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dpavlin |
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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>TIAVET</b><b><sup>®</sup></b><b> 20%</b> |
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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>injection solution</i> |
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</p> |
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<div align="justify"> |
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<b><i>Composition</i></b> |
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</p> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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1 mL contains 200 mg of tiamulin hydrogen fumarate. |
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</p> |
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</div> |
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<b><i>Action</i></b><b></b> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Tiamulin is a semi-synthetic antibiotic of a broad antimicrobial spectrum. In the sensitive bacteria it interferes with their protein synthesis. It is potent against mycoplasma (<i>Mycoplasma hyopneumoniae</i>, <i>M. hyorhinis</i> and <i>M. hyosynoviae</i>) and is very active against bloody scours in swine (<i>Serpulina</i> <i>hyodysenteriae</i>). Tiavet<b><sup>®</sup></b> 20% inhibits the growth and multiplication of many gram-positive bacteria (<i>Staphylococcus </i>spp., <i>Streptococcus</i> spp., <i>Clostridium perfrigens</i>, <i>Listeria monocytogenes</i>, <i>Erysipelothrix</i> spp. and <i>Actinomyces pyogenes</i>) as well as of gram-negative organisms (<i>Pasteurella</i> spp., <i>Klebsiella pneumoniae</i>, <i>Actinobacillus</i> spp., <i>Fusobacterium necrophorum</i>,<i> Bacteroides</i> spp. and <i>Campylobacter</i> <i>coli</i>) and leptospira. However, it is not active against gram-negative intestinal bacteria. After i. m. administration tiamulin is rapidly resorbed and achieves peak plasma-levels within one hour. Major part of it is excreted via bile and urine. |
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</p> |
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<b><i>Indications</i></b> |
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</p> |
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</div> |
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Treatment of swine against: |
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- bloody scours (swine dysentery) due to <i>Serpulina</i> <i>hyodysenteriae</i> and secondary infections caused by <i>Bacteroides</i> spp. and <i>Fusobacterium necrophorum</i>; |
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- enzootic pneumonia complex caused by <i>M</i>. <i>hyopneumoniae</i> and associated infections due to <i>Pasteurella</i> <i>multocida</i>, <i>Staphylococcus</i> and <i>Streptococcus</i> spp., <i>Bordetella bronchiseptica</i>, <i>Actinomyces pyogenes</i> and <i>Actinobacillus</i> spp.; |
