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

Excede Sterile Suspension for Cattle is an antibiotic indicated for the treatment of bovine respiratory disease (BRD) and foot rot, and for the control of respiratory disease in cattle at high risk for developing BRD. 

(Ceftiofur Crystalline Free Acid)

Sterile Suspension

For subcutaneous injection in the posterior aspect of the ear where it attaches to the head (base 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 it attaches to the head (base of the ear) in beef and non-lactating dairy cattle. Not for use in calves to be processed for veal.

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

Each mL of this ready-to-use sterile suspension contains ceftiofur crystalline free acid equivalent to 200 mg ceftiofur, in a caprylic/capric triglyceride (Miglyol^®) and cottonseed oil based suspension.

Figure 1. Structure of ceftiofur crystalline free acid:

 Chemical name of ceftiofur crystalline free acid: 7-[[2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-3-[[(2-furanylcarbonyl)thio]methyl]- 8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene 2-carboxylic acid

INDICATIONS

EXCEDE Sterile Suspension is indicated for treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non-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 risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni.

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

DOSAGE

Treatment of BRD and bovine foot rot

Administer as a single subcutaneous injection in the posterior aspect of the ear where it attaches to the head (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 Suspension may also be administered as a single subcutaneous injection in the middle third of the posterior aspect of the ear at a dosage of 3.0 mg CE/lb (6.6 mg CE/kg) BW (1.5 mL sterile suspension per 100 lb BW).

Most animals will respond to treatment within three to five days. If no improvement is observed, the diagnosis should be reevaluated.

Control of BRD

Administer as a subcutaneous injection either in the middle third of the posterior aspect of the ear or in the posterior aspect of the ear where it attaches to the head (base 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 suspension per 100 lb BW).

Clinical studies indicate that administration of EXCEDE Sterile Suspension is effective for the control of respiratory disease in beef and non-lactating dairy cattle at "high risk" of developing BRD. One or more of the following factors typically characterizes calves on arrival at high risk of developing BRD.

- Cattle are from multiple farm origins,

- cattle have had extended transport times (that may have included few if any rest stops),

- ambient temperature change from origin to arrival of 30° F or more,

- cattle have had continued exposure to extremely wet or cold weather conditions,

- cattle have experienced excessive shrink or excessive arrival processing procedures (such as castration, dehorning).

Table 1. Dosing Schedule for EXCEDE Sterile Suspension

ADMINISTRATION

ADMINISTRATION FOR THE MIDDLE THIRD OF THE EAR

- Shake well before using. Please read the complete package insert before administering EXCEDE Sterile Suspension subcutaneously in the posterior ear of cattle.

- Deposit as a single subcutaneous injection in the middle third of the posterior aspect of the ear, avoiding all blood vessels. See Figures 2 and 3.

- Adjust the needle insertion point to avoid any blood vessels, previous implants, ear tags or ear tag holes. Do not administer intra-arterially.

- Deliver the entire contents of the syringe.

- When administered correctly, a subcutaneous bleb of EXCEDE Sterile Suspension will appear.

- When withdrawing the needle, apply pressure to the needle insertion point, and massage toward the base of the ear.

ADMINISTRATION FOR THE BASE OF THE EAR

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

- 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 (base of the ear) while maintaining this angle. See Figure 4.

- Deliver the entire contents of the syringe.

- Do not administer EXCEDE Sterile Suspension in the neck.

CONTRAINDICATIONS

As with all drugs, the use of EXCEDE Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug.

WARNINGS

FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN.

Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth and clothing. Sensitization of the skin may be avoided by wearing latex gloves.

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

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. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention.

The material safety data sheet contains more detailed occupational safety information. To obtain a material safety data sheet please call 1-800-733-5500. To report any adverse event please call 1-800-366-5288.

Injection of EXCEDE Sterile Suspension into the arteries of the ear is likely to result in sudden death to the animal.

PRECAUTIONS

Following subcutaneous injection in the middle third 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 result in abscess formation. Attention to hygienic procedures can minimize their occurrence.

Following injections at the posterior aspect of the ear where it attaches to the head (base 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 middle third of the ear, may result in open draining lesions in a small percentage of cattle.

The effects of ceftiofur on bovine reproductive performance, pregnancy, and lactation have not been determined.

ADVERSE EFFECTS

Administration of EXCEDE Sterile Suspension into the ear arteries is likely to result in sudden death in cattle. During the conduct of clinical studies, there was a low incidence of acute death (nine out of approximately 6000 animals). Three of these deaths were confirmed to be the result of inadvertent intra-arterial injection. No other adverse systemic effects were noted for either the antibiotic or formulation during any of the clinical and target animal safety studies.

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 first dose is removed.