What Happens to Beef Cows When the Get Injected With Ceftiofur

For subcutaneous injection in the posterior aspect of the ear where it attaches to the caput (base of operations of the ear) in lactating dairy cattle. For subcutaneous injection in the middle third of the posterior aspect of the ear or in the posterior aspect of the ear where information technology attaches to the caput (base of the ear) in beef and non-lactating dairy cattle. Not for use in calves to be processed for veal.

Circumspection

Federal (USA) police restricts this drug to use by or on the order of a licensed veterinary. Federal police prohibits extra-label use of this drug in cattle for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food producing species/production classes.

Clarification

EXCEDE Sterile Suspension is a ready-to-use formulation that contains the crystalline gratis acid of ceftiofur, which is a wide spectrum cephalosporin antibiotic active against Gram-positive and Gram-negative bacteria including ß-lactamase-producing strains. Like other cephalosporins, ceftiofur is bactericidal, in vitro, resulting from inhibition of cell wall synthesis.

Each mL of this ready-to-utilise sterile pause contains ceftiofur crystalline free acid equivalent to 200 mg ceftiofur, in a caprylic/capric triglyceride and cottonseed oil based suspension.

Figure i. Construction of ceftiofur crystalline gratis acid:

Chemic name of ceftiofur crystalline gratuitous acid:

seven-[[ii-(two-Amino-four-thiazolyl)-two-(methoxyimino)acetyl]amino]- three-[[(two-furanylcarbonyl) thio] methyl]-8-oxo-5-thia-one- azabicyclo[4.two.0]october-2-ene two-carboxylic acid

INDICATIONS

EXCEDE Sterile Suspension is indicated for handling of bovine respiratory affliction (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beefiness, not-lactating dairy, and lactating dairy cattle.

EXCEDE Sterile Suspension is also indicated for the control of respiratory disease in beef and non-lactating dairy cattle which are at high take chances of developing BRD associated with M. haemolytica, P. multocida, and H. somni.

EXCEDE Sterile Suspension is also indicated for the treatment of bovine pes rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle.

EXCEDE Sterile Break is also indicated for treatment of acute metritis (0-10 days mail service-partum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle.

DOSAGE

Treatment of BRD and bovine foot rot

Administer equally a unmarried subcutaneous injection in the posterior attribute of the ear where it attaches to the caput (base of the ear) to cattle at a dosage of 3.0 mg ceftiofur equivalents (CE)/lb (6.6 mg CE/kg) body weight (BW) (1.5 mL sterile suspension per 100 lb BW).

In beef and non-lactating dairy cattle, EXCEDE Sterile Break may also exist administered as a single subcutaneous injection in the middle third of the posterior attribute of the ear at a dosage of 3.0 mg CE/lb (6.six mg CE/kg) BW (1.5 mL sterile suspension per 100 lb BW).

Most animals volition respond to treatment inside three to v days. If no improvement is observed, the diagnosis should be reevaluated.

Control of BRD

Administrate as a subcutaneous injection either in the centre third of the posterior attribute of the ear or in the posterior attribute of the ear where it attaches to the caput (base of operations of the ear) to beef and non-lactating dairy cattle at a dosage of 3.0 mg CE/lb (6.6 mg CE/kg) BW (1.5 mL sterile intermission per 100 lb BW).

Clinical studies indicate that assistants of EXCEDE Sterile Suspension is effective for the control of respiratory illness in beefiness and non-lactating dairy cattle at "high risk" of developing BRD. One or more of the post-obit factors typically characterizes calves on arrival at loftier risk of developing BRD.

• Cattle are from multiple subcontract origins,
• cattle accept had extended transport times (that may take included few if any remainder stops),
• ambience temperature change from origin to inflow of 30° F or more than,
• cattle have had continued exposure to extremely wet or cold weather conditions,
• cattle accept experienced excessive compress or excessive arrival processing procedures (such as castration, dehorning).

Treatment of Acute Metritis

Administer as a subcutaneous injection in the posterior attribute of the ear where it attaches to the head (base of the ear) to lactating dairy cattle at a dosage of three.0 mg CE/lb (6.6 mg CE/kg) BW (one.v mL sterile intermission per 100 lb BW). Repeat this dose in the contra-lateral (opposite) ear approximately 72 hours following the initial dose.

Table 1. Dosing Schedule for EXCEDE Sterile Interruption.

Weight (lb)	Dose Book (mL)		Weight (lb)	Dose Book (mL)
100	1.v		1100	16.5
200	3.0		1200	18.0
300	iv.5		1300	19.v
400	vi.0		1400	21.0
500	vii.5		1500	22.v
600	9.0		1600	24.0
700	ten.5		1700	25.5
800	12.0		1800	27.0
900	thirteen.5		1900	28.5
1000	15.0		2000	30.0

ADMINISTRATION

Administration FOR THE MIDDLE Third OF THE EAR

• Shake well earlier using. Please read the complete packet insert before administering EXCEDE Sterile Pause subcutaneously in the posterior ear of cattle.
• Deposit as a unmarried subcutaneous injection in the middle third of the posterior aspect of the ear, avoiding all claret vessels. See Figures 2 and iii.
• Adjust the needle insertion signal to avoid whatsoever blood vessels, previous implants, ear tags or ear tag holes. Practise not administer intra-arterially.
• Deliver the unabridged contents of the syringe.
• When administered correctly, a subcutaneous bleb of EXCEDE Sterile Intermission will appear.
• When withdrawing the needle, apply pressure to the needle insertion point, and massage toward the base of the ear.

Figure two. Subcutaneous administration of EXCEDE Sterile Break in the heart tertiary of the posterior aspect of the ear.

Effigy 3. Diagram of the gauge locations of the major arteries of the posterior ear and the recommended needle insertion locations. Assistants of EXCEDE Sterile Suspension into ear arteries is likely to be fatal.

Assistants FOR BASE OF THE EAR

In lactating dairy cattle the injection techniques for subcutaneous (SC) injection in the posterior aspect of the ear where it attaches to the caput (base of the ear) can be fabricated past the rostral or ventral injection techniques.

In beef and not-lactating dairy cattle the SC injection in the base of the ear tin can exist made by the rostral, ventral or toward the opposite eye injection techniques.

