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<!--Section Begins--><br> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<b>TRIMETOSUL</b><b><sup>®</sup></b> |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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<i>soluble powder</i> |
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</p> |
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</div> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<b><i>Composition</i></b><b></b> |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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1 g contains: |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Trimethoprim 20 mg |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Sulfafurazole 100 mg |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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Carrier and corrigent up to 1000 mg |
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</p> |
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</div> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<b><i>Action</i></b> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Trimetosul<b><sup>®</sup></b> powder is a combined sulfonamide preparation. Its antimicrobial effect is based on a double blockade of folic acid synthesis and is enhanced by synergism of the active ingredients. Trimethoprim and sulfafurazole inhibit the growth of organisms in the lower concentrations than when applied separately and at the same time reduce development of the resistant strains. |
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</p> |
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</div> |
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</div> |
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Trimetosul<b><sup>®</sup></b> acts against many gram-positive and gram-negative bacteria and is particularly potent in the treatment of the infections caused by <i>E. coli, Salmonella </i>spp. and <i>Pasteurella multocida</i>. Potentiated sulfonamides in fish act against <i>Vibrio </i>spp., <i>Yersinia ruckeri</i> and<i> Aeromonas salmonicida</i>. Trimetosul<b><sup>®</sup></b> powder is not active against leptospira, <i>Pseudomonas aeruginosa </i>and<i> Erysipelothrix insidiosa</i>. |
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</p> |
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</div> |
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Active ingredients of Trimetosul<b><sup>®</sup></b> powder are extensively and rapidly resorbed from gastrointestinal tract, and rapidly achieve effective blood- and tissue levels. They are successful in the management of intestinal and other infections. |
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</p> |
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</div> |
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<b><i></i></b> |
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</p> |
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</div> |
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Indications |
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</p> |
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</div> |
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<div align="justify"> |
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Treatment of primary and secondary bacterial infections. |
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</p> |
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</div> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<i>Swine:</i> treatment of neonatal diarrhea in piglets; rhinitis due to <i>Bordetella</i> <i>bronchiseptica</i>; MMA syndrome in sows and many other systemic bacterial infections. |
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</p> |
