Complete Up To Date Information about Naxcel XT Sterile Suspension.
NADA Number: 141-209 | |
| Proprietary Name |
Naxcel® XT Sterile Suspension Excede™ Sterile Suspension |
|---|---|
| Sponsor |
Pharmacia & Upjohn Co. |
| Sponsor Address |
a Division of Pfizer, Inc. 235 East 42nd St. New York, NY 10017 USA |
| Ingredients |
Ceftiofur Crystalline Free Acid |
| Species |
Cattle, dairy, not lactating Cattle, beef Cattle, dairy, lactating |
| Routes of Administration |
Subcutaneous |
| Dose Form |
Liquid (suspension) |
| Drug Form |
Liquid (suspension) |
| Dispensing Status |
RX |
| Patent Number |
5721359 |
| Exclusivity |
Exclusivity is granted based on a supplemental approval for ceftiofur crystalline free acid suspension use via a new injection site (posterior aspect of the ear where it attaches to the head [base of the ear]) in beef and nonlactating dairy cattle, and for the treatment of respiratory disease in lactating dairy cattle. No product using crystalline free acid as an active ingredient has been previously approved for use in cattle in any other application. |
| Withdrawal Time |
Following label use as a single treatment, a 13-
day pre-slaughter withdrawal period is required. |
|
Dosage Amount, Indications & Limitations |
Ceftiofur crystalline free acid. Specifications: Each milliliter of suspension contains 200 milligrams ceftiofur equivalents. Conditions of use: Cattle: Amount: 6.6 milligrams ceftiofur equivalents per kilogram of body weight as a single injection. 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. For subcutaneous injection in the posterior aspect of the ear where it attaches to the head (base of the ear) lactating dairy cattle. Indications: For the 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. 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. 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. Limitations: Following label use as a single treatment, a 13- day pre-slaughter withdrawal period is required. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.
|
| Tolerances |
A tolerance for residues of ceftiofur in edible tissue of poultry and sheep is not required. Tolerances in swine for desfuroylceftiofur (marker residue) in edible swine tissues are 0.25 part per million in kidney (target tissue), 3 parts per million in liver, and 2 parts per million in muscle. Tolerances are established for residues of desfuroylceftiofur (marker residue) in edible cattle tissues at 0.4 parts per million in kidney (target tissue), 2 parts per million in the liver, 1 part per million in muscle, 100 parts per billion in milk. |