• Shake well earlier using. Please read the consummate bundle insert before administering EXCEDE Sterile Intermission subcutaneously in the posterior aspect of the ear where information technology attaches to the head (base of the ear).
• The subcutaneous (SC) injection may be made using the toward the contrary eye, rostral, or ventral techniques. Concur the syringe and needle and insert the needle as described beneath.
• Evangelize the unabridged contents of the syringe.
• Do not administer EXCEDE Sterile Suspension in the neck.

Administration for the Base of the Ear: Toward the Contrary Eye Technique

• Hold the syringe and needle behind the ear to be dosed so the needle and syringe bespeak in the direction of an imaginary line that would laissez passer through the head toward the animal's opposite middle. See Figures 4 and v.
• Insert the needle through the loose skin in the posterior aspect of the ear where it attaches to the head (base of the ear) while maintaining this angle. See Figure iv.

Figure iv. Subcutaneous assistants of EXCEDE Sterile Suspension in the posterior aspect of the ear where it attaches to the head (base of the ear).

Figure v. Injection location for the subcutaneous administration of EXCEDE Sterile Intermission in the posterior aspect of the ear where it attaches to the head (base of the ear).

Assistants for the Base of Ear: Toward the Same Eye Technique or Rostral Direction

• Hold the syringe and needle behind the ear to be dosed so the needle and syringe bespeak in the direction of an imaginary line that would pass through the head toward the eye on the same side of the caput. See Figures 5 and 6.
• Insert the needle through the loose peel in the posterior aspect of the ear where it attaches to the head (base of operations of the ear) while maintaining the needle position. See Figure 6.

Figure half-dozen. Diagram of caput showing the management for the base of ear injections administered rostrally toward the centre on the same side of the caput into the loose skin in the caudal aspect of the base of operations of the ear.

Assistants for Base of the Ear: Ventral Technique

• Concord the syringe and needle to a higher place the ear to exist dosed and so that the needle and syringe are pointing ventrally toward the base of the ear. The needle will be inserted into the loose skin in the posterior aspect of the ear where it attaches to the head (base of the ear) while pointing ventrally. Care should be taken to non insert the needle through the cartilage of the ear. See Figure 7.
• Insert the needle through the loose skin in the posterior attribute of the ear where it attaches to the caput (base of operations of the ear) while maintaining needle position. Run across Figure vii.

Effigy vii. Diagram of head showing the management of base of operations of ear injections when administered ventrally into the loose pare in the caudal aspect of the base of the ear.

CONTRAINDICATIONS

Equally with all drugs, the employ of EXCEDE Sterile Suspension is contraindicated in animals previously institute to be hypersensitive to the drug.

WARNINGS

FOR USE IN ANIMALS Only. NOT FOR HUMAN Apply.
KEEP OUT OF Accomplish OF CHILDREN.

Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit balmy to astringent allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid straight contact of the production with the pare, eyes, mouth and clothing. Sensitization of the skin may be avoided by wearing protective gloves.

Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product.

In instance of accidental heart exposure, flush with water for fifteen minutes. In case of accidental skin exposure, wash with lather and water. Remove contaminated clothing. If allergic reaction occurs (due east.g., skin rash, hives, difficult breathing), seek medical attention.

The material safety data sheet contains more detailed occupational safety data. To obtain a textile safety data canvass or to report any agin event please call one-888-963-8471.

Intra-arterial injection may occur during administration of EXCEDE Sterile Suspension via heart third of the ear injection or base of the ear injection directed towards the contrary eye. Intra-arterial injection of EXCEDE Sterile Break is likely to result in sudden death of the animal.

Balance WARNINGS

• Following label utilise every bit either a single-dose or ii-dose regimen, a 13-day pre-slaughter withdrawal period is required after the last treatment.
  
• Following label employ equally either a single-dose or 2-dose regimen, no milk discard period is required for this production.
  
• Use of dosages in excess of 3.0 mg CE/lb (6.vi mg CE/kg) BW or administration by unapproved routes (subcutaneous injection in
  the neck or intramuscular injection) may cause violative residues.
  
• A withdrawal catamenia has non been established for this product in preruminating calves.
  
• Exercise not use in calves to be processed for veal.

ANTIBACTERIAL WARNINGS

Utilise of antibacterial drugs in the absence of a susceptible bacterial infection is unlikely to provide benefit to treated animals and may increment the take chances of the development of drug-resistant bacteria.

PRECAUTIONS

Following subcutaneous injection in the middle tertiary of the posterior aspect of the ear, thickening and swelling  (characterized by aseptic cellular infiltrate) of the ear may occur. As with other parenteral injections, localized post-injection bacterial infections may upshot in abscess formation. Attention to hygienic procedures tin minimize their occurrence.

Post-obit injection in the posterior attribute of the ear where it attaches to the head (base of operations of the ear), areas of discoloration and signs of inflammation may persist at least 13 days post administration resulting in trim loss of edible tissue at slaughter. Injection of volumes greater than 20 mL, in the eye third of the ear, may outcome in open draining lesions in a small percentage of cattle.

The effects of ceftiofur on bovine reproductive performance, pregnancy, and lactation have non been determined.

ADVERSE Furnishings

Intra-arterial injection may occur during administration of EXCEDE Sterile Suspension via middle 3rd of the ear injection or base of the ear injection directed towards the opposite center. Intra-arterial injection of EXCEDE Sterile Suspension is probable to result in sudden death of the brute. During the bear of clinical studies, at that place was a low incidence of acute expiry (see Creature SAFETY) confirmed to be the outcome of inadvertent intra-arterial injection. No other adverse systemic furnishings were noted for either the antibiotic or conception during whatsoever of the clinical and target beast condom studies.

CLINICAL PHARMACOLOGY

Ceftiofur administered every bit either ceftiofur sodium (NAXCEL® Sterile Pulverization), ceftiofur hydrochloride (EXCENEL® RTU Sterile Suspension), or ceftiofur crystalline free acid (EXCEDE Sterile Interruption) is metabolized rapidly to desfuroylceftiofur, the primary metabolite. Subcutaneous administration of ceftiofur crystalline gratis acid, either in the middle tertiary of the posterior aspect of the ear (middle tertiary of the ear, MOE) of beef and non-lactating dairy cattle, or in the posterior aspect of the ear where it attaches to the head (base of the ear, BOE) of beef, non-lactating dairy, and lactating dairy cattle, provides therapeutic concentrations of ceftiofur and desfuroylceftiofur-related metabolites in plasma above the everyman minimum inhibitory concentration to embrace 90% of the nigh susceptible isolates (MICxc) for the labeled BRD pathogens, Pasteurella multocida, Mannheimia haemolytica and Histophilus somni, for generally not less than 150 hours subsequently a unmarried administration (See Figure viii).

