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Revision 1.1 - (show annotations)
Thu Apr 5 12:26:37 2001 UTC (18 years, 4 months 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>SUSTREPEN</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>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
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><b></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 Procaine benzylpenicillin 250,000 iu.
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 Dihydrostreptomycin as sulfate 250 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><b></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 A combination of penicillin, acting primarily on gram-positive bacteria, and dihydrostreptomycin, acting mostly on gram-negative bacteria, has broadened antibacterial spectrum of Sustrepen<b><sup>®</sup></b> which acts bactericidally and bacteriostatically against commonest causes of infections in domestic animals: <i>Staphylococcus</i> spp., <i>Streptococcus</i> spp., <i>Pasteurella</i> spp., <i>Salmonella</i> spp., <i>Actinobacillus</i> spp., <i>B. anthracis</i>, <i>Diplococcus</i> spp., <i>Erysipelothrix insidiosa</i>, <i>E. coli</i>, <i>Clostridium</i> spp., <i>Leptospira</i> spp., <i>Proteus</i> spp., <i>Corynebacterium renale</i>, <i>Campylobacter</i> spp. etc.
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 Treatment of acute and chronic, primary and secondary, general and local infections caused by penicillin- and dihydrostreptomycin-sensitive organisms: respiratory infections, urinary infections, prophylaxis of postoperative infections, suppurative inflammation of wounds, phlegmon, paronychia, panarthritis, umbilical inflammations, puerperal infections, septicemia, mastitis (accompanied by local therapy), infections secondary to distemper, parvovirosis, panleukopenia, influenza, etc.
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 <b><i>Contraindications</i></b>
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 The drug should not be given by i. v. route.
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 Penicillin antibiotics are contraindicated in guinea-pigs, hamsters and other small monogastric herbivore due to clostridiotoxicosis and fatal enterocolitis.
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 Hypersensitivity to the ingredients, which is very rare.
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 <b><i>Administration and dosage</i></b><b></b>
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 Shake well before use. Administer by deep intramuscular injection. Dogs and cats may be given s. c. injection as well.
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
489
490 </p>
491 </div>
492
493
494
495
496
497
498
499
500 <table width="57.43%" border="1" cols="2" rows="4">
501 <tr>
502 <td bgcolor="White" width="62.86%" rowspan="1" colspan="1">
503
504 <div align="left">
505 <p style="text-align: left;">
506
507 Species and class
508
509 </p>
510 </div>
511
512
513
514
515 </td>
516
517
518
519
520
521 <td bgcolor="White" width="37.14%" rowspan="1" colspan="1">
522
523 <div align="left">
524 <p style="text-align: left;">
525
526 Dose
527
528 </p>
529 </div>
530
531
532
533
534 </td>
535
536
537
538
539
540
541
542 </tr>
543
544
545
546 <tr>
547 <td bgcolor="White" width="62.86%" rowspan="1" colspan="1">
548
549 <div align="left">
550 <p style="text-align: left;">
551
552 Horses, cattle
553
554 </p>
555 </div>
556
557
558
559
560 </td>
561
562
563
564
565
566 <td bgcolor="White" width="37.14%" rowspan="1" colspan="1">
567
568 <div align="left">
569 <p style="text-align: left;">
570
571 4 mL/100 kg b.w.
572
573 </p>
574 </div>
575
576
577
578
579 </td>
580
581
582
583
584
585
586
587 </tr>
588
589
590
591 <tr>
592 <td bgcolor="White" width="62.86%" rowspan="1" colspan="1">
593
594 <div align="left">
595 <p style="text-align: left;">
596
597 Foals, calves, swine sheep, goats
598
599 </p>
600 </div>
601
602
603
604
605 </td>
606
607
608
609
610
611 <td bgcolor="White" width="37.14%" rowspan="1" colspan="1">
612
613 <div align="left">
614 <p style="text-align: left;">
615
616 2 mL/50 kg b.w.
617
618 </p>
619 </div>
620
621
622
623
624 </td>
625
626
627
628
629
630
631
632 </tr>
633
634
635
636 <tr>
637 <td bgcolor="White" width="62.86%" rowspan="1" colspan="1">
638
639 <div align="left">
640 <p style="text-align: left;">
641
642 Dogs, cats
643
644 </p>
645 </div>
646
647
648
649
650 </td>
651
652
653
654
655
656 <td bgcolor="White" width="37.14%" rowspan="1" colspan="1">
657
658 <div align="left">
659 <p style="text-align: left;">
660
661 0.1 mL/1 kg b.w.
