Monday, November 28, 2022

Excede Antibiotic For Cattle Withdrawal

Benefits Of Excede Include:

EXCEDE (ceftiofur crystalline free acid) Sterile Suspension Administration Training

Keep your milk in the tank and profits in the bank.

ONLY TWO INJECTIONS

Give both doses and be assured EXCEDE is working.

NO PEN MOVES

Cows remain in the fresh pen with their group, avoiding the stress and potential disease transmission of a hospital pen move.

BQA FRIENDLY

Because its administered subcutaneously at the base of the ear, EXCEDE supports Beef Quality Assurance.

In addition, EXCEDE is a proven therapy for bovine respiratory disease and bovine foot rot. And EXCEDE is backed by the Residue Free Guarantee* from Zoetis, a promise no other animal health company has made. When you use EXCEDE according to the label, you dont have to worry about violative ceftiofur residues in milk or meat.

Administration For Base Of The Ear: Ventral Technique

  • Hold the syringe and needle above the ear to be dosed 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 while pointing ventrally. Care should be taken to not insert the needle through the cartilage of the ear. See Figure 7.
  • Insert the needle through the loose skin in the posterior aspect of the ear where it attaches to the head while maintaining needle position. See Figure 7.

Figure 7. Diagram of head showing the direction of base of ear injections when administered ventrally into the loose skin in the caudal aspect of the base of the ear.

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 Suspension was evaluated in a multi-location field study in 2926 beef cattle. Normal restraint was adequate for administration of EXCEDE Sterile Suspension for 99.8% of cattle. No post injection problems were observed in 99.8% of cattle. On Days 28 and 56 post-injection, 97.8% and 98.9% of the cattle had “normal” ears.

In a residue study, 72 beef cattle were injected in the base of the ear with EXCEDE Sterile Suspension at a dose rate of 3.0 mg CE/lb BW. Injection sites were observed daily from treatment to necropsy 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 and presence of drug material were seen in the area around the injection site and on the carcass. At 13 days post-injection, gross lesions were found 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.

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Screening Tests After Dilution

All samples that tested positive were first diluted with three parts of commercial milk, presumably free of ceftiofur residues. All results were negative but one from cow #5. This sample tested d for the ROSA test and + forthe SNAP test. After the addition of this sample into nine parts of commercial milk reflecting the situation of most of the dairy farms, results were negative for both tests.

Excede 200 Sterile Suspension

EXCEDE® Cattle/Equine

ceftiofur crystalline free acid sterile injectable suspension

DIN 02360586

Veterinary Use Only

For subcutaneous injection at the base of the ear only in cattle and for intramuscular injection in horses

DESCRIPTION: EXCEDE 200 sterile suspension is a ready-to-use formulation that contains ceftiofur crystalline free acid, the designation for 7 – amino] – 3 – methyl] – 8 – oxo – 5 – thia – 1 – azabicyclooct – 2 – ene 2-carboxylic acid.

Ceftiofur crystalline free acid is a broad spectrum cephalosporin antibiotic active against gram-positive and gram-negative bacteria including -lactamase-producing strains. Like other cephalosporins, ceftiofur is bactericidal, in vitro, resulting from inhibition of cell wall synthesis.

Each mL contains 200 mg ceftiofur equivalents .

Figure 1. The chemical structure of ceftiofur crystalline free acid.

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Administration For Base Of The Ear

In lactating dairy cattle the injection techniques for subcutaneous injection in the posterior aspect of the ear where it attaches to the head can be made by the rostral or ventral injection techniques.

In beef and non-lactating dairy cattle the SC injection in the base of the ear can be made by the rostral, ventral or toward the opposite eye injection techniques.

  • Shake well before using. Please read the complete package insert before administering EXCEDE Sterile Suspension subcutaneously in the posterior aspect of the ear where it attaches to the head .
  • The subcutaneous injection may be made using the toward the opposite eye, rostral, or ventral techniques. Hold the syringe and needle and insert the needle as described below.
  • Deliver the entire contents of the syringe.
  • Do not administer EXCEDE Sterile Suspension in the neck.

Administration For The Base Of The Ear: Toward The Opposite Eye Technique

  • Hold the syringe and needle behind the ear to be dosed so the needle and syringe point in the direction of an imaginary line that would pass through the head toward the animal’s opposite eye. See Figures 4 and 5.
  • Insert the needle through the loose skin in the posterior aspect of the ear where it attaches to the head while maintaining this angle. See Figure 4.

Figure 4. Subcutaneous administration of EXCEDE Sterile Suspension in the posterior aspect of the ear where it attaches to the head .

Figure 5. Injection location for the subcutaneous administration of EXCEDE Sterile Suspension in the posterior aspect of the ear where it attaches to the head .

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/15/2018posted By Doug Hammon

Take quick action to get cows back to full health and peak production after your veterinarian has confirmed a metritis diagnosis. And quick action can come in only two shots and zero milk discard.

