2-last: Area under the plasma concentration versus time curve measured between 2 hours and the time of the last quantifiable concentration T1/2: Terminal elimination half-life Cmax (ng/mL) 1496 769 N/A N/A Concentration at 2 hFirst blood level in the licking group was taken at 2 hours post-dose. First blood sample in non-licking group was taken at 0.25 hours post-dose. 1282 533 1072 353 Tmax (h) 1.29 0.464 N/A N/A AUC2-last (ng*h/mL) 7499 2131 6827 4672 T1/2 (h) 8 2 9 6 Absorption of flunixin transdermal solution in cattle is dependent on environmental temperature. The effect of temperature on flunixin absorption was tested in temperatures ranging from 15.3 to 20.1 °F (average low in the coldest study) to 80 to 100 °F (average high in the warmest study). Flunixin concentrations were consistently lower when the pour-on product was administered in a cold (temperature) rather than hot (temperature) environment. However, the clinical effectiveness was demonstrated over the range of environmental conditions expected under field conditions. No dose adjustments are necessary due to environmental temperature.

Banamine® Transdermal(flunixin transdermal solution)

Pharmacology Flunixin meglumine is a potent, non-narcotic, non-steroidal, analgesic agent with anti-inflammatory and anti-pyretic activity. It is significantly more potent than pentazocine, meperidine and codeine as an analgesic in the rat yeast paw test. Horse : Flunixin is four times as potent on a mg/per mg basis as phenylbutazone as measured by the reduction of lameness and swelling in the horse. Plasma half-life in horse serum is 1.6 hours following a single dose of 1.1 mg/kg. Measurable amounts are detectable in horse plasma at 8 hours post injection. Cattle : Flunixin meglumine is a weak acid (pKa=5.82)1 which exhibits a high degree of plasma protein binding (approximately 99%).2 However, free (unbound) drug appears to readily partition into body tissues (Vss predictions range from 297 to 782 mL/kg.2-5 Total body water is approximately equal to 570 ml/kg).6 In cattle, elimination occurs primarily through biliary excretion.7 This may, at least in part, explain the presence of multiple peaks in the blood concentration/time profile following IV administration.2 In healthy cattle, total body clearance has been reported to range from 90 to 151 mL/kg/hr.2-5 These studies also report a large discrepancy between the volume of distribution at a steady state (Vss) and the volume of distribution associated with the terminal elimination phase (Vβ). This discrepancy appears to be attributable to extended drug elimination from a deep compartment.8 The terminal half-life has been shown to vary from 3.14 to 8.12 hours.2-5 Flunixin persists in inflammatory tissues9 and is associated with anti-inflammatory properties which extend well beyond the period associated with detectable plasma drug concentrations.4,9 These observations account for the counterclock-wise hysteresis associated with flunixin's pharmacokinetic/pharmacodynamic relationships.10 Therefore, prediction of drug concentrations based upon the estimated plasma terminal elimination half-life will likely underestimate both the duration of drug action and the concentration of drug remaining at the site of activity.

FDA application 200-061

CLINICAL PHARMACOLOGY Flunixin meglumine is a potent non-narcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent that pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test. Flunixin is known to persist in inflammatory tissues1 and is associated with anti-inflammatory properties which extend well beyond the period associated with detectable plasma drug concentrations2. Therefore, prediction of drug concentrations based upon estimated plasma terminal elimination half-life will likely underestimate both the duration of drug action and the concentration of drug remaining at the site of activity. The pharmacokinetic profiles were found to follow a 2-compartmental model, although a deep (third) compartment was observed in some animals. The mean terminal elimination half-life (β half-life) of flunixin after a single intramuscular injection of flunixin meglumine injection (2.2 mg/kg) to pigs was between 3 and 4 hours. The mean observed maximum plasma concentration was 2944 ng/mL, achieved at a mean time of approximately 0.4 hours. The mean AUC(0-LOQ) was 6431 ng*hr/mL. Following IM administration of flunixin, quantifiable drug concentration could be measured up to 18 hours post dose. The mean volume of distribution was 2003 mL/kg and the mean total clearance was 390 mL/hr/kg. The mean absolute bioavailability of flunixin following an intramuscular injection in the neck was 87%.

