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<div align="justify"> |
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<p style="text-align: justify;"> |
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<b>SULFAKOMB</b><b> PLUS</b><b><sup>®</sup></b> |
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</p> |
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</div> |
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<i>medicated additive for swine</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><i>Composition</i></b> |
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</p> |
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</div> |
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1 kg contains: |
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</p> |
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<p style="text-align: justify;"> |
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Tylosin as tylosin phosphate 20 g |
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</p> |
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Sulfadimidine 70 g |
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</p> |
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Carrier and adjuvants up to 1000 g |
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</p> |
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</div> |
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<b><i>Action</i></b> |
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Sulfakomb Plus<b><sup>®</sup></b> contains antibiotic tylosin and a synthetic chemotherapeutic sulfadimidine. Both active ingredients complement one another, acting antimicrobially against major pathogens in swine, particularly in young animals. |
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</p> |
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</div> |
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- Tylosin, a macrolide antibiotic, is used for the control and treatment of animals only. It has a wide antimicrobial spectrum of activity and inhibits protein synthesis during growth and multiplication of gram-positive streptococci, staphylococci, Corynebacteria, clostridia and the cause of erysipelas (<i>Erysipelothrix insidiosa</i>). In gram-negative pasteurellae, salmonellae and spirochetes (<i>Serpulina hyodysenteriae</i> and <i>Leptospira</i> sp.) it is slightly less effective. Its antimicrobial action on mycoplasma is very marked. When taken orally tylosin is rapidly and completely resorbed and extensively distributed in most organs and tissues, achieving high levels in lungs, liver, mammary gland and kidneys. Most of it is excreted through bile (85%) and less via urine. |
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</p> |
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- Sulfadimidine acts bacteriostatically, particularly on gram-positive bacteria (haemolytic streptococci, pneumococci and bacilli) as well as on gram-negative pasteurellae, salmonellae and some rickettsiae. In the sensitive organisms it competitively inhibits the synthesis of folic acid. Combination with tylosin is very effective against many pathogens causing respiratory and gastrointestinal diseases in young animals. |
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<b><i>Indications</i></b> |
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</p> |
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Metaphylaxis of primary and secondary bacterial infections in swine: |
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</p> |
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- reduction of the incidence of atrophic rhinitis (<i>Bordetella bronchiseptica</i>) and alleviation of the disease; |
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- prevention of the damages caused by enzootic pneumonia and atrophic rhinitis in terms of reduced weight gain and feed conversion; |
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- control of pneumonia in piglets (<i>Pasteurella multocida</i> and <i>Actinomyces pyogenes</i>); |
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</div> |
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- prophylaxis of dysentery, i. e. bloody scours (<i>Serpulina hyodysenteriae</i>), bacterial enteritis (<i>Salmonella</i> spp.) and non-specific bacterial enteritis under stress conditions (weaning, transportation, change of housing, overcrowding, change of feed); |
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</p> |
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</div> |
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- control of diarrhea in piglets resulting from MMA syndrome in sows and gilts. |
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</p> |
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</div> |
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<b><i></i></b> |
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</p> |
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Contraindications |
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</p> |
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</div> |
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Sulfakomb Plus<b><sup>®</sup></b> should not be given to species and classes for which it is not registered (ungulates, ruminants and fowl). |
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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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Swine with severe hepatic and renal impairment should not be given the preparation. |
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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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Sulfakomb Plus<b><sup>®</sup></b> is contraindicated in allergic reactions to the preparation, which is extremely rare. |
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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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</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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Sulfakomb Plus<b><sup>®</sup></b> is given to swine over 30 days, homogeneously mixed with feed in the amount of 0.5%, i. e. 5 kg of preparation/1 T of feed, making 100 ppm of tylosin and 100 ppm of sulfadimidine. In usual daily diet this is equal ratio of tylosin and sulfadimidine, i. e. 3 -7 mg/kg of b. w. both. |
