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dpavlin |
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<b></b> |
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<div align="justify"> |
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KLOKSAVET<b><sup>®</sup></b><b> M</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 intramammary (i/mam) administration </i> |
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</p> |
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<div align="justify"> |
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treatment of mastitis in lactating cows |
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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> |
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<div align="justify"> |
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Each injector with 5 mL of suspension contains: |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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dpavlin |
1.2 |
Cloxacillin as cloxacillin sodium monohydrate 200 mg |
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dpavlin |
1.1 |
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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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dpavlin |
1.2 |
Prednisolone as prednisolone acetate 10 mg |
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dpavlin |
1.1 |
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</p> |
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</div> |
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dpavlin |
1.2 |
Base - white paraffin and liquid paraffin up to 5 mL |
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dpavlin |
1.1 |
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</p> |
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</div> |
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</p> |
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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> |
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<div align="justify"> |
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Kloksavet<b><sup>®</sup></b><sup> </sup>i/mam suspension contains an efficient combination of antibiotic cloxacillin and glucocorticoid prednisolone with synergistic action against the commonest causes of mastitis in the lactating cows. |
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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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Cloxacillin, a semi-synthetic penicillin, inhibits the action of transpeptidase during re-arrangement of the cell wall in the sensitive bacteria. It is stable in the presence of penicillinase (beta-lactamase) and acts bactericidally on benzylpenicillin-resistant staphylococci and streptococci. Its important feature is its activity against major gram-positive causes of mastitis - <i>Streptococcus agalactiae</i>, <i>Staphylococcus aureus</i>, <i>Actinomyces pyogenes</i> etc. Injected into the udder it is slowly released from the base without causing tissue irritation. Administration should be repeated after 48 hours. |
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</p> |
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Prednisolone, a synthetic glucocorticoid, alleviates inflammation, formation of exudate and fibrin and facilitates treatment of mastitis by enabling penetration of cloxacillin into deeper inflammatory foci in the mammary gland. |
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</p> |
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<b><i>Indications</i></b> |
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Mastitis in the lactating dairy cows caused by staphylococci, streptococci and other gram-positive bacteria sensitive to cloxacillin. |
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<b><i>Contraindications</i></b><b></b> |
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Do not administer to dry cows. |
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Hypersensitivity to ingredients or the whole preparation, which is extremely rare. |
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Administration and dosage |
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</p> |
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</div> |
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540 |
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|
|
541 |
|
|
|
542 |
|
|
<div align="justify"> |
543 |
|
|
<p style="text-align: justify;"> |
544 |
|
|
|
545 |
|
|
Milk out the udder, clean and disinfect the teat end. Shake the injector and warm it in the hand. Introduce carefully its tip into the beginning of the teat canal and slowly infuse the contents into the milk cistern, ducts and alveoli. Then press firmly the teat end with the thumb and forefinger of one hand and with the other hand gently massage the udder upward, from the teats to the udder base to ensure even distribution of the suspension in the upper parts of the udder. |
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 |
|
|
|
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 |
|
|
Treat the affected quarter 3 times in 48-hour intervals. Milk out the treated quarter during every milking. |
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 |
|
|
<b><i>Side effects</i></b> |
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 |
|
|
Unknown. |
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 |
|
|
<b><i>Warnings and precautions</i></b><b></b> |
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 |
|
|
If more cows in a herd are diseased, it is recommended to perform sensitivity test before the onset of treatment. |
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 |
|
|
The milkers must observe compulsory hygienic measures. |
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 |
|
|
It is not advisable to concomitantly administer intramammary penicillins and systemic tetracycline antibiotics. |
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 |
|
|
|
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>Withdrawal</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 |
dpavlin |
1.2 |
Milk from the treated quarters is not suitable for human consumption during the treatment and 72 hours after the last infusion. In other words, if the cows are milked twice daily, milk is suitable for consumption 6 milkings from the last dose of KLOKSAVET<b><sup>®</sup></b> M. |
850 |
dpavlin |
1.1 |
|
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 |
|
|
Meat, organs and other edible tissues - 7 days. |
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 |
|
|
|
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 |
|
|
<b><i>Storage</i></b> |
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 |
|
|
Store in a cool place up to 15°C. Keep away from children. |
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 |
|
|
|
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>Shelf life</i></b><b></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 |
|
|
Denoted on the packaging (18 months). |
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 |
|
|
|
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 |
|
|
<b><i>Legal category</i></b><b></b> |
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 |
|
|
On prescription only. |
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 |
|
|
|
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 |
|
|
<b><i>Supply</i></b><b></b> |
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 |
|
|
Box with 12 injectors of 5 mL suspension. |
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 |
|
|
<b></b> |
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 |
|
|
<b><i>Manufacturer</i></b><b></b> |
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 |
|
|
VETERINA Animal Health Ltd., Croatia |
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 |
|
|
|
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 |
|
|
|