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- mycoplasmal arthritis caused by <i>M</i>. <i>hyosynoviae</i>. The treatment alleviates lameness and improves gain. |
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</p> |
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<b><i>Contraindications</i></b><b></b> |
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Tiavet<b><sup>®</sup></b> 20% should not be given concomitantly with feed ionofor antibiotics (salinomycine, monensin and narasin). These antibiotics must not be instituted to swine 7 days before and 7 days after the treatment with Tiavet<b><sup>®</sup></b>. |
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<b><i></i></b> |
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Administration<b></b> |
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Tiavet<b><sup>®</sup></b> 20% injection solution is given to swine by i. m. route behind the auricular base. |
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</div> |
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<b><i>Dosage</i></b><b></b> |
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</p> |
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</div> |
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<i>Treatment of bloody scours (swine dysentery):</i><b><i> </i></b>The injections are administered to clinically diseased swine in a single dose of 1 mL per 20 kg of b. w. (10 mg of tiamulin hydrogen fumarate/kg of b. w.). Severe cases may require an additional dose on the following day. Treatment of clinically diseased and other swine in the affected herd must be continued with oral administration of Tiavet<b><sup>®</sup></b> P 2% mixed with feed in the dose of 5 kg per 1 T of feed mix over 7-10 days. |
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</p> |
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</p> |
510 |
|
|
</div> |
511 |
|
|
|
512 |
|
|
|
513 |
|
|
|
514 |
|
|
|
515 |
|
|
|
516 |
|
|
|
517 |
|
|
|
518 |
|
|
|
519 |
|
|
|
520 |
|
|
|
521 |
|
|
|
522 |
|
|
|
523 |
|
|
<div align="justify"> |
524 |
|
|
<p style="text-align: justify;"> |
525 |
|
|
|
526 |
|
|
<i>Enzootic (mycoplasmal) pneumonia:</i> 1.5 -2.0 mL of Tiavet<b><sup>®</sup></b>20% per 20 kg of b. w. daily over three consecutive days (15-20 mg of tiamulin hydrogen fumarate/kg of b. w.). The injections are administered to clinically diseased animals, whereas all other swine in the affected herd are given Tiavet<b><sup>®</sup></b> P 2% mixed with feed in the ratio of 1.5 kg per 1 T of feed mix over 3-6 weeks or till the end of the fattening period. |
527 |
|
|
|
528 |
|
|
</p> |
529 |
|
|
</div> |
530 |
|
|
|
531 |
|
|
|
532 |
|
|