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</div> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<i>Broilers and pullets:</i> treatment of the infections caused by potentiated sulfonamide-sensitive organisms <i>E. coli</i>,<i> Salmonella </i>spp<i>. </i>and<i> Pasteurella</i> <i>multocida</i>). |
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</p> |
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</div> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<i>Calves:</i> oral treatment of bacterial enteritis (<i>E. coli</i> and<i> Salmonella </i>spp<i>.</i>).<b></b> |
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</p> |
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</div> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<i>Foals:</i> respiratory and gastrointestinal infections (adenitis equorum); infected wounds, antimicrobial therapy following surgical operations that do not guarantee sterile conditions. |
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</p> |
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</div> |
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<div align="justify"> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<i>Fish:</i> trout, lobsters, sea basses, and giltheads - treatment of vibriosis (<i>Vibrio</i> spp.), yersiniosis (<i>Yersinia ruckeri</i>) and furunculosis (<i>Aeromonas salmonicida</i>). |
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</p> |
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</div> |
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<div align="justify"> |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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<b><i>Contraindications</i></b> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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The preparations is contraindicated in: |
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</p> |
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</div> |
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<ul> |
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<li> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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commercial layers; |
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</p> |
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</div> |
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<li> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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severe hepatic and renal impairment or disordered hematopoiesis, i. e. in the established hypersensitivity to sulfonamides or potentiated sulfonamides, which is extremely rare. |
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</p> |
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</div> |
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</ul> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<b><i></i></b> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Administration and dosage |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Trimetosul<b><sup>® </sup></b>powder is given with feed over 5 consecutive days and to fish over 10 days, i. e. over 2 additional days after remission of clinical symptoms. The powder is readily resuspendable in water, milk or milk supplements in which way it is given to calves, lambs and kids. |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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719 |
</p> |
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</div> |
721 |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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|
736 |
Daily dose for all animals, except fish, is 10 g/40 kg of b. w., i. e. 30 mg of both active ingredients per 1 kg of b. w. It is recommended to halve the dose, the first subdose to be given in the morning and the other one in the evening, i. e. in 12-hours interval. |
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738 |
</p> |
739 |
</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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</p> |