FDA application 200-489

The pharmacokinetics (PK) of florfenicol (Table 1) and flunixin (Table 2) after subcutaneous injection of RESFLOR GOLD® is described below: Table 1. Mean (n=28) pharmacokinetic parameters for florfenicol in cattle after a single subcutaneous administration of RESFLOR GOLD (florfenicol dose of 40 mg/kg BW). Mean Florfenicol PK parameters in Cattle PK Parameter AUC0-t (ng*hr/mL) AUC0-inf (ng*hr/mL) Cmax (ng/mL) Tmax (hr) T½ (hr) MRT0-inf (hr) Mean 242527 247577 11151 6.25 28.5 27.3 SD 42741 41391 4194 3.87 9.91 11.6 Table 2. Mean (n=28) pharmacokinetic parameters for flunixin in cattle after a single subcutaneous administration of RESFLOR GOLD (flunixin dose of 2.2 mg/kg BW). Mean Flunixin PK parameters in Cattle PK Parameter AUC0-t AUC0-t = Area under the plasma-concentration-time curve (AUC) from time zero to the last quantifiable concentrations (ng*hr/mL) AUC0-inf AUC0-inf = AUC from time zero to infinity (ng*hr/mL) Cmax Cmax = Maximum plasma concentration (ng/mL) Tmax Tmax = Time at which Cmax was observed (hr) T½ T½ = Terminal elimination half-life (hr) MRT0-inf MRT0-inf = Mean residence time from time zero to infinity (hr) Mean 13370 14448n=27 1913 1.14 9.5 11.4 SDSD = Standard deviation 4964 5116 791 0.97 3.27 4.41

Resflor GOLD®

PHARMACOLOGY Flunixin meglumine is a potent, non-narcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test.

Banamine® (flunixin meglumine injection)

The pharmacokinetics (PK) of florfenicol (Table 1) and flunixin (Table 2) after subcutaneous injection of florfenicol and flunixin meglumine is described below:

nixiFLOR™(florfenicol and flunixin meglumine)Antimicrobial/Non-Steroidal Anti-Inflammatory Drug

CONTRAINDICATIONS Horse: There are no known contraindications to this drug when used as directed. Intra-arterial injection should be avoided. Horses inadvertently injected intra-arterially can show adverse reactions. Signs can be ataxia, incoordination, hyperventilation, hysteria, and muscle weakness. Signs are transient and disappear without antidotal medication within a few minutes. Do not use in horses showing hypersensitivity to flunixin meglumine. Cattle: NSAIDS inhibit production of prostaglandins which are important in signaling the initiation of parturition. The use of flunixin can delay parturition and prolong labor which may increase the risk of still birth. Do not use Flunixin Injection (flunixin meglumine injection) within 48 hours of expected parturition. Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal impairment or gastric ulceration are suspected.

FDA application 200-387

CONTRAINDICATIONS Horse: There are no known contraindications to this drug when used as directed. Intra-arterial injection should be avoided. Horses inadvertently injected intra-arterially can show adverse reactions. Signs can be ataxia, incoordination, hyperventilation, hysteria, and muscle weakness. Signs are transient and disappear without antidotal medication within a few minutes. Do not use in horses showing hypersensitivity to flunixin meglumine.

Banamine® (flunixin meglumine injection)

CONTRAINDICATIONS: NSAIDs inhibit production of prostaglandins which are important in signaling the initiation of parturition. The use of flunixin can delay parturition and prolong labor which may increase the risk of stillbirth. Do not use Banamine Transdermal pour-on within 48 hours of expected parturition. Do not use in animals showing hypersensitivity to flunixin meglumine.

Banamine® Transdermal(flunixin transdermal solution)

CONTRAINDICATIONS There are no known contraindications to this drug in swine when used as directed. Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal impairment or gastric ulceration is suspected.

FDA application 200-489

CONTRAINDICATIONS: Do not use in animals that have shown hypersensitivity to florfenicol or flunixin.

Resflor GOLD®

CONTRAINDICATIONS There are no known contraindications to this drug when used as directed.

Banamine® (flunixin meglumine paste)

Do not use in animals that have shown hypersensitivity to florfenicol or flunixin.

nixiFLOR™(florfenicol and flunixin meglumine)Antimicrobial/Non-Steroidal Anti-Inflammatory Drug

