Complete Up To Date Information about Pirsue Aqueous Gel.
NADA Number: 141-036 | |
| Proprietary Name |
Pirsue® Aqueous Gel Pirsue® Sterile Solution |
|---|---|
| Sponsor |
Pharmacia & Upjohn Co. |
| Sponsor Address |
a Division of Pfizer, Inc. 235 East 42nd St. New York, NY 10017 USA |
| Ingredients |
Pirlimycin Hydrochloride |
| Species |
Cattle, dairy, lactating |
| Routes of Administration |
Intramammary |
| Dose Form |
Gel Liquid |
| Drug Form |
Gel Liquid |
| Dispensing Status |
RX |
| Patent Number |
4278789 6648851 |
| Exclusivity |
Product qualifies for an additional exclusivity period of 3 years following supplemental approval to extend daily treatment in lactating cows for up to 8 day. No active ingredient of the drug has been previously approved in any other application. Granted for a new sterile formulation for the treatment of clinical and subclinical mastitis in lactating dairy cattle. |
| Withdrawal Time |
Lactating Dairy Cattle (2 or fewer treaments in 48 hours): 9 days before slaughter
Lactating Dairy Cattle (2 treatments in 24 hours repeated for 2 to 8 days): 21 days before slaughter
Milk: 36 hours. |
|
Dosage Amount, Indications & Limitations |
526.1810 Pirlimycin hydrochloride aqueous gel. Specifications: Each 10-milliliter syringe contains 50 milligrams of pirlimycin (as pirlimycin hydrochloride). Conditions of use: Cattle (lactating dairy) Amount: 50 milligrams in each infected quarter, repeated once after 24 hours. Daily treatment may be repeated at 24-hour intervals for up to 8 consecutive days. Indications: For the treatment of clinical and subclinical mastitis, caused by Staphylococcus species, such as Staphylococcus aureus; and Streptococcus species, such as Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis. Limitations: Milk taken from animals during treatment and for 36 hours following the last treatment must not be used for food regardless of treatment duration. Following infusion twice at a 24-hour interval, treated animals must not be slaughtered for 9 days. Following any extended duration of therapy (infusion longer than twice at a 24-hour interval, up to 8 consecutive days), animals must not be slaughtered for 21 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. |
| Tolerances |
Tolerances in cattle: 1) Liver (the target tissue). The tolerance for parent pirlimycin (the marker residue) is 0.5 part per million (ppm). 2) Muscle. The tolerance for parent pirlimycin (the marker residue) is 0.3 ppm. 3) Milk. The tolerance for parent pirlimycin (the marker residue in cattle milk) is 0.4 ppm. |