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</div> |
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769 |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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774 |
Always give in the volume of feed, milk or water that will be consumed. |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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</p> |
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</div> |
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<div align="justify"> |
810 |
<p style="text-align: justify;"> |
811 |
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<i>Foals:</i> |
813 |
|
814 |
</p> |
815 |
</div> |
816 |
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817 |
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818 |
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819 |
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820 |
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821 |
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822 |
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823 |
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824 |
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825 |
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826 |
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827 |
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828 |
<div align="justify"> |
829 |
<p style="text-align: justify;"> |
830 |
|
831 |
Mix the recommended dose with some moistened oats. |
832 |
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833 |
</p> |
834 |
</div> |
835 |
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836 |
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837 |
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838 |
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839 |
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842 |
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844 |
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845 |
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<div align="justify"> |
848 |
<p style="text-align: justify;"> |
849 |
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850 |
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851 |
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</p> |
853 |
</div> |
854 |
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855 |
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857 |
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863 |
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864 |
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865 |
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866 |
<div align="justify"> |
867 |
<p style="text-align: justify;"> |
868 |
|
869 |
<i>Fish:</i> |
870 |
|
871 |
</p> |
872 |
</div> |
873 |
|
874 |
|
875 |
|
876 |
|
877 |
|
878 |
|
879 |
|
880 |
|
881 |
|
882 |
|
883 |
|
884 |
|
885 |
<div align="justify"> |
886 |
<p style="text-align: justify;"> |
887 |
|
888 |
Daily consumption of feed in fish is 1-2% of their body weight. Trimetosul<b><sup>®</sup></b> powder is usually given with morning meal. The volume of feed intake depends on water temperature and clinical condition of the animal. Before administering the powder, spray the pelleted feed with edible oil (e. g. 1 L of oil/25 kg of pellets). Calculate Trimetosul<b><sup>®</sup></b> powder dose on the basis of 0.5 g of powder/1kg of fish b. w. and evenly dredge it over feed. Mix and allow to dry till use. |
889 |
|
890 |
</p> |
891 |
</div> |
892 |
|
893 |
|
894 |
|
895 |
|
896 |
|
897 |
|
898 |
|
899 |
|
900 |
|
901 |
|
902 |
|
903 |
|
904 |
<div align="justify"> |
905 |
<p style="text-align: justify;"> |
906 |
|
907 |
|
908 |
|
909 |
</p> |
910 |
</div> |
911 |
|
912 |
|
913 |
|
914 |
|
915 |
|
916 |
|
917 |
|
918 |
|
919 |
|
920 |
|
921 |
|
922 |
|
923 |
<div align="justify"> |
924 |
<p style="text-align: justify;"> |