Unmarried Dose Regimen

The pharmacokinetic parameters for the two subcutaneous locations of injection (MOE and BOE) are found in Table ii. Statistical analyses of the data from these 2 subcutaneous injection sites (MOE and BOE) demonstrate that they are therapeutically equivalent.

Figure viii. Average (northward=12/group) plasma concentrations of ceftiofur and desfuroylceftiofur-related metabolites after administration of EXCEDE Sterile Intermission at three.0 mg CE/lb (6.6 mg CE/kg) BW via subcutaneous injection into one of ii different locations of the ear, eye third of the ear (MOE Cattle) and base of operations of the ear (BOE Cattle) in beef cattle as well into the base of the ear (BOE Lactating) in lactating dairy cattle.

Table two. Average (n = 12/group) pharmacokinetic parameters for ceftiofur and desfuroylceftiofur metabolites calculated after a unmarried subcutaneous assistants of 3.0 mg CE/lb (six.six mg CE/kg) BW of EXCEDE Sterile Suspension in either the middle tertiary of the ear or the base of the ear.

Pharmacokinetic Parameter	Beef - Middle 3rd of the Ear Mean Value ± Standard Deviation	Beef - Base of operations of the Ear Mean Value ± Standard Departure	Dairy Cow - Base of the Ear Hateful Value ± Standard Difference
Cmax (µg CE/mL) = maximum plasma concentration (in µg CE/mL). tmax (h) = the time afterward injection when Cmax occurs (in hours). AUC 0-LOQ (µg∙h/mL) = the area under the plasma concentration vs. time bend from time of injection to the limit of quantitation of the analysis (0.15 µg CE/mL). t>0.2, model (h) = the time plasma concentrations remain to a higher place 0.2 µg CE/mL (in hours), estimated using compartmental pharmacokinetic techniques. t>0.2, nca (h) = the fourth dimension plasma concentrations remain above 0.two µg CE/mL (in hours), estimated using noncompartmental pharmacokinetic techniques. t1/2 (h) = terminal phase biological half life (in hours) NE = Not estimated
Cmax (µg CE/mL)	half dozen.90 ± 2.68	6.39 ± i.79	4.44 ± ane.65
tmax (h)	12.0 ± 6.2	19.viii ± 5.81	19.00 ± 8.02
AUC 0-LOQ (µg∙h/mL)	376 ± 66.1	412 ± 67.iii	313 ± 85.five
t>0.2, model (h)	183 ± 40.viii	NE	NE
t>0.2, nca (h)	246 ± 48.5	218 ± 45.5	205 ± 35.7
tane/ii (h)	62.3 ± thirteen.5	40.7 ± 11.2	43.92 ± 9.84

Ii-Dose Regimen

A two-dose regimen of 6.vi mg CE/kg BW administered 72 hours apart is required for the handling of acute metritis in lactating cows. The mean plasma concentration vs. time contour for ceftiofur and desfuroylceftiofur-related metabolites for the 2-dose regimen in 12 cows is shown in Figure nine beneath. The pharmacokinetic parameters for the 2-dose regimen are provided in Table three.

Effigy 9. LS-Hateful DCA Plasma Concentration Time Profile Following 2 Subcutaneous Injections of EXCEDE 72 hours apart at a Dose of 3.0 mg CE/lb (6.6 mg CE/kg) BW in 12 lactating cows.

Table three. Average (n = 12) Pharmacokinetic Parameters Post-obit Two Subcutaneous Injections of EXCEDE Sterile Intermission at a Dose 3.0 mg CE/lb (6.half-dozen mg CE/kg) BW at a 72 Hour Interval.

PK Parameter	Mean ± Standard Difference
AUC0-LOQ (µg∙h/mL)	651 ± 119
t½ (h)	55.7 ± iv.84
t>0.2 (h)	341 ± 34.0
Tmax (h)	77.one ± 33.4
Cmax (µg/mL)	v.98 ± 2.51

MICROBIOLOGY

Ceftiofur has demonstrated in vitro activity against Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, three major pathogens associated with BRD, and against Fusobacterium necrophorum and Porphyromonas levii associated with bovine foot rot.

A summary of the susceptibility of BRD and foot rot pathogens is presented in Table 4. BRD isolates were obtained from cattle enrolled in a field study conducted in the United States that were diagnosed with BRD. Pes rot isolates were obtained from cattle enrolled in a field study conducted in the Usa and Canada that were diagnosed with pes rot. Susceptibility testing was conducted according to the Clinical and Laboratory Standards Establish (CLSI) M7-A3 and M11-A6 standards for BRD and human foot rot isolates, respectively.

Table 4. Ceftiofur minimum inhibitory concentration (MIC) values* of indicated pathogens isolated from cattle with naturally occurring BRD or pes rot.

Indicated pathogen	Year of isolation	Number of isolates	MICl† (μg/mL)	MICninety† (µg/mL)	MIC range (µg/mL)
* The correlation between in vitro susceptibility data and clinical effectiveness is unknown. † The everyman MIC to cover 50% and 90% of the well-nigh susceptible isolates, respectively.
Mannheimia haemolytica	1996 to 1997	75	0.008	0.015	0.001 to 0.015
Pasteurella multocida	1996 to 1997	43	0.004	0.004	0.001 to 0.015
Histophilus somni	1996 to 1997	11	0.004	0.004	0.002 to 0.015
Fusobacterium necrophorum	2006 to 2007	148	≤ 0.25	0.5	≤ 0.25 to >128
Porphyromonas levii	2006 to 2007	141	≤ 0.25	2.0	≤ 0.25 to 16

Based on pharmacokinetic and clinical effectiveness studies of ceftiofur in cattle later on a unmarried administration of 3.0 mg CE/lb (six.half dozen mg CE/kg) BW and the MIC and susceptibility data, the following breakpoints are recommended for BRD pathogens past CLSI.

Table five. CLSI-accepted interpretive criteria* for ceftiofur against cattle respiratory pathogens.