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</p> |
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</div> |
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</p> |
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<b><i>Side effects</i></b> |
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</p> |
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</div> |
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<div align="justify"> |
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Unknown. |
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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>Warnings and precautions</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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Sick animals taking scarce feed, should be treated with medicated drinking water, or preferably by parenteral administration. |
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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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If after three days of treatment there is no apparent improvement, the preparation may be continued only if laboratory tests show sensitivity of the causative organism to tylosin/sulfadimidine combination. |
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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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849 |
Sulfakomb Plus<b><sup>®</sup></b> should not be given concomitantly with other preparations or medicated additives. |
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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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|
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 |
The feed containing Sulfakomb Plus<b><sup>®</sup></b> should not contain more than 2% of bentonite or its analogues (e. g. Benal<b><sup>®</sup></b>), particularly at the end of the fattening period. |
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 |
To ensure easy and homogeneous mixing of Sulfakomb Plus<b><sup>®</sup></b><sup> </sup>with the complete feed, mix it beforehand with some feed<sup> </sup>(e. g. 7-20 kg), or with one of the complete feed components (e. g. mineral additives). |
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 |
As with other antimicrobials, avoid direct contact with mucosa and skin. When using wear face/eyes protection, suitable protective clothing and shoes. Do not smoke, eat or drink. After handling thoroughly wash the hands with water and soap. |
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 |
Packaging and leftovers must be disposed of in a safe way. |
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 |
Usual pelleting procedure does not diminish potency of the mixed preparation. |
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>Withdrawal</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 |
Meat, organs and other edible tissues of swine - 12 days. |
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>Storage</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 |
Store in a dry and dark place, protected from humidity and at controlled room temperature (15-25°C). Keep away from children. |
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>Legal category</i></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 |
On prescription or a written veterinarian's request to prepare. |
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>Shelf life</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 |
Denoted on the packaging (2 years in the original pack). |
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="justify"> |
1303 |
<p style="text-align: justify;"> |
1304 |
|
1305 |
Once prepared use within 3 months. |
1306 |
|
1307 |
</p> |
1308 |
</div> |
1309 |
|
1310 |
|
1311 |
|
1312 |
|
1313 |
|
1314 |
|
1315 |
|
1316 |
|
1317 |
|
1318 |
|
1319 |
|
1320 |
|
1321 |
<div align="justify"> |
1322 |
<p style="text-align: justify;"> |
1323 |
|
1324 |
|
1325 |
|
1326 |
</p> |
1327 |
</div> |
1328 |
|
1329 |
|
1330 |
|
1331 |
|
1332 |
|
1333 |
|
1334 |
|
1335 |
|
1336 |
|
1337 |
|
1338 |
|
1339 |
|
1340 |
<div align="justify"> |
1341 |
<p style="text-align: justify;"> |
1342 |
|
1343 |
<b><i>Supply</i></b> |
1344 |
|
1345 |
</p> |
1346 |
</div> |
1347 |
|
1348 |
|
1349 |
|
1350 |
|
1351 |
|
1352 |
|
1353 |
|
1354 |
|
1355 |
|
1356 |
|
1357 |
|
1358 |
|
1359 |
<div align="justify"> |
1360 |
<p style="text-align: justify;"> |
1361 |
|
1362 |
Polyethylene/natron bags with 5 kg and 25 kg. |
1363 |
|
1364 |
</p> |
1365 |
</div> |
1366 |
|
1367 |
|
1368 |
|
1369 |
|
1370 |
|
1371 |
|
1372 |
|
1373 |
|
1374 |
|
1375 |
|
1376 |
|
1377 |
|
1378 |
<div align="justify"> |
1379 |
<p style="text-align: justify;"> |
1380 |
|
1381 |
|
1382 |
|
1383 |
</p> |
1384 |
</div> |
1385 |
|
1386 |
|
1387 |
|
1388 |
|
1389 |
|
1390 |
|
1391 |
|
1392 |
|
1393 |
|
1394 |
|
1395 |
|
1396 |
|
1397 |
<div align="justify"> |
1398 |
<p style="text-align: justify;"> |
1399 |
|
1400 |
<b><i>Manufacturer</i></b> |
1401 |
|
1402 |
</p> |
1403 |
</div> |
1404 |
|
1405 |
|
1406 |
|
1407 |
|
1408 |
|
1409 |
|
1410 |
|
1411 |
|
1412 |
|
1413 |
|
1414 |
|
1415 |
|
1416 |
<div align="justify"> |
1417 |
<p style="text-align: justify;"> |
1418 |
|
1419 |
VETERINA Animal Health Ltd., Croatia |
1420 |
|
1421 |
</p> |
1422 |
</div> |
1423 |
|
1424 |
|
1425 |
|
1426 |
|
1427 |
|
1428 |
|
1429 |
|
1430 |
|
1431 |
|
1432 |
|
1433 |
|
1434 |
|
1435 |
<div align="justify"> |
1436 |
<p style="text-align: justify;"> |
1437 |
|
1438 |
|
1439 |
|
1440 |
</p> |
1441 |
</div> |
1442 |
|
1443 |
|
1444 |
|
1445 |
|
1446 |
|
1447 |
|
1448 |
|
1449 |
|
1450 |
|
1451 |
|
1452 |
|
1453 |
|
1454 |
<div align="left"> |
1455 |
<p style="text-align: left;"> |
1456 |
|
1457 |
|
1458 |
|
1459 |
</p> |
1460 |
</div> |
1461 |
|
1462 |
|
1463 |
|
1464 |
|
1465 |
|
1466 |
|
1467 |
|
1468 |
<!--Section Ends--> |
1469 |
|
1470 |
|
1471 |
|
1472 |
|
1473 |
|
1474 |
|
1475 |
|
1476 |
|