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Revision 1.2 - (show annotations)
Tue Apr 10 11:02:11 2001 UTC (18 years ago) by dpavlin
Branch: MAIN
CVS Tags: HEAD
Changes since 1.1: +8 -8 lines
File MIME type: text/html
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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> 48% </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>injection suspension</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 <b></b>
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 mL 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 Sulfadiazine as sulfadiazine sodium 400 mg
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 Trimethoprim 80 mg
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
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 <b><i>Action</i></b>
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 Trimetosul<b><sup>®</sup></b> 48% injection suspension is a potentiated combined sulfonamide preparation. Its active ingredients, sulfonamide sulfadiazine and diaminopyrimidine trimethoprim, inhibit at two stages the synthesis of folic acid. This contributes to the increased effect of the suspension, which has higher potency than each of its ingredients does. Trimetosul<b><sup>®</sup></b> 48% injections are bactericidal against many gram-positive and gram-negative organisms streptococci, staphylococci, diplococci, enterococci, Corynebacteria, <i>E. coli</i>, salmonella, pasteurellae, <i>Proteus </i>strains, brucellae, bordetellae, clostridiae, <i>Haemophilus</i> strains, klebsiellae, shigellae and actinomycetae. However, Trimetosul<b><sup>®</sup></b> is not active against leptospira, pseudomonas and the cause of erysipelas.
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
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 <b><i>Indications</i></b>
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 Various diseases of bacterial etiology in cattle, sheep, swine and horses:
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 - respiratory infections (rhinitis, bronchitis and pneumonia);
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 - genitourinary infections (cystitis, vaginitis, urethritis, nephritis and metritis);
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 - gastrointestinal infections (coli infections, salmonellosis);
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 - other infections (e. g. necrotic pododermatitis, mastitis, MMA syndrome in sows, infections of the eyes, ear or mouth);
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 - postoperative infections, infections after parturition and septicemia.
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
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 <b><i>Contraindications</i></b>
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 Trimetosul<b><sup>®</sup></b> 48% injections should not be given by i. v. or intraperitoneal route.
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
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 Established hypersensitivity to sulfonamides and severe renal and hepatic impairment, blood disorders.
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 <b><i>Administration </i></b>
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 Shake well before withdrawing from the bottle into the syringe.
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 Trimetosul<b><sup>®</sup></b> 48% suspension is given by i. m. route. Administration into the neck muscles being less painful is recommended.
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
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 Treatment commenced with 2-3 Trimetosul<b><sup>®</sup></b> injections may, after 2-3 administrations, be continued with oral Trimetosul<b><sup>®</sup></b> powder or Trimetosul<b><sup>®</sup></b> 48 % oral suspension.
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></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 <b><i>Dosage</i></b>
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 All animals are given the dose of 1 mL once daily per 30 kg of b. w. (15 mg of active ingredients/kg/day). Severe cases are managed with 1.5 mL/30 kg of b. w./day (22.5 mg of active ingredients/kg/day).
641
642 </p>
643 </div>
644
645
646
647
648
649
650
651
652
653
654
655
656 <div align="left">
657 <p style="text-align: left;">
658
659
660
661 </p>
662 </div>
663
664
665
666
667
668
669
670
671 <table width="88.60%" border="1" cols="4" rows="6">
672 <tr>
673 <td bgcolor="White" width="24.52%" rowspan="1" colspan="1">
674
675 <div align="center">
676 <p style="text-align: center;">
677
678 Species and class
679
680 </p>
681 </div>
682
683
684
685
686 </td>
687
688
689
690
691
692 <td bgcolor="White" width="21.78%" rowspan="1" colspan="1">
693
694 <div align="center">
695 <p style="text-align: center;">
696
697 Body weight
698
699 </p>
700 </div>
701
702
703
704
705 </td>
706
707
708
709
710
711 <td bgcolor="White" width="25.93%" rowspan="1" colspan="1">
712
713 <div align="center">
714 <p style="text-align: center;">
715
716 Dose 15 mg/kg/d
717
718 </p>
719 </div>
720
721
722
723
724 </td>
725
726
727
728
729
730 <td bgcolor="White" width="27.77%" rowspan="1" colspan="1">
731
