ROMET 30<br/> <br/>Sulfadimethoxine & Ormetoprim<br/>Type A Medicated Article<br/>For freshwater-reared salmonids (trout and salmon) and catfish


               
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                        <name>ROMET<suffix>30</suffix>
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                              <name>Sulfadimethoxine and Ormetoprim</name>
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                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="113.5" unit="g"/>
                              <denominator value="0.45" unit="kg"/>
                           </quantity>
                           <ingredientSubstance>
                              <code code="30CPC5LDEX" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>Sulfadimethoxine</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="30CPC5LDEX" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>SULFADIMETHOXINE</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <ingredient classCode="ACTIB">
                           <quantity>
                              <numerator value="22.7" unit="g"/>
                              <denominator value="0.45" unit="kg"/>
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                           <ingredientSubstance>
                              <code code="M3EFS94984" codeSystem="2.16.840.1.113883.4.9"/>
                              <name>Ormetoprim</name>
                              <activeMoiety>
                                 <activeMoiety>
                                    <code code="M3EFS94984" codeSystem="2.16.840.1.113883.4.9"/>
                                    <name>ORMETOPRIM</name>
                                 </activeMoiety>
                              </activeMoiety>
                           </ingredientSubstance>
                        </ingredient>
                        <asContent>
                           <quantity>
                              <numerator value="22.68" unit="kg"/>
                              <denominator value="1" unit="1"/>
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                        <approval>
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                                    <code code="USA" codeSystem="2.16.840.1.113883.5.28"/>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>CAUTION:
               
                  Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian


         
            
               
               
               Active drug ingredients
               
                  Sulfadidemthoxine 113.5 grams per pound (25%) ormetoprim 22.7 grams per pound (5%) in a carrier suitable for incorporation in feeds.
               
               
            

         
         
            
               
               
               For use in manufacturing medicated feeds only
               
               
            

         
         
            
               
               
               Indications
               
                  For control of furunculosis in freshwater-reared salmonids (trout and salmon) caused by Aeromonas salmonicida and of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to the sulfadimethoxine and ormetoprim combination.
               
               
            

         
         
            
               
               
               Preparation of medicated feeds
               
                  Establish the weight of fish to be treated and calculate the amount of feed needed per day according to fish size and water temperature.  Calculate the amount of Romet® 30 required for medicating the feed at the rate of 16.7 g of Romet®30 per 100 kg (7.6 g of Romet® 30/100 lbs) of fish body weight per day.
                  
                  
                     Medication of feed before pelletizing or extruding
                  
                  Thoroughly mix the calculated amount of Romet® 30 into the mash feed prior to pelletizing or extruding.  Refer to the dosage table below for recommended levels of use.
                  
                     
                     
                        
                           
                              
                                 Feed Intake of Fish as
                              
                              
                                 Percent (%) of Body Weight 
                              
                           
                           
                              
                                 Lbs of Romet® 30
                              
                              
                                 per Ton of Feed
                              
                           
                        
                        
                            1
                            33.30
                        
                        
                            2
                            16.70
                        
                        
                            3
                            11.10
                        
                        
                            4
                            8.33
                        
                        
                            5
                            6.66
                        
                        
                            6
                            5.55
                        
                     
                  
                  
                     Medication of feed after pelletizing
                  
                  Prepare a liquid slurry by suspending Romet® 30 in a 5% gelatin solution.  Coat the pelleted fish feed with the slurry, which should be constantly agitated to ensure uniform suspension of the Romet® 30 during addition.  As a general rule, 10 gallons of gelatin solution is required to coat 2000 lb (1T) of pellets.  The coated pellets be allowed to dry prior to bagging.  Do NOT top dress pellets with Romet® 30 in a vegetable or fish oil suspension.
               
               
            

         
         
            
               
               
               Use/Feeding Directions
               
                  Administer medicated feed daily for five consecutive days to provide approximately 50 mg of active ingredients per kg (23 mg/lb) of live body of fish per day.
               
               
            

         
         
            
               
               
               Storage
               
                  Store dry in closed bag at or below 25° C (77° F), excursions permitted to 37° C (99° F)
               
               
            

         
         
            
               
               
               Caution
               
                  If fish show no improvement within 2 to 3 days, or if signs of disease reappear after termination of treatment, reevaluate management practices, diagnosis of outbreak and establish susceptibility of the bacterial isolate(s) to the drug.
               
               
            

         
         
            
               
               
               Warning
               
                  
                     Withdraw 42 days in freshwater-reared salmonids (trout and salmon) and 3 days in catfish before slaughter or release as stocker fish.
                  
               
               
            

         
         
            
               
               
               
               <text>
                  <paragraph/>
                  <paragraph/>
                  <paragraph>Labels for feeds containing Romet® 30 must contain appropriate indications, limitations
and warnings as well as required feed ingredient information </paragraph>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under NADA # 125-933</content>
                  </paragraph>
               </text>
               <effectiveTime value="20230718"/>
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               <title/>
               <text>
                  <paragraph>Marketed by</paragraph>
                  <paragraph>PHARMAQ</paragraph>
                  <paragraph>part of Zoetis</paragraph>
                  <paragraph/>
                  <paragraph>PHARMAQ AS</paragraph>
                  <paragraph>Skogmo Industriomrade</paragraph>
                  <paragraph>N-7863 Overhalla</paragraph>
                  <paragraph>Norway</paragraph>
                  <paragraph>
                     <br/>US-4-6001 <content styleCode="bold">Net wt 50 LB (22.68 kg)</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Take Time</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Observe Label Directions</content>
                  </paragraph>
                  <paragraph/>
                  <paragraph>
                     <content styleCode="bold">Made in USA</content>
                  </paragraph>
               </text>
               <effectiveTime value="20170621"/>
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               <title>Package Label
               
                  
                     
                  
               
               
               
                  
                     image description

Feed Intake of Fish as Percent (%) of Body Weight	Lbs of Romet® 30 per Ton of Feed
1	33.30
2	16.70
3	11.10
4	8.33
5	6.66
6	5.55