Naxcel - 1gm vial 20ml

NAXCEL is an efficacious treatment for foot rot and pneumonia with a track record of successful results. A single dose of NAXCEL every day for three days reduces body temperature and kills pathogens fast. Its low-volume dosage, subcutaneous administration and aqueous formulation help meet quality assurance guidelines. And unlike penicillin, NAXCEL requires zero milk discard, so it eliminates concerns over drug residues in milk.

Key Features

Used as directed, NAXCEL (ceftiofur sodium) Sterile Powder:

• Broad spectrum treatment - Treats the major causes of pneumonia and foot rot
• Zero milk discard - Cows stay in the milking string
• Short pre-slaughter withdrawal - When used according to label directions, you have the confidence of a four-day meat withholding time
• Multiple-dose treatment options (3 to 5 days)
• Low-volume dose via subcutaneous (SC) or intramuscular (IM) administration
• Aqueous base for greater syringeability and virtually no carcass trim

How It Works

NAXCEL Sterile Powder includes ceftiofur sodium salt, which is a comprehensive cephalosporin antibiotic that works against gram-negative and gram-positive bacteria, including ß-lactamase-producing strains.

Indications

NAXCEL is indicated for treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia (Pasteurella) haemolytica, Pasteurella multocida and Haemophilus somnus. NAXCEL also is indicated for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

View Naxcel Drug Facts Sheet.

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 judgement 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 recov ered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner's judgement of severity of disease (i.e., extent of elevated body tem perature, depressed physical appearance, increased respiratory rate, coughing and/or loss of appetite).

Goats

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 recov ered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner's judgement of severity of disease (i.e., extent of elevated body tem perature, 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 NAXCEL Sterile Powder 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.

Day-Old Chicks

Administer by subcutaneous injection in the neck region of day-old chicks at the dosage of 0.08 to 0.20 mg ceftiofur/chick. One mL of the 50 mg/mL reconstituted solution will treat approximately 250 to 625 day-old chicks. Reconstituted NAXCEL Sterile Powder is to be administered by subcutaneous injection only. A sterile 26 gauge needle and syringe or properly cleaned automatic injection machine should be used.

Day-Old Turkey Poults

Administer by subcutaneous injection in the neck region of day-old turkey poults at the dosage of 0.17 to 0.5 mg ceftiofur/poult. One mL of the 50 mg/mL reconstituted solution will treat approximately 100 to 294 day-old turkey poults.Reconstituted NAXCEL Sterile Powder is to be administered by subcutaneous injection only.

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, swine, chickens and turkeys 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 NAXCEL Sterile Powder 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 material safety data sheet contains more detailed occupational safety information. To obtain a material safety data sheet (MSDS) or to report any adverse event please call Zoetis Inc. at 1-888-963-8471.

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 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.

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 ceftiofur 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 ceftiofur has not been determined for swine intended for breeding.

Horses:

The safety of ceftiofur 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 anti microbial and initiate appropriate therapy.

Dogs

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

Storage:

Store unreconstituted product at controlled room temperature 20° to 25° C (68° to 77° F). 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) for up to 12 hours. Protect from light. Color of the cake may vary from off-white to a tan color. Color does not affect potency.