|
533 |
|
|
|
534 |
|
|
|
535 |
|
|
|
536 |
|
|
|
537 |
|
|
|
538 |
|
|
|
539 |
|
|
|
540 |
|
|
|
541 |
|
|
|
542 |
|
|
<div align="justify"> |
543 |
|
|
<p style="text-align: justify;"> |
544 |
|
|
|
545 |
|
|
|
546 |
|
|
|
547 |
|
|
</p> |
548 |
|
|
</div> |
549 |
|
|
|
550 |
|
|
|
551 |
|
|
|
552 |
|
|
|
553 |
|
|
|
554 |
|
|
|
555 |
|
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|
556 |
|
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|
557 |
|
|
|
558 |
|
|
|
559 |
|
|
|
560 |
|
|
|
561 |
|
|
<div align="justify"> |
562 |
|
|
<p style="text-align: justify;"> |
563 |
|
|
|
564 |
|
|
<i>Mycoplasmal arthritis:</i> 1 mL of Tiavet<b><sup>®</sup></b> 20% injection solution per 10 kg of b. w. daily over three consecutive days (20 mg of tiamulin hydrogen fumarate/kg of b. w.). |
565 |
|
|
|
566 |
|
|
</p> |
567 |
|
|
</div> |
568 |
|
|
|
569 |
|
|
|
570 |
|
|
|
571 |
|
|
|
572 |
|
|
|
573 |
|
|
|
574 |
|
|
|
575 |
|
|
|
576 |
|
|
|
577 |
|
|
|
578 |
|
|
|
579 |
|
|
|
580 |
|
|
<div align="justify"> |
581 |
|
|
<p style="text-align: justify;"> |
582 |
|
|
|
583 |
|
|
|
584 |
|
|
|
585 |
|
|
</p> |
586 |
|
|
</div> |
587 |
|
|
|
588 |
|
|
|
589 |
|
|
|
590 |
|
|
|
591 |
|
|
|
592 |
|
|
|
593 |
|
|
|
594 |
|
|
|
595 |
|
|
|
596 |
|
|
|
597 |
|
|
|
598 |
|
|
|
599 |
|
|
<div align="justify"> |
600 |
|
|
<p style="text-align: justify;"> |
601 |
|
|
|
602 |
|
|
<b><i>Warnings and precautions</i></b> |
603 |
|
|
|
604 |
|
|
</p> |
605 |
|
|
</div> |
606 |
|
|
|
607 |
|
|
|
608 |
|
|
|
609 |
|
|
|
610 |
|
|
|
611 |
|
|
|
612 |
|
|
|
613 |
|
|
|
614 |
|
|
|
615 |
|
|
|
616 |
|
|
|
617 |
|
|
|
618 |
|
|
<div align="justify"> |
619 |
|
|
<p style="text-align: justify;"> |
620 |
|
|
|
621 |
|
|
On very rare occasions tiamulin may produce skin erythema on the stomach and genitals of swine which requires its discontinuation and washing of the animals with water to remove traces of faeces and urine. |
622 |
|
|
|
623 |
|
|
</p> |
624 |
|
|
</div> |
625 |
|
|
|
626 |
|
|
|
627 |
|
|
|
628 |
|
|
|
629 |
|
|
|
630 |
|
|
|
631 |
|
|
|
632 |
|
|
|
633 |
|
|
|
634 |
|
|
|
635 |
|
|
|
636 |
|
|
|
637 |
|
|
<div align="justify"> |
638 |
|
|
<p style="text-align: justify;"> |
639 |
|
|
|
640 |
|
|
|
641 |
|
|
|
642 |
|
|
</p> |
643 |
|
|
</div> |
644 |
|
|
|
645 |
|
|
|
646 |
|
|
|
647 |
|
|
|
648 |
|
|
|
649 |
|
|
|
650 |
|
|
|
651 |
|
|
|
652 |
|
|
|
653 |
|
|
|
654 |
|
|
|
655 |
|
|
|
656 |
|
|
<div align="justify"> |
657 |
|
|
<p style="text-align: justify;"> |
658 |
|
|
|
659 |
|
|
Tiavet<b><sup>®</sup></b> injections cause local irritation. In multiple administration always apply at different sites. |
660 |
|
|
|
661 |
|
|
</p> |
662 |
|
|
</div> |
663 |
|
|
|
664 |
|
|
|
665 |
|
|
|
666 |
|
|
|
667 |
|
|
|
668 |
|
|
|
669 |
|
|
|
670 |
|
|
|
671 |
|
|
|
672 |
|
|
|
673 |
|
|
|
674 |
|
|
|
675 |
|
|
<div align="justify"> |
676 |
