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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>
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18
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20
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22
23
24
25
26
27
28
29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>SIMIVET</b><b><sup>®</sup></b><b> 20%</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>soluble powder</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="left">
87 <p style="text-align: left;">
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 g contains 200 mg of amoxicillin as amoxicillin trihydrate.
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 <b></b>
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 <b><i>Action</i></b><i></i>
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 Amoxicillin is a broad-spectrum semi-synthetic penicillin. It exerts bactericidal action on many gram-positive and gram-negative organisms, is stable in gastric acid and is well resorbed from the gastrointestinal tract, achieving rapidly high blood- and tissue levels. Its resorption and antimicrobial action are superior to that of ampicillin. Unlike with ampicillin, resorption of Simivet<b><sup>®</sup></b> is not diminished by food in gastrointestinal tract.
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>Indications</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 General and local infections due to gram-positive and gram-negative bacteria sensitive to amoxicillin:
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 - gastrointestinal infections;
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 - respiratory 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 - genitourinary infections;
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 - skin and soft tissue infection;
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 - prophylaxis and treatment of chronic respiratory disease complex (CRD) in poultry.
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
341
342
343
344
345
346
347
348
349
350
351
352 <div align="justify">
353 <p style="text-align: justify;">
354
355 <b><i>Contraindications</i></b>
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 - Commercial layers;
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 - rabbits, guinea-pigs, hamsters and other small monogastric herbivore;
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 - hypersensitivity to penicillin antibiotics, which is extremely rare.
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 <b><i>Administration</i></b>
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 Simivet<b><sup>®</sup></b> 20% soluble powder is given mixed with feed or dissolved in drinking water, milk or milk substitute. Always prepare a fresh solution. To ensure the intake of medicated drinking water, the animals should be restricted from other sources of liquid 2 hours prior to treatment and during it.
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
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 <b><i>Dosage</i></b>
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, lambs, kids, piglets and swine</i>
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 Average dose of amoxicillin for majority of animals is 6-10 mg/kg of b. w., i. e. 1 g of Simivet<b><sup>®</sup></b> 20% soluble powder per 20-33 kg of b. w. every 12 hours. One levelled teaspoonful of powder contains 4 g of the preparation, which is sufficient for the animal weighing 80-130 kg (e. g. calf).
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 When preparing medicated feed (e. g. for swine) mix 200-320 g of powder with 100 kg of feed, which makes 400-640 ppm of amoxicillin trihydrate.
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
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 <i>Poultry</i>
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 Simivet<b><sup>®</sup></b> 20% soluble powder is given with drinking water in the dose of 100 g per 70-140 L of water, which makes 300 mg, i. e. 150 mg of amoxicillin per 1 L of water. The doses are relevant to the required water volume:
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
660
661 </p>
662 </div>
663