925 |
|
926 |
<b><i>Side effects</i></b> |
927 |
|
928 |
</p> |
929 |
</div> |
930 |
|
931 |
|
932 |
|
933 |
|
934 |
|
935 |
|
936 |
|
937 |
|
938 |
|
939 |
|
940 |
|
941 |
|
942 |
<div align="justify"> |
943 |
<p style="text-align: justify;"> |
944 |
|
945 |
Unknown. |
946 |
|
947 |
</p> |
948 |
</div> |
949 |
|
950 |
|
951 |
|
952 |
|
953 |
|
954 |
|
955 |
|
956 |
|
957 |
|
958 |
|
959 |
|
960 |
|
961 |
<div align="justify"> |
962 |
<p style="text-align: justify;"> |
963 |
|
964 |
<b></b> |
965 |
|
966 |
</p> |
967 |
</div> |
968 |
|
969 |
|
970 |
|
971 |
|
972 |
|
973 |
|
974 |
|
975 |
|
976 |
|
977 |
|
978 |
|
979 |
|
980 |
<div align="justify"> |
981 |
<p style="text-align: justify;"> |
982 |
|
983 |
<b><i>Warnings and precautions</i></b> |
984 |
|
985 |
</p> |
986 |
</div> |
987 |
|
988 |
|
989 |
|
990 |
|
991 |
|
992 |
|
993 |
|
994 |
|
995 |
|
996 |
|
997 |
|
998 |
|
999 |
<div align="justify"> |
1000 |
<p style="text-align: justify;"> |
1001 |
|
1002 |
To ensure the intake of medicated feed, the animals should be restricted from other sources of feed during the treatment. |
1003 |
|
1004 |
</p> |
1005 |
</div> |
1006 |
|
1007 |
|
1008 |
|
1009 |
|
1010 |
|
1011 |
|
1012 |
|
1013 |
|
1014 |
|
1015 |
|
1016 |
|
1017 |
|
1018 |
<div align="justify"> |
1019 |
<p style="text-align: justify;"> |
1020 |
|
1021 |
|
1022 |
|
1023 |
</p> |
1024 |
</div> |
1025 |
|
1026 |
|
1027 |
|
1028 |
|
1029 |
|
1030 |
|
1031 |
|
1032 |
|
1033 |
|
1034 |
|
1035 |
|
1036 |
|
1037 |
<div align="justify"> |
1038 |
<p style="text-align: justify;"> |
1039 |
|
1040 |
The powder is not suitable for oral treatment of systemic infections in the adult ruminants. |
1041 |
|
1042 |
</p> |
1043 |
</div> |
1044 |
|
1045 |
|
1046 |
|
1047 |
|
1048 |
|
1049 |
|
1050 |
|
1051 |
|
1052 |
|
1053 |
|
1054 |
|
1055 |
|
1056 |
<div align="justify"> |
1057 |
<p style="text-align: justify;"> |
1058 |
|
1059 |
|
1060 |
|
1061 |
</p> |
1062 |
</div> |
1063 |
|
1064 |
|
1065 |
|
1066 |
|
1067 |
|
1068 |
|
1069 |
|
1070 |
|
1071 |
|
1072 |
|
1073 |
|
1074 |
|
1075 |
<div align="justify"> |
1076 |
<p style="text-align: justify;"> |
1077 |
|
1078 |
Untreated animals should not have an access to medicated feed. |
1079 |
|
1080 |
</p> |
1081 |
</div> |
1082 |
|
1083 |
|
1084 |
|
1085 |
|
1086 |
|
1087 |
|
1088 |
|
1089 |
|
1090 |
|
1091 |
|
1092 |
|
1093 |
|
1094 |
<div align="justify"> |
1095 |
<p style="text-align: justify;"> |
1096 |
|
1097 |
|
1098 |
|
1099 |
</p> |
1100 |
</div> |
1101 |
|
1102 |
|
1103 |
|
1104 |
|
1105 |
|
1106 |
|
1107 |
|
1108 |
|
1109 |
|
1110 |
|
1111 |
|
1112 |
|
1113 |
<div align="justify"> |
1114 |
<p style="text-align: justify;"> |
1115 |
|
1116 |
<b><i>Withdrawal</i></b><b></b> |
1117 |
|
1118 |
</p> |
1119 |
</div> |
1120 |
|
1121 |
|
1122 |
|
1123 |
|
1124 |
|
1125 |
|
1126 |
|
1127 |
|
1128 |
|
1129 |
|
1130 |
|
1131 |
|
1132 |
<div align="justify"> |
1133 |
<p style="text-align: justify;"> |
1134 |
|
1135 |
Swine, calves, foals, poultry - |
1136 |
|
1137 |
</p> |
1138 |
</div> |
1139 |
|
1140 |
|
1141 |
|
1142 |
|
1143 |
|
1144 |
|
1145 |
|
1146 |
|
1147 |
|
1148 |
|
1149 |
|
1150 |
|
1151 |
<div align="justify"> |
1152 |
<p style="text-align: justify;"> |
1153 |
|
1154 |
meat, organs and other edible tissues 5 days |
1155 |
|
1156 |
</p> |
1157 |
</div> |
1158 |
|
1159 |
|
1160 |
|
1161 |
|
1162 |
|
1163 |
|
1164 |
|
1165 |
|
1166 |
|
1167 |
|
1168 |
|
1169 |
|
1170 |
<div align="justify"> |
1171 |
<p style="text-align: justify;"> |
1172 |
|
1173 |
Fish 350° days (e. g. 35 days if water temperature is 10°C, i. e. 18 days at 20°C). <b><i></i></b> |
1174 |
|
1175 |
</p> |
1176 |
</div> |
1177 |
|
1178 |
|
1179 |
|
1180 |
|
1181 |
|
1182 |
|
1183 |
|
1184 |
|
1185 |
|
1186 |
|
1187 |
|
1188 |
|
1189 |
<div align="justify"> |
1190 |
<p style="text-align: justify;"> |
1191 |
|
1192 |
Storage |
1193 |
|
1194 |
</p> |
1195 |
</div> |
1196 |
|
1197 |
|
1198 |
|
1199 |
|
1200 |
|
1201 |
|
1202 |
|
1203 |
|
