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Revision 1.1 - (show annotations)
Thu Apr 5 12:26:37 2001 UTC (18 years ago) by dpavlin
Branch: MAIN
CVS Tags: HEAD
File MIME type: text/html
smpc for veterina

1
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3 <!--Section Begins--><br>
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15 </p>
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29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>VETOFLOK</b><b><sup>®</sup></b><b> 10%</b>
33
34 </p>
35 </div>
36
37
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45
46
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48 <div align="justify">
49 <p style="text-align: justify;">
50
51 <i>solution for oral administration</i>
52
53 </p>
54 </div>
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67 <div align="justify">
68 <p style="text-align: justify;">
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70 <b></b>
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72 </p>
73 </div>
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86 <div align="justify">
87 <p style="text-align: justify;">
88
89 <b><i>Composition</i></b>
90
91 </p>
92 </div>
93
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95
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100
101
102
103
104
105 <div align="justify">
106 <p style="text-align: justify;">
107
108 1 mL contains 100 mg of enrofloxacin.
109
110 </p>
111 </div>
112
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119
120
121
122
123
124 <div align="justify">
125 <p style="text-align: justify;">
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127
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129 </p>
130 </div>
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141
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143 <div align="justify">
144 <p style="text-align: justify;">
145
146 <b><i>Action</i></b><b></b>
147
148 </p>
149 </div>
150
151
152
153
154
155
156
157
158
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160
161
162 <div align="justify">
163 <p style="text-align: justify;">
164
165 Enrofloxacin is an antimicrobial, a synthetic derivative of quinolone carboxylic acid pertaining to floroquinolones, i. e. 2nd generation quinolones. In the sensitive organisms it inhibits the action of DNA gyrase, the enzyme that catalyses DNA replication in the cell nucleus, and in very low levels acts against bacteria and mycoplasma. Vetoflok<b><sup>®</sup></b> has a very broad spectrum of activity that includes major gram-negative (<i>E</i>. <i>coli</i>, <i>Klebsiella</i> spp., <i>Salmonella</i> spp., <i>Proteus</i> spp., <i>Campylobacter</i> spp., <i>Pseudomonas</i> <i>aeruginosa</i>, <i>Bordetella</i> spp., <i>Pasteurella</i> spp., <i>Haemophilus paragallinarum</i> and <i>Actinobacillus</i> spp.) and gram-positive bacteria (<i>Staphylococcus</i> spp., <i>Listeria monocytogenes</i>, <i>Corynebacterium</i> spp., <i>Erysipelothrix</i> <i>insidiosa</i> and <i>Clostridium</i> spp.), as well as mycoplasma and Chlamydia. Post-antibiotic effect is maintained over 4-8 hours. In addition to antibacterial effect of enrofloxacin, there is also the same effect of its basic metabolite - ciprofloxacin. Resorption of Vetoflok<b><sup>®</sup></b> is equally good when given orally or parenterally, and its bodily distribution is rapid and extensive. Peak tissue levels are 2-3 times in excess of blood-levels. Markedly high enrofloxacin concentrations have been recorded in lungs, liver, kidneys, bones and lymphatic organs. Pharmacodynamic of the preparation is quite different from that of to-date used similar drugs. Therefore, Vetoflok<b><sup>®</sup></b> is bactericidal against the organisms resistant or multiply resistant to beta-lactam-, tetracycline-, macrolide-, aminoglycoside- and sulfonamide antibiotics.
166
167 </p>
168 </div>
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181 <div align="justify">
182 <p style="text-align: justify;">
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184
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186 </p>
187 </div>
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198
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200 <div align="justify">
201 <p style="text-align: justify;">
202
203 <b><i>Indications</i></b><b></b>
204
205 </p>
206 </div>
207
208
209
210
211
212
213
214
215
216
217
218
219 <div align="justify">
220 <p style="text-align: justify;">
221
222 Treatment and prophylaxis of primary and secondary diseases of respiratory and gastrointestinal tract in hens and turkeys (broilers, fattening turkeys, pullets, parent flocks, parents of broilers and layers, etc.) caused by enrofloxacin-sensitive bacteria and mycoplasma (<i>E. coli</i>, <i>Salmonella</i> spp., <i>Mycoplasma</i> spp., <i>Pasteurella</i> spp., <i>Haemophilus paragallinarum</i>, <i>Staphylococcus</i> spp., <i>Erysipelothrix</i> <i>insidiosa</i>, <i>Campylobacter jejuni</i>, etc.).
