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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>GUMPESKAL</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 bivalent oily vaccine against Gumboro and Newcastle disease</i> |
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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></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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<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 Newcastle disease virus (NDV) and Gumboro disease virus inactivated with formaldehyde. NDV is also dissociated with non-ionic detergent. Both immunogens are 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> |
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<div align="justify"> |
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<p style="text-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 the formation of specific antibodies for Gumboro and Newcastle disease viruses. |
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</p> |
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</div> |
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<b><i>Indications</i></b> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Immunoprophylaxis of heavy and light hybrids against Gumboro and Newcastle disease and immunisation 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><i>Contraindications</i></b> |
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</p> |
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</div> |
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Unknown. |
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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></i></b> |
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</p> |
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</div> |
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Administration, dosage and vaccination programme<b></b> |
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Before administration the vaccine should be heated to room temperature and shaken well prior to and occasionally during administration. GUMPESKAL<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. |
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</p> |
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</p> |
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</div> |
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The dose per bird is 0.5 mL. |
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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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As a rule, healthy 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> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Before being vaccinated with GUMPESKAL<b><sup>®</sup></b> the birds should be given live attenuated vaccine against Gumboro and Newcastle diseases. Time between these two vaccinations and administration of GUMPESKAL<b><sup>®</sup></b> 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> |
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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> |
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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 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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</div> |
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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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The vaccine is administered to all healthy birds and the whole flock. |
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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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Vaccination equipment should be sterile. |
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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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During vaccination care should be taken to avoid transmission of the infection from one flock to another. |
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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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Once opened use within 24 hours. |
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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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The vaccine should not be administered by i. v. route. |
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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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Avoid direct exposure to sunlight and high temperatures. |
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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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Packaging and vaccine leftovers must be disposed of in a safe way, e. g. sterilised by heat. |
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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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Beware of accidental injecting into the hand. In severe local reaction, seek medical advice (surgeon). |
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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>Withdrawal</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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Meat, and edible tissues of the vaccinated chicks - 0 days. |
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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></b> |
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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 dark place at 2-8°C (refrigerator). Keep away from children. Avoid freezing. |
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 |
Bottles of 100 mL (200 doses) and 500 mL (1000 doses). |
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 |
|
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="justify"> |
1208 |
<p style="text-align: justify;"> |
1209 |
|
1210 |
<b><i>Important note</i></b><b></b> |
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 |
The vaccine ensures sound immunisation against classical serotype of Gumboro disease virus. |
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 |
|
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 |
In every animal population there are some with poorer response to vaccination. In addition to proper storage and administration, success of vaccination depends on immunocompetence, i. e. on hereditary factors, subclinical diseases, condition of the animal, stress factors, concurrent administration of other drugs, etc. |
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 |
|