Complete Up To Date Information about Paratect Flex™.
NADA Number: 134-779 | |
| Proprietary Name |
Paratect Flex™ |
|---|---|
| Sponsor |
Pfizer, Inc. |
| Sponsor Address |
235 East 42d St. New York, NY 10017 USA |
| Ingredients |
Morantel Tartrate |
| Species |
Cattle, grazing animals over 200 pounds |
| Routes of Administration |
Per Os |
| Dose Form |
Sustained release cylinder |
| Drug Form |
Sustained release cylinder |
| Dispensing Status |
OTC |
| Patent Number |
4220152 4220153 4601893 4861596 5141810 5284658 |
| Exclusivity |
This supplemental provides for the use of a plastic tri-laminate cylinder/sheet providing for the sustained release of morantel tartrate to control the adult stages of the following gastrointestinal nematode infections in weaned calves
and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum. It also provides for changing the tradename from Paratect Cartridge to Paratect Flex. The product is OTC and the concentration is 19.8 g/unit (11.8 g morantel base). |
| Withdrawal Time |
Cattle: 102 days before slaughter. |
|
Dosage Amount, Indications & Limitations |
520.1450c Morantel tartrate sustained-release trilaminate cylinder/sheet. Specifications: The drug product consists of a tri-laminated, perforated, plastic sheet formed into a cylinder having plastic plugs in its ends. The core lamina contains 19.8 grams of morantel tartrate equivalent to 11.8 grams of morantel base. Conditions of use: Cattle (grazing) Amount: Administer 1 cartridge to each animal at the start of the grazing season. Indications: For control of the adult stage of the following gastrointestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia species, Trichostrongylus axei, Cooperia species, and Oesophagostomum radiatum. Limitations: Administer orally with the dosing gun to all cattle that will be grazing the same pasture. Effectiveness of the drug product is dependent upon continuous control of the gastrointestinal parasites for approximately 90 days following administration. Therefore treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 102 days of slaughter. Consult your veterinarian before administering to debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. |
| Tolerances |
A tolerance of 0.7 part per million is established for N-methyl-1,3-propanediamine (MAPA, marker residue) in the liver (target tissue) of cattle and goats. A tolerance for residues of morantel tartrate in milk is not required. |