|
|
<p style="text-align: justify;"> |
677 |
|
|
|
678 |
|
|
|
679 |
|
|
|
680 |
|
|
</p> |
681 |
|
|
</div> |
682 |
|
|
|
683 |
|
|
|
684 |
|
|
|
685 |
|
|
|
686 |
|
|
|
687 |
|
|
|
688 |
|
|
|
689 |
|
|
|
690 |
|
|
|
691 |
|
|
|
692 |
|
|
|
693 |
|
|
|
694 |
|
|
<div align="justify"> |
695 |
|
|
<p style="text-align: justify;"> |
696 |
|
|
|
697 |
|
|
Tiamulin is not recommended in sows and gilts in the first trimester of pregnancy. |
698 |
|
|
|
699 |
|
|
</p> |
700 |
|
|
</div> |
701 |
|
|
|
702 |
|
|
|
703 |
|
|
|
704 |
|
|
|
705 |
|
|
|
706 |
|
|
|
707 |
|
|
|
708 |
|
|
|
709 |
|
|
|
710 |
|
|
|
711 |
|
|
|
712 |
|
|
|
713 |
|
|
<div align="justify"> |
714 |
|
|
<p style="text-align: justify;"> |
715 |
|
|
|
716 |
dpavlin |
1.2 |
|
717 |
dpavlin |
1.1 |
|
718 |
|
|
</p> |
719 |
|
|
</div> |
720 |
|
|
|
721 |
|
|
|
722 |
|
|
|
723 |
|
|
|
724 |
|
|
|
725 |
|
|
|
726 |
|
|
|
727 |
|
|
|
728 |
|
|
|
729 |
|
|
|
730 |
|
|
|
731 |
|
|
|
732 |
|
|
<div align="justify"> |
733 |
|
|
<p style="text-align: justify;"> |
734 |
|
|
|
735 |
|
|
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 Tiavet<b><sup>®</sup></b> 2% P. |
736 |
|
|
|
737 |
|
|
</p> |
738 |
|
|
</div> |
739 |
|
|
|
740 |
|
|
|
741 |
|
|
|
742 |
|
|
|
743 |
|
|
|
744 |
|
|
|
745 |
|
|
|
746 |
|
|
|
747 |
|
|
|
748 |
|
|
|
749 |
|
|
|
750 |
|
|
|
751 |
|
|
<div align="justify"> |
752 |
|
|
<p style="text-align: justify;"> |
753 |
|
|
|
754 |
|
|
|
755 |
|
|
|
756 |
|
|
</p> |
757 |
|
|
</div> |
758 |
|
|
|
759 |
|
|
|
760 |
|
|
|
761 |
|
|
|
762 |
|
|
|
763 |
|
|
|
764 |
|
|
|
765 |
|
|
|
766 |
|
|
|
767 |
|
|
|
768 |
|
|
|
769 |
|
|
|
770 |
|
|
<div align="justify"> |
771 |
|
|
<p style="text-align: justify;"> |
772 |
|
|
|
773 |
|
|
<b><i>Withdrawal</i></b><b></b> |
774 |
|
|
|
775 |
|
|
</p> |
776 |
|
|
</div> |
777 |
|
|
|
778 |
|
|
|
779 |
|
|
|
780 |
|
|
|
781 |
|
|
|
782 |
|
|
|
783 |
|
|
|
784 |
|
|
|
785 |
|
|
|
786 |
|
|
|
787 |
|
|
|
788 |
|
|
|
789 |
|
|
<div align="justify"> |
790 |
|
|
<p style="text-align: justify;"> |
791 |
|
|
|
792 |
|
|
Swine - meat, organs and other edible tissues - 10 days. |
793 |
|
|
|
794 |
|
|
</p> |
795 |
|
|
</div> |
796 |
|
|
|
797 |
|
|
|
798 |
|
|
|
799 |
|
|
|
800 |
|
|
|
801 |
|
|
|
802 |
|
|
|
803 |
|
|
|
804 |
|
|
|
805 |
|
|
|
806 |
|
|
|
807 |
|
|
|
808 |
|
|
<div align="justify"> |
809 |
|
|
<p style="text-align: justify;"> |
810 |
|
|
|
811 |
|
|
|
812 |
|
|
|
813 |
|
|
</p> |
814 |
|
|
</div> |
815 |
|
|
|
816 |
|
|
|
817 |
|
|
|
818 |
|
|
|
819 |
|
|
|
820 |
|
|
|
821 |
|
|
|
822 |
|
|
|
823 |
|
|
|
824 |
|
|
|
825 |
|
|
|
826 |
|
|
|
827 |
|
|
<div align="justify"> |
828 |
|
|
<p style="text-align: justify;"> |
829 |
|
|
|
830 |
|
|
<b><i>Storage</i></b><b></b> |
831 |
|
|
|
832 |
|
|
</p> |
833 |
|
|
</div> |
834 |
|
|
|
835 |
|
|
|
836 |
|
|
|
837 |
|
|
|
838 |
|
|
|
839 |
|
|
|
840 |
|
|
|
841 |