732 <div align="center">
733 <p style="text-align: center;">
734
735 Dose 22.5 mg/kg/d
736
737 </p>
738 </div>
739
740
741
742
743 </td>
744
745
746
747
748
749
750
751 </tr>
752
753
754
755 <tr>
756 <td bgcolor="White" width="24.52%" rowspan="1" colspan="1">
757
758 <div align="left">
759 <p style="text-align: left;">
760
761 Horses, cows
762
763 </p>
764 </div>
765
766
767
768
769 </td>
770
771
772
773
774
775 <td bgcolor="White" width="21.78%" rowspan="1" colspan="1">
776
777 <div align="left">
778 <p style="text-align: left;">
779
780 500 kg
781
782 </p>
783 </div>
784
785
786
787
788 </td>
789
790
791
792
793
794 <td bgcolor="White" width="25.93%" rowspan="1" colspan="1">
795
796 <div align="left">
797 <p style="text-align: left;">
798
799 15 mL
800
801 </p>
802 </div>
803
804
805
806
807 </td>
808
809
810
811
812
813 <td bgcolor="White" width="27.77%" rowspan="1" colspan="1">
814
815 <div align="left">
816 <p style="text-align: left;">
817
818 23 mL
819
820 </p>
821 </div>
822
823
824
825
826 </td>
827
828
829
830
831
832
833
834 </tr>
835
836
837
838 <tr>
839 <td bgcolor="White" width="24.52%" rowspan="1" colspan="1">
840
841 <div align="left">
842 <p style="text-align: left;">
843
844 Steers
845
846 </p>
847 </div>
848
849
850
851
852 </td>
853
854
855
856
857
858 <td bgcolor="White" width="21.78%" rowspan="1" colspan="1">
859
860 <div align="left">
861 <p style="text-align: left;">
862
863 250 kg
864
865 </p>
866 </div>
867
868
869
870
871 </td>
872
873
874
875
876
877 <td bgcolor="White" width="25.93%" rowspan="1" colspan="1">
878
879 <div align="left">
880 <p style="text-align: left;">
881
882 7.0 mL
883
884 </p>
885 </div>
886
887
888
889
890 </td>
891
892
893
894
895
896 <td bgcolor="White" width="27.77%" rowspan="1" colspan="1">
897
898 <div align="left">
899 <p style="text-align: left;">
900
901 12 mL
902
903 </p>
904 </div>
905
906
907
908
909 </td>
910
911
912
913
914
915
916
917 </tr>
918
919
920
921 <tr>
922 <td bgcolor="White" width="24.52%" rowspan="1" colspan="1">
923
924 <div align="left">
925 <p style="text-align: left;">
926
927 Calves, foals
928
929 </p>
930 </div>
931
932
933
934
935 </td>
936
937
938
939
940
941 <td bgcolor="White" width="21.78%" rowspan="1" colspan="1">
942
943 <div align="left">
944 <p style="text-align: left;">
945
946 150 kg
947
948 </p>
949 </div>
950
951
952
953
954 </td>
955
956
957
958
959
960 <td bgcolor="White" width="25.93%" rowspan="1" colspan="1">
961
962 <div align="left">
963 <p style="text-align: left;">
964
965 5.0 mL
966
967 </p>
968 </div>
969
970
971
972
973 </td>
974
975
976
977
978
979 <td bgcolor="White" width="27.77%" rowspan="1" colspan="1">
980
981 <div align="left">
982 <p style="text-align: left;">
983
984 7.0 mL
985
986 </p>
987 </div>
988
989
990
991
992 </td>
993
994
995
996
997
998
999
1000 </tr>
1001
1002
1003
1004 <tr>
1005 <td bgcolor="White" width="24.52%" rowspan="1" colspan="1">
1006
1007 <div align="left">
1008 <p style="text-align: left;">
1009
1010 Swine
1011
1012 </p>
1013 </div>
1014
1015
1016
1017
1018 </td>
1019
1020
1021
1022
1023
1024 <td bgcolor="White" width="21.78%" rowspan="1" colspan="1">
1025
1026 <div align="left">
1027 <p style="text-align: left;">
1028
1029 100 kg
1030
1031 </p>
1032 </div>
1033
1034
1035
1036
1037 </td>
1038
1039
1040
1041
1042
1043 <td bgcolor="White" width="25.93%" rowspan="1" colspan="1">
1044
1045 <div align="left">
1046 <p style="text-align: left;">
1047
1048 3.0 mL
1049
1050 </p>
1051 </div>
1052
1053
1054
1055
1056 </td>
1057
1058
1059
1060
1061
1062 <td bgcolor="White" width="27.77%" rowspan="1" colspan="1">
1063
1064 <div align="left">
1065 <p style="text-align: left;">
1066
1067 5.0 mL
1068
1069 </p>
1070 </div>
1071
1072
1073
1074
1075 </td>
1076
1077
1078
1079
1080
1081
1082
1083 </tr>
1084
1085
1086
1087 <tr>
1088 <td bgcolor="White" width="24.52%" rowspan="1" colspan="1">
1089
1090 <div align="left">
1091 <p style="text-align: left;">
1092
1093 Sheep
1094
1095 </p>
1096 </div>
1097
1098
1099
1100
1101 </td>
1102
1103
1104
1105
1106
1107 <td bgcolor="White" width="21.78%" rowspan="1" colspan="1">
1108
1109 <div align="left">
1110 <p style="text-align: left;">
1111
1112 50 kg
1113
1114 </p>
1115 </div>
1116
1117
1118
1119
1120 </td>
1121
1122
1123
1124
1125
1126 <td bgcolor="White" width="25.93%" rowspan="1" colspan="1">
1127
1128 <div align="left">
1129 <p style="text-align: left;">
1130
1131 1.5 mL
1132
1133 </p>
1134 </div>
1135
1136
1137
1138
1139 </td>
1140
1141
1142
1143
1144
1145 <td bgcolor="White" width="27.77%" rowspan="1" colspan="1">
1146
1147 <div align="left">
1148 <p style="text-align: left;">
1149
1150 2.5 mL
1151
1152 </p>
1153 </div>
1154
1155
1156
1157
1158 </td>
1159
1160
1161
1162
1163
1164
1165
1166 </tr>
1167
1168 </table>
1169
1170
1171
1172
1173 <div align="justify">
1174 <p style="text-align: justify;">
1175
1176
1177
1178 </p>
1179 </div>
1180
1181
1182
1183
1184
1185
1186
1187
1188
1189
1190
1191
1192 <div align="justify">
1193 <p style="text-align: justify;">
1194
1195 A single dose is sufficient to treat mild infections only (wounds and postoperative infections). In severe and complicated infections administration should be repeated up to maximum 5 consecutive days, i. e. over 2 additional days from remission of clinical signs.