664
665
666
667
668
669
670
671 <table width="100.00%" border="1" cols="2" rows="4">
672 <tr>
673 <td bgcolor="White" width="50.00%" rowspan="1" colspan="1">
674
675 <div align="justify">
676 <p style="text-align: justify;">
677
678 <b>150 mg of amoxicillin/L of water</b>
679
680 </p>
681 </div>
682
683
684
685
686 </td>
687
688
689
690
691
692 <td bgcolor="White" width="50.00%" rowspan="1" colspan="1">
693
694 <div align="justify">
695 <p style="text-align: justify;">
696
697 300 mg of amoxicillin/L of water
698
699 </p>
700 </div>
701
702
703
704
705 </td>
706
707
708
709
710
711
712
713 </tr>
714
715
716
717 <tr>
718 <td bgcolor="White" width="50.00%" rowspan="1" colspan="1">
719
720 <div align="justify">
721 <p style="text-align: justify;">
722
723 1 g of Simivet<b><sup>®</sup></b>powder/1.4 L of water
724
725 </p>
726 </div>
727
728
729
730
731 </td>
732
733
734
735
736
737 <td bgcolor="White" width="50.00%" rowspan="1" colspan="1">
738
739 <div align="justify">
740 <p style="text-align: justify;">
741
742 1 g of Simivet<b><sup>®</sup></b>powder/0.7 L of water
743
744 </p>
745 </div>
746
747
748
749
750 </td>
751
752
753
754
755
756
757
758 </tr>
759
760
761
762 <tr>
763 <td bgcolor="White" width="50.00%" rowspan="1" colspan="1">
764
765 <div align="justify">
766 <p style="text-align: justify;">
767
768 10 g of Simivet<b><sup>®</sup></b>powder/14 L of water
769
770 </p>
771 </div>
772
773
774
775
776 </td>
777
778
779
780
781
782 <td bgcolor="White" width="50.00%" rowspan="1" colspan="1">
783
784 <div align="justify">
785 <p style="text-align: justify;">
786
787 10 g of Simivet<b><sup>®</sup></b>powder/7 L of water
788
789 </p>
790 </div>
791
792
793
794
795 </td>
796
797
798
799
800
801
802
803 </tr>
804
805
806
807 <tr>
808 <td bgcolor="White" width="50.00%" rowspan="1" colspan="1">
809
810 <div align="justify">
811 <p style="text-align: justify;">
812
813 100 g of Simivet<b><sup>®</sup></b>powder/140 L of water
814
815 </p>
816 </div>
817
818
819
820
821 </td>
822
823
824
825
826
827 <td bgcolor="White" width="50.00%" rowspan="1" colspan="1">
828
829 <div align="justify">
830 <p style="text-align: justify;">
831
832 100 g of Simivet<b><sup>®</sup></b>powder/70 L of water
833
834 </p>
835 </div>
836
837
838
839
840 </td>
841
842
843
844
845
846
847
848 </tr>
849
850 </table>
851
852
853
854
855 <div align="justify">
856 <p style="text-align: justify;">
857
858
859
860 </p>
861 </div>
862
863
864
865
866
867
868
869
870
871
872
873
874 <div align="justify">
875 <p style="text-align: justify;">
876
877 Relevant to severity of the infection, the treatment lasts for 3-5 days, i. e. at least 1 additional day upon remission of clinical symptoms. Gram-negative infections and severe diseases, particularly acute infections, are treated with higher doses without any risk of side effects.
878
879 </p>
880 </div>
881
882
883
884
885
886
887
888
889
890
891
892
893 <div align="justify">
894 <p style="text-align: justify;">
895
896
897
898 </p>
899 </div>
900
901
902
903
904
905
906
907
908
909
910
911
912 <div align="justify">
913 <p style="text-align: justify;">
914
915 <b><i>Warnings, precautions and interactions</i></b>
916
917 </p>
918 </div>
919
920
921
922
923
924
925
926
927
928
929
930
931 <div align="justify">
932 <p style="text-align: justify;">
933
934 In the ruminants with functionally developed forestomach, systemic infections are not treated with oral amoxicillin.
935
936 </p>
937 </div>
938
939
940
941
942
943
944
945
946
947
948
949
950 <div align="justify">
951 <p style="text-align: justify;">
952
953
954
955 </p>
956 </div>
957
958
959
960
961
962
963
964
965
966
967
968
969 <div align="justify">
970 <p style="text-align: justify;">
971
972 Sick animals taking scarce water and feed should be treated by parenteral route.
973
974 </p>
975 </div>
976
977
978
979
980
981
982
983
984
985
986
987
988 <div align="justify">
989 <p style="text-align: justify;">
990
991
992
993 </p>
994 </div>
995
996
997
998
999
1000
1001
1002
1003
1004
1005
1006
1007 <div align="justify">
1008 <p style="text-align: justify;">
1009
1010 If after three days of treatment there is no apparent improvement, causative organism is probably amoxicillin-resistant, which requires institution of another antimicrobial.