|
|
|
842 |
|
|
|
843 |
|
|
|
844 |
|
|
|
845 |
|
|
|
846 |
|
|
<div align="justify"> |
847 |
|
|
<p style="text-align: justify;"> |
848 |
|
|
|
849 |
|
|
Store in a dark place at controlled room temperature (8-25°C). Keep away from children. Avoid freezing. |
850 |
|
|
|
851 |
|
|
</p> |
852 |
|
|
</div> |
853 |
|
|
|
854 |
|
|
|
855 |
|
|
|
856 |
|
|
|
857 |
|
|
|
858 |
|
|
|
859 |
|
|
|
860 |
|
|
|
861 |
|
|
|
862 |
|
|
|
863 |
|
|
|
864 |
|
|
|
865 |
|
|
<div align="justify"> |
866 |
|
|
<p style="text-align: justify;"> |
867 |
|
|
|
868 |
|
|
|
869 |
|
|
|
870 |
|
|
</p> |
871 |
|
|
</div> |
872 |
|
|
|
873 |
|
|
|
874 |
|
|
|
875 |
|
|
|
876 |
|
|
|
877 |
|
|
|
878 |
|
|
|
879 |
|
|
|
880 |
|
|
|
881 |
|
|
|
882 |
|
|
|
883 |
|
|
|
884 |
|
|
<div align="justify"> |
885 |
|
|
<p style="text-align: justify;"> |
886 |
|
|
|
887 |
|
|
<b><i>Shelf life</i></b><b></b> |
888 |
|
|
|
889 |
|
|
</p> |
890 |
|
|
</div> |
891 |
|
|
|
892 |
|
|
|
893 |
|
|
|
894 |
|
|
|
895 |
|
|
|
896 |
|
|
|
897 |
|
|
|
898 |
|
|
|
899 |
|
|
|
900 |
|
|
|
901 |
|
|
|
902 |
|
|
|
903 |
|
|
<div align="justify"> |
904 |
|
|
<p style="text-align: justify;"> |
905 |
|
|
|
906 |
|
|
Denoted on the packaging (3 years in the original pack). |
907 |
|
|
|
908 |
|
|
</p> |
909 |
|
|
</div> |
910 |
|
|
|
911 |
|
|
|
912 |
|
|
|
913 |
|
|
|
914 |
|
|
|
915 |
|
|
|
916 |
|
|
|
917 |
|
|
|
918 |
|
|
|
919 |
|
|
|
920 |
|
|
|
921 |
|
|
|
922 |
|
|
<div align="justify"> |
923 |
|
|
<p style="text-align: justify;"> |
924 |
|
|
|
925 |
|
|
|
926 |
|
|
|
927 |
|
|
</p> |
928 |
|
|
</div> |
929 |
|
|
|
930 |
|
|
|
931 |
|
|
|
932 |
|
|
|
933 |
|
|
|
934 |
|
|
|
935 |
|
|
|
936 |
|
|
|
937 |
|
|
|
938 |
|
|
|
939 |
|
|
|
940 |
|
|
|
941 |
|
|
<div align="justify"> |
942 |
|
|
<p style="text-align: justify;"> |
943 |
|
|
|
944 |
|
|
<b><i>Legal category</i></b><b></b> |
945 |
|
|
|
946 |
|
|
</p> |
947 |
|
|
</div> |
948 |
|
|
|
949 |
|
|
|
950 |
|
|
|
951 |
|
|
|
952 |
|
|
|
953 |
|
|
|
954 |
|
|
|
955 |
|
|
|
956 |
|
|
|
957 |
|
|
|
958 |
|
|
|
959 |
|
|
|
960 |
|
|
<div align="justify"> |
961 |
|
|
<p style="text-align: justify;"> |
962 |
|
|
|
963 |
|
|
On prescription only. |
964 |
|
|
|
965 |
|
|
</p> |
966 |
|
|
</div> |
967 |
|
|
|
968 |
|
|
|
969 |
|
|
|
970 |
|
|
|
971 |
|
|
|
972 |
|
|
|
973 |
|
|
|
974 |
|
|
|
975 |
|
|
|
976 |
|
|
|
977 |
|
|
|
978 |
|
|
|
979 |
|
|
<div align="justify"> |
980 |
|
|
<p style="text-align: justify;"> |
981 |
|
|
|
982 |
|
|
<b><i></i></b> |
983 |
|
|
|
984 |
|
|
</p> |
985 |
|
|
</div> |
986 |
|
|
|
987 |
|
|
|
988 |
|
|
|
989 |
|
|
|
990 |
|
|
|
991 |
|
|
|
992 |
|
|
|
993 |
|
|
|
994 |
|
|
|
995 |
|
|
|
996 |
|
|
|
997 |
|
|
|
998 |
|
|
<div align="justify"> |
999 |
|
|
<p style="text-align: justify;"> |
1000 |
|
|
|
1001 |
|
|
Supply<b></b> |
1002 |
|
|
|
1003 |
|
|
</p> |
1004 |
|
|
</div> |
1005 |
|
|
|
1006 |
|
|
