Complete Up To Date Information about Draxxin™ Injectable Solution.
NADA Number: 141-244 | |
| Proprietary Name |
Draxxin™ Injectable Solution |
|---|---|
| Sponsor |
Pfizer, Inc. |
| Sponsor Address |
235 East 42d St. New York, NY 10017 USA |
| Ingredients |
Tulathromycin |
| Species |
Cattle, dairy, not lactating Cattle, beef Swine, no use class stated or implied |
| Routes of Administration |
Intramuscular (swine) Subcutaneous (cattle) |
| Dose Form |
Liquid (solution) |
| Drug Form |
Liquid (solution) |
| Dispensing Status |
RX |
| Patent Number |
6329345 6420536 6514945 6583274 6777393 6861412 6936592 |
| Exclusivity |
Exclusivity is granted based on a supplemental approval allowing the addition of Mycoplasma bovis to the list of target pathogens for cattle at high risk of bovine respiratory disease (BRD). Exclusivity is granted based on a supplemental approval allowing thr addition of Mycoplasma bovis to the list of target pathogens for bovine respiratory disease (BRD) treatment indication. Granted because no active ingredient of the new animal drug has previously been approved. |
| Withdrawal Time |
Cattle - 18 days prior to slaughter
Swine - 5 days prior to slaughter |
|
Dosage Amount, Indications & Limitations |
Tulathromycin Specifications: Each milliliter of solution contains 100 milligrams (mg) tulathromycin. Conditions of use: Beef and nonlactating dairy cattle Amount: Administer 2.5 mg per kilogram (/kg) body weight as a single subcutaneous injection in the neck. Indications: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni (Haemophilus somnus), and Mycoplasma bovis; for the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis; and for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.
For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii. Limitations: Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Conditions of use: Swine Amount: Administer 2.5 mg per kilogram (/kg) body weight as a single intramuscular injection in the neck. Indications: For the treatment of swine respiratory disease (SRD) associated with Actinobaccillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, and H. parasuis and Mycoplasma hyopneumoniae. Limitations: Swine intended for human consumption must not be slaughtered within 5 days from the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
|
| Tolerances |
Tulathromycin: Cattle: The established tolerance in liver (target tissue) for CP-60,300 (marker residue) is 5.5 parts per million. Swine: The established tolerance in kidney (target tissue) for CP-60,300 (marker residue) is 15 parts per million. |