VetaMeg® Equine Paste (flunixin meglumine paste) CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: Each 30-g syringe of VetaMeg Equine Paste contains flunixin meglumine equivalent to 1500 mg flunixin. INDICATIONS: VetaMeg Equine Paste is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. ACTIVITY: Flunixin meglumine is a potent, nonnarcotic, nonsteroidal analgesic agent with anti-inflammatory and antipyretic activity, It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test. Oral studies in the horse show onset of flunixin activity occurs withing 2 hours of administration. Peak response occurs between 12 and 16 hours and duration of activity is 24-36 hours. CONTRAINDICATIONS: There are no known contraindications to this drug when used as directed. WARNING: Do not use in horses intended for human consumption. PRECAUTIONS: The effect of flunixin meglumine on pregnancy has not been determined. Studies to date show there is no detrimental effect on stallion spermatogenesis with or following the recommended dose of flunixin meglumine. SIDE EFFECTS: During field studies with flunixin meglumine, no significant side effects were reported. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Aspen Veterinary Resources at info@aspenveterinaryresources.com. 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 200-581

USER SAFETY WARNINGS: Not for use in humans. Keep out of reach of children. Flunixin transdermal solution is a potent non-steroidal anti-inflammatory drug (NSAID), and ingestion may cause gastrointestinal irritation and bleeding, kidney, and central nervous system effects. This product has been shown to cause severe and potentially irreversible eye damage (conjunctivitis, iritis, and corneal opacity) and irritation to skin in laboratory animals. Users should wear suitable eye protection (face shields, safety glasses, or goggles) to prevent eye contact; and chemical resistant gloves and appropriate clothing (such as long-sleeve shirt and pants) to prevent skin contact and/or drug absorption. Wash hands after use. In case of accidental eye contact, flush eyes immediately with water and seek medical attention. If wearing contact lenses, flush eyes immediately with water before removing lenses. In case of accidental skin contact and/or clothing contamination, wash skin thoroughly with soap and water and launder clothing with detergent. In case of ingestion do not induce vomiting and seek medical attention immediately. Probable mucosal damage may contraindicate the use of gastric lavage. Provide product label and/or package insert to medical personnel.

Banamine® Transdermal(flunixin transdermal solution)

SAFETY Horse: A 3-fold intramuscular dose of 1.5 mg/lb of body weight daily for 10 consecutive days was safe. No changes were observed in hematology, serum chemistry, or urinalysis values. Intravenous dosages of 0.5 mg/lb daily for 15 days; 1.5 mg/lb daily for 10 days; and 2.5 mg/lb daily for 5 days produced no changes in blood or urine parameters. No injection site irritation was observed following intramuscular injection of the 0.5 mg/lb recommended dose. Some irritation was observed following a 3-fold dose administered intramuscularly. Cattle: No flunixin-related changes (adverse reactions) were noted in cattle administered a 1X (2.2 mg/kg; 1.0 mg/lb) dose for 9 days three times the maximum clinical duration. Minimal toxicity manifested itself at moderately elevated doses (3X and 5X) when flunixin was administered daily for 9 days, with occasional findings of blood in the feces and/or urine. Discontinue use if hematuria or fecal blood are observed.

FDA application 200-387

For oral use in horses only CONTRAINDICATIONS: There are no known contraindications to this drug when used as directed. WARNING: Do not use in horses intended for human consumption. PRECAUTIONS: The effect of flunixin meglumine on pregnancy has not been determined. Studies to date show there is no detrimental effect on stallion spermatogenesis with or following the recommended dose of flunixin meglumine. SIDE EFFECTS: During field studies with flunixin meglumine, no significant side effects were reported. 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-VET or online at www.fda.gov/reportanimalaeduration of activity is 24 to 36 hours.

FDA application 200-581

WARNINGS: NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. This product contains material that can be irritating to skin and eyes. Avoid direct contact with skin, eyes, and clothing. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Consult a physician if irritation persists. Accidental injection of this product may cause local irritation. Consult a physician immediately. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, contact Parnell at 1-800-887-2763. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

nixiFLOR™(florfenicol and flunixin meglumine)Antimicrobial/Non-Steroidal Anti-Inflammatory Drug

A target animal safety study was conducted to evaluate the effects of florfenicol and flunixin meglumine when administered to cattle subcutaneously at 1X, 3X, or 5X the labeled dose for three consecutive days (3X the labeled duration). Decreased feed and water consumption, and decreased body weights (secondary to decreased feed consumption) were observed in the 1X, 3X, and 5X groups. Injection site swellings were noted in the 1X, 3X, and 5X groups. A separate injection site study was conducted in cattle. The study demonstrated that florfenicol and flunixin meglumine, when administered according to the label directions, may induce a transient local reaction in the subcutaneous and underlying muscle tissue.

nixiFLOR™(florfenicol and flunixin meglumine)Antimicrobial/Non-Steroidal Anti-Inflammatory Drug

Withdrawal Periods and Residue Warnings: Milk that has been taken during treatment and for 48 hours after treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days of treatment. Not for use in replacement dairy heifers 20 months of age or older or dry dairy cows; use in these cattle may cause drug residues in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Approved only as a single topical dose in cattle. Repeated treatments may result in violative residues in milk or in edible tissues.

