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NADA Number: 125-933

Proprietary Name Romet®-30
Sponsor Pharmaq AS
Sponsor Address Skogmo Industriomrade, N-7863
Overhalla,   
Norway
Ingredients Sulfadimethoxine
Ormetoprim
Species (Class) FISH (Salmonids, reared)
FISH (Catfish, reared)
Routes of Administration Per Os
Dosage Form Medicated feed
Dispensing Status OTC
Patent Number (Expiration Date) 3903275 (No Expiration Date)
Withdrawal Time Fish (Salmonids): 42 days before slaughter or release. Fish (Catfish): 3 days before slaughter or release.
Dosage Amount,
Indications
& Limitations

558.575 Sulfadimethoxine, ormetoprim.

Specifications: Type A medicated articles: 25 percent sulfadimethoxine and 5 percent ormetoprim.

Conditions of use:

Salmonids

Amount: 50 milligrams of active ingredients per kilogram of body weight per day.

Indications: For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination.

Limitations: Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter.

Catfish

Amount: 50 milligrams of active ingredients per kilogram of body weight per day.

Indications: For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim combination.

Limitations: Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish.

Tolerances

Sulfadimethoxine: Tolerances are established for residues of sulfadimethoxine in edible products of animals as follows: a. Chickens, turkeys, cattle, ducks, salmonids, catfish and chukar partridges: 0.1 part per million (negligible residue) in uncooked edible tissues b. Milk: 0.01 part per million (negligible residue).Tolerances are established for residues of sulfadimethoxine in edible products of animals as follows: a. Chickens, turkeys, cattle, ducks, salmonids, catfish and chukar partridges: 0.1 part per million (negligible residue) in uncooked edible tissues b. Milk: 0.01 part per million (negligible residue).

Ormetoprim: A tolerance of 0.1 part per million is established for negligible residues of ormetoprim in the edible tissues of chickens, turkeys, ducks, salmonids, and catfish.