Pathogen	Disk potency	Zone bore (mm)			MIC breakpoint (µg/mL)
		S	I	R	Due south	I	R
S – Susceptible
I – Intermediate
R – Resistant
* These interpretive criteria are only intended for employ when CLSI M31-A2 operation standards are used to determine antimicrobial susceptibility. Interpretive criteria for bovine foot rot pathogens have not been established.
Mannheimia haemolytica Pasteurella multocida Histophilus somni	xxx µg	≥ 21	18 to 20	≤ 17	≤ 2.0	4.0	≥ 8.0

EFFECTIVENESS

A field dose confirmation study for the treatment of BRD evaluated the effectiveness of unmarried doses of 2.0 and 3.0 mg CE/lb (four.4 or vi.half dozen mg CE/kg) BW for the handling of the bacterial component of BRD under field conditions. All treatments were administered subcutaneously in the middle third of the posterior aspect of the ear. Cattle were clinically evaluated on Days 2 to 4, 14 and 28 and were observed on all other report days. The iii.0 mg CE/lb (half-dozen.6 mg CE/kg) BW EXCEDE Sterile Interruption dose significantly (p ≤ 0.05) increased Day 14 treatment success rate, defined as animals that did not require whatever ancillary handling and had a rectal temperature of < 104°F, normal respiration index, and had no or mild low on that day.

The effectiveness of a unmarried dose of EXCEDE Sterile Suspension for the control of BRD in feedlot cattle was evaluated in a nine-location field effectiveness written report. In addition to standard processing on inflow at feedlots, cattle (northward=3911) considered to be at loftier adventure for BRD were assigned to one of four arrival treatments, including EXCEDE Sterile Pause at 2.0 or 3.0 mg CE/lb (4.4 or six.half dozen mg CE/kg) BW or negative control. Effectiveness evaluation was based on the incidence of clinical BRD inside 28 days following inflow processing. Administration of a single dose of EXCEDE Sterile Suspension administered subcutaneously in the center 3rd of the posterior aspect of the ear at inflow processing significantly reduced the incidence of BRD in loftier-risk feedlot cattle in the 28-day period after inflow processing compared to negative controls.

Base of the ear administration (beef and non-lactating dairy cattle) and middle third of the ear administration (lactating dairy cattle) were compared to the middle third of the ear pharmacokinetic information for beef and not-lactating dairy cattle and were establish to be therapeutically equivalent.

The effectiveness of EXCEDE Sterile Suspension for the treatment of bovine foot rot was evaluated in a six-location field effectiveness report. Cattle diagnosed with bovine pes rot were enrolled and treated with EXCEDE Sterile Break, administered by subcutaneous injection in the base of the ear as a single dose of three.0 mg CE/lb (half dozen.6 mg CE/kg) BW or an equivalent volume of a vehicle control. Cattle were clinically evaluated 7 days mail service-handling for treatment success, which was based on defined decreases in lesion, swelling and lameness scores. A total of 169 beef and dairy cattle were included in the analysis. There was a statistically significant difference (p = 0.0054) in treatment success for EXCEDE-treated cattle (58.4%) compared to vehicle-treated control cattle (13.ii%).

The effectiveness of EXCEDE Sterile Suspension for the treatment of acute metritis was evaluated in a 15-location field effectiveness study. A total of 1023 cows with a fetid vaginal discharge and a rectal temperature of ≥ 103 °F were enrolled in the study and treated with either a two-dose regimen of EXCEDE (six.vi mg CE/BW) or an equivalent volume of vehicle control, administered approximately 72 hours autonomously at the base of opposite ears. At 14 days mail service-handling, each moo-cow remaining in the report was examined and rectal temperature and vaginal discharge score were recorded. Cows with a non-fetid discharge, and a rectal temperature < 103 °F, and that did not crave alternate ("escape") therapy during the 14_day observation menstruum were classified equally a cure. The cure rate was significantly higher (p < 0.0001) in EXCEDE-treated cows (362/493, 74.three%) than in vehicle-treated cows (271/489, 55.3%). One cow died 15 to 20 minutes subsequently the 2nd administration of EXCEDE. Necropsy findings determined the probable crusade of decease to be intra-arterial injection.

Beast SAFETY

Systemic Condom Studies

After parenteral assistants, ceftiofur crystalline free acid (as EXCEDE Sterile Break), ceftiofur sodium and ceftiofur hydrochloride are rapidly metabolized to desfuroylceftiofur. Therefore, studies conducted with ceftiofur sodium are adequate to evaluate the systemic safety of EXCEDE Sterile Pause. Results from a v-day tolerance study conducted with ceftiofur sodium in normal feeder calves indicated that ceftiofur was well tolerated at 25 mg CE/lb/day for five sequent days, approximately 8 times the approved dose of EXCEDE Sterile Suspension 3.0 mg CE/lb (6.half-dozen mg CE/kg) BW. Ceftiofur administered parenterally had no adverse systemic effects.

In a 15-day safety/toxicity study, 5 steer and five heifer calves per grouping were administered ceftiofur sodium intramuscularly at 0 (vehicle control), ane, 3, 5 or x mg CE/lb/mean solar day thus, evaluating up to iii.three times the approved dose of EXCEDE Sterile Suspension of 3.0 mg CE/lb/twenty-four hours (vi.6 mg CE/kg) BW. There were no adverse systemic effects, indicating that ceftiofur has a wide margin of safety when injected intramuscularly into feeder calves. Local tissue tolerance to subcutaneous injection of EXCEDE Sterile Suspension in the posterior ear of cattle was evaluated in a separate study.

The systemic safety of ceftiofur concentrations resulting from product assistants at the base of operations of the ear was established via a pharmacokinetic comparing of the two routes of assistants (base of the ear versus centre third of the ear). Based upon the results of this relative bioavailability report, it was determined that the ii routes of administration are therapeutically equivalent.

To back up systemic target animal rubber for the 2-dose metritis regimen, v projected daily doses of NAXCEL Sterile Powder (ceftiofur sodium) at two.ii mg/kg BW were compared pharmacokinetically with EXCEDE administered ii times at a 72 hour interval at 6.half-dozen mg/kg BW. The tiptop concentration (Cmax) and the extent of exposure (AUC) afterwards 2 doses of EXCEDE were statistically no higher than the exposure following five daily doses of NAXCEL Sterile Powder in beef cattle.

Investigation of Intra-Arterial and Intravenous Injection

In approximately 6000 animals enrolled in the BRD clinical studies, nine animals died post-obit injection of EXCEDE Sterile Interruption. All deaths were within 30 minutes of the time of injection. The verbal cause was confirmed in three animals. These deaths resulted from inadvertent intra-arterial injection of this oil-based suspension into ane of the two major auricular (ear) arteries. Intra-arterial injection at this location resulted in direct administration of the oil-based formulation into the arterial blood supply of the encephalon resulting in embolism and death.