Banamine® Transdermal(flunixin transdermal solution)

RESIDUE WARNINGS: Cattle must not be slaughtered for human consumption within 4 days of the last treatment. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Not for use in dry dairy cows. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Not for use in horses intended for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter.

FDA application 200-387

RESIDUE WARNINGS: Animals intended for human consumption must not be slaughtered within 38 days of treatment. This product is not approved for use in 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 in preruminating calves. Do not use in calves to be processed for veal.

Resflor GOLD®

For subcutaneous use in beef and non-lactating dairy cattle only. Not for use in female dairy cattle 20 months of age or older or in calves to be processed for veal. CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

nixiFLOR™(florfenicol and flunixin meglumine)Antimicrobial/Non-Steroidal Anti-Inflammatory Drug

RESIDUE WARNINGS Swine must not be slaughtered for human consumption within 12 days of the last treatment.

FDA application 200-489

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

Banamine® (flunixin meglumine paste)

NDC 60270-209-13 Flunixin Injection (flunixin meglumine injection) 50 mg/mL Sterile

FDA application 200-061

ADVERSE REACTIONS In horses, isolated reports of local reactions following intramuscular injection, particularly in the neck, have been received. These include localized swelling, sweating, induration, and stiffness. In rare instances in horses, fatal or nonfatal clostridial infections or other infections have been reported in association with intramuscular use of flunixin meglumine injection. In horses and cattle, rare instances of anaphylactic-like reactions, some of which have been fatal, have been reported, primarily following intravenous use. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Aspen Veterinary Resources at info@aspenveterinaryresources.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.

FDA application 200-387

Adverse Reactions In horses, isolated reports of local reactions following intramuscular injection, particularly in the neck, have been received. These include localized swelling, sweating, induration, and stiffness. In rare instances in horses, fatal or nonfatal clostridial infections or other infections have been reported in association with intramuscular use of Flunixin Meglumine Injection. In horses and cattle, rare instances of anaphylactic-like reactions, some of which have been fatal, have been reported, primarily following intravenous use. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

FDA application 200-061

ADVERSE REACTIONS In horses, isolated reports of local reactions following intramuscular injection, particularly in the neck, have been received. These include localized swelling, sweating, induration, and stiffness. In rare instances in horses, fatal or nonfatal clostridial infections or other infections have been reported in association with intramuscular use of flunixin meglumine injection. In horses and cattle, rare instances of anaphylactic-like reactions, some of which have been fatal, have been reported, primarily following intravenous use. 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 www.fda.gov/reportanimalae.

FDA application 200-387

ADVERSE REACTIONS In horses, isolated reports of local reactions following intramuscular injection, particularly in the neck, have been received. These include localized swelling, sweating, induration, and stiffness. In rare instances in horses, fatal or nonfatal clostridial infections or other infections have been reported in association with intramuscular use of BANAMINE (flunixin meglumine injection). In horses and cattle, rare instances of anaphylactic-like reactions, some of which have been fatal, have been reported, primarily following intravenous use.

Banamine® (flunixin meglumine injection)

ADVERSE REACTIONS Flunixin was mildly irritating at the injection sites. No other flunixin-related changes (adverse reactions) were noted in swine administered a 1X (2.2 mg/kg; 1.0 mg/lb) dose for 9 days. 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 www.fda.gov/reportanimalae.

FDA application 200-489

Flunixin was mildly irritating at the injection sites. No other flunixin-related changes (adverse reactions) were noted in swine administered a 1 x (2.2 mg/kg; 1.0 mg/lb) dose for 9 days. 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.

Flunixin Injection -S(flunixin meglumine injection)50 mg/mLFor intramuscular use in swine.

ADVERSE REACTIONS: Transient inappetence, diarrhea, decreased water consumption, and injection site swelling have been associated with the use of florfenicol in cattle. In addition, anaphylaxis and collapse have been reported post-approval with the use of another formulation of florfenicol in cattle. In cattle, rare instances of anaphylactic-like reactions, some of which have been fatal, have been reported, primarily following intravenous use of flunixin meglumine.