1196
1197 </p>
1198 </div>
1199
1200
1201
1202
1203
1204
1205
1206
1207
1208
1209
1210
1211 <div align="justify">
1212 <p style="text-align: justify;">
1213
1214
1215
1216 </p>
1217 </div>
1218
1219
1220
1221
1222
1223
1224
1225
1226
1227
1228
1229
1230 <div align="justify">
1231 <p style="text-align: justify;">
1232
1233 Avoid applying at one site more than 20 mL (cattle and horses) or more than 10 mL (swine).
1234
1235 </p>
1236 </div>
1237
1238
1239
1240
1241
1242
1243
1244
1245
1246
1247
1248
1249 <div align="justify">
1250 <p style="text-align: justify;">
1251
1252
1253
1254 </p>
1255 </div>
1256
1257
1258
1259
1260
1261
1262
1263
1264
1265
1266
1267
1268 <div align="justify">
1269 <p style="text-align: justify;">
1270
1271 <b><i>Warnings and precautions</i></b>
1272
1273 </p>
1274 </div>
1275
1276
1277
1278
1279
1280
1281
1282
1283
1284
1285
1286
1287 <div align="justify">
1288 <p style="text-align: justify;">
1289
1290 Transient swelling may develop at the site of injection, which disappears a few days from administration.
1291
1292 </p>
1293 </div>
1294
1295
1296
1297
1298
1299
1300
1301
1302
1303
1304
1305
1306 <div align="justify">
1307 <p style="text-align: justify;">
1308
1309
1310
1311 </p>
1312 </div>
1313
1314
1315
1316
1317
1318
1319
1320
1321
1322
1323
1324
1325 <div align="justify">
1326 <p style="text-align: justify;">
1327
1328 <b><i>Withdrawal</i></b>
1329
1330 </p>
1331 </div>
1332
1333
1334
1335
1336
1337
1338
1339
1340
1341
1342
1343
1344 <div align="justify">
1345 <p style="text-align: justify;">
1346
1347 Meat, organs and other edible tissues -
1348
1349 </p>
1350 </div>
1351
1352
1353
1354
1355
1356
1357
1358
1359
1360
1361
1362
1363 <div align="justify">
1364 <p style="text-align: justify;">
1365
1366 cattle, swine, sheep, horses 10 days
1367
1368 </p>
1369 </div>
1370
1371
1372
1373
1374
1375
1376
1377
1378
1379
1380
1381
1382 <div align="justify">
1383 <p style="text-align: justify;">
1384
1385 Milk - cow and sheep 3 days
1386
1387 </p>
1388 </div>
1389
1390
1391
1392
1393
1394
1395
1396
1397
1398
1399
1400
1401 <div align="justify">
1402 <p style="text-align: justify;">
1403
1404
1405
1406 </p>
1407 </div>
1408
1409
1410
1411
1412
1413
1414
1415
1416
1417
1418
1419
1420 <div align="justify">
1421 <p style="text-align: justify;">
1422
1423 <b><i>Storage</i></b>
1424
1425 </p>
1426 </div>
1427
1428
1429
1430
1431
1432
1433
1434
1435
1436
1437
1438
1439 <div align="justify">
1440 <p style="text-align: justify;">
1441
1442 Store in a dark place at the controlled room temperature (15-25°C). Keep away from children. Avoid freezing.
1443
1444 </p>
