Norbrook Cefenil RTU (Ceftiofur Hydrochloride) Sterile Suspension

Description

Norbrook Cefenil RTU for cattle and swine is an antibiotic for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. It is also for treatment of acute bovine interdigital necrobacillosis (foot rot) caused by Fusobacterium necrophorum and Bacteroides spp. Also indicated for acute metritis (0 to 14 days post-partum) associated with organisms susceptible to ceftiofur. May be used in lactating dairy cattle.

Key Benefits

• Ready to use; does not require premixing or refrigeration.
• Safe to use in lactating dairy cattle and requires no milk withhold time when used according to label directions.

Indications

Swine: CEFENIL RTU is indicated for treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.

Cattle

CEFENIL RTU is indicated for treatment of the following bacterial diseases:

• Bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
• Acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
• Acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.

Directions

Shake for 90 seconds to ensure complete resuspension before using.

Swine

Administer intramuscularly at a dosage of 1.36 to 2.27 mg ceftiofur equivalents/lb (3.0 to 5.0 mg/kg) BW (1 mL of sterile suspension per 22 to 37 lb BW). Treatment should be repeated at 24 h intervals for a total of three consecutive days.

Cattle

For bovine respiratory disease and acute bovine interdigital necrobacillosis: administer by intramuscular or subcutaneous administration at the dosage of 0.5 to 1.0 mg ceftiofur equivalents/lb (1.1 to 2.2 mg/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24 h intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments. In addition, for BRD only, administer intramuscularly or subcutaneously 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW every other day on Days 1 and 3 (48 h interval). Do not inject more than 15 mL per injection site.

Selection of dosage level (0.5 to 1.0 mg/lb) and regimen/duration (daily or every other day for BRD only) should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response.

For acute post-partum metritis: administer by intramuscular or subcutaneous administration at the dosage of 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW (2 mL sterile suspension per 100 lb BW). Administer at 24 h intervals for five consecutive days. Do not inject more than 15 mL per injection site.

Caution

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

Contraindications

As with all drugs, the use of CEFENIL RTU is contraindicated in animals previously found to be hypersensitive to the drug.

Warnings

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. 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 safety data sheet contains more detailed occupational safety information. 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.

Residue Warnings

Swine

When used according to label indications, dosage, and route of administration, treated swine must not be slaughtered for 4 days following the last treatment.

Use of dosages in excess of those indicated or by unapproved routes of administration may result in illegal residues in edible tissues.

Cattle

When used according to label indications, dosage and route of administration, treated cattle must not be slaughtered for 3 days following the last treatment. When used according to label indications, dosage and route of administration, a milk discard time is not required. Uses of dosages in excess of those indicated or by unapproved routes of administration, such as intramammary, may result in illegal residues in edible tissues and/or milk. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.

Precautions

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

Swine

Areas of discoloration associated with the injection site at time periods of 11 days or less may result in trim-out of edible tissues at slaughter. The safety of ceftiofur has not been demonstrated for pregnant swine or swine intended for breeding.

Cattle

Following intramuscular or subcutaneous administration in the neck, areas of discoloration at the site may persist beyond 11 days resulting in trim loss of edible tissues at slaughter. Following intramuscular administration in the rear leg, areas of discoloration at the injection site may persist beyond 28 days resulting in trim loss of edible tissues at slaughter.

Storage

Do not store above 30°C (86°F). Shake well before using. Protect from freezing. Contents should be used within 42 days after the first dose is removed.