Resflor GOLD®

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae. ®Registered trademark of Huvepharma, Inc. Manufactured for Huvepharma, Inc. Rev. 09-2021 Peachtree City, GA 30269 F-2847-04

FDA application 200-061

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae. Manufactured for VetTek Blue Springs, MO 64014

FDA application 200-061

Flunixin was mildly irritating at the injection sites. No other flunixin-related changes (adverse reactions) were noted in swine administered a 1× (2.2 mg/kg; 1.0 mg/lb) dose for 9 days.

Banamine®-S (flunixin meglumine injection)

The recommended dose for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia, is 1.1 to 2.2 mg/kg (0.5 to 1 mg/lb; 1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration either once a day as a single dose or divided into two doses administered at 12-hour intervals for up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Avoid rapid intravenous administration of the drug. The recommended dose for acute bovine mastitis is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) of body weight given once by intravenous administration.

Intramuscular, Intravenous

Flunine™

1.1 to 2.2 mg/kg (0.5 to 1 mg/lb; 1 to 2 mL per 100 lbs) body weight given by slow intravenous administration, either once a day as a single dose, or divided into two doses at 12-hour intervals for up to 3 days; for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia. 2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lbs) of body weight given once by intravenous administration for acute bovine mastitis.

Intravenous, Intramuscular

The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in calves to be processed for veal. Do not use in dry dairy cows.

Flunazine™

1. 1 to 2.2 mg/kilogram (0.5 to 1.0 mg/lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days (control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia). 2. 2mg/kg (1.0 mg/lb) of body weight given once by intravenous administration for control of pyrexia associated with acute bovine mastitis.

Intravenous, Intramuscular

Do not slaughter for human consumption within 4 days of last treatment. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Do not use in dry dairy cows. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Banamine®

1.1 to 2.2 mg/kg (0.5 to 1.0 mg/lb; 1 to 2 mL per 100 lbs) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days.

Intravenous, Intramuscular

Do not use in calves to be processed for veal. Do not use in dry dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian

Flunixin Injection

2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lb) of body weight given once by intravenous administration.

Intravenous, Intramuscular

Do not use in calves to be processed for veal. Do not use in dry dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flunixin Meglumine Injection

Cattle (Beef and dairy)

1.1 to 2.2 mg/kilogram (0.5 to 1.0 mg/lb) of body weight per day, as a single dose or divided into 2 doses administered at 12-hour intervals, intravenously, for up to 3 days.

Intramuscular, Intravenous

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flu-Nix™

Cattle (Beef and Non-Lactating Dairy)

Administer once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight (6 mL/100 lb).

Subcutaneous

Resflor GOLD®

Cattle (Beef, Non-Lactating Dairy, Calves, Yearlings)

Administer once as an intramuscular or subcutaneous injection of 1 mL per 22 pounds (lb) body weight (BW) (13.6 mg oxytetracycline and 0.9 mg flunixin per lb BW) where retreatment of calves and yearlings for bacterial pneumonia is impractical due to husbandry conditions, such as cattle on range, or where their repeated restraint is inadvisable

Intramuscular, Subcutaneous

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For intramuscular or subcutaneous use in beef and non-lactating dairy cattle, calves and yearlings. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows, bulls intended for breeding, and calves intended to be processed for veal. Do not use in animals showing hypersensitivity to either flunixin meglumine or oxytetracycline.

Hexasol® Injection

Cattle (beef cattle 2 months of age and older and dairy cattle. Not for use in beef and dairy bulls intended for breeding over 1 year of age, replacement dairy heifers over 20 months of age, dry dairy cows, dairy calves, or veal calves)

Apply only once at a dose of 3.3 mg flunixin per kg body weight (1.5 mg/lb; 3 mL per 100 lbs) topically in a narrow strip along the dorsal midline from the withers to the tailhead.

Transdermal

Banamine® Transdermal

Beef and non-lactating dairy cattle

40 mg florfenicol/kg body weight (BW) and 2.2 mg flunixin/kg BW (equivalent to 2 mL/15 kg BW or 6 mL/100 lbs) once, by subcutaneous injection.

Subcutaneous

nixiFLOR™

The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1 mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular injection and repeated for up to 5 days. The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound of body weight. Intravenous administration is recommended for prompt relief. Treatment may be repeated when signs of colic recur.

Intramuscular, Intravenous

Flunine™

0.5 mg per pound (1mL/100lbs) of body weight once daily, intravenously or intramuscularly, for up to 5 days.

Intravenous, Intramuscular

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flunixin Injection

0.5 milligram of flunixin per pound of body weight (one packet per 500 pounds) per day.

