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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
2
3 <!--Section Begins--><br>
4
5
6
7
8
9
10 <div align="justify">
11 <p style="text-align: justify;">
12
13
14
15 </p>
16 </div>
17
18
19
20
21
22
23
24
25
26
27
28
29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>TRIMETOSUL</b><b><sup>®</sup></b><b> P</b>
33
34 </p>
35 </div>
36
37
38
39
40
41
42
43
44
45
46
47
48 <div align="justify">
49 <p style="text-align: justify;">
50
51 <i>medicated additive</i>
52
53 </p>
54 </div>
55
56
57
58
59
60
61
62
63
64
65
66
67 <div align="justify">
68 <p style="text-align: justify;">
69
70
71
72 </p>
73 </div>
74
75
76
77
78
79
80
81
82
83
84
85
86 <div align="justify">
87 <p style="text-align: justify;">
88
89 <b><i>Composition</i></b>
90
91 </p>
92 </div>
93
94
95
96
97
98
99
100
101
102
103
104
105 <div align="justify">
106 <p style="text-align: justify;">
107
108 1 kg contains:
109
110 </p>
111 </div>
112
113
114
115
116
117
118
119
120
121
122
123
124 <div align="justify">
125 <p style="text-align: justify;">
126
127 Trimethoprim 24 g
128
129 </p>
130 </div>
131
132
133
134
135
136
137
138
139
140
141
142
143 <div align="justify">
144 <p style="text-align: justify;">
145
146 Sulfafurazole 120 g
147
148 </p>
149 </div>
150
151
152
153
154
155
156
157
158
159
160
161
162 <div align="justify">
163 <p style="text-align: justify;">
164
165 Carrier and adjuvants up to 1000 g
166
167 </p>
168 </div>
169
170
171
172
173
174
175
176
177
178
179
180
181 <div align="justify">
182 <p style="text-align: justify;">
183
184
185
186 </p>
187 </div>
188
189
190
191
192
193
194
195
196
197
198
199
200 <div align="justify">
201 <p style="text-align: justify;">
202
203 <b><i>Action</i></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 Trimetosul<b><sup>®</sup></b> P is a potentiated sulfonamide preparation of a broad antimicrobial action, which in the sensitive organisms interferes with the synthesis of nucleic acids. Its active ingredients, sulfafurazole and trimethoprim, inhibit in two consecutive steps bacterial and protozoal synthesis of folic acid. Given their synergistic action, in addition to bacteriostatic effect, they exert bactericidal as well. Combination of these two ingredients ensures desired effect of lower doses than required for each of them separately. Potentiated sulfonamides reduce the risk of resistance.
223
224 </p>
225 </div>
226
227
228
229
230
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
247
248
249
250
251
252
253
254
255
256
257 <div align="justify">
258 <p style="text-align: justify;">
259
260 Trimetosul<b><sup>®</sup></b> P acts against many gram-positive and gram-negative organisms (streptococci, staphylococci, diplococci, <i>Clostridium perfringens</i>, Corynebacteria, shigellae, klebsiellae and actinomycetae) and is particularly effective in the management of <i>E.</i> <i>coli</i>, <i>Salmonella</i> spp, and <i>Pasteurella</i> spp. infections.
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
280
281 </p>
282 </div>
283
284
285
286
287
288
289
290
291
292
293
294
295 <div align="justify">
296 <p style="text-align: justify;">
297
298 However, potentiated combinations of sulfonamide and trimethoprim are not efficient against mycoplasma, rickettsiae and spirochetes (<i>Serpulina</i> <i>hyodysenteriae</i>, <i>Leptospira</i> spp.), <i>Pseudomonas</i> <i>aeruginosa</i> and <i>Erysipelothrix</i> <i>insidiosa</i>.
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
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 Active ingredients are extensively resorbed from gastrointestinal tract and rapidly achieve effective blood- and tissue-levels. Therefore, they are equally effective in the intestines and the organs.
337
338 </p>
339 </div>
340
341
342
343
344
345
346
347
348
349
350
351
352 <div align="justify">
353 <p style="text-align: justify;">
354
355
356
357 </p>
358 </div>
359
360
361
362
363
364
365
366
367
368
369
370
371 <div align="justify">
372 <p style="text-align: justify;">
373
374 <b><i>Indications</i></b>
375
376 </p>
377 </div>
378
379
380
381
382
383
384
385
386
387
388
389
390 <div align="justify">
391 <p style="text-align: justify;">
392
393 Treatment of primary and secondary bacterial infections; prevention of stress conditions following weaning, transportation, change of housing, feed, etc.
