| Printable Version |
NADA Number: 141-095 | |
| Proprietary Name |
Dectomax® Pour-on Solution for Cattle Dectomax® Pour-on Dectomax® Pour-on Solution |
|---|---|
| Sponsor |
Pfizer, Inc. |
| Sponsor Address |
235 East 42d St. New York, NY 10017 USA |
| Ingredients |
Doramectin |
| Species |
Cattle, beef Cattle, dairy, females under 20 months of age Cattle, calves, excluding veal calves |
| Routes of Administration |
Topical |
| Dose Form |
Liquid (solution) |
| Drug Form |
Liquid (solution) |
| Dispensing Status |
OTC |
| Patent Number |
5089480 |
| Exclusivity |
Granted for the increased period of re-infection from three species of internal parasites when used topically in cattle. Granted for a 42 day persistency effectiveness claim for L.vituli and a 77 day persistency effectiveness claim for B.(Damalinia) bovis in cattle. Exclusivity applies only to the persistent effectiveness claims for these two species of external parasites. Granted for the treatment and control of horn flies, Haematobia irritans in beef and non-lactating dairy cattle Granted for therapeutic claim for T. axei L4 and 35 day persistency claim for H. placei for use in cattle. Granted for controlling infections and to protect cattle from re-infection with Cooperia oncophora and Dictyocaulus viviparus for 21 days, and Ostertagia ostertagi, Cooperia punctata, and Oesophagostomum radiatum for 28 days after treatment. |
| Withdrawal Time |
Cattle: 45 days before slaughter. |
|
Dosage Amount, Indications & Limitations |
524.770 Doramectin. Specifications: Each milliliter of solution contains 5 milligrams of doramectin. Conditions of use: Cattle Amount: 5 milligrams per 10 kilograms (5 milligrams per 22 pounds). Indications: For treatment and control of gastrointestinal roundworms: Ostertagia ostertagi (adults and fourth- stage larvae), O. ostertagi (inhibited fourth-stage larvae), O. lyrata (adults), Haemonchus placei(adults and fourth-stage larvae), Trichostrongylus axei (adults and fourth-stage larvae), T. colubriformis (adults and fourth-stage larvae), Cooperia oncophora(adults and fourth-stage larvae), C. punctata (adults and fourth-stage larvae), C. pectinata (adults), C. surnabada (adults), Bunostomum phlebotomum (adults), Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); lungworms: Dictyocaulus viviparus(adults and fourth-stage larvae); eyeworms: Thelazia gulosa (adults), T. skrjabini (adults); grubs: Hypoderma bovis and H. lineatum; sucking lice: Linognathus vituli, Haematopinus eurysternus, and Solenopotes capillatus; biting lice: Damalinia bovis; mange mites: Chorioptes bovis and Sarcoptes scabiei; horn flies: Haematobia irritans; and to control infections and to protect from reinfection with C. oncophora, D. viviparus, O. ostertagi, and O. radiatum for 28 days; and with C. punctata, and H. placei for 35 days after treatment; and to control infestations and to protect from reinfestation with Linognathus vituli for 42 days and with Bovicola (Damalinia) bovis for 77 days after treatment. Limitations: Do not slaughter cattle within 45 days of latest treatment. Not for use in female dairy cattle 20 months of age or older. Do not use in calves to be processed for veal. |
| Tolerances |
Tolerances for residues of doramectin in food are established as follows: a Swine: 160 parts per billion for parent doramectin (marker residue) in liver (target tissue) b. Cattle: 100 parts per billion for parent doramectin (marker residue) in liver (target tissue) and of 30 parts per billion for parent doramectin in muscle. |
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