ANADA #200-420, Approved by FDA

CeftiFlex® Injection

ceftiofur sodium sterile powder

A sterile powder for intramuscular and subcutaneous injection containing an antibiotic active against gram-positive and gram-negative bacteria.

Species: Category:

Product Information

For intramuscular and subcutaneous injection in cattle only. For intramuscular injection in swine, sheep, goats, and horses. For subcutaneous injection only in dogs. This product may be used in lactating dairy cattle, sheep, and goats.

CAUTION:

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

DESCRIPTION:

Ceftiflex® contains the sodium salt 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 the reconstituted drug contains ceftiofur sodium equivalent to 50 mg ceftiofur. The pH was adjusted with sodium hydroxide and monobasic potassium phosphate.

Shake thoroughly prior to use.

Reconstitution of the sterile powder: Ceftiflex® should be reconstituted as follows:

1 gram vial- Reconstitute with 20 mL Sterile Water for Injection. Each mL of the resulting solution contains ceftiofur sodium equivalent to 50 mg ceftiofur.

4 gram vial- Reconstitute with 80 mL Sterile Water for Injection. Each mL of the resulting solution contains ceftiofur sodium equivalent to 50 mg ceftiofur.

INDICATIONS:

Cattle:

Ceftiflex® is indicated for treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. Ceftiofur Sodium Sterile Powder is also indicated for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

Swine:

Ceftiflex® 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.

Sheep:

Ceftiflex® is indicated for treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.

Goat:

Ceftiflex® is indicated for treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.

Horses:

Ceftiflex® is indicated for treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.

Dogs:

Ceftiflex® is indicated for the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis.

DOSAGE AND ADMINSTRATION:

Cattle:

Administer to cattle by intramuscular or subcutaneous injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner’s judgment of severity of disease (i.e., for respiratory disease, extent of elevated body temperature, depressed physical appearance, increased respiratory rate, coughing and /or loss of appetite; and for foot rot, extent of swelling, lesion and severity of lameness).

Swine:

Administer to swine by intramuscular injection at the dosage of 1.36 to 2.27 mg ceftiofur per pound (3.0 to 5.0 mg/kg) of body weight (1 mL of reconstituted sterile solution per 22 to 37 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days.

Sheep:

Administer to sheep by intramuscular injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner’s judgment of severity of disease (i.e., extent of elevated body temperature, depressed physical appearance, increased respiratory rate, coughing and/or loss of appetite).

Goat:

Administer to goats by intramuscular injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/ lb) should be based on the practitioner’s judgment of severity of disease (i.e., extent of elevated body temperature, depressed physical appearance, increased respiratory rate, coughing and/or loss of appetite). Pharmacokinetic data indicate that elimination of the drug is more rapid in lactating does. For lactating does, the high end of the dose range is recommended.

Horses:

Administer to horses by intramuscular injection at the dosage of 1.0 to 2.0 mg ceftiofur per pound (2.2 to 4.4 mg/kg) of body weight (2-4 mL reconstituted sterile solution per 100 lbs body weight). A maximum of 10 mL may be administered per injection site. Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared and should not exceed 10 days.

Dogs:

Administer to dogs by subcutaneous injection at the dosage of 1.0 mg ceftiofur per pound (2.2 mg/kg) of body weight (0.1 mL reconstituted sterile solution per 5 lbs body weight). Treatment should be repeated at 24-hour intervals for 5-14 days. Reconstituted CEFTIFLEX® is to be administered to dogs by subcutaneous injection. No vial closure should be entered more than 20 times. Therefore, only the 1 gram vial is approved for use in dogs.

CONTRAINDICATIONS:

As with all drugs, the use of Ceftiflex® 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 obtain a Safety Data Sheet (SDS) please call 1-800-587- 4306. To report any adverse event please call 1-800-587-4306.

RESIDUE WARNINGS:

Cattle:

When used according to label indications, dosage and routes of administration, treated cattle must not be slaughtered for 4 days following the last treatment. When used according to label indications, dosage and routes of administration, a milk discard time is not required. Use 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 in milk.

Swine:

When used according to label indications, dosage and route of administration, treated pigs 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.

Sheep:

Neither a pre-slaughter drug withdrawal interval nor a mild discard time is required when this product is used according to label indications, dosage, and route of administration. Use 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 in milk.

Goats:

Neither a pre-slaughter drug withdrawal interval nor a milk discard time is required when this product is used according to label indications, dosage, and route of administration. Use 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 in milk.

Horses:

Do not use in horses intended for human consumption.

PRECAUTIONS:

The effects of Ceftiflex® on the reproductive performance, pregnancy, and lactation of cattle, swine, sheep, and goats have not been determined.

Cattle:

Following subcutaneous administration of ceftiofur sodium in the neck, small areas of discoloration at the site may persist beyond five days, potentially resulting in trim loss of edible tissues at slaughter.
As with any parenteral injection, localized post-injection bacterial infections may result in abscess formation. Attention to hygienic procedures can minimize their occurrence.

Swine:

The safety of Ceftiflex® has not been determined for swine intended for breeding.

Horses:

The safety of Ceftiflex® has not been determined for horses intended for breeding. The administration of antimicrobials to horses under conditions of stress may be associated with acute diarrhea that could be fatal. If acute diarrhea is observed, discontinue use of this antimicrobial and initiate appropriate therapy.

Dogs:

The safety of Ceftiflex® has not been determined for dogs intended for breeding, or pregnant dogs.

ADVERSE REACTIONS:

The use of CEFTIFLEX® may result in some sign of immediate and transient local pain to the animal.

STORAGE CONDITIONS:

Store unreconstituted product at controlled room temperature 20˚ to 25˚ C (68˚ to 77˚ F) [see USP].
Store reconstituted product either in a refrigerator 2˚ to 8˚ C (36˚ to 46˚ F) for up to 7 days or at controlled room temperature 20˚ to 25˚ C (68˚ to 77˚ F) [see USP] for up to 12 hours. Protect from light. Color may vary from off-white to a tan color. Color does not affect potency.

ONE-TIME SALVAGE PROCEDURE FOR RECONSTITUTED PRODUCT:

At the end of the 7-day refrigeration or 12-hour room temperature storage period following reconstitution, any remaining reconstituted product may be frozen for up to 8 weeks without loss in potency or other chemical properties. This is a one-time only salvage procedure for the remaining product. To use this salvaged product at any time during the 8-week storage period, hold the vial under warm running water, gently swirling the container to accelerate thawing, or allow the frozen material to thaw at room temperature. Rapid freezing or thawing may result in vial breakage. Any product not used immediately upon thawing should be discarded.

NET CONTENTS:

1 gram vial
4 gram vial

NDC

54925-082-01
54925-082-04

This website uses cookies to ensure you get the best experience on our website.

Companion

Equine

Livestock