EXCEDE® Sterile Suspension is approved to treat acute postpartum metritis in a two-dose regimen. The protocol for the two-dose treatment of EXCEDE begins with the first dose administered at the base of one ear. Then, 72 hours later, another dose is administered at the base of the opposite ear.

This two-dose treatment is efficacious, cost-effective and likely more convenient than daily metritis treatments.

  • In a field research trial conducted on 15 large dairies, 74.3% of cows with acute metritis were cured after being treated with two doses of EXCEDE.1
  • EXCEDE has zero milk discard, which means the treated cow doesnt need to be moved to a hospital or treated pen. This not only saves time and labor but also is beneficial to the cow, according to the University of Wisconsin-Madison.2
  • EXCEDE also is backed by the Residue Free Guarantee,* providing peace of mind that you wont have a violative drug residue as long as you follow the labeled directions and the meat withdrawal time.

For more information on EXCEDE, visit excede.com/dairy or contact your veterinarian or Zoetis representative.

References:

1 Data on file, Study Report No. 1133C-60-06-509, Zoetis Inc.

EXD-00045

Contact Your Zoetis Representative Or Veterinarian

EXCEDE® (ceftiofur crystalline free acid) Sterile Suspension Administration

If you have questions about administration of EXCEDE, contact your Zoetis representative or your veterinarian.

IMPORTANT SAFETY INFORMATION: People with known hypersensitivity to penicillin or cephalosporins should avoid exposure to EXCEDE. EXCEDE is contraindicated in animals with known allergy to ceftiofur or to the -lactam group of antimicrobials. Do not use in horses intended for human consumption. The administration of antimicrobials in horses under conditions of stress may be associated with diarrhea, which may require appropriate veterinary therapy. In cattle, inadvertent intra-arterial injection is possible and fatal. Do not use in calves to be processed for veal. Pre-slaughter withdrawal time in cattle is 13 days. See full Prescribing Information.

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Safety Studies In Beef Cattle

Middle of the ear injection:

A study was designed and conducted to specifically address tissue tolerance in cattle when EXCEDE Sterile Suspension was administered as a single subcutaneous injection into the posterior aspect of the ear of cattle at the recommended dose of 3.0 mg CE/lb BW. Results from this study indicate that the subcutaneous injection of EXCEDE Sterile Suspension into the middle third of the posterior aspect 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 space required for the volume of injected material. Additional increases in thickness were observed through Day 14 after injection. After Day 14, post injection ear thickness decreased in all animals. One animal carried an injected ear in a drooping position for 7 days post 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 study. Ears are inedible tissues in the US . No signs of irritation were observed on the edible portions of the carcass around the base of the ear.

Base of the ear injection:

Administration For The Base Of The Ear

In lactating dairy cattle the injection techniques for subcutaneous injection in the posterior aspect of the ear where it attaches to the head can be made by the rostral or ventral injection techniques.

In beef and non-lactating dairy cattle the SC injection in the base of the ear can be made by the rostral, ventral or toward the opposite eye injection techniques.

Shake well before using. Please read the complete package insert before administering EXCEDE Sterile Suspension subcutaneously in the posterior aspect of the ear where it attaches to the head .

The subcutaneous injection may be made using the toward the opposite eye, rostral, or ventral techniques. Hold the syringe and needle and insert the needle as described below.

Deliver the entire contents of the syringe.

Do not administer EXCEDE Sterile Suspension in the neck.

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

Hold the syringe and needle behind the ear to be dosed so the needle and syringe point in the direction of an imaginary line that would pass through the head toward the animals opposite eye. See Figures 4 and 5.

Insert the needle through the loose skin in the posterior aspect of the ear where it attaches to the head while maintaining this angle. See Figure 4.

Figure 4. Subcutaneous administration of EXCEDE Sterile Suspension in the posterior aspect of the ear where it attaches to the head .

Administration for Base of the Ear: Ventral Technique

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Special Report: Powerful Antibiotic For Cows Often Misused By Farmers

By Michael Erman, Brian Grow

15 Min Read

NEW YORK/ATLANTA – It is one of the most potent antibiotics used by U.S. cattle and dairy farmers, the key component in the top-selling drug line of Zoetis, the worlds largest animal health company.

But the strength of the antibiotic ceftiofur and the frequency with which its being misused on farms across America has created a threat to human health that may overshadow the drugs effectiveness, a Reuters examination shows.

The U.S. Food and Drug Administration cautioned in 2012 that ceftiofur could pose a high public health risk, in part because the drug belongs to a class of antibiotics considered critically important in human medicine. The warning is the FDAs strongest kind. The concern is that ceftiofur in animals could spawn antibiotic-resistant bacteria, superbugs that can infect people and defeat conventional medical treatment, even when the drug is used as directed.