Oral

Administer daily dose for up to 5 days by sprinkling on small amount of feed. The effect of this drug on pregnancy has not been determined. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Banamine® Granules

0.5 milligram of flunixin per pound of body weight daily.

Oral

For oral use only. Treatment should not exceed 5 consecutive days. The effect of this drug on pregnancy has not been determined. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Banamine® Paste

Administer 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight as a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site.

Intramuscular

For intramuscular use in swine. Not tor use in breeding swine.

Flunazine®-S

2.2 mg/kilogram (1.0 mg/lb) of body weight as a single intramuscular injection.

Intramuscular

Swine must not be slaughtered for human consumption within 12 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Banamine®-S

DOSE AND ADMINISTRATION 100 mL: Use within 28 days of first puncture and puncture a maximum of 19 times. If using a needle larger than 16 gauge, discard any product remaining in the vial immediately after use. 250 mL: Use within 28 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. Puncture a maximum of 5 times with a dosage delivery device no larger than 4 gauge. Any product remaining beyond these parameters should be discarded. Horse: The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1 mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular injection and repeated for up to 5 days. Studies show onset of activity is within 2 hours. Peak response occurs between 12 and 16 hours and duration of activity is 24-36 hours. The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound of body weight. Intravenous administration is recommended for prompt relief. Clinical studies show pain is alleviated in less than 15 minutes in many cases. Treatment may be repeated when signs of colic recur. During clinical studies approximately 10% of the horses required one or two additional treatments. The cause of colic should be determined and treated with concomitant therapy. Cattle: The recommended dose for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia is 1.1 to 2.2 mg/kg (0.5 to 1.0 mg/lb; 1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration either once a day as a single dose or divided into two doses administered at 12-hour intervals for up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Avoid rapid intravenous administration of the drug. The recommended dose for acute bovine mastitis is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) of body weight given once by intravenous administration.

INTRAVENOUS, INTRAMUSCULAR

FDA application 200-387

DOSE AND ADMINISTRATION Use within 28 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. Puncture a maximum of 5 times with a dosage delivery device no larger than 4 gauge. Any product remaining beyond these parameters should be discarded. Horse: The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1 mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular injection and repeated for up to 5 days. Studies show onset of activity is within 2 hours. Peak response occurs between 12 and 16 hours and duration of activity is 24-36 hours. The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound of body weight. Intravenous administration is recommended for prompt relief. Clinical studies show pain is alleviated in less than 15 minutes in many cases. Treatment may be repeated when signs of colic recur. During clinical studies approximately 10% of the horses required one or two additional treatments. The cause of colic should be determined and treated with concomitant therapy. Cattle: The recommended dose for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia is 1.1 to 2.2 mg/kg (0.5 to 1.0 mg/lb; 1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration either once a day as a single dose or divided into two doses administered at 12-hour intervals for up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) body weight. Avoid rapid intravenous administration of the drug. The recommended dose for acute bovine mastitis is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) of body weight given once by intravenous administration.

INTRAMUSCULAR, INTRAVENOUS

FDA application 200-387

USE WITHIN 28 DAYS OF FIRST PUNCTURE AND PUNCTURE A MAXIMUM OF 10 TIMES FOR 100 ML FILL, 25 TIMES FOR 250 ML FILL AND 50 TIMES FOR 500 ML FILL. WHEN USING A DRAW-OFF SPIKE, DISCARD ANY PRODUCT REMAINING IN THE VIAL IMMEDIATELY AFTER USE. Horse: The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1 mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular injection and repeated for up to 5 days. Studies show onset of activity is within 2 hours. Peak response occurs between 12 and 16 hours and duration of activity is 24-36 hours. The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound of body weight. Intravenous administration is recommended for prompt relief. Clinical studies show pain is alleviated in less than 15 minutes in many cases. Treatment may be repeated when signs of colic recur. During clinical studies approximately 10% of the horses required one or two additional treatments. The cause of colic should be determined and treated with concomitant therapy. Cattle: The recommended dose for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia, is 1.1 to 2.2 mg/kg (0.5 to 1 mg/lb; 1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration either once a day as a single dose or divided into two doses administered at 12-hour intervals for up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Avoid rapid intravenous administration of the drug. The recommended dose for acute bovine mastitis is 2.2 mg/kg (1 mg/lb; 2 ml per 100 lbs) of body weight given once by intravenous administration.

