1. Romet-30 has not been approved by the FDA for use with tilapia and should not be fed to tilapia unless according to specific guidelines in an FDA approved INADA for this purpose.
2. Avoid human or animal exposure to fish feeds fortified with Romet-30.
3. After the treatment is completed, the withdrawl time for Romet-30 treatment in salmonids is 42 days and three days for channel catfish. Follow the withdrwal time according to the INADA for tilapia, if this becomes avialable.
romet-30 has not been approved by the Food and Drug Administration (FDA) for use with tilapia. Thus, it is not currently legal to use this substance to treat tilapia especially if these fish or their offspring are intended for human consumption.
romet-30 may be legally used only if there is a current Investigational New Animal Drug Application (INADA) in effect for treatment of the particular disease at the particular site. It is the responsibility of the user to know if an INADA is in effect for romet-30 for use with tilapia on his or her site. The user must be familiar with and to comply with the conditions for an INADA for romet-30.
Romet-30þ (sulfadimethoxine + ormetoprin) is a powerful oral antibacterial which has been approved by the FDA for the treatment of specific bacterial diseases (furunculosis and enteric septicemia) in salmonids and channel catfish. Romet-30þ has not been approved by the FDA for treatment of bacterial diseases in tilapia. Romet-30þ is not water soluble thus is not suitable for bath treatment. Romet-30þ medicated feed is formulated for salmonid and channel catfish culture.
Follow dosage and withdrawal time indicated on the INADA for Romet-30þ treatment of tilapia (if and when this INADA is available).