/[corp_html]/vet/1055.html
This is repository of my old source code which isn't updated any more. Go to git.rot13.org for current projects!
ViewVC logotype

Contents of /vet/1055.html

Parent Directory Parent Directory | Revision Log Revision Log


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>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>suspension for oral administration</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 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 Trimethoprim 80 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 Sulfadiazine sodium 400 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% suspension contains a potentiated combination of trimethoprim and sulfadiazine (cotrimazine). Antimicrobial effect of cotrimazine is based on a double block of folic acid synthesis. This activity is enhanced by syngerism of the active ingredients in the suspension. Therefore, trimethoprim and sulfadiazine exert a joint antibacterial effect in significantly lower concentrations than each of them does. At the same time, the possibility of resistance is reduced.
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 Trimetosul<b><sup>®</sup></b> 48% suspension is active against many gram-positive and gram-negative organisms, particularly in the infections caused by <i>E. coli,</i> <i>Salmonella</i> and <i>Pasteurella</i> spp. Potentiated sulfonamides are not active against <i>Pseudomonas aeruginosa</i> and the causes of leptospirosis and erysipelas.
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
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 Trimethoprim and sulfadiazine are rapidly and extensively resorbed from gastrointestinal tract and shortly after oral administration achieve efficient plasma- and tissue-levels. In addition to their action in the intestines, they exert systemic effect too.
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
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 <b><i>Indications</i></b><b></b>
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 Primary and secondary bacterial infections of respiratory and gastrointestinal tract in calves, lambs, kids, foals, piglets and poultry (e. g. colibacillosis, salmonellosis, pasteurellosis, etc.).
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>Contraindications</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 - Commercial layers;
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 - severe hepatic and renal impairment, impairment of hematopoietic organs;
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 - established hypersensitivity to sulfonamides, which is extremely rare.
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
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 <b><i>Administration and dosage</i></b><b></b>
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 Shake well before adding to drinking water. Trimetosul<b><sup>®</sup></b> 48% suspension is well dispersed in water, forming stable solution in the dilution over 1:800. For accurate dosage use the enclosed doser of 5 mL (2400 mg cotrimazine).
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
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 <i>Calves, foals, lambs, kids, piglets and poultry:</i>
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 30 mg of cotrimazine/1 kg of b. w./daily, or
547
548 </p>
549 </div>
550
551
552
553
554
555
556
557
558
559
560 <li>
561
562 <div align="justify">
563 <p style="text-align: justify;">
564
565 0.06 mL of Trimetosul<b><sup>®</sup></b><sup> </sup>48% susp./1 kg of b. w. in two equal morning and evening subdoses, or
566
567 </p>
568 </div>
569
570
571
572
573
574
575
576
577
578
579 <li>
580
581 <div align="justify">
582 <p style="text-align: justify;">
583
584 2.0 mL of Trimetosul<b><sup>®</sup></b> 48% susp./30 kg of b. w./day.
585
586 </p>
587 </div>
588
589
590
591
592
593
594
595
596
597
598 </ul>
599
600 <div align="justify">
601 <p style="text-align: justify;">
602
603
604
605 </p>
606 </div>
607
608
609
610
611
612
613
614
615
616
617
618
619 <div align="justify">
620 <p style="text-align: justify;">
621
622 <i>Individual treatment</i>: divide a daily dose in two equal subdoses, one for the morning and the other after 12 hours, as an evening dose. Administer with drinking water in the volume the animals will ingest.
623
624 </p>
625 </div>
626
627
628
629
630
631
632
633
634
635
636
637
638 <div align="justify">
639 <p style="text-align: justify;">
640
641
642
643 </p>
644 </div>
645
646
647
648
649
650
651
652
653
654
655
656
657 <div align="justify">
658 <p style="text-align: justify;">
659
660 <i>Mass treatment:</i> add specified dose to the volume of drinking water equivalent to approx. 3/4 of the daily volume. This ensures the intake of the whole daily dose, e. g.:
661
662 </p>
663 </div>
664
665
666
667
668
669
670
671
672
673
674
675
676 <div align="justify">
677 <p style="text-align: justify;">
678
679
680
681 </p>
682 </div>
683
684
685
686
687
688
689
690
691
692
693
694
695 <div align="justify">
696 <p style="text-align: justify;">
697
698 - swine weighing 20-50 kg are given 0.5 mL of Trimetosul<b><sup>®</sup></b> 48% susp./1 L of drinking water/day;
699
700 </p>
701 </div>
702
703
704
705
706
707
708
709
710
711
712
713
714 <div align="justify">
715 <p style="text-align: justify;">
716
717 - broilers (aged 6 weeks) - 1 mL of Trimetosul<b><sup>®</sup></b> 48% susp./5 L of drinking water/day.