1445 </div>
1446
1447
1448
1449
1450
1451
1452
1453
1454
1455
1456
1457
1458 <div align="justify">
1459 <p style="text-align: justify;">
1460
1461
1462
1463 </p>
1464 </div>
1465
1466
1467
1468
1469
1470
1471
1472
1473
1474
1475
1476
1477 <div align="justify">
1478 <p style="text-align: justify;">
1479
1480 <b><i>Shelf life</i></b>
1481
1482 </p>
1483 </div>
1484
1485
1486
1487
1488
1489
1490
1491
1492
1493
1494
1495
1496 <div align="justify">
1497 <p style="text-align: justify;">
1498
1499 Denoted on the packaging (3 years).
1500
1501 </p>
1502 </div>
1503
1504
1505
1506
1507
1508
1509
1510
1511
1512
1513
1514
1515 <div align="justify">
1516 <p style="text-align: justify;">
1517
1518
1519
1520 </p>
1521 </div>
1522
1523
1524
1525
1526
1527
1528
1529
1530
1531
1532
1533
1534 <div align="justify">
1535 <p style="text-align: justify;">
1536
1537 <b><i>Legal category</i></b>
1538
1539 </p>
1540 </div>
1541
1542
1543
1544
1545
1546
1547
1548
1549
1550
1551
1552
1553 <div align="justify">
1554 <p style="text-align: justify;">
1555
1556 On prescription only.
1557
1558 </p>
1559 </div>
1560
1561
1562
1563
1564
1565
1566
1567
1568
1569
1570
1571
1572 <div align="justify">
1573 <p style="text-align: justify;">
1574
1575
1576
1577 </p>
1578 </div>
1579
1580
1581
1582
1583
1584
1585
1586
1587
1588
1589
1590
1591 <div align="justify">
1592 <p style="text-align: justify;">
1593
1594 <b><i>Supply</i></b>
1595
1596 </p>
1597 </div>
1598
1599
1600
1601
1602
1603
1604
1605
1606
1607
1608
1609
1610 <div align="justify">
1611 <p style="text-align: justify;">
1612
1613 Vials with 100 mL.
1614
1615 </p>
1616 </div>
1617
1618
1619
1620
1621
1622
1623
1624
1625
1626
1627
1628
1629 <div align="justify">
1630 <p style="text-align: justify;">
1631
1632
1633
1634 </p>
1635 </div>
1636
1637
1638
1639
1640
1641
1642
1643
1644
1645
1646
1647
1648 <div align="justify">
1649 <p style="text-align: justify;">
1650
1651 <b><i>Manufacturer</i></b><b></b>
1652
1653 </p>
1654 </div>
1655
1656
1657
1658
1659
1660
1661
1662
1663
1664
1665
1666
1667 <div align="justify">
1668 <p style="text-align: justify;">
1669
1670 VETERINA Animal Health Ltd., Croatia
1671
1672 </p>
1673 </div>
1674
1675
1676
1677
1678
1679
1680
1681
1682
1683
1684
1685
1686 <div align="justify">
1687 <p style="text-align: justify;">
1688
1689
1690
1691 </p>
1692 </div>
1693
1694
1695
1696
1697
1698
1699
1700
1701
1702
1703
1704
1705 <div align="left">
1706 <p style="text-align: left;">
1707
1708
1709
1710 </p>
1711 </div>
1712
1713
1714
1715
1716
1717
1718
1719 <!--Section Ends-->
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