|
1007 |
|
|
|
1008 |
|
|
|
1009 |
|
|
|
1010 |
|
|
|
1011 |
|
|
|
1012 |
|
|
|
1013 |
|
|
|
1014 |
|
|
|
1015 |
|
|
|
1016 |
|
|
|
1017 |
|
|
<div align="justify"> |
1018 |
|
|
<p style="text-align: justify;"> |
1019 |
|
|
|
1020 |
|
|
Pierced bottle of 50 mL. |
1021 |
|
|
|
1022 |
|
|
</p> |
1023 |
|
|
</div> |
1024 |
|
|
|
1025 |
|
|
|
1026 |
|
|
|
1027 |
|
|
|
1028 |
|
|
|
1029 |
|
|
|
1030 |
|
|
|
1031 |
|
|
|
1032 |
|
|
|
1033 |
|
|
|
1034 |
|
|
|
1035 |
|
|
|
1036 |
|
|
<div align="justify"> |
1037 |
|
|
<p style="text-align: justify;"> |
1038 |
|
|
|
1039 |
|
|
|
1040 |
|
|
|
1041 |
|
|
</p> |
1042 |
|
|
</div> |
1043 |
|
|
|
1044 |
|
|
|
1045 |
|
|
|
1046 |
|
|
|
1047 |
|
|
|
1048 |
|
|
|
1049 |
|
|
|
1050 |
|
|
|
1051 |
|
|
|
1052 |
|
|
|
1053 |
|
|
|
1054 |
|
|
|
1055 |
|
|
<div align="justify"> |
1056 |
|
|
<p style="text-align: justify;"> |
1057 |
|
|
|
1058 |
|
|
<b><i>Manufacturer</i></b> |
1059 |
|
|
|
1060 |
|
|
</p> |
1061 |
|
|
</div> |
1062 |
|
|
|
1063 |
|
|
|
1064 |
|
|
|
1065 |
|
|
|
1066 |
|
|
|
1067 |
|
|
|
1068 |
|
|
|
1069 |
|
|
|
1070 |
|
|
|
1071 |
|
|
|
1072 |
|
|
|
1073 |
|
|
|
1074 |
|
|
<div align="justify"> |
1075 |
|
|
<p style="text-align: justify;"> |
1076 |
|
|
|
1077 |
|
|
VETERINA Animal Health Ltd., Croatia |
1078 |
|
|
|
1079 |
|
|
</p> |
1080 |
|
|
</div> |
1081 |
|
|
|
1082 |
|
|
|
1083 |
|
|
|
1084 |
|
|
|
1085 |
|
|
|
1086 |
|
|
|
1087 |
|
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|
1088 |
|
|
|
1089 |
|
|
|
1090 |
|
|
|
1091 |
|
|
|
1092 |
|
|
|
1093 |
|
|
<div align="justify"> |
1094 |
|
|
<p style="text-align: justify;"> |
1095 |
|
|
|
1096 |
|
|
|
1097 |
|
|
|
1098 |
|
|
</p> |
1099 |
|
|
</div> |
1100 |
|
|
|
1101 |
|
|
|
1102 |
|
|
|
1103 |
|
|
|
1104 |
|
|
|
1105 |
|
|
|
1106 |
|
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|
1107 |
|
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|
1108 |
|
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|
1109 |
|
|
|
1110 |
|
|
|
1111 |
|
|
|
1112 |
|
|
<div align="left"> |
1113 |
|
|
<p style="text-align: left;"> |
1114 |
|
|
|
1115 |
|
|
|
1116 |
|
|
|
1117 |
|
|
</p> |
1118 |
|
|
</div> |
1119 |
|
|
|
1120 |
|
|
|
1121 |
|
|
|
1122 |
|
|
|
1123 |
|
|
|
1124 |
|
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|
1125 |
|
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|
1126 |
|
|
<!--Section Ends--> |
1127 |
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|
1128 |
|
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|
1129 |
|
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|
1130 |
|
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|
1131 |
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1132 |
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1133 |
|
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|
1134 |
|
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|