INTRAVENOUS, INTRAMUSCULAR

FDA application 200-781

Dose and Administration Horse: The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1 mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular injection and repeated for up to 5 days. Studies show onset of activity is within 2 hours. Peak response occurs between 12 and 16 hours. Peak response occurs between 12 and 16 hours and duration of activity is 24-36 hours. The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound of body weight. Intravenous administration is recommended for prompt relief. Clinical studies show pain is alleviated in less than 15 minutes in many cases. Treatment may be repeated when signs of colic recur. During clinical studies approximately 10% of the horses required one or two additional treatments. The cause of colic should be determined and treated with concomitant therapy. Cattle: The recommended dose for control of pyrexia associated with bovine respiratory disease and endotoxemia and control of inflammation in endotoxemia is 1.1 to 2.2 mg/kg (0.5 to 1 mg/lb;1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration either once a day as a single dose or divided into two doses administered at 12-hour intervals for up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight. Avoid rapid intravenous administration of the drug. The recommended dose for acute bovine mastitis is 2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lbs) of body weight given once by intravenous administration.

INTRAVENOUS, INTRAMUSCULAR

FDA application 200-061

DOSAGE AND ADMINISTRATION: The recommended dose of flunixin meglumine is 0.5 mg per lb of body weight once daily. The VetaMeg Equine Paste syringe, calibrated in twelve 250-lb weight increments, delivers 125 mg of flunixin for each 250 lbs (see dosage table). One syringe will treat a 1000-lb horse once daily for 3 days, or three 1000-lb horses one time. DOSAGE TABLE Syringe Mark* Horse Weight (lbs) VetaMeg™ Equine Paste Delevered (g) mg Flunixin Delivered 0 --- --- --- 250 250 2.5 125 500 500 5.0 250 750 750 7.5 375 1000 1000 10.0 500 * Use dial edge nearest syringe barrel to mark dose. The paste is orally administered by inserting the nozzle of the syringe through the interdental space, and depositing the required amount of paste on the back of the tongue by depressing the plunger. Treatment may be given initially by intravenous or intramuscular injection of VetaMeg Injectable Solution, followed by VetaMeg Equine Paste on Days 2 to 5. Flunixin meglumine treatment should not exceed 5 consecutive days. TOXICITY: No toxic effects were observed in rats given oral flunixin meglumine 2 mg/kg per day for 42 days. Higher doses produced ulceration of the gastrointestinal tract. The emetic dose in dogs is between 150 and 250 mg/kg. Flunixin was well tolerated in monkeys dosed daily with 4 mg/kg for 56 days. No adverse effects occurred in horses dosed orally with 1.0 or 1.5 mg/lb for 5 consecutive days.

ORAL

FDA application 200-581

DOSAGE AND ADMINISTRATION The recommended dose of flunixin is 0.5 mg per lb of body weight once daily. The BANAMINE Paste syringe, calibrated in twelve 250-lb weight increments, delivers 125 mg of flunixin for each 250 lbs (see dosage table). One syringe will treat a 1000-lb horse once daily for 3 days, or three 1000-lb horses one time. DOSAGE TABLE Syringe MarkUse dial edge nearest syringe barrel to mark dose. Horse Weight (lbs) BANAMINE Paste Delivered (g) Mg Flunixin Delivered 0 — — — 250 250 2.5 125 500 500 5.0 250 750 750 7.5 375 1000 1000 10.0 500 The paste is orally administered by inserting the nozzle of the syringe through the interdental space, and depositing the required amount of paste on the back of the tongue by depressing the plunger. Treatment may be given initially by intravenous or intramuscular injection of BANAMINE Solution, followed by BANAMINE Granules or BANAMINE Paste on Days 2 to 5. BANAMINE treatment should not exceed 5 consecutive days.

ORAL

Banamine® (flunixin meglumine paste)

DOSAGE AND ADMINISTRATION The recommended dose for swine is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site. 100 mL: Use within 28 days of first puncture and puncture a maximum of 19 times. If using a needle larger than 16 gauge, discard any remaining product in the vial immediately after use. 250 mL: Use within 28 days of first puncture and puncture a maximum of 30 times with a needle or 5 times with a dosage delivery device. If using a needle larger than 4 gauge, discard any remaining product in the vial immediately after use. Note: Intramuscular injection may cause local tissue irritation and damage. In an injection-site irritation study, the tissue damage did not resolve in all animals by Day 28 post-injection. This may result in trim loss of edible tissue at slaughter.

