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NADA Number: 141-061

Proprietary Name Dectomax® Injectable Solution
Dectomax® Injectable Solution for Cattle and Swine
Sponsor Pfizer, Inc.
Sponsor Address 235 East 42d St.
New York, NY    10017
USA
Ingredients Doramectin
Species Cattle, beef
Cattle, calves, excluding veal calves
Cattle, dairy, not breeding age
Swine, no use class stated or implied
Routes of Administration Intramuscular (swine)
Intramuscular
Subcutaneous
Dose Form Liquid (solution)
Drug Form Liquid (solution)
Dispensing Status OTC
Patent Number 5089480
6001822
Exclusivity No active ingredient has been previously approved in any other application.
Granted for additional persistent efficacy to protect cattle from re-infection with Haemonchus placei for 14 days after treatment.
Granted for addition of persistent efficacy to protect cattle from re-infection with Cooperia oncophora for 14 days and Oesophagostomum radiatum for 28 days after treatment.
Granted for the addition of persistent efficacy claims for Dictyocaulus viviparus and Cooperia punctata .
Granted for use in a new species (swine).
Withdrawal Time Cattle: 35 days before slaughter. Swine: 24 days before slaughter.
Dosage Amount,
Indications
& Limitations

522.770 Doramectin.

Specifications: Each milliliter of sterile aqueous solution contains 10 milligrams of doramectin.

Conditions of use:

Cattle

Amount: 200 micrograms per kilogram (10 milligrams per 110 pounds). Administer as a single subcutaneous or intramuscular injection.

Indications: For treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, and mange mites. To control infections and to protect from reinfection with Cooperia oncophora and Haemonchus placei for 14 days, Ostertagia ostertagi for 21 days, and C. punctata, Oesophagostomum radiatum, and Dictyocaulus viviparus for 28 days after treatment.

Limitations: Not for use in female dairy cattle 20 months of age or older. Do not use in calves to be processed for veal.

Swine.

Amount: 300 micrograms per kilogram (10 milligrams per 75 pounds). Administer as a single intramuscular injection.

Indications: For treatment and control of gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and mange mites.

Limitations: Do not slaughter swine within 24 days of treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

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.