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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><b>48%</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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<i>suspension for oral administration</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> |
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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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1 mL 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 80 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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Sulfadiazine sodium 400 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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</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> 48% suspension contains a potentiated combination of trimethoprim and sulfadiazine (cotrimazine). Antimicrobial effect of cotrimazine is based on a double block of folic acid synthesis. This activity is enhanced by syngerism of the active ingredients in the suspension. Therefore, trimethoprim and sulfadiazine exert a joint antibacterial effect in significantly lower concentrations than each of them does. At the same time, the possibility of resistance is reduced. |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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Trimetosul<b><sup>®</sup></b> 48% suspension is active against many gram-positive and gram-negative organisms, particularly in the infections caused by <i>E. coli,</i> <i>Salmonella</i> and <i>Pasteurella</i> spp. Potentiated sulfonamides are not active against <i>Pseudomonas aeruginosa</i> and the causes of leptospirosis and erysipelas. |
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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 and sulfadiazine are rapidly and extensively resorbed from gastrointestinal tract and shortly after oral administration achieve efficient plasma- and tissue-levels. In addition to their action in the intestines, they exert systemic effect too. |
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</p> |
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</div> |
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<b><i>Indications</i></b><b></b> |
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</p> |
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</div> |
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<div align="justify"> |
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Primary and secondary bacterial infections of respiratory and gastrointestinal tract in calves, lambs, kids, foals, piglets and poultry (e. g. colibacillosis, salmonellosis, pasteurellosis, etc.). |
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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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- Commercial layers; |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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- severe hepatic and renal impairment, impairment of hematopoietic organs; |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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- established hypersensitivity to sulfonamides, which is extremely rare. |
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</p> |
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</div> |
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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>Administration and dosage</i></b><b></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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Shake well before adding to drinking water. Trimetosul<b><sup>®</sup></b> 48% suspension is well dispersed in water, forming stable solution in the dilution over 1:800. For accurate dosage use the enclosed doser of 5 mL (2400 mg cotrimazine). |
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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>Calves, foals, lambs, kids, piglets and poultry:</i> |
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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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30 mg of cotrimazine/1 kg of b. w./daily, or |
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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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0.06 mL of Trimetosul<b><sup>®</sup></b><sup> </sup>48% susp./1 kg of b. w. in two equal morning and evening subdoses, or |
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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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2.0 mL of Trimetosul<b><sup>®</sup></b> 48% susp./30 kg of b. w./day. |
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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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</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>Individual treatment</i>: divide a daily dose in two equal subdoses, one for the morning and the other after 12 hours, as an evening dose. Administer with drinking water in the volume the animals will ingest. |
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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"> |
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<p style="text-align: justify;"> |
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<i>Mass treatment:</i> add specified dose to the volume of drinking water equivalent to approx. 3/4 of the daily volume. This ensures the intake of the whole daily dose, e. g.: |
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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"> |
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<p style="text-align: justify;"> |
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- swine weighing 20-50 kg are given 0.5 mL of Trimetosul<b><sup>®</sup></b> 48% susp./1 L of drinking water/day; |
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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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- broilers (aged 6 weeks) - 1 mL of Trimetosul<b><sup>®</sup></b> 48% susp./5 L of drinking water/day. |
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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"> |
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<p style="text-align: justify;"> |
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Commonest duration of treatment is 3-5 consecutive days. |
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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"> |
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<p style="text-align: justify;"> |
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<b><i>Warnings and precautions</i></b><b></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 animals should have free access to medicated drinking water and should be restricted from other sources of liquid. Dehydrated animals should not be treated with sulfonamides before being re-hydrated. |
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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"> |
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<p style="text-align: justify;"> |
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The suspension is not suitable for p. o. treatment of systemic infections in older calves with developed forestomach. |
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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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875 |
|
876 |
|
877 |
|
878 |
|
879 |
|
880 |
|
881 |
|
882 |
|
883 |
|
884 |
|
885 |
<div align="justify"> |
886 |
<p style="text-align: justify;"> |
887 |
|
888 |
|
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 |
If after three days of treatment there is no apparent improvement, the preparation may be continued only if laboratory tests show sensitivity of the causative organism to trimethoprim-sulfadiazine combination. Otherwise, administer another antimicrobial. |
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 |
|
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 |
<b><i>Side effects</i></b> |
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 |
Unknown. |
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 |
|
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 |
<b><i>Withdrawal</i></b> |
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 |
Meat, organs and other edible tissues - |
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 |
Calves, foals, lambs, kids, piglets 10 days |
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 |
Broilers 5 days |
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 |
|
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 |
<b><i>Storage</i></b><b></b> |
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 |
Store in a dark place at controlled room temperature (15-25°C). Keep away from children. Avoid freezing. |
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 |
|
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 |
<b><i>Shelf life</i></b><b></b> |
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 |
Denoted on the packaging (3 years in the original pack). |
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 |
|
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 |
<b><i>Legal category</i></b><b></b> |
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 |
On prescription only. |
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 |
|
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 |
<b><i>Supply</i></b><b></b> |
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 |
Bottles with 100 mL and 200 mL. |
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 |
|
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 |
<b><i>Manufacturer</i></b><b></b> |
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 |
VETERINA Animal Health Ltd., Croatia |
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 |
|
1364 |
|
1365 |
</p> |
1366 |
</div> |
1367 |
|
1368 |
|
1369 |
|
1370 |
|
1371 |
|
1372 |
|
1373 |
|
1374 |
|
1375 |
|
1376 |
|
1377 |
|
1378 |
|
1379 |
<div align="left"> |
1380 |
<p style="text-align: left;"> |
1381 |
|
1382 |
|
1383 |
|
1384 |
</p> |
1385 |
</div> |
1386 |
|
1387 |
|
1388 |
|
1389 |
|
1390 |
|
1391 |
|
1392 |
|
1393 |
<!--Section Ends--> |
1394 |
|
1395 |
|
1396 |
|
1397 |
|
1398 |
|
1399 |
|
1400 |
|
1401 |
|