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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>GUMBOKAL</b><b><sup>®</sup></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>inactivated oily vaccine against Gumboro disease</i> |
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</p> |
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</div> |
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<div align="justify"> |
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<b></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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<b><i>Composition</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 vaccine contains inactivated Gumboro disease virus grown in embryonated chicks' eggs, inactivated with formaldehyde and re-suspended, with the addition of an emulsifier, in mineral oil as a multiple emulsion water/oil/water type. |
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</p> |
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<div align="justify"> |
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</p> |
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<div align="justify"> |
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<b><i>Action</i></b><b></b> |
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</p> |
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<div align="justify"> |
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The vaccine stimulates formation of the specific antibodies for Gumboro disease virus. |
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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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<b><i>Indications</i></b> |
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</p> |
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</div> |
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<div align="justify"> |
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Immunoprophylaxis of healthy hybrids of light and heavy breeds against infectious bursal disease (Gumboro disease) and immunisation of their offspring during their first 2-4 weeks of life. |
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</p> |
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</div> |
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</p> |
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<div 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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Unknown. |
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<b><i></i></b> |
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</p> |
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Administration, dosage and vaccination programme<b></b> |
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</p> |
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</div> |
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GUMBOKAL<b><sup>®</sup></b> is given by i. m<i>.</i> route into the breast muscle or s. c. into the skin fold at the dorsal neck side. The dose per bird is 0.5 mL. Before administration the vaccine should be heated to room temperature and shaken well prior to and occasionally during administration. |
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</p> |
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</div> |
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</p> |
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As a rule, the birds are vaccinated at the age of 16-20 weeks. |
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</p> |
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</div> |
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</p> |
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<div align="justify"> |
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Before being vaccinated with GUMBOKAL<b><sup>®</sup></b> the chicks should be given live vaccine against Gumboro disease. Time between these two vaccinations should not be shorter than 2 weeks. Optimum effect is achieved with an interval of 6 weeks. |
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</p> |
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</div> |
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</p> |
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<div align="justify"> |
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<b><i>Immunity</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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In healthy chicks the immunity is established 2-3 weeks after vaccination and is maintained till the end of the production cycle. This ensures the immunity of their offspring against infectious bursal disease during their first 2-4 weeks of life. |
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</p> |
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</div> |
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<b></b> |
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</p> |
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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 vaccine is administered to all birds in the flock. |
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</p> |
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</div> |
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<div align="justify"> |
543 |
|
|
<p style="text-align: justify;"> |
544 |
|
|
|
545 |
|
|
|
546 |
|
|
|
547 |
|
|
</p> |
548 |
|
|
</div> |
549 |
|
|
|
550 |
|
|
|
551 |
|
|
|
552 |
|
|
|
553 |
|
|
|
554 |
|
|
|
555 |
|
|
|
556 |
|
|
|
557 |
|
|
|
558 |
|
|
|
559 |
|
|
|
560 |
|
|
|
561 |
|
|
<div align="justify"> |
562 |
|
|
<p style="text-align: justify;"> |
563 |
|
|
|
564 |
|
|
Once opened use within 24 hours. |
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 |
|
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|
594 |
|
|
|
595 |
|
|
|
596 |
|
|
|
597 |
|
|
|
598 |
|
|
|
599 |
|
|
<div align="justify"> |
600 |
|
|
<p style="text-align: justify;"> |
601 |
|
|
|
602 |
|
|
Packaging and vaccine leftovers must be disposed in a safe way. |
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 |
|
|
|
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 |
|
|
Avoid direct exposure to sunlight and high temperatures. |
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 |
|
|
|