1204 |
|
1205 |
|
1206 |
|
1207 |
|
1208 |
<div align="justify"> |
1209 |
<p style="text-align: justify;"> |
1210 |
|
1211 |
Store in a dry and ventilated place up to 25°C. Keep away from children. |
1212 |
|
1213 |
</p> |
1214 |
</div> |
1215 |
|
1216 |
|
1217 |
|
1218 |
|
1219 |
|
1220 |
|
1221 |
|
1222 |
|
1223 |
|
1224 |
|
1225 |
|
1226 |
|
1227 |
<div align="justify"> |
1228 |
<p style="text-align: justify;"> |
1229 |
|
1230 |
|
1231 |
|
1232 |
</p> |
1233 |
</div> |
1234 |
|
1235 |
|
1236 |
|
1237 |
|
1238 |
|
1239 |
|
1240 |
|
1241 |
|
1242 |
|
1243 |
|
1244 |
|
1245 |
|
1246 |
<div align="justify"> |
1247 |
<p style="text-align: justify;"> |
1248 |
|
1249 |
<b><i>Shelf life</i></b> |
1250 |
|
1251 |
</p> |
1252 |
</div> |
1253 |
|
1254 |
|
1255 |
|
1256 |
|
1257 |
|
1258 |
|
1259 |
|
1260 |
|
1261 |
|
1262 |
|
1263 |
|
1264 |
|
1265 |
<div align="justify"> |
1266 |
<p style="text-align: justify;"> |
1267 |
|
1268 |
Denoted on the packaging (5 years in the original pack). |
1269 |
|
1270 |
</p> |
1271 |
</div> |
1272 |
|
1273 |
|
1274 |
|
1275 |
|
1276 |
|
1277 |
|
1278 |
|
1279 |
|
1280 |
|
1281 |
|
1282 |
|
1283 |
|
1284 |
<div align="justify"> |
1285 |
<p style="text-align: justify;"> |
1286 |
|
1287 |
<b><i></i></b> |
1288 |
|
1289 |
</p> |
1290 |
</div> |
1291 |
|
1292 |
|
1293 |
|
1294 |
|
1295 |
|
1296 |
|
1297 |
|
1298 |
|
1299 |
|
1300 |
|
1301 |
|
1302 |
|
1303 |
<div align="justify"> |
1304 |
<p style="text-align: justify;"> |
1305 |
|
1306 |
Legal category |
1307 |
|
1308 |
</p> |
1309 |
</div> |
1310 |
|
1311 |
|
1312 |
|
1313 |
|
1314 |
|
1315 |
|
1316 |
|
1317 |
|
1318 |
|
1319 |
|
1320 |
|
1321 |
|
1322 |
<div align="justify"> |
1323 |
<p style="text-align: justify;"> |
1324 |
|
1325 |
On prescription only. |
1326 |
|
1327 |
</p> |
1328 |
</div> |
1329 |
|
1330 |
|
1331 |
|
1332 |
|
1333 |
|
1334 |
|
1335 |
|
1336 |
|
1337 |
|
1338 |
|
1339 |
|
1340 |
|
1341 |
<div align="justify"> |
1342 |
<p style="text-align: justify;"> |
1343 |
|
1344 |
<b><i></i></b> |
1345 |
|
1346 |
</p> |
1347 |
</div> |
1348 |
|
1349 |
|
1350 |
|
1351 |
|
1352 |
|
1353 |
|
1354 |
|
1355 |
|
1356 |
|
1357 |
|
1358 |
|
1359 |
|
1360 |
<div align="justify"> |
1361 |
<p style="text-align: justify;"> |
1362 |
|
1363 |
Supply<b></b> |
1364 |
|
1365 |
</p> |
1366 |
</div> |
1367 |
|
1368 |
|
1369 |
|
1370 |
|
1371 |
|
1372 |
|
1373 |
|
1374 |
|
1375 |
|
1376 |
|
1377 |
|
1378 |
|
1379 |
<div align="justify"> |
1380 |
<p style="text-align: justify;"> |
1381 |
|
1382 |
Bags with 100 g. |
1383 |
|
1384 |
</p> |
1385 |
</div> |
1386 |
|
1387 |
|
1388 |
|
1389 |
|
1390 |
|
1391 |
|
1392 |
|
1393 |
|
1394 |
|
1395 |
|
1396 |
|
1397 |
|
1398 |
<div align="justify"> |
1399 |
<p style="text-align: justify;"> |
1400 |
|
1401 |
|
1402 |
|
1403 |
</p> |
1404 |
</div> |
1405 |
|
1406 |
|
1407 |
|
1408 |
|
1409 |
|
1410 |
|
1411 |
|
1412 |
|
1413 |
|
1414 |
|
1415 |
|
1416 |
|
1417 |
<div align="justify"> |
1418 |
<p style="text-align: justify;"> |
1419 |
|
1420 |
<b><i>Manufacturer</i></b><b></b> |
1421 |
|
1422 |
</p> |
1423 |
</div> |
1424 |
|
1425 |
|
1426 |
|
1427 |
|
1428 |
|
1429 |
|
1430 |
|
1431 |
|
1432 |
|
1433 |
|
1434 |
|
1435 |
|
1436 |
<div align="justify"> |
1437 |
<p style="text-align: justify;"> |
1438 |
|
1439 |
VETERINA Animal Health Ltd., Croatia |
1440 |
|
1441 |
</p> |
1442 |
</div> |
1443 |
|
1444 |
|
1445 |
|
1446 |
|
1447 |
|
1448 |
|
1449 |
|
1450 |
|
1451 |
|
1452 |
|
1453 |
|
1454 |
|
1455 |
<div align="justify"> |
1456 |
<p style="text-align: justify;"> |
1457 |
|
1458 |
|
1459 |
|
1460 |
</p> |
1461 |
</div> |
1462 |
|
1463 |
|
1464 |
|
1465 |
|
1466 |
|
1467 |
|
1468 |
|
1469 |
|
1470 |
|
1471 |
|
1472 |
|
1473 |
|
1474 |
<div align="left"> |
1475 |
<p style="text-align: left;"> |
1476 |
|
1477 |
|
1478 |
|
1479 |
</p> |
1480 |
</div> |
1481 |
|
1482 |
|
1483 |
|
1484 |
|
1485 |
|
1486 |
|
1487 |
|
1488 |
<!--Section Ends--> |
1489 |
|
1490 |
|
1491 |
|
1492 |
|
1493 |
|
1494 |
|
1495 |
|
1496 |
|