718
719 </p>
720 </div>
721
722
723
724
725
726
727
728
729
730
731
732
733 <div align="justify">
734 <p style="text-align: justify;">
735
736
737
738 </p>
739 </div>
740
741
742
743
744
745
746
747
748
749
750
751
752 <div align="justify">
753 <p style="text-align: justify;">
754
755 Commonest duration of treatment is 3-5 consecutive days.
756
757 </p>
758 </div>
759
760
761
762
763
764
765
766
767
768
769
770
771 <div align="justify">
772 <p style="text-align: justify;">
773
774
775
776 </p>
777 </div>
778
779
780
781
782
783
784
785
786
787
788
789
790 <div align="justify">
791 <p style="text-align: justify;">
792
793 <b><i>Warnings and precautions</i></b><b></b>
794
795 </p>
796 </div>
797
798
799
800
801
802
803
804
805
806
807
808
809 <div align="justify">
810 <p style="text-align: justify;">
811
812 The animals should have free access to medicated drinking water and should be restricted from other sources of liquid. Dehydrated animals should not be treated with sulfonamides before being re-hydrated.
813
814 </p>
815 </div>
816
817
818
819
820
821
822
823
824
825
826
827
828 <div align="justify">
829 <p style="text-align: justify;">
830
831
832
833 </p>
834 </div>
835
836
837
838
839
840
841
842
843
844
845
846
847 <div align="justify">
848 <p style="text-align: justify;">
849
850 The suspension is not suitable for p. o. treatment of systemic infections in older calves with developed forestomach.
851
852 </p>
853 </div>
854
855
856
857
858
859
860
861
862
863
864
865
866 <div align="justify">
867 <p style="text-align: justify;">
868
869
870
871 </p>
872 </div>
873
874
875
876
877
878
879
880
881
882
883
884
885 <div align="justify">
886 <p style="text-align: justify;">
887
888
889
890 </p>
891 </div>
892
893
894
895
896
897
898
899
900
901
902
903
904 <div align="justify">
905 <p style="text-align: justify;">
906
907 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 trimethoprim-sulfadiazine combination. Otherwise, administer another antimicrobial.