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 |
|
|
Beware of accidental injecting into the hand. In severe local reaction seek medical advice (surgeon). |
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 |
|
|
|
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 |
|
|
<b><i>Withdrawal</i></b> |
717 |
|
|
|
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 |
|
|
Meat, organs and other edible tissues of the vaccinated pullets - 0 days. |
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 |
|
|
<b></b> |
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>Storage</i></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 |
dpavlin |
1.2 |
Store in a dark place at 2-8°C (refrigerator). Keep away from children. Avoid freezing. |
793 |
dpavlin |
1.1 |
|
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>Shelf life</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 |
|
|
Denoted on the packaging (18 months in the original pack). |
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>Legal category</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 |
|
|
On prescription only. |
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>Supply</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 |
|
|
Pierced bottle of 100 mL (200 doses) and 500 mL (1000 doses). |
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 |
|
|
|
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 |
|
|
<b><i>Manufacturer</i></b><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 |
|
|
VETERINA Animal Health Ltd., Croatia |
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>Important note</i></b><b></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 |
|
|
Infectious bursal disease virus (Gumboro disease) affects bursa of Fabricius, which is an important part of the chicks' immune system. Its infection markedly affects the bird's resistance to infectious diseases, particularly if occurs during the first 2 weeks of hatching. Infected chicks may have reduced immune response to other avian vaccines. |
1078 |
|
|
|
1079 |
|
|
</p> |
1080 |
|
|
</div> |
1081 |
|
|
|
1082 |
|
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|
1083 |
|
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|
1084 |
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|
1085 |
|
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|
1086 |
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1087 |
|
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|
1088 |
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1089 |
|
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|
1090 |
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|
1091 |
|
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|
1092 |
|
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|
1093 |
|
|
<div align="justify"> |
1094 |
|
|
<p style="text-align: justify;"> |
1095 |
|
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|
1096 |
|
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|
1097 |
|
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|
1098 |
|
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</p> |
1099 |
|
|
</div> |
1100 |
|
|
|
1101 |
|
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|
1102 |
|
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|
1103 |
|
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|
1104 |
|
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|
1105 |
|
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1106 |
|
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1107 |
|
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|
1108 |
|
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|
1109 |
|
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|
1110 |
|
|
|
1111 |
|
|
|
1112 |
|
|
<div align="justify"> |
1113 |
|
|
<p style="text-align: justify;"> |
1114 |
|
|
|
1115 |
|
|
In every animal population there are some with poorer response to vaccination. In addition to proper storage and administration, success of vaccination depends on hereditary factors, age of the animal, subclinical diseases, maternal antibodies, feed, stress factors and concurrent administration of other drugs. |
1116 |
|
|
|
1117 |
|
|
</p> |
1118 |
|
|
</div> |
1119 |
|
|
|
1120 |
|
|
|
1121 |
|
|
|
1122 |
|
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|
1123 |
|
|
|
1124 |
|
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|
1125 |
|
|
|
1126 |
|
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|
1127 |
|
|
|
1128 |
|
|
|
1129 |
|
|
|
1130 |
|
|
|
1131 |
|
|
<div align="justify"> |
1132 |
|
|
<p style="text-align: justify;"> |
1133 |
|
|
|
1134 |
|
|
|
1135 |
|
|
|
1136 |
|
|
</p> |
1137 |
|
|
</div> |
1138 |
|
|
|
1139 |
|
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1140 |
|
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1141 |
|
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1142 |
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1143 |
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1144 |
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1145 |
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1146 |
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1147 |
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1148 |
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1149 |
|
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|
1150 |
|
|
<div align="left"> |
1151 |
|
|
<p style="text-align: left;"> |
1152 |
|
|
|
1153 |
|
|
|
1154 |
|
|
|
1155 |
|
|
</p> |
1156 |
|
|
</div> |
1157 |
|
|
|
1158 |
|
|
|
1159 |
|
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|
1160 |
|
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|
1161 |
|
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1162 |
|
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|
1163 |
|
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|
1164 |
|
|
<!--Section Ends--> |
1165 |
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1166 |
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1167 |
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1168 |
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1169 |
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1170 |
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1171 |
|
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1172 |
|
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|