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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>PESTIKAL</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 Newcastle 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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</p> |
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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 Newcastle disease virus grown in chicks embryonated eggs, inactivated with formaldehyde, dissociated with non-ionic detergent and resuspended, 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> |
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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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<p style="text-align: justify;"> |
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The vaccine stimulates formation of specific antibodies for Newcastle 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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<p style="text-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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Immunisation of poultry against Newcastle disease. |
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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>Contraindications</i></b> |
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</p> |
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</div> |
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Sick animals should not be vaccinated. |
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</p> |
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</div> |
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<div align="justify"> |
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<b><i></i></b> |
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</p> |
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</div> |
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Administration and dosage<b></b> |
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</p> |
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</div> |
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<div align="justify"> |
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Chicks before point of lay are vaccinated at the age of 16-20 weeks, i. e. not later than 2-4 weeks before the onset of egg production. Before being vaccinated with PESTIKAL<b><sup>®</sup></b> the birds should be given live vaccine against Newcastle 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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Dose per bird is 0.5 mL given i. m. into the breast muscle or s. c. into the skin fold at the dorsal side of the neck. |
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</p> |
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</div> |
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Turkeys and hens are given the dose of 1 mL administered at the same sites as hens. Turkey-hens are vaccinated at the age of 16 weeks and re-vaccinated when 25 weeks old. Turkey cocks are vaccinated at week 19 and re-vaccinated at week 25. |
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</p> |
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</div> |
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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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Vaccinated poultry maintain immunity during the entire egg production period. |
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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>Side effects</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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Sometimes, irrespective of sterile vaccination, a small swelling may develop at the site of administration. <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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|
|
545 |
|
|
<b><i> </i></b><b></b> |
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 |
|
|
<b><i>Warnings and precautions</i></b><b></b> |
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 |
|
|
Before administration the vaccine should be heated to room temperature (18-28°C), and shaken well prior to and occasionally during administration. |
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 |
|
|
|
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 |
|
|
Vaccination equipment should be sterile. |
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 |
|
|
Once opened use within 24 hours. |
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 |
|
|
Vaccinate only healthy birds. |
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 |
|
|
|
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 |
|
|
In case of accidental injecting local reaction may develop. If necessary, seek medical advice (surgeon). |
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> |
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 |
|
|
Meat, and edible tissues - 0 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 |
|
|
<b></b> |
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> |
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 2-8°C (refrigerator). 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 (18 months 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 |
|
|
|
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>Supply</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 |
|
|
Bottles of 500 mL (1000 doses). |
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><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 |
|
|
VETERINA Animal Health Ltd., Croatia |
1078 |
|
|
|
1079 |
|
|
</p> |
1080 |
|
|
</div> |
1081 |
|
|
|
1082 |
|
|
|
1083 |
|
|
|
1084 |
|
|
|
1085 |
|
|
|
1086 |
|
|
|
1087 |
|
|
|
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 |
|
|
|
1107 |
|
|
|
1108 |
|
|
|
1109 |
|
|
|
1110 |
|
|
|
1111 |
|
|
|
1112 |
|
|
<div align="justify"> |
1113 |
|
|
<p style="text-align: justify;"> |
1114 |
|
|
|
1115 |
|
|
<b><i>Important note</i></b> |
1116 |
|
|
|
1117 |
|
|
</p> |
1118 |
|
|
</div> |
1119 |
|
|
|
1120 |
|
|
|
1121 |
|
|
|
1122 |
|
|
|
1123 |
|
|
|
1124 |
|
|
|
1125 |
|
|
|
1126 |
|
|
|
1127 |
|
|
|
1128 |
|
|
|
1129 |
|
|
|
1130 |
|
|
|
1131 |
|
|
<div align="justify"> |
1132 |
|
|
<p style="text-align: justify;"> |
1133 |
|
|
|
1134 |
|
|
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, condition of the animal, stress and concurrent administration of other medicines. |
1135 |
|
|
|
1136 |
|
|
</p> |
1137 |
|
|
</div> |
1138 |
|
|
|
1139 |
|
|
|
1140 |
|
|
|
1141 |
|
|
|
1142 |
|
|
|
1143 |
|
|
|
1144 |
|
|
|
1145 |
|
|
|
1146 |
|
|
|
1147 |
|
|
|
1148 |
|
|
|
1149 |
|
|
|
1150 |
|
|
<div align="justify"> |
1151 |
|
|
<p style="text-align: justify;"> |
1152 |
|
|
|
1153 |
|
|
|
1154 |
|
|
|
1155 |
|
|
</p> |
1156 |
|
|
</div> |
1157 |
|
|
|
1158 |
|
|
|
1159 |
|
|
|
1160 |
|
|
|
1161 |
|
|
|
1162 |
|
|
|
1163 |
|
|
|
1164 |
|
|
|
1165 |
|
|
|
1166 |
|
|
|
1167 |
|
|
|
1168 |
|
|
|
1169 |
|
|
<div align="justify"> |
1170 |
|
|
<p style="text-align: justify;"> |
1171 |
|
|
|
1172 |
|
|
Given the variations in vaccination programmes, before vaccinating the whole flock it is recommended to consult the veterinarian - a poultry expert. |
1173 |
|
|
|
1174 |
|
|
</p> |
1175 |
|
|
</div> |
1176 |
|
|
|
1177 |
|
|
|
1178 |
|
|
|
1179 |
|
|
|
1180 |
|
|
|
1181 |
|
|
|
1182 |
|
|
|
1183 |
|
|
|
1184 |
|
|
|
1185 |
|
|
|
1186 |
|
|
|
1187 |
|
|
|
1188 |
|
|
<div align="justify"> |
1189 |
|
|
<p style="text-align: justify;"> |
1190 |
|
|
|
1191 |
|
|
<b></b> |
1192 |
|
|
|
1193 |
|
|
</p> |
1194 |
|
|
</div> |
1195 |
|
|
|
1196 |
|
|
|
1197 |
|
|
|
1198 |
|
|
|
1199 |
|
|
|
1200 |
|
|
|
1201 |
|
|
|
1202 |
|
|
|
1203 |
|
|
|
1204 |
|
|
|
1205 |
|
|
|
1206 |
|
|
|
1207 |
|
|
<div align="left"> |
1208 |
|
|
<p style="text-align: left;"> |
1209 |
|
|
|
1210 |
|
|
|
1211 |
|
|
|
1212 |
|
|
</p> |
1213 |
|
|
</div> |
1214 |
|
|
|
1215 |
|
|
|
1216 |
|
|
|
1217 |
|
|
|
1218 |
|
|
|
1219 |
|
|
|
1220 |
|
|
|
1221 |
|
|
<!--Section Ends--> |
1222 |
|
|
|
1223 |
|
|
|
1224 |
|
|
|
1225 |
|
|
|
1226 |
|
|
|
1227 |
|
|
|
1228 |
|
|
|
1229 |
|
|
|