Since intra-arterial injection was confirmed in 3 animals that died following injection of EXCEDE Sterile Suspension, the consequences of purposeful intra-arterial injection of EXCEDE Sterile Suspension were investigated in feeder cattle. Two heifers (body weight approximately 225 kg) were given a single 3.0 mg CE/lb (6.6 mg CE/kg) BW bolus dose of EXCEDE Sterile Intermission in the eye auricular artery. Both heifers collapsed immediately and died within approximately eight minutes of injection. Intra-arterial injection of EXCEDE Sterile Suspension in the ear will result in expiry and must exist avoided.

Since subcutaneous injection in the ear may potentially event in inadvertent intravenous administration of an injectable product, the consequences of purposeful intravenous injection of EXCEDE Sterile Interruption were investigated in feeder cattle. Iii heifers and three steers (body weight range 197-223 kg) were given a single 3.0 mg CE/lb (6.6 mg CE/kg) BW bolus dose of EXCEDE Sterile Suspension in the jugular vein and were monitored for adverse effects post-obit injection. One steer and i heifer had transient (2 to 5 minutes) increases in center rate without any other untoward signs in these or the other cattle. Intravenous injection of EXCEDE Sterile Suspension is an unacceptable route of assistants.

Safety Studies in Beef Cattle

Heart of the ear injection:

A study was designed and conducted to specifically address tissue tolerance in cattle when EXCEDE Sterile Intermission was administered every bit a single subcutaneous injection into the posterior aspect of the ear of cattle at the recommended dose of 3.0 mg CE/lb (vi.6 mg CE/kg) BW. Results from this study indicate that the subcutaneous injection of EXCEDE Sterile Intermission into the middle third of the posterior attribute of the ear of cattle is well tolerated and characterized by a biphasic thickening of the ear. The initial increase in thickness is attributed to the infinite required for the volume of injected textile. Additional increases in thickness were observed through Twenty-four hour period 14 after injection. Subsequently Day 14, post injection ear thickness decreased in all animals. One animal carried an injected ear in a drooping position for vii days mail service injection. At necropsy, subcutaneous areas of discoloration and some foci of hemorrhage were observed in ears of injected cattle. The discoloration was markedly reduced in size by the end of the written report. Ears are inedible tissues in the United states (nine CFR 301.two). No signs of irritation were observed on the edible portions of the carcass effectually the base of operations of the ear.

The local tolerance of the ear of cattle to a single subcutaneous injection of EXCEDE Sterile Intermission was also evaluated in a large multi-location effectiveness study. None of the 1927 animals treated with EXCEDE Sterile Interruption were removed from this trial due to ear irritation although swelling was noted at some injection sites. Leak back and/or bleeding from the injection site was observed in a small fraction of the treated animals immediately after assistants. It was concluded that administration of EXCEDE Sterile Suspension in the posterior aspect of the ear was well tolerated and was acceptable under feedlot conditions.

A study evaluated the 56-solar day feedlot performance of beefiness steers administered EXCEDE Sterile Suspension alone, EXCEDE Sterile Interruption with a growth promoting implant, growth promoting implant alone, or neither product, in a total of 207 Angus and Angus cantankerous-bred steers. The administration of EXCEDE Sterile Suspension in the posterior attribute of the ear with or without growth promoting implants was well tolerated by cattle and did not adversely impact feedlot cattle performance. Based upon the results of this study, the location of implants administered after EXCEDE Sterile Break may need to exist adjusted slightly within the boundaries of the center third of the ear in some animals.

Base of the ear injection:

The local tolerance of the ear to a single subcutaneous injection at the base of the ear of EXCEDE Sterile Intermission was evaluated in a multi-location field study in 2926 beef cattle. Normal restraint was acceptable for assistants of EXCEDE Sterile Suspension for 99.8% of cattle. No post injection issues (excessive bleeding or leak back) were observed in 99.8% of cattle. On Days 28 and 56 postal service-injection, 97.8% and 98.ix% of the cattle had "normal" (no observed swelling) ears.

In a residue study, 72 beef cattle were injected in the base of the ear with EXCEDE Sterile Interruption at a dose rate of 3.0 mg CE/lb (6.6 mg CE/kg) BW. Injection sites were observed daily from treatment to necropsy (4, 7, 10, or 13 days mail service-injection) for swelling and drooping, and evaluated grossly at necropsy, using skinning and trimming procedures similar to slaughterhouse practices. All animals had injection site swelling during the study; swelling resolved prior to euthanasia in 23 of 72 animals. None of the animals showed ear drooping. At necropsy, signs of inflammation (hemorrhage, congestion, and compactness of tissue) and presence of drug textile were seen in the surface area around the injection site and on the carcass. At xiii days post-injection, gross lesions were institute in the inedible portions of the base of the ear in all 18 animals, and in the exposed carcass tissue in 11 of 18 animals.

The ventral base of operations of the ear injection technique was evaluated in a weather condition of utilise study in 200 beef cattle. Each fauna received a single injection of EXCEDE Sterile Suspension at a dose of 6.6 mg CE/kg BW at the base of the ear using the ventral injection technique. Normal restraint was acceptable for 95.v% of animals in the study. Injection site scores were normal for 65.3% and 92.5% of cattle on Days 14 and 28, respectively. I beast had an unusually large swelling on Day seven which reduced to a size comparable to other report animals past Twenty-four hour period 14.

Safety Studies in Lactating Dairy Cattle

The local tolerance of the ear to a single subcutaneous injection at the base of the ear of EXCEDE Sterile Suspension was evaluated in a multi-location field study in 114 adult dairy cattle. Successful injection in the base of the ear was achieved in 97.iv% of cattle using normal facilities and restraint equipment. No leak dorsum or excessive bleeding was observed following injection for 99.1% of cattle, with injection volumes ranging from 15 to 30 mL. On Days 28 and 56 post-obit injection of EXCEDE Sterile Suspension in the base of the ear, 95.6% and 100% of ears, respectively, were observed as normal with no injection site swelling.