394
395 </p>
396 </div>
397
398
399
400
401
402
403
404
405
406
407
408
409 <div align="justify">
410 <p style="text-align: justify;">
411
412
413
414 </p>
415 </div>
416
417
418
419
420
421
422
423
424
425
426
427
428 <div align="justify">
429 <p style="text-align: justify;">
430
431 <i>Swine:</i>
432
433 </p>
434 </div>
435
436
437
438
439
440
441
442
443
444
445
446
447 <div align="justify">
448 <p style="text-align: justify;">
449
450 Colibacillosis, salmonellosis, atrophic rhinitis, pneumonia caused by the organisms sensitive to potentiated sulfonamides, MMA syndrome in sows (supportive parenteral treatment is necessary), systemic bacterial infections and other diseases.
451
452 </p>
453 </div>
454
455
456
457
458
459
460
461
462
463
464
465
466 <div align="justify">
467 <p style="text-align: justify;">
468
469
470
471 </p>
472 </div>
473
474
475
476
477
478
479
480
481
482
483
484
485 <div align="justify">
486 <p style="text-align: justify;">
487
488 <i>Calves-heifers:</i>
489
490 </p>
491 </div>
492
493
494
495
496
497
498
499
500
501
502
503
504 <div align="justify">
505 <p style="text-align: justify;">
506
507 Bacterial enteritis (<i>E.</i> <i>coli</i>, <i>Salmonella spp.</i>), necrobacillosis, prophylaxis of enzootic bronchopneumonia (<i>Pasteurella</i> spp.), supportive treatment of umbilical infection, etc.
508
509 </p>
510 </div>
511
512
513
514
515
516
517
518
519
520
521
522
523 <div align="justify">
524 <p style="text-align: justify;">
525
526
527
528 </p>
529 </div>
530
531
532
533
534
535
536
537
538
539
540
541
542 <div align="justify">
543 <p style="text-align: justify;">
544
545 <i>Poultry:</i>
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 Diseases caused by the bacteria sensitive to potentiated sulfonamides (<i>E.</i> <i>coli</i>, <i>Salmonella</i> spp., <i>Pasteurella</i> spp. etc.).
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 <b></b>
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 <b><i>Contraindications</i></b><b></b>
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 Severe hepatic and renal impairment.
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
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 Trimethoprim/sulfonamide combinations are contraindicated in the animals with the established hypersensitivity to potentiated sulfonamides, which is extremely rare.
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
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 <b><i>Administration</i></b><b></b>
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 Trimetosul<b><sup>®</sup></b> P is given with feed over 5 consecutive days.
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
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 To prevent the outcomes of stress at weaning, Trimetosul<b><sup>®</sup></b> P is given 2 days before and 3 days after it.
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
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 Severe conditions allow administration longer than 5 days.
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 If necessary the treatment may be repeated after one week of withdrawal.
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
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 <b><i>Dosage</i></b>
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 <i>Swine:</i>
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 0.5% in feed (0.5 kg of Trimetosul<b><sup>®</sup></b> P homogeneously mixed with 100 kg of feed).
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
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 <i>Calves:</i>
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 1.5% in feed (1.5 kg of Trimetosul<b><sup>®</sup></b> P homogeneously mixed with 100 kg of feed).
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 <i>Poultry:</i>
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 0.2% in feed (0.2 kg of Trimetosul<b><sup>®</sup></b> P homogeneously mixed with 100 kg of feed).
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
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 <b><i>Side effects</i></b>
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 Unknown.
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
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 <b><i>Warnings and precautions</i></b><b></b>
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 Sick animals taking scarce feed should be treated parenterally (e. g. Trimetosul<b><sup>®</sup></b> 48% injection suspension).
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
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 During treatment with medicated ration, the animals should not have access to any other source of feed.
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 To minimise renal impairment during the treatment, the animals should have free access to drinking water.
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 Prolonged administration of high doses of sulfonamide may interfere with disintegration of cellulose in the forestomach of ruminants.
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
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 Sulfonamides rarely decrease broilers' leaving capacity or gain.
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
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 To prevent potential incompatibility, Trimetosul<b><sup>®</sup></b> P should not be mixed with other drugs or medicated additives.
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
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 As with other antimicrobials, when using wear face/eyes protection, suitable protective clothing and shoes. Avoid contact with skin and mucosa. After handling thoroughly wash with water and soap.