223
224 </p>
225 </div>
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231
232
233
234
235
236
237
238 <div align="justify">
239 <p style="text-align: justify;">
240
241
242
243 </p>
244 </div>
245
246
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248
249
250
251
252
253
254
255
256
257 <div align="justify">
258 <p style="text-align: justify;">
259
260 <b><i>Contraindications</i></b><b></b>
261
262 </p>
263 </div>
264
265
266
267
268
269
270
271
272
273
274
275
276 <div align="justify">
277 <p style="text-align: justify;">
278
279 Pullets should not be given the preparation 14 days before point of lay.
280
281 </p>
282 </div>
283
284
285
286
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289
290
291
292
293
294
295 <div align="justify">
296 <p style="text-align: justify;">
297
298
299
300 </p>
301 </div>
302
303
304
305
306
307
308
309
310
311
312
313
314 <div align="justify">
315 <p style="text-align: justify;">
316
317 Resistance to floroquinolones.
318
319 </p>
320 </div>
321
322
323
324
325
326
327
328
329
330
331
332
333 <div align="justify">
334 <p style="text-align: justify;">
335
336
337
338 </p>
339 </div>
340
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347
348
349
350
351
352 <div align="justify">
353 <p style="text-align: justify;">
354
355 <b><i>Administration</i></b><b></b>
356
357 </p>
358 </div>
359
360
361
362
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364
365
366
367
368
369
370
371 <div align="justify">
372 <p style="text-align: justify;">
373
374 Vetoflok<b><sup>®</sup></b> 10% is dissolved in drinking water prepared immediately prior to use.
375
376 </p>
377 </div>
378
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390 <div align="justify">
391 <p style="text-align: justify;">
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393
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395 </p>
396 </div>
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404
405
406
407
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409 <div align="justify">
410 <p style="text-align: justify;">
411
412 During treatment the birds should have free access to medicated water and restricted from other sources of liquid.
413
414 </p>
415 </div>
416
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428 <div align="justify">
429 <p style="text-align: justify;">
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431
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433 </p>
434 </div>
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447 <div align="justify">
448 <p style="text-align: justify;">
449
450 Always prepare a fresh solution.
451
452 </p>
453 </div>
454
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463
464
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466 <div align="justify">
467 <p style="text-align: justify;">
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471 </p>
472 </div>
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482
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485 <div align="justify">
486 <p style="text-align: justify;">
487
488 Once prepared use within 24 hours.
489
490 </p>
491 </div>
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500
501
502
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504 <div align="justify">
505 <p style="text-align: justify;">
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509 </p>
510 </div>
511
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519
520
521
522
523 <div align="justify">
524 <p style="text-align: justify;">
525
526 <b><i>Dosage</i></b><b></b>
527
528 </p>
529 </div>
530
531
532
533
534
535
536
537
538
539
540 <ul>
541 <li>
542
543 <div align="justify">
544 <p style="text-align: justify;">
545
546 Broilers, fattening turkeys, parents of meat-type poultry aged 1-3 weeks;
547
548 </p>
549 </div>
550
551
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555
556
557
558
559
560 </ul>
561
562 <div align="justify">
563 <p style="text-align: justify;">
564
565 layers and their parent flocks aged 1-5 weeks:
566
567 </p>
568 </div>
569
570
571
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576
577
578
579
580
581 <div align="justify">
582 <p style="text-align: justify;">
583
584 0.5 mL of Vetoflok<b><sup>®</sup></b> 10% per 1 L of water, i. e. 5 mL/10 L; 50 mL/100 L. (50 mg of enrofloxacin/1 L, i. e. about 10 mg of enrofloxacin/kg of b. w./day).
585
586 </p>
587 </div>
588
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599
600 <div align="justify">
601 <p style="text-align: justify;">
602
603
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605 </p>
606 </div>
607
608
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610
611
612
613
614
615
616
617 <ul>
618 <li>
619
620 <div align="justify">
621 <p style="text-align: justify;">
622
623 Salmonellosis and pasteurellosis, mixed and chronic infections in broilers, fattening turkeys and parents of meat-type poultry over 3 weeks of age, layers and their parents over 5 weeks of age:
624
625 </p>
626 </div>
627
628
629
630
631
632
633
634
635
636
637 </ul>
638
639 <div align="justify">
640 <p style="text-align: justify;">
641
642 1 mL of Vetoflok<b><sup>®</sup></b> 10% per 1 L of water, i. e. 10 mL/10 L; 100 mL/100 L. (100 mg of enrofloxacin/1 L, i. e. 10 mg of enrofloxacin per 1 kg of b. w./day).