In a residual study, half-dozen dairy cows were injected in the base of the ear at a dose charge per unit of 3.0 mg CE/lb (6.6 mg CE/kg) BW of EXCEDE Sterile Suspension. No animals exhibited drooping ears at any time after treatment simply all animals had signs of swelling at the injection site at all observation times after treatment. Cows were slaughtered x days after injection. At necropsy, all half-dozen cows showed evidence of injection site inflammation (discoloration of fat tissue/fascia) and four of six cows had discoloration of tissue dorsal and posterior to the ear canal on the carcass. In add-on to discoloration, tan nodules and a milky white fluid exudate were also nowadays at the sectioned surface.

Injection site prophylactic for base of the ear administration was evaluated in the metritis effectiveness study described higher up. Normal restraint was adequate for ≥ 97.8% of injections administered. Injection site scores were normal in l.3%, 73.2%, and 96.4% at 2 or three, 11, and 54±3 days afterwards the second injection, respectively.

The ventral and rostral base of the ear injection techniques were compared with the toward the opposite heart technique in a conditions of apply study in 197 lactating dairy cattle. Normal restraint was adequate for 89.8% (ventral), 98% (rostral), and 100% (opposite eye) of animals in the study. Injection site scores were normal for 32% (rostral), 46.9% (ventral), and 47.ix% (opposite eye) of cattle on Day 14, and 73% (rostral), 87.8% (ventral), and 64.6% (opposite eye) of cattle on Day 28, respectively.

TISSUE AND MILK Residual DEPLETION

A radiolabeled rest metabolism study established tolerances for ceftiofur residues in cattle kidney, liver and muscle. A separate written report established the tolerance for ceftiofur residues in milk. The tolerances for ceftiofur residues are 0.4 ppm in kidney, 2.0 ppm in liver, 1.0 ppm in musculus and 0.one ppm in milk.

A pivotal tissue residual decline written report was conducted in dairy cattle. In this study, cows received a single injection of 3.0 mg CE/lb (6.6 mg CE/kg) BW. Ceftiofur residues in tissues were less than the tolerances for ceftiofur residues in tissues such as the kidney, liver and muscle by xiii days after dosing. These data collectively support a 13‑mean solar day pre-slaughter withdrawal flow.

A pivotal milk residue decline study was conducted in lactating dairy cattle. In this written report, cows received a unmarried injection of 3.0 mg CE/lb (6.half dozen mg CE/kg) BW. Ceftiofur residues in milk were less than tolerances at all time points after treatment. These data collectively back up that no milk discard menstruation is required for this product.

Two-Dose Residue Reject Studies
A pivotal tissue residue reject written report was conducted in dairy cattle. In this study, cows received two injections of 3.0 mg CE/lb (6.6 mg CE/kg) BW with a 72 hour interval between injections. Ceftiofur residues in tissues were less than the tolerances for ceftiofur residues in the kidney past 13 days later on the 2d dose. These information collectively keep to support a 13-day pre-slaughter withdrawal period after the last dose.

A pivotal milk balance turn down study was conducted in lactating dairy cattle. In this report, cows received ii injections of 3.0 mg CE/lb (vi.6 mg CE/kg) BW with a 72 hour interval between injections. Milk residuum decline data from this study supports that no milk discard catamenia is required for this product.

STORAGE CONDITIONS

Store at controlled room temperature 20° to 25°C (68° to 77°F). Shake well before using. Contents should be used within 12 weeks after the kickoff dose is removed.

HOW SUPPLIED

EXCEDE Sterile Suspension is available in the following package sizes:

100 mL vial
250 mL vial

Approved by FDA under NADA # 141-209

zoetis

Distributed past:
Zoetis Inc.
Kalamazoo, MI 49007

world wide web.EXCEDE.com or call 1-888-963-8471

Revised: Jan 2020

40029632

Come across other side for instructions for utilize in cattle.

For intramuscular injection in the equus caballus.

Circumspection

Federal (Usa) law restricts this drug to utilize past or on the order of a licensed veterinarian. Federal law prohibits actress-label apply of this drug in cattle for affliction prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major nutrient producing species/production classes.

DESCRIPTION

EXCEDE Sterile Suspension is a ready-to-use conception that contains the crystalline free acid of ceftiofur, which is a broad spectrum cephalosporin antibiotic agile against Gram-positive and Gram-negative bacteria including ß-lactamase-producing strains. Like other cephalosporins, ceftiofur is bactericidal, in vitro, resulting from inhibition of prison cell wall synthesis.

Each mL of this fix-to-utilise sterile intermission contains ceftiofur crystalline free acrid equivalent to 200 mg ceftiofur, in a caprylic/capric triglyceride and cottonseed oil based suspension.

Figure i. Structure of ceftiofur crystalline free acid:

Chemical name of ceftiofur crystalline free acrid:

seven-[[2-(2-Amino-four-thiazolyl)-2-(methoxyimino)acetyl]amino]- 3-[[(two-furanylcarbonyl)thio] methyl]-8-oxo-5-thia-1- azabicyclo[four.ii.0]oct-two-ene 2-carboxylic acid

INDICATION

EXCEDE Sterile Suspension is indicated for the handling of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.

DOSAGE AND ADMINISTRATION

Milkshake well before using.

Administrate 2 intramuscular injections to horses, 4 days apart, at a dose of 3.0 mg/lb (6.6 mg/kg). A maximum of 20 mL per injection site may be administered. Therapeutic drug concentrations are maintained for six days subsequently the 2d injection (or a full of x days from the beginning of treatment) against Streptococcus equi ssp. zooepidemicus.

Tabular array 1. Dosing Schedule for EXCEDE Sterile Intermission.

Weight (lb)	Dose Book (mL)		Weight (lb)	Dose Volume (mL)
100	1.five		1100	sixteen.5
200	3.0		1200	18.0
300	iv.5		1300	19.v
400	vi.0		1400	21.0
500	7.v		1500	22.5
600	9.0		1600	24.0
700	10.5		1700	25.five
800	12.0		1800	27.0
900	thirteen.5		1900	28.5
yard	xv.0		2000	30.0

CONTRAINDICATIONS

EXCEDE Sterile Break is contraindicated in horses with known allergy to ceftiofur or to ß-lactam (penicillins and cephalosporins) group antimicrobials. Due to the extended exposure in horses, based on the drug's pharmacokinetic properties, adverse reactions may crave prolonged care.

Warnings and Precautions

Human Safe Warnings
Not for utilise in humans. For apply in animals only. Continue this and all drugs out of reach of children.