662
663 </p>
664 </div>
665
666
667
668
669 </td>
670
671
672
673
674
675
676
677 </tr>
678
679 </table>
680
681
682
683
684 <div align="justify">
685 <p style="text-align: justify;">
686
687
688
689 </p>
690 </div>
691
692
693
694
695
696
697
698
699
700
701
702
703 <div align="justify">
704 <p style="text-align: justify;">
705
706 Repeat administration every 24 hours till remission of the symptoms and then continue for at least 48 hours from the establishment of normal body temperature and remission of all sings of infection.
707
708 </p>
709 </div>
710
711
712
713
714
715
716
717
718
719
720
721
722 <div align="justify">
723 <p style="text-align: justify;">
724
725
726
727 </p>
728 </div>
729
730
731
732
733
734
735
736
737
738
739
740
741 <div align="justify">
742 <p style="text-align: justify;">
743
744 In severe infections the dose may be doubled.
745
746 </p>
747 </div>
748
749
750
751
752
753
754
755
756
757
758
759
760 <div align="justify">
761 <p style="text-align: justify;">
762
763
764
765 </p>
766 </div>
767
768
769
770
771
772
773
774
775
776
777
778
779 <div align="justify">
780 <p style="text-align: justify;">
781
782 <b><i>Warnings and precautions</i></b>
783
784 </p>
785 </div>
786
787
788
789
790
791
792
793
794
795
796
797
798 <div align="justify">
799 <p style="text-align: justify;">
800
801 Beta-lactamase producing organisms are resistant to Sustrepen<b><sup>®</sup></b>.
802
803 </p>
804 </div>
805
806
807
808
809
810
811
812
813
814
815
816
817 <div align="justify">
818 <p style="text-align: justify;">
819
820
821
822 </p>
823 </div>
824
825
826
827
828
829
830
831
832
833
834
835
836 <div align="justify">
837 <p style="text-align: justify;">
838
839 Prolonged administration of high doses may impair hearing and equilibrium, particularly in cats.
840
841 </p>
842 </div>
843
844
845
846
847
848
849
850
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="left">
875 <p style="text-align: left;">
876
877 On very rare occasions the animals may develop allergic reactions (e. g. dyspnea, edema on the head, neck or extremities, ptyalism, erythema etc.). In such instances immediately withdraw the preparation and, if necessary, institute corresponding drugs (adrenaline, H1 receptor blokers and glucocorticoids).
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 Do not mix Sustrepen<b><sup>®</sup></b> with other drugs in the same syringe.
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
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 Concomitant administration of tetracyclines, macrolides, or chloramphenicol may diminish the effect of penicillin.
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
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 It is not recommended to administer dihydrostreptomycin in renal impairment.
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
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 Concurrent administration with halothane or myorelaxant may enhance neuromuscular blockade.
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
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 <b><i>Withdrawal</i></b><b></b>
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 Meat and other edible tissues 12 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 Kidneys 45 days
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 Milk 6 days
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
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 <b><i>Storage</i></b><b></b>
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 Store in a dark place at 8-15°C. Keep away from children. Avoid freezing.
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
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 <b><i>Shelf life</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 Denoted on the packaging (2 years in the original pack).
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
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 <b><i>Legal category</i></b><b></b>
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 On prescription only.
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
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 <b><i>Supply</i></b><b></b>
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 Pierced bottle of 100 mL.
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></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 Manufacturer
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 VETERINA Animal Health Ltd., Croatia
1410
1411 </p>
1412 </div>
1413
1414
1415
1416
1417
1418
1419
1420
1421
1422
1423
1424
1425 <div align="justify">
1426 <p style="text-align: justify;">
1427
1428
1429
1430 </p>
1431 </div>
1432
1433
1434
1435
1436
1437
1438
1439
1440
1441
1442
1443
1444 <div align="left">
1445 <p style="text-align: left;">
1446
1447
1448
1449 </p>
1450 </div>
1451
1452
1453
1454
1455
1456
1457
1458 <!--Section Ends-->
1459
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