A Reuters analysis of government data indicates that the risks to human health may be more significant than previously known. Since last year, records kept by the U.S. Department of Agriculture show that traces of ceftiofur were found at illegal levels in slaughtered animals more frequently than with any other drug. In 2013, ceftiofur alone accounted for one-fourth of all residue violations logged by the USDA, the data show.

For Treatment Of Bovine Respiratory Disease And Bovine Interdigital Phlegmon :

EXCEDE® Cattle/Equine

NUFLOR Injectable Solution should be administered by intramuscular injection to cattle at a dose rate of 20mg/kg body weight . A second dose should be administered 48 hours later. Alternatively, NUFLOR Injectable Solution can be administered by a single subcutaneous injection to cattle at a dose rate of 40mg/kg body weight . Do not administer more than 10 mL at each site. The injection should be given only in the neck.

NOTE: Intramuscular injection may result in local tissue reaction which persists beyond 28 days. This may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck is likely to be more severe.

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Tissue And Milk Residue Depletion

A radiolabeled residue metabolism study established tolerances for ceftiofur residues in cattle kidney, liver and muscle. A separate study 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 muscle and 0.1 ppm in milk.

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

A pivotal milk residue decline study was conducted in lactating dairy cattle. In this study, cows received a single injection of 3.0 mg CE/lb BW. Ceftiofur residues in milk were less than tolerances at all time points after treatment. These data collectively support that no milk discard period is required for this product.

Two-Dose Residue Decline Studies

A pivotal tissue residue decline study was conducted in dairy cattle. In this study, cows received two injections of 3.0 mg CE/lb BW with a 72 hour interval between injections. Ceftiofur residues in tissues were less than the tolerances for ceftiofur residues in the kidney by 13 days after the second dose. These data collectively continue to support a 13-day pre-slaughter withdrawal period after the last dose.

Keep Your Cattle Healthy

Sickness in cattle can be costly. Left untreated, economic losses can include labor and treatment costs, milk discard, decreased weight gain and death loss.

One instance of metritis can cost a producer more than $350 and the costs keep adding up: from decreased milk production and discarded milk to increased veterinary treatments, reduced fertility and prolonged days open to additional culling.3

In the U.S. dairy industry, respiratory disease is the leading cause of illness and death in weaned calves.5 Morbidity due to BRD affects survivability while reducing dairy performance later in life.

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Animal Safety Warnings And Precautions

Immediate onset of seizures or collapse have been reported following Excede administration.The injection of EXCEDE Sterile Suspension in the horse may cause firmness, swelling, sensitivity, and/or edema at the injection site.Injection site reactions may be extensive and require 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 not be administered and appropriate therapy should be initiated.Due to the extended exposure in horses, based on the drug’s pharmacokinetic properties, adverse reactions may require prolonged care. EXCEDE is slowly eliminated from the body, with approximately 17 days needed to eliminate 97% of the dose from the body. Animals experiencing adverse reactions may need to be monitored for this duration of time.The use of ceftiofur has not been evaluated in horses less than 4 months of age and in breeding, pregnant, or lactating horses. The long term effects on injection sites have not been evaluated.

Middle Of The Ear Injection:

EXCEDE (C2C)

A study was designed and conducted to specifically address tissue tolerance in cattle when EXCEDE Sterile Suspension was administered as a single subcutaneous injection into the posterior aspect of the ear of cattle at the recommended dose of 3.0 mg CE/lb BW. Results from this study indicate that the subcutaneous injection of EXCEDE Sterile Suspension into the middle third of the posterior aspect 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 space required for the volume of injected material. Additional increases in thickness were observed through Day 14 after injection. After Day 14, post injection ear thickness decreased in all animals. One animal carried an injected ear in a drooping position for 7 days post 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 study. Ears are inedible tissues in the US . No signs of irritation were observed on the edible portions of the carcass around the base of the ear.

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Excede 200 Sterile Suspension Indications

Cattle : EXCEDE200 sterile suspension is indicated for the treatment of Bovine Respiratory Disease associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni .

EXCEDE200 sterile suspension is also indicated for the treatment of bovine foot rot associated with Fusobacterium necrophorum and Porphyromonas levii.

Horses: EXCEDE200 sterile suspension is indicated for the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.

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 97.4% of cattle using normal facilities and restraint equipment. No leak back 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 following 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 residue study, six dairy cows were injected in the base of the ear at a dose rate of 3.0 mg CE/lb BW of EXCEDE Sterile Suspension. No animals exhibited drooping ears at any time after treatment but all animals had signs of swelling at the injection site at all observation times after treatment. Cows were slaughtered 10 days after injection. At necropsy, all six cows showed evidence of injection site inflammation and four of six cows had discoloration of tissue dorsal and posterior to the ear canal on the carcass. In addition to discoloration, tan nodules and a milky white fluid exudate were also present at the sectioned surface.

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