Consult a dr. in case of adventitious human exposure. Penicillins and cephalosporins tin cause allergic reactions in sensitized individuals. Topical exposure to such antimicrobials, including ceftiofur, may arm-twist mild to astringent allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the pare, eyes, mouth and habiliment. Sensitization of the skin may be avoided past wearing protective gloves. Persons with a known sensitivity to penicillin or cephalosporins should avoid exposure to this product. In the case of accidental eye exposure, flush with water for 15 minutes. In instance of adventitious skin exposure, launder with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g. skin rash, hives, hard breathing) seek medical attending.

Beast Safe Warnings and Precautions

Immediate onset of seizures or plummet accept been reported following Excede assistants.

The injection of EXCEDE Sterile Break in the horse may crusade firmness, swelling, sensitivity, and/or edema at the injection site.

Injection site reactions may be all-encompassing and crave veterinary care.

The administration of antimicrobials to horses under conditions of stress may be associated with acute diarrhea that can be fatal. If acute diarrhea is observed, additional doses of EXCEDE should non exist administered and appropriate therapy should exist initiated.

Due to the extended exposure in horses, based on the drug'southward pharmacokinetic properties, adverse reactions may crave prolonged care. EXCEDE is slowly eliminated from the trunk, with approximately 17 days needed to eliminate 97% of the dose from the body. Animals experiencing adverse reactions may demand to be monitored for this duration of fourth dimension.

The use of ceftiofur has non been evaluated in horses less than 4 months of age and in breeding, meaning, or lactating horses. The long term effects on injection sites accept not been evaluated.

(See Animal Prophylactic and Post Approval Experience sections)

Antibacterial Warnings

Use of antibacterial drugs in the absenteeism of a susceptible bacterial infection is unlikely to provide benefit to treated animals and may increase the chance of the development of drug-resistant bacteria.

Adverse REACTIONS

Pre-Approval Experience:
A total of 373 horses of various breeds, ranging in historic period from 4 months to 20 years, were included in the field study rubber assay. Adverse reactions reported in horses treated with EXCEDE and the placebo control are summarized in Table 2.

Injection site swelling (edema) was reported in 10 of 278 (3.6%) EXCEDE-treated horses and 1 of 95 (1 %) of the placebo-treated horses. Of the ten EXCEDE-treated horses with injection site swelling, viii horses had swellings of 4 cm or less in diameter, ane horse had a ten cm bore swelling and one horse had injection site reactions to both injections measuring 25 x 12 cm each. The injection site reactions in EXCEDE treated horses resolved over 1 to twenty days.

At least ane episode of diarrhea, loose, soft, or cowpie stools were observed in 25 of 278 (nine%) of the EXCEDE-treated horses and vii of 95 (vii%) of the placebo-treated horses. The duration of episodes in EXCEDE-treated horses ranged from a single ascertainment of loose stool to observations lasting half dozen days. All cases were self-limiting and resolved with minimal (a single dose of loperamide) or no treatment.

Table 2. Number of Horses with Agin Reactions During the Field Study with EXCEDE.

Adverse Reaction	EXCEDE (n=278)	Placebo (n=95)
Diarrhea/Soft Stool	25 (ix%)	7 (7%)
Injection Site Swelling	10 (iv%)	ane (1%)

Mail Blessing Feel (2019):
The following adverse events are based on post-blessing adverse drug feel reporting for Excede. Not all agin events are reported to FDA/CVM. It is non ever possible to reliably estimate the adverse event frequency or establish a causal relationship to production exposure using these information.

The following agin events for horses are listed in decreasing order past system and decreasing order within system classes.

Injection site reactions: swelling, pain, inflammation, infection, necrosis, muscle stiffness, fibrosis, injection site stiffness/ reluctance to motility, hair change, lameness, granuloma.

Systemic: fever, lethargy, edema at locations other than injection site, anorexia.

Gastrointestinal: colic, diarrhea.

Neurologic: ataxia, muscle tremor, seizure, loss of consciousness.

Allowed (Allergic reactions): anaphylaxis, urticaria, allergic edema (face, face and cervix, lip, or limb edema).

In some cases, death has been reported as an consequence of the adverse events listed above. Sudden expiry (within minutes), or the immediate onset of seizures or plummet, followed by death or euthanasia, take been reported.

To report suspected agin events, for technical assist or to obtain a copy of the Condom Data Sail (SDS) contact Zoetis, Inc. at (888) 963-8471. For additional information about adverse drug experience reporting for fauna drugs, contact FDA at 1-888-FDA-VETS or online at http://world wide web.fda.gov/reportanimalae.

CLINICAL PHARMACOLOGY

Ceftiofur is a beta-lactam antibiotic from the cephalosporin class. Beta lactams exert their inhibitory result by interfering with bacterial cell wall synthesis. This interference is primarily due to its covalent binding to the penicillin-binding proteins, which are essential for synthesis of the bacterial wall. Ceftiofur administered as either ceftiofur sodium (NAXCEL® Sterile Powder) or ceftiofur crystalline free acrid (EXCEDE Sterile Suspension) is rapidly metabolized to desfuroylceftiofur, the primary metabolite with antimicrobial activeness. Two intramuscular injections of EXCEDE Sterile Break at a dose of 6.6 mg/kg torso weight in the equus caballus provide concentrations of ceftiofur and desfuroylceftiofur related metabolites in plasma to a higher place the therapeutic target of 0.2 µg/mL for the entire 96 hour (4 solar day) dosing interval and for 6 days afterward the 2d injection (or a total of x days from the beginning of treatment) (see Figure 2 and Table 3).

Figure two. Average plasma concentration of ceftiofur and desfuroylceftiofur related metabolites in horses post-obit the intramuscular administration of either EXCEDE Sterile Break at a dose of 3.0 mg/lb (six.6 mg/kg) administered twice at a 96 hour interval or NAXCEL Sterile Powder at a dose of 1.0 mg/lb (2.2 mg/kg BW) once daily for ten consecutive days.

Tabular array 3. Pharmacokinetic parameters measured after either 2 intramuscular injections of EXCEDE Sterile Pause at a dose of three.0 mg/lb (half dozen.6 mg/kg) BW at a 96 hour interval or NAXCEL Sterile Powder at a dose of one.0 mg/lb (ii.two mg/kg) BW once daily for 10 consecutive days are summarized in the post-obit table.

