NADA Number: 125-933

Proprietary Name Romet®-30
Sponsor Pharmaq AS
Sponsor Address Skogmo Industriomrade, N-7863
Overhalla,   
Norway
Ingredients Sulfadimethoxine
Ormetoprim
Species Salmonids, reared
Catfish, reared
Routes of Administration Per Os
Dose Form Medicated feed
Drug Form Type A Medicated Article
Dispensing Status OTC
Patent Number 3903275
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

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).

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.