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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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</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>BRONHIKAL</b><b><sup>®</sup></b><b> I SPF and BRONHIKAL</b><b><sup>®</sup></b><b> II SPF</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>lyophilised vaccine against infectious bronchitis in poultry</i> |
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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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</div> |
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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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One dose of BRONHIKAL<sup>®</sup> I SPF<b> </b>vaccine<b> </b>for chicks<b> </b>contains at least 10<sup>3.5 </sup>EID<sub>50</sub> of attenuated live infectious bronchitis virus (H-120) grown in chick' embryos obtained from SPF eggs. |
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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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One dose of Bronhikal<sup>®</sup> II SPF vaccine for hens contains at least 10<sup>3.5 </sup>EID<sub>50</sub> of attenuated live infectious bronchitis virus (H-52) grown in chick' embryos obtained from SPF eggs. |
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</p> |
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</div> |
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</p> |
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</div> |
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H-120 strain has been more attenuated than H-52 strain. |
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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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<p style="text-align: justify;"> |
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The vaccine stimulates formation of specific antibodies for bronchitis virus in poultry. |
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</p> |
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</div> |
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</div> |
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<b><i>Indications</i></b> |
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</p> |
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</div> |
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Immunisation of healthy chicks and hens against infectious bronchitis. The chicks are vaccinated with Bronhikal<b><sup>®</sup></b> I (H-120) and the hens, relevant to epizootiologic situation, with Bronhikal<b><sup>®</sup></b> I (H-120) and Bronhikal<b><sup>®</sup></b> II (H-52). |
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</p> |
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</div> |
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</p> |
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</div> |
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<b><i>Contraindications</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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Bronhikal<b><sup>®</sup></b> II (H-52) is not used in primary immunisation of poultry. |
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</p> |
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</div> |
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</p> |
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</div> |
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<b><i>Administration and dosage</i></b><b></b> |
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</div> |
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Bronhikal<b><sup>®</sup></b>I SPF and Bronhikal<b><sup>®</sup></b> II SPF may be administered by the following routes: |
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</p> |
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</div> |
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</p> |
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</div> |
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<b><i>1. Oculonasally</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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One dose of the diluted vaccine, irrespective of the age and body weight, is 0.1 mL, i. e. two drops/bird. The vaccine is administered dropwise into the eye and nostril. |
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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>2. In drinking water</i></b> |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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Immediately before use reconstitute the vaccine in cold and clean water without chlorine or other disinfectants, in the dosage equivalent to the number of birds to be vaccinated. The number of doses should not be less than the number of birds. |
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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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Use 10 L of water to reconstitute 1000 vaccinal doses for the chicks in the first week of life and 40 L of water for the chicks aged two months and for older poultry. |
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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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To ensure the intake of medicated drinking water, the animals should be restricted from other sources of liquid 3 hours prior to treatment. Waterers should be clean, with no traces of food or disinfectant. Sufficient number of waterers should be provided, i. e. about 30% more than required for that age, to ensure that all birds take the water with the vaccine within one hour. |