INTRAMUSCULAR

FDA application 200-489

DOSAGE AND ADMINISTRATION: Apply only once at a dose of 3.3 mg flunixin per kg body weight (1.5 mg/lb; 3 mL per 100 lbs) topically in a narrow strip along the dorsal midline from the withers to the tailhead. Round the dose up to the nearest weight increment on the dosing chamber. If pyrexia, or the pain associated with foot rot persists, the diagnosis should be re-evaluated and alternative therapy considered. Do not treat cattle if the hide is wet or may get wet in the six hours after dosing because effectiveness has not been evaluated under wet hide conditions. Practice the Administration and Overfill Reduction Instructions a few times to become familiar with operating the package before dosing animals. If the dosing chamber is overfilled follow the Overfill Reduction Instructions. A small amount of liquid will remain on the walls of the chamber, but the chamber is calibrated to account for this.

TRANSDERMAL

Banamine® Transdermal(flunixin transdermal solution)

Horse: The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1 mL/100 lbs) of bodyweight once daily. Treatment may be given by intravenous or intramuscular injection and repeated for up to five days. Studies show onset of activity is within 2 hours. Peak response occurs between 12 and 16 hours and duration of activity is 24-36 hours. The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound of bodyweight. Intravenous administration is recommended for prompt relief. Clinical studies show pain is alleviated in less than 15 minutes in many cases. Treatment may be repeated when signs of colic recur. During clinical studies approximately 10% of the horses required one or two additional treatments. The cause of the colic should be determined and treated with concomitant therapy.

INTRAMUSCULAR, INTRAVENOUS

covetrus® Flunixin Injection(flunixin meglumine injection)50 mg/ml

The recommended dose for swine is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site. USE WITHIN 28 DAYS OF FIRST PUNCTURE AND PUNCTURE A MAXIMUM OF 10 TIMES. WHEN USING A DRAW-OFF SPIKE OR NEEDLE WITH BORE DIAMETER LARGER THAN 18 GAUGE, DISCARD ANY PRODUCT REMAINING IN THE VIAL IMMEDIATELY AFTER USE. Note: Intramuscular injection may cause local tissue irritation and damage. In an injection-site irritation study, the tissue damage did not resolve in all animals by Day 28 post-injection. This may result in trim loss of edible tissue at slaughter.

INTRAMUSCULAR

Banamine®-S (flunixin meglumine injection)

DOSAGE AND ADMINISTRATION: RESFLOR GOLD® should be administered once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight (6 mL/100 lb). Do not administer more than 10 mL at each site. The injection should be given only in the neck. Injection sites other than the neck have not been evaluated. For the 500 mL vial, do not puncture the stopper more than 20 times. RESFLOR GOLD® Dosage GuideDo not administer more than 10 mL at each site. ANIMAL WEIGHT (lbs) DOSAGE (mL) 100 6.0 Recommended Injection Location 200 12.0 300 18.0 400 24.0 500 30.0 600 36.0 700 42.0 800 48.0 900 54.0 1000 60.0

SUBCUTANEOUS

Resflor GOLD®

The recommended dose for swine is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site. Note: Intramuscular injection may cause local tissue irritation and damage. In an injection-site irritation study, the tissue damage did not resolve in all animals by Day 28 post-injection. This may result in trim loss of edible tissue at slaughter.

INTRAMUSCULAR

Flunixin Injection -S(flunixin meglumine injection)50 mg/mLFor intramuscular use in swine.

nixiFLOR™ should be administered once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight (6 mL/100 lb). Do not administer more than 10 mL at each site. The injection should be given only in the neck. Injection sites other than the neck have not been evaluated. For the 500 mL vial, do not puncture the stopper more than 20 times. * Do not administer more than 10 mL at each site.

SUBCUTANEOUS

nixiFLOR™(florfenicol and flunixin meglumine)Antimicrobial/Non-Steroidal Anti-Inflammatory Drug

The recommended dose for swine is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site

Intramuscular

Not for use in breeding swine. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flunixin Injection - S

USE WITHIN 28 DAYS OF FIRST PUNCTURE AND PUNCTURE A MAXIMUM OF 10 TIMES. WHEN USING A DRAW-OFF SPIKE OR NEEDLE WITH BORE DIAMETER LARGER THAN 18 GAUGE, DISCARD ANY PRODUCT REMAINING IN THE VIAL IMMEDIATELY AFTER USE.

INTRAVENOUS, INTRAMUSCULAR

Banamine® (flunixin meglumine injection)

0.5 mg per pound of body weight per day for up to 5 days

Oral

For oral use in horses only. Treatment should not exceed 5 consecutive days. The effect of flunixin meglumine on pregnancy has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian

Flunazine®