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>Withdrawal</i></b><b></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 Meat and other edible tissues -
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 calves, swine 8 days
1439
1440 </p>
1441 </div>
1442
1443
1444
1445
1446
1447
1448
1449
1450
1451
1452
1453
1454 <div align="justify">
1455 <p style="text-align: justify;">
1456
1457 poultry 4 days
1458
1459 </p>
1460 </div>
1461
1462
1463
1464
1465
1466
1467
1468
1469
1470
1471
1472
1473 <div align="justify">
1474 <p style="text-align: justify;">
1475
1476 Eggs 10 days
1477
1478 </p>
1479 </div>
1480
1481
1482
1483
1484
1485
1486
1487
1488
1489
1490
1491
1492 <div align="justify">
1493 <p style="text-align: justify;">
1494
1495
1496
1497 </p>
1498 </div>
1499
1500
1501
1502
1503
1504
1505
1506
1507
1508
1509
1510
1511 <div align="justify">
1512 <p style="text-align: justify;">
1513
1514 <b><i>Storage</i></b><b></b>
1515
1516 </p>
1517 </div>
1518
1519
1520
1521
1522
1523
1524
1525
1526
1527
1528
1529
1530 <div align="justify">
1531 <p style="text-align: justify;">
1532
1533 Store in a dry and dark place at room temperature (up to 25°C). Keep away from children.
1534
1535 </p>
1536 </div>
1537
1538
1539
1540
1541
1542
1543
1544
1545
1546
1547
1548
1549 <div align="justify">
1550 <p style="text-align: justify;">
1551
1552
1553
1554 </p>
1555 </div>
1556
1557
1558
1559
1560
1561
1562
1563
1564
1565
1566
1567
1568 <div align="justify">
1569 <p style="text-align: justify;">
1570
1571 <b><i>Shelf life</i></b><b></b>
1572
1573 </p>
1574 </div>
1575
1576
1577
1578
1579
1580
1581
1582
1583
1584
1585
1586
1587 <div align="justify">
1588 <p style="text-align: justify;">
1589
1590 Denoted on the packaging (18 months in the original pack).
1591
1592 </p>
1593 </div>
1594
1595
1596
1597
1598
1599
1600
1601
1602
1603
1604
1605
1606 <div align="justify">
1607 <p style="text-align: justify;">
1608
1609
1610
1611 </p>
1612 </div>
1613
1614
1615
1616
1617
1618
1619
1620
1621
1622
1623
1624
1625 <div align="justify">
1626 <p style="text-align: justify;">
1627
1628 Once prepared use within 3 months.
1629
1630 </p>
1631 </div>
1632
1633
1634
1635
1636
1637
1638
1639
1640
1641
1642
1643
1644 <div align="justify">
1645 <p style="text-align: justify;">
1646
1647
1648
1649 </p>
1650 </div>
1651
1652
1653
1654
1655
1656
1657
1658
1659
1660
1661
1662
1663 <div align="justify">
1664 <p style="text-align: justify;">
1665
1666 <b><i>Legal category</i></b><b></b>
1667
1668 </p>
1669 </div>
1670
1671
1672
1673
1674
1675
1676
1677
1678
1679
1680
1681
1682 <div align="justify">
1683 <p style="text-align: justify;">
1684
1685 On prescription only.
1686
1687 </p>
1688 </div>
1689
1690
1691
1692
1693
1694
1695
1696
1697
1698
1699
1700
1701 <div align="justify">
1702 <p style="text-align: justify;">
1703
1704
1705
1706 </p>
1707 </div>
1708
1709
1710
1711
1712
1713
1714
1715
1716
1717
1718
1719
1720 <div align="justify">
1721 <p style="text-align: justify;">
1722
1723 <b><i>Supply</i></b><b> </b>
1724
1725 </p>
1726 </div>
1727
1728
1729
1730
1731
1732
1733
1734
1735
1736
1737
1738
1739 <div align="justify">
1740 <p style="text-align: justify;">
1741
1742 Bag with 25 kg.
1743
1744 </p>
1745 </div>
1746
1747
1748
1749
1750
1751
1752
1753
1754
1755
1756
1757
1758 <div align="justify">
1759 <p style="text-align: justify;">
1760
1761
1762
1763 </p>
1764 </div>
1765
1766
1767
1768
1769
1770
1771
1772
1773
1774
1775
1776
1777 <div align="justify">
1778 <p style="text-align: justify;">
1779
1780 <b><i>Manufacturer</i></b><b></b>
1781
1782 </p>
1783 </div>
1784
1785
1786
1787
1788
1789
1790
1791
1792
1793
1794
1795
1796 <div align="justify">
1797 <p style="text-align: justify;">
1798
1799 VETERINA Animal Health Ltd., Croatia
1800
1801 </p>
1802 </div>
1803
1804
1805
1806
1807
1808
1809
1810
1811
1812
1813
1814
1815 <div align="justify">
1816 <p style="text-align: justify;">
1817
1818
1819
1820 </p>
1821 </div>
1822
1823
1824
1825
1826
1827
1828
1829
1830
1831
1832
1833
1834 <div align="left">
1835 <p style="text-align: left;">
1836
1837
1838
1839 </p>
1840 </div>
1841
1842
1843
1844
1845
1846
1847
1848 <!--Section Ends-->
1849
1850
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1856

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