643
644 </p>
645 </div>
646
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653
654
655
656
657
658 <div align="justify">
659 <p style="text-align: justify;">
660
661
662
663 </p>
664 </div>
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672
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674
675
676
677 <div align="justify">
678 <p style="text-align: justify;">
679
680 Older birds gradually decrease their daily water consumption. This allows administration of higher doses.
681
682 </p>
683 </div>
684
685
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689
690
691
692
693
694
695
696 <div align="justify">
697 <p style="text-align: justify;">
698
699
700
701 </p>
702 </div>
703
704
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706
707
708
709
710
711
712
713 <ul>
714 <li>
715
716 <div align="justify">
717 <p style="text-align: justify;">
718
719 Treatment usually lasts over 3-5 consecutive days. In case of salmonellosis, pasteurellosis, mixed of chronic infections, Vetoflok<b><sup>®</sup></b>10% should be given during 5-10 consecutive days.
720
721 </p>
722 </div>
723
724
725
726
727
728
729
730
731
732
733 </ul>
734
735 <div align="justify">
736 <p style="text-align: justify;">
737
738
739
740 </p>
741 </div>
742
743
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747
748
749
750
751
752
753
754 <div align="justify">
755 <p style="text-align: justify;">
756
757 <b><i>Warnings and precautions</i></b><b></b>
758
759 </p>
760 </div>
761
762
763
764
765
766
767
768
769
770
771
772
773 <div align="justify">
774 <p style="text-align: justify;">
775
776 The purpose of salmonellosis treatment is to alleviate clinical symptoms, decrease mortality and in several weeks time to cut down the excretion of bacteria. Enrofloxacin cannot entirely eradicate salmonellosis or mycoplasmosis from the infected flock.
777
778 </p>
779 </div>
780
781
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784
785
786
787
788
789
790
791
792 <div align="justify">
793 <p style="text-align: justify;">
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795
796
797 </p>
798 </div>
799
800
801
802
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805
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807
808
809
810
811 <div align="justify">
812 <p style="text-align: justify;">
813
814 If floroquinolones are given to chicks during the growing period and under elevated temperature in the houses, their intake from the medicated drinking water over a prolonged period will be much higher, which might damage their joint cartilage and cause walking disorders.
815
816 </p>
817 </div>
818
819
820
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822
823
824
825
826
827
828
829
830 <div align="justify">
831 <p style="text-align: justify;">
832
833
834
835 </p>
836 </div>
837
838
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841
842
843
844
845
846
847
848
849 <div align="justify">
850 <p style="text-align: justify;">
851
852 Resistance to enrofloxacin is very rarely developed. If after three days of treatment there is no clinical improvement, perform sensitivity test.