1011
1012 </p>
1013 </div>
1014
1015
1016
1017
1018
1019
1020
1021
1022
1023
1024
1025
1026 <div align="justify">
1027 <p style="text-align: justify;">
1028
1029
1030
1031 </p>
1032 </div>
1033
1034
1035
1036
1037
1038
1039
1040
1041
1042
1043
1044
1045 <div align="justify">
1046 <p style="text-align: justify;">
1047
1048 <b><i>Withdrawal</i></b>
1049
1050 </p>
1051 </div>
1052
1053
1054
1055
1056
1057
1058
1059
1060
1061
1062
1063
1064 <div align="justify">
1065 <p style="text-align: justify;">
1066
1067 Meat, organs and other edible tissues
1068
1069 </p>
1070 </div>
1071
1072
1073
1074
1075
1076
1077
1078
1079
1080
1081
1082
1083 <div align="justify">
1084 <p style="text-align: justify;">
1085
1086 Calves, swine, lambs, kids 7 days
1087
1088 </p>
1089 </div>
1090
1091
1092
1093
1094
1095
1096
1097
1098
1099
1100
1101
1102 <div align="justify">
1103 <p style="text-align: justify;">
1104
1105 Broilers 1 day
1106
1107 </p>
1108 </div>
1109
1110
1111
1112
1113
1114
1115
1116
1117
1118
1119
1120
1121 <div align="justify">
1122 <p style="text-align: justify;">
1123
1124
1125
1126 </p>
1127 </div>
1128
1129
1130
1131
1132
1133
1134
1135
1136
1137
1138
1139
1140 <div align="justify">
1141 <p style="text-align: justify;">
1142
1143 <b><i>Storage</i></b>
1144
1145 </p>
1146 </div>
1147
1148
1149
1150
1151
1152
1153
1154
1155
1156
1157
1158
1159 <div align="justify">
1160 <p style="text-align: justify;">
1161
1162 Store in a dry place at room temperature (up to 25°C). Keep away from children.
1163
1164 </p>
1165 </div>
1166
1167
1168
1169
1170
1171
1172
1173
1174
1175
1176
1177
1178 <div align="justify">
1179 <p style="text-align: justify;">
1180
1181
1182
1183 </p>
1184 </div>
1185
1186
1187
1188
1189
1190
1191
1192
1193
1194
1195
1196
1197 <div align="justify">
1198 <p style="text-align: justify;">
1199
1200 <b><i>Shelf life</i></b>
1201
1202 </p>
1203 </div>
1204
1205
1206
1207
1208
1209
1210
1211
1212
1213
1214
1215
1216 <div align="justify">
1217 <p style="text-align: justify;">
1218
1219 Denoted on the packaging (3 years in the original pack).<b><i></i></b>
1220
1221 </p>
1222 </div>
1223
1224
1225
1226
1227
1228
1229
1230
1231
1232
1233
1234
1235 <div align="justify">
1236 <p style="text-align: justify;">
1237
1238
1239
1240 </p>
1241 </div>
1242
1243
1244
1245
1246
1247
1248
1249
1250
1251
1252
1253
1254 <div align="justify">
1255 <p style="text-align: justify;">
1256
1257 Legal category
1258
1259 </p>
1260 </div>
1261
1262
1263
1264
1265
1266
1267
1268
1269
1270
1271
1272
1273 <div align="justify">
1274 <p style="text-align: justify;">
1275
1276 On prescription only.
1277
1278 </p>
1279 </div>
1280
1281
1282
1283
1284
1285
1286
1287
1288
1289
1290
1291
1292 <div align="justify">
1293 <p style="text-align: justify;">
1294
1295
1296
1297 </p>
1298 </div>
1299
1300
1301
1302
1303
1304
1305
1306
1307
1308
1309
1310
1311 <div align="justify">
1312 <p style="text-align: justify;">
1313
1314 <b><i>Supply</i></b>
1315
1316 </p>
1317 </div>
1318
1319
1320
1321
1322
1323
1324
1325
1326
1327
1328
1329
1330 <div align="justify">
1331 <p style="text-align: justify;">
1332
1333 Bags with 100 g and 1000 g.
1334
1335 </p>
1336 </div>
1337
1338
1339
1340
1341
1342
1343
1344
1345
1346
1347
1348
1349 <div align="justify">
1350 <p style="text-align: justify;">
1351
1352
1353
1354 </p>
1355 </div>
1356
1357
1358
1359
1360
1361
1362
1363
1364
1365
1366
1367
1368 <div align="justify">
1369 <p style="text-align: justify;">
1370
1371 <b><i>Manufacturer</i></b>
1372
1373 </p>
1374 </div>
1375
1376
1377
1378
1379
1380
1381
1382
1383
1384
1385
1386
1387 <div align="justify">
1388 <p style="text-align: justify;">
1389
1390 VETERINA Animal Health Ltd., Croatia
1391
1392 </p>
1393 </div>
1394
1395
1396
1397
1398
1399
1400
1401
1402
1403
1404
1405
1406 <div align="justify">
1407 <p style="text-align: justify;">
1408
1409
1410
1411 </p>
1412 </div>
1413
1414
1415
1416
1417
1418
1419
1420
1421
1422
1423
1424
1425 <div align="left">
1426 <p style="text-align: left;">
1427
1428
1429
1430 </p>
1431 </div>
1432
1433
1434
1435
1436
1437
1438
1439 <!--Section Ends-->
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