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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>SULFAKOMB</b><b> PLUS</b><b><sup>®</sup></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 for swine</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 Tylosin as tylosin phosphate 20 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 Sulfadimidine 70 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 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.
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 - 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.
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 - 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.
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 <b><i>Indications</i></b>
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 Metaphylaxis of primary and secondary bacterial infections in swine:
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 - reduction of the incidence of atrophic rhinitis (<i>Bordetella bronchiseptica</i>) and alleviation of the disease;
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 - prevention of the damages caused by enzootic pneumonia and atrophic rhinitis in terms of reduced weight gain and feed conversion;
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 - control of pneumonia in piglets (<i>Pasteurella multocida</i> and <i>Actinomyces pyogenes</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 - 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);
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 - control of diarrhea in piglets resulting from MMA syndrome in sows and gilts.
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></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 Contraindications
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 Sulfakomb Plus<b><sup>®</sup></b> should not be given to species and classes for which it is not registered (ungulates, ruminants and fowl).
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
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 Swine with severe hepatic and renal impairment should not be given the preparation.
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
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 Sulfakomb Plus<b><sup>®</sup></b> is contraindicated in allergic reactions to the preparation, which is extremely rare.
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
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 <b><i>Administration and dosage</i></b><b></b>
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 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.
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>Side effects</i></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 Unknown.
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 <b><i>Warnings and precautions</i></b>
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 Sick animals taking scarce feed, should be treated with medicated drinking water, or preferably by parenteral administration.
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
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 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.
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
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 Sulfakomb Plus<b><sup>®</sup></b> should not be given concomitantly with other preparations or medicated additives.
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
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
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1454 <div align="left">
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