853
854 </p>
855 </div>
856
857
858
859
860
861
862
863
864
865
866
867
868 <div align="justify">
869 <p style="text-align: justify;">
870
871
872
873 </p>
874 </div>
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883
884
885
886
887 <div align="justify">
888 <p style="text-align: justify;">
889
890 To avoid interaction with other drugs, do not administer concomitantly tetracycline or macrolide antibiotics.
891
892 </p>
893 </div>
894
895
896
897
898
899
900
901
902
903
904
905
906 <div align="justify">
907 <p style="text-align: justify;">
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909
910
911 </p>
912 </div>
913
914
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920
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922
923
924
925 <div align="justify">
926 <p style="text-align: justify;">
927
928 Enrofloxacin is not suitable in the control of streptococcal infections.
929
930 </p>
931 </div>
932
933
934
935
936
937
938
939
940
941
942
943
944 <div align="justify">
945 <p style="text-align: justify;">
946
947
948
949 </p>
950 </div>
951
952
953
954
955
956
957
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960
961
962
963 <div align="justify">
964 <p style="text-align: justify;">
965
966 <b><i>Withdrawal</i></b><b></b>
967
968 </p>
969 </div>
970
971
972
973
974
975
976
977
978
979
980
981
982 <div align="justify">
983 <p style="text-align: justify;">
984
985 Meat and other edible tissues -
986
987 </p>
988 </div>
989
990
991
992
993
994
995
996
997
998
999
1000
1001 <div align="justify">
1002 <p style="text-align: justify;">
1003
1004 hens 7 days
1005
1006 </p>
1007 </div>
1008
1009
1010
1011
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1015
1016
1017
1018
1019
1020 <div align="justify">
1021 <p style="text-align: justify;">
1022
1023 turkeys 10 days
1024
1025 </p>
1026 </div>
1027
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1032
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1036
1037
1038
1039 <div align="justify">
1040 <p style="text-align: justify;">
1041
1042 Eggs 9 days
1043
1044 </p>
1045 </div>
1046
1047
1048
1049
1050
1051
1052
1053
1054
1055
1056
1057
1058 <div align="justify">
1059 <p style="text-align: justify;">
1060
1061
1062
1063 </p>
1064 </div>
1065
1066
1067
1068
1069
1070
1071
1072
1073
1074
1075
1076
1077 <div align="justify">
1078 <p style="text-align: justify;">
1079
1080 <b><i>Storage</i></b><b></b>
1081
1082 </p>
1083 </div>
1084
1085
1086
1087
1088
1089
1090
1091
1092
1093
1094
1095
1096 <div align="justify">
1097 <p style="text-align: justify;">
1098
1099 Store in a dark place at controlled room temperature (up to 25°C). Keep away from children. Avoid freezing.
1100
1101 </p>
1102 </div>
1103
1104
1105
1106
1107
1108
1109
1110
1111
1112
1113
1114
1115 <div align="justify">
1116 <p style="text-align: justify;">
1117
1118
1119
1120 </p>
1121 </div>
1122
1123
1124
1125
1126
1127
1128
1129
1130
1131
1132
1133
1134 <div align="justify">
1135 <p style="text-align: justify;">
1136
1137 <b><i>Shelf life</i></b>
1138
1139 </p>
1140 </div>
1141
1142
1143
1144
1145
1146
1147
1148
1149
1150
1151
1152
1153 <div align="justify">
1154 <p style="text-align: justify;">
1155
1156 Denoted on the packaging (3 years in the original pack).
1157
1158 </p>
1159 </div>
1160
1161
1162
1163
1164
1165
1166
1167
1168
1169
1170
1171
1172 <div align="justify">
1173 <p style="text-align: justify;">
1174
1175
1176
1177 </p>
1178 </div>
1179
1180
1181
1182
1183
1184
1185
1186
1187
1188
1189
1190
1191 <div align="justify">
1192 <p style="text-align: justify;">
1193
1194 <b><i>Legal category</i></b><b></b>
1195
1196 </p>
1197 </div>
1198
1199
1200
1201
1202
1203
1204
1205
1206
1207
1208
1209
1210 <div align="justify">
1211 <p style="text-align: justify;">
1212
1213 On prescription only.
1214
1215 </p>
1216 </div>
1217
1218
1219
1220
1221
1222
1223
1224
1225
1226
1227
1228
1229 <div align="justify">
1230 <p style="text-align: justify;">
1231
1232
1233
1234 </p>
1235 </div>
1236
1237
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1239
1240
1241
1242
1243
1244
1245
1246
1247
1248 <div align="justify">
1249 <p style="text-align: justify;">
1250
1251 <b><i>Supply</i></b>
1252
1253 </p>
1254 </div>
1255
1256
1257
1258
1259
1260
1261
1262
1263
1264
1265
1266
1267 <div align="justify">
1268 <p style="text-align: justify;">
1269
1270 Bottle with 100 mL and 1000 mL.
1271
1272 </p>
1273 </div>
1274
1275
1276
1277
1278
1279
1280
1281
1282
1283
1284
1285
1286 <div align="justify">
1287 <p style="text-align: justify;">
1288
1289
1290
1291 </p>
1292 </div>
1293
1294
1295
1296
1297
1298
1299
1300
1301
1302
1303
1304
1305 <div align="justify">
1306 <p style="text-align: justify;">
1307
1308 <b><i>Manufacturer</i></b>
1309
1310 </p>
1311 </div>
1312
1313
1314
1315
1316
1317
1318
1319
1320
1321
1322
1323
1324 <div align="justify">
1325 <p style="text-align: justify;">
1326
1327 VETERINA Animal Health Ltd., Croatia
1328
1329 </p>
1330 </div>
1331
1332
1333
1334
1335
1336
1337
1338
1339
1340
1341
1342
1343 <div align="justify">
1344 <p style="text-align: justify;">
1345
1346
1347
1348 </p>
1349 </div>
1350
1351
1352
1353
1354
1355
1356
1357
1358
1359
1360
1361
1362 <div align="left">
1363 <p style="text-align: left;">
1364
1365
1366
1367 </p>
1368 </div>
1369
1370
1371
1372
1373
1374
1375
1376 <!--Section Ends-->
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