PK Parameter	CCFA-SS at 6.6 mg/kg BW administered twice 96 h autonomously (Mean ± SD; n=12)		Ceftiofur sodium at 2.2 mg/kg BW once daily for 10 days (Hateful ± SD; n=xi)
AUC0-∞ (µg∙h/mL)	157 (19.1)		353 (44.9)
t>0.two (h)	262 (29.0)		ND
	Dose 1	Dose 2	Dose 1	Dose ten
Tmax (h)	21.6 (v.8)	fifteen.six (6.3)	1.0	two.0 (three.3)
Cmax (µg/mL)	0.78 (0.19)	1.0 (0.24)	four.31 ± 0.78	3.99 (ane.23)

MICROBIOLOGY

Ceftiofur is a cephalosporin antibiotic. Like other ß-lactam antimicrobials, ceftiofur exerts its inhibitory effect by interfering with bacterial cell wall synthesis. This interference is primarily due to its covalent binding to the penicillin-bounden proteins (PBPs) (i.e., transpeptidase and carboxypeptidase), which are essential for synthesis of the bacterial wall. Ceftiofur is non active confronting Pseudomonas spp. and enterococci.

The minimum inhibitory concentration (MIC) values for ceftiofur confronting characterization-merits pathogens isolated from lower respiratory tract infections in horses enrolled in a 2007-2008 field effectiveness study are presented in Table four. All MICs were determined in accordance with the Clinical and Laboratory Standards Institute (CLSI) standards.

Table iv. Activity of EXCEDE Confronting Pathogens Isolated from Horses Treated With EXCEDE in Field Studies in the U.S. During 2007-2008.

Disease	Pathogen	Treatment Outcome	# of Isolates	Time of Sample Collection	MICl µg/mL	MIC90 µg/mL	MIC Range µg/mL
* One horse cultured Staphylococcus aureus (successfully treated) and is non represented in the table.
Lower Respiratory Tract Infection	Streptococcus equi ssp. zooepidemicus	Success	93*	Pre-Handling	0.06	0.12	0.03-0.5
		Failure	42	Pre-Treatment	0.06	0.25	0.03-0.5

EFFECTIVENESS

A double masked, randomized, negative control, field study evaluated the effectiveness of two intramuscular doses of six.6 mg/kg EXCEDE Sterile Suspension administered 4 days apart for the treatment of lower respiratory infections caused by Streptococcus equi ssp. zooepidemicus in the horse. In this report, a total of 278 horses were treated with EXCEDE, and 95 horses were treated with saline injections. One hundred ninety-3 horses (136 EXCEDE and 57 saline placebo) were included in the statistical assay. Therapeutic success was characterized by no worsening of clinical signs at Solar day 4, clinical improvement at 24-hour interval 9, resolution of the clinical signs by Mean solar day 15, and no recurrence of clinical signs past Twenty-four hour period 25 afterwards initial dosing. EXCEDE was superior to the saline control. Table 5 summarizes the clinical success rates obtained 15 and 25 days after the first dose.

Table 5. Clinical success rates at Day 15 and 25.

Effectiveness parameter	EXCEDE	Saline Control	P-value
Clinical success Day xv	73.53%	38.60%	Northward/A
Clinical success Twenty-four hours 25	69.12%	31.58%	0.0215

Creature SAFETY

Two studies, a target creature prophylactic (TAS) report and a pharmacokinetic (PK) study (see CLINICAL PHARMACOLOGY department), were conducted to assess the safety of EXCEDE in the equus caballus.

In the TAS study, salubrious adult horses received 6 intramuscular (lateral neck) injections of EXCEDE Sterile Suspension at doses of either iii.0 (1×), six.0 (two×) or 9.0 (3×) mg/lb with a 4 day interval betwixt each injection. In the TAS study, there were no treatment related gastrointestinal findings for the three EXCEDE Sterile Pause treatment groups. In the PK report, one horse treated with half-dozen.0 mg/lb (2×) EXCEDE experienced a balmy episode of colic the day after the second injection of EXCEDE. The equus caballus recovered without treatment.

Injection sites were observed in both studies. In both studies, the largest injection volume administered was xx mL per injection site. There were no observations of erythema, necrosis or drainage at the injection sites in these studies. Firmness, swelling, and/or sensitivity were observed in at least one injection site in all horses treated at the characterization dose. In the TAS report, injection site reaction measurements ranged from no measurable reaction to 16 × 33 × 1.v cm. In the PK study, the largest area of edema associated with the injection site ranged from no detectable reaction to a thirty × 36 cm area of edema. Injection site reactions developed within 2 days of injection and resolved within 1-18 days. In the PK study, 2 horses had small areas of firmness that had not resolved at the end of the report (21 days after injection). In both studies, a greater incidence of injection site reactions occurred after the second injection, and in several horses, swelling at the injection site resolved then recurred 1-5 days after.

In the PK study, several horses adult clinical signs consistent with foot pain (potent in the front limbs when turned in tight circles, and increased pulses and heat to the front anxiety). I horse in the NAXCEL group and one horse in the vi.0 mg/lb (ii×) EXCEDE group were euthanized due to laminitis. Clinical signs of pes pain (potent front limbs and increased heat and pulses in feet) affected more horses, for a longer flow of time, in all EXCEDE-treated groups as compared to the NAXCEL-treated group. The study housing (multi-horse pens on concrete slabs) and diet (free option alfalfa/grass mix and in one case a day pellets) may accept contributed to the evolution of pes pain. The prevalence and severity of injection site reactions in EXCEDE-treated horses may also accept contributed to the development of a stiff gait. A causal relationship between ceftiofur and foot pain could not be definitively determined.

STORAGE Weather

Store at controlled room temperature xx° to 25°C (68° to 77°F). Milk shake well before using. Contents should be used inside 12 weeks afterward the offset dose is removed.

HOW SUPPLIED

EXCEDE Sterile Suspension is available in the post-obit package sizes:

100 mL vial
250 mL vial

Canonical by FDA nether NADA # 141-209

zoetis

Distributed past:
Zoetis Inc.
Kalamazoo, MI 49007

www.EXCEDE.com or call 1-888-963-8471

Revised: January 2020

40029632

PRINCIPAL DISPLAY PANEL - 100 mL Vial label

PRINCIPAL DISPLAY PANEL - 250 mL Vial characterization

Zoetis Inc.

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Source: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=9922e056-dcb0-46fd-bb56-9863bb0a189e

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