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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>3. Spraying</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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Vaccination of the one-day old chicks is performed preferably in the hatchery or in the transport boxes. Use 100-150 mL of water, preferably distilled, to resuspend 1000 vaccinal doses. Use a sprayer forming 30-100 mm size particles. The particles for young birds are larger than for the old ones. First vaccination can be performed already in the hatchery, or later, relevant to other immunoprophylactic procedures. If the hens are already vaccinated with Bronhikal<b><sup>®</sup></b> I SPF, then Bronhikal<b><sup>®</sup></b>II SPF can be administered one month before the animals are mature. |
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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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<b><i>Immunity</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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Immunity is established 4-5 days after vaccination. In revaccinated birds it is maintained for at least one year. |
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</p> |
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</div> |
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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> |
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</p> |
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</div> |
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| 769 |
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| 770 |
<div align="justify"> |
| 771 |
<p style="text-align: justify;"> |
| 772 |
|
| 773 |
Bronhikal<b><sup>®</sup></b> II SPF is administered exclusively to the poultry already vaccinated with Bronhikal<b><sup>®</sup></b> I SPF, irrespective of its age. |
| 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 |
If given as the first vaccine Bronhikal<b><sup>®</sup></b> II SPF produces severe vaccinal reactions. In the laying hens it may cause a transient drop in egg production. |
| 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 |
|
| 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 |
Once reconstituted use within 3 hours. |
| 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 |
Packaging and vaccine leftovers must be disposed of in a safe way, preferably by boiling in water. |
| 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 |
In every animal population there are some with poorer response to vaccination. Immune response is affected by hereditary factors, subclinical diseases, health condition, stress, concurrent administration of other medicines, storage and administration of the vaccine. |
| 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 |
|
| 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 |
<b><i>Withdrawal</i></b> |
| 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 |
Meat, organs and other edible tissues - 0 days. |
| 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 |
|
| 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 |
<b><i>Storage</i></b> |
| 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 |
Store in a dark place at 2-8°C (refrigerator). Keep away from children. |
| 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 |
|
| 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 |
<b><i>Shelf life</i></b> |
| 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 |
Denoted on the packaging (18 months). |
| 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 |
|
| 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><i>Legal category</i></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 |
On prescription only. |
| 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 |
|
| 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><i>Supply</i></b><b></b> |
| 1192 |
|
| 1193 |
</p> |
| 1194 |
</div> |
| 1195 |
|
| 1196 |
|
| 1197 |
|
| 1198 |
|
| 1199 |
|
| 1200 |
|
| 1201 |
|
| 1202 |
|
| 1203 |
|
| 1204 |
|
| 1205 |
|
| 1206 |
|
| 1207 |
<div align="justify"> |
| 1208 |
<p style="text-align: justify;"> |
| 1209 |
|
| 1210 |
Bottles with 1000 and 2000 vaccinal doses with diluent. |
| 1211 |
|
| 1212 |
</p> |
| 1213 |
</div> |
| 1214 |
|
| 1215 |
|
| 1216 |
|
| 1217 |
|
| 1218 |
|
| 1219 |
|
| 1220 |
|
| 1221 |
|
| 1222 |
|
| 1223 |
|
| 1224 |
|
| 1225 |
|
| 1226 |
<div align="justify"> |
| 1227 |
<p style="text-align: justify;"> |
| 1228 |
|
| 1229 |
|
| 1230 |
|
| 1231 |
</p> |
| 1232 |
</div> |
| 1233 |
|
| 1234 |
|
| 1235 |
|
| 1236 |
|
| 1237 |
|
| 1238 |
|
| 1239 |
|
| 1240 |
|
| 1241 |
|
| 1242 |
|
| 1243 |
|
| 1244 |
|
| 1245 |
<div align="justify"> |
| 1246 |
<p style="text-align: justify;"> |
| 1247 |
|
| 1248 |
<b><i>Manufacturer</i></b> |
| 1249 |
|
| 1250 |
</p> |
| 1251 |
</div> |
| 1252 |
|
| 1253 |
|
| 1254 |
|
| 1255 |
|
| 1256 |
|
| 1257 |
|
| 1258 |
|
| 1259 |
|
| 1260 |
|
| 1261 |
|
| 1262 |
|
| 1263 |
|
| 1264 |
<div align="justify"> |
| 1265 |
<p style="text-align: justify;"> |
| 1266 |
|
| 1267 |
VETERINA Animal Health Ltd., Croatia |
| 1268 |
|
| 1269 |
</p> |
| 1270 |
</div> |
| 1271 |
|
| 1272 |
|
| 1273 |
|
| 1274 |
|
| 1275 |
|
| 1276 |
|
| 1277 |
|
| 1278 |
|
| 1279 |
|
| 1280 |
|
| 1281 |
|
| 1282 |
|
| 1283 |
<div align="justify"> |
| 1284 |
<p style="text-align: justify;"> |
| 1285 |
|
| 1286 |
|
| 1287 |
|
| 1288 |
</p> |
| 1289 |
</div> |
| 1290 |
|
| 1291 |
|
| 1292 |
|
| 1293 |
|
| 1294 |
|
| 1295 |
|
| 1296 |
|
| 1297 |
|
| 1298 |
|
| 1299 |
|
| 1300 |
|
| 1301 |
|
| 1302 |
<div align="left"> |
| 1303 |
<p style="text-align: left;"> |
| 1304 |
|
| 1305 |
|
| 1306 |
|
| 1307 |
</p> |
| 1308 |
</div> |
| 1309 |
|
| 1310 |
|
| 1311 |
|
| 1312 |
|
| 1313 |
|
| 1314 |
|
| 1315 |
|
| 1316 |
<!--Section Ends--> |
| 1317 |
|
| 1318 |
|
| 1319 |
|
| 1320 |
|
| 1321 |
|
| 1322 |
|
| 1323 |
|
| 1324 |
|
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| 
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