908
909 </p>
910 </div>
911
912
913
914
915
916
917
918
919
920
921
922
923 <div align="justify">
924 <p style="text-align: justify;">
925
926
927
928 </p>
929 </div>
930
931
932
933
934
935
936
937
938
939
940
941
942 <div align="justify">
943 <p style="text-align: justify;">
944
945 <b><i>Side effects</i></b>
946
947 </p>
948 </div>
949
950
951
952
953
954
955
956
957
958
959
960
961 <div align="justify">
962 <p style="text-align: justify;">
963
964 Unknown.
965
966 </p>
967 </div>
968
969
970
971
972
973
974
975
976
977
978
979
980 <div align="justify">
981 <p style="text-align: justify;">
982
983
984
985 </p>
986 </div>
987
988
989
990
991
992
993
994
995
996
997
998
999 <div align="justify">
1000 <p style="text-align: justify;">
1001
1002 <b><i>Withdrawal</i></b>
1003
1004 </p>
1005 </div>
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017
1018 <div align="justify">
1019 <p style="text-align: justify;">
1020
1021 Meat, organs and other edible tissues -
1022
1023 </p>
1024 </div>
1025
1026
1027
1028
1029
1030
1031
1032
1033
1034
1035
1036
1037 <div align="justify">
1038 <p style="text-align: justify;">
1039
1040 Calves, foals, lambs, kids, piglets 10 days
1041
1042 </p>
1043 </div>
1044
1045
1046
1047
1048
1049
1050
1051
1052
1053
1054
1055
1056 <div align="justify">
1057 <p style="text-align: justify;">
1058
1059 Broilers 5 days
1060
1061 </p>
1062 </div>
1063
1064
1065
1066
1067
1068
1069
1070
1071
1072
1073
1074
1075 <div align="justify">
1076 <p style="text-align: justify;">
1077
1078
1079
1080 </p>
1081 </div>
1082
1083
1084
1085
1086
1087
1088
1089
1090
1091
1092
1093
1094 <div align="justify">
1095 <p style="text-align: justify;">
1096
1097 <b><i>Storage</i></b><b></b>
1098
1099 </p>
1100 </div>
1101
1102
1103
1104
1105
1106
1107
1108
1109
1110
1111
1112
1113 <div align="justify">
1114 <p style="text-align: justify;">
1115
1116 Store in a dark place at controlled room temperature (15-25°C). Keep away from children. Avoid freezing.
1117
1118 </p>
1119 </div>
1120
1121
1122
1123
1124
1125
1126
1127
1128
1129
1130
1131
1132 <div align="justify">
1133 <p style="text-align: justify;">
1134
1135
1136
1137 </p>
1138 </div>
1139
1140
1141
1142
1143
1144
1145
1146
1147
1148
1149
1150
1151 <div align="justify">
1152 <p style="text-align: justify;">
1153
1154 <b><i>Shelf life</i></b><b></b>
1155
1156 </p>
1157 </div>
1158
1159
1160
1161
1162
1163
1164
1165
1166
1167
1168
1169
1170 <div align="justify">
1171 <p style="text-align: justify;">
1172
1173 Denoted on the packaging (3 years in the original pack).
1174
1175 </p>
1176 </div>
1177
1178
1179
1180
1181
1182
1183
1184
1185
1186
1187
1188
1189 <div align="justify">
1190 <p style="text-align: justify;">
1191
1192
1193
1194 </p>
1195 </div>
1196
1197
1198
1199
1200
1201
1202
1203
1204
1205
1206
1207
1208 <div align="justify">
1209 <p style="text-align: justify;">
1210
1211 <b><i>Legal category</i></b><b></b>
1212
1213 </p>
1214 </div>
1215
1216
1217
1218
1219
1220
1221
1222
1223
1224
1225
1226
1227 <div align="justify">
1228 <p style="text-align: justify;">
1229
1230 On prescription only.
1231
1232 </p>
1233 </div>
1234
1235
1236
1237
1238
1239
1240
1241
1242
1243
1244
1245
1246 <div align="justify">
1247 <p style="text-align: justify;">
1248
1249
1250
1251 </p>
1252 </div>
1253
1254
1255
1256
1257
1258
1259
1260
1261
1262
1263
1264
1265 <div align="justify">
1266 <p style="text-align: justify;">
1267
1268 <b><i>Supply</i></b><b></b>
1269
1270 </p>
1271 </div>
1272
1273
1274
1275
1276
1277
1278
1279
1280
1281
1282
1283
1284 <div align="justify">
1285 <p style="text-align: justify;">
1286
1287 Bottles with 100 mL and 200 mL.
1288
1289 </p>
1290 </div>
1291
1292
1293
1294
1295
1296
1297
1298
1299
1300
1301
1302
1303 <div align="justify">
1304 <p style="text-align: justify;">
1305
1306
1307
1308 </p>
1309 </div>
1310
1311
1312
1313
1314
1315
1316
1317
1318
1319
1320
1321
1322 <div align="justify">
1323 <p style="text-align: justify;">
1324
1325 <b><i>Manufacturer</i></b><b></b>
1326
1327 </p>
1328 </div>
1329
1330
1331
1332
1333
1334
1335
1336
1337
1338
1339
1340
1341 <div align="justify">
1342 <p style="text-align: justify;">
1343
1344 VETERINA Animal Health Ltd., Croatia
1345
1346 </p>
1347 </div>
1348
1349
1350
1351
1352
1353
1354
1355
1356
1357
1358
1359
1360 <div align="justify">
1361 <p style="text-align: justify;">
1362
1363
1364
1365 </p>
1366 </div>
1367
1368
1369
1370
1371
1372
1373
1374
1375
1376
1377
1378
1379 <div align="left">
1380 <p style="text-align: left;">
1381
1382
1383
1384 </p>
1385 </div>
1386
1387
1388
1389
1390
1391
1392
1393 <!--Section Ends-->
1394
1395
1396
1397
1398
1399
1400
1401

  ViewVC Help
Powered by ViewVC 1.1.26