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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
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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>SUSTREPEN</b><b><sup>®</sup></b><b> D</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 Procaine benzylpenicillin 200,000 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 sulfate 200 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 Dexamethasone sodium phosphate 0.5 mg
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 Carrier and adjuvants up to 1 mL
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
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 <b><i>Action</i></b><b></b>
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 A combination of penicillin (which acts primarily on gram-positive bacteria) and of dihydrostreptomycin (with prevailing action against gram-negative bacteria), has broadened antibacterial spectrum of the preparation. Sustrepen<b><sup>®</sup></b> D exerts bactericidal and bacteriostatic effect on the commonest causes of the 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. Dexamethasone is a potent corticosterroid with a high degree of anti-inflammatory, antiallergenic and generally stimulating effect.
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 <b><i>Indications</i></b>
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 Management of diseases and pathological conditions requiring concurrent administration of antibiotics and supportive treatment with corticosteroids: pneumonia, colitis, septicemia, peritonitis, puerperal fever, MMA syndrome in sows, inflammation of osteo-muscular system, gingivitis, abscess, all infections caused by penicillin- and dihydrostreptomycin-sensitive bacteria accompanied by intoxication and allergic conditions such as urticaria, rash, insect bites, dermatoses, etc.
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>Contraindications</i></b><b></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 The drug should not be administered intravenously.
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 Treatment with Sustrepen<b><sup>®</sup></b> D should not exceed two days.
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 Pregnancy, renal and cardiac insufficiency or diseases, dogs and cats with diabetes and hypersensitivity to beta-lactam antibiotics (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 Sustrepen<b><sup>®</sup></b> D should not be given to guinea-pigs, hamsters, rabbits and other small monogastric herbivore because of the risk of clostridiococcidosis and fatal enterocolitis.
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>Administration and dosage</i></b><b></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 The drug is given by i. m. route only.<b> </b>
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 Shake well before use.
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 Daily dose for large animals is 1 mL/20 kg of b. w. and for small animals 1 mL/12 kg of b. w.
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 Sustrepen<b><sup>®</sup></b> D is given once in 24 hours.
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
672
673
674
675 <div align="justify">
676 <p style="text-align: justify;">
677
678 Treatment should not exceed 2 consecutive days. Then it is continued with penicillin and streptomycin preparation without dexamethasone (e. g. Sustrepen<b><sup>®</sup></b>) till the remission of clinical signs.
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
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 Dosage is relevant to body weight:
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 <table width="52.50%" border="1" cols="2" rows="7">
748 <tr>
749 <td bgcolor="White" width="59.39%" rowspan="1" colspan="1">
750
751 <div align="left">
752 <p style="text-align: left;">
753
754 Species and class
755
756 </p>
757 </div>
758
759
760
761
762 </td>
763
764
765
766
767
768 <td bgcolor="White" width="40.61%" rowspan="1" colspan="1">
769
770 <div align="left">
771 <p style="text-align: left;">
772
773 Sustrepen<b><sup>®</sup></b> D
774
775 </p>
776 </div>
777
778
779
780
781 </td>
782
783
784
785
786
787
788
789 </tr>
790
791
792
793 <tr>
794 <td bgcolor="White" width="59.39%" rowspan="1" colspan="1">
795
796 <div align="left">
797 <p style="text-align: left;">
798
799 Horses, cattle
800
801 </p>
802 </div>
803
804
805
806
807 </td>
808
809
810
811
812
813 <td bgcolor="White" width="40.61%" rowspan="1" colspan="1">
814
815 <div align="left">
816 <p style="text-align: left;">
817
818 15-25 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="59.39%" rowspan="1" colspan="1">
840
841 <div align="left">
842 <p style="text-align: left;">
843
844 Foal, calves, swine
845
846 </p>
847 </div>
848
849
850
851
852 </td>
853
854
855
856
857
858 <td bgcolor="White" width="40.61%" rowspan="1" colspan="1">
859
860 <div align="left">
861 <p style="text-align: left;">
862
863 4-10 mL
864
865 </p>
866 </div>
867
868
869
870
871 </td>
872
873
874
875
876
877
878
879 </tr>
880
881
882
883 <tr>
884 <td bgcolor="White" width="59.39%" rowspan="1" colspan="1">
885
886 <div align="left">
887 <p style="text-align: left;">
888
889 Sheep, goats
890
891 </p>
892 </div>
893
894
895
896
897 </td>
898
899
900
901
902
903 <td bgcolor="White" width="40.61%" rowspan="1" colspan="1">
904
905 <div align="left">
906 <p style="text-align: left;">
907
908 4-6 mL
909
910 </p>
911 </div>
912
913
914
915
916 </td>
917
918
919
920
921
922
923
924 </tr>
925
926
927
928 <tr>
929 <td bgcolor="White" width="59.39%" rowspan="1" colspan="1">
930
931 <div align="left">
932 <p style="text-align: left;">
933
934 Piglets
935
936 </p>
937 </div>
938
939
940
941
942 </td>
943
944
945
946
947
948 <td bgcolor="White" width="40.61%" rowspan="1" colspan="1">
949
950 <div align="left">
951 <p style="text-align: left;">
952
953 0.5 mL
954
955 </p>
956 </div>
957
958
959
960
961 </td>
962
963
964
965
966
967
968
969 </tr>
970
971
972
973 <tr>
974 <td bgcolor="White" width="59.39%" rowspan="1" colspan="1">
975
976 <div align="left">
977 <p style="text-align: left;">
978
979 Dogs
980
981 </p>
982 </div>
983
984
985
986
987 </td>
988
989
990
991
992
993 <td bgcolor="White" width="40.61%" rowspan="1" colspan="1">
994
995 <div align="left">
996 <p style="text-align: left;">
997
998 0.5-5 mL
999
1000 </p>
1001 </div>
1002
1003
1004
1005
1006 </td>
1007
1008
1009
1010
1011
1012
1013
1014 </tr>
1015
1016
1017
1018 <tr>
1019 <td bgcolor="White" width="59.39%" rowspan="1" colspan="1">
1020
1021 <div align="left">
1022 <p style="text-align: left;">
1023
1024 Cats
1025
1026 </p>
1027 </div>
1028
1029
1030
1031
1032 </td>
1033
1034
1035
1036
1037
1038 <td bgcolor="White" width="40.61%" rowspan="1" colspan="1">
1039
1040 <div align="left">
1041 <p style="text-align: left;">
1042
1043 0.5-1 mL
1044
1045 </p>
1046 </div>
1047
1048
1049
1050
1051 </td>
1052
1053
1054
1055
1056
1057
1058
1059 </tr>
1060
1061 </table>
1062
1063
1064
1065
1066 <div align="justify">
1067 <p style="text-align: justify;">
1068
1069
1070
1071 </p>
1072 </div>
1073
1074
1075
1076
1077
1078
1079
1080
1081
1082
1083
1084
1085 <div align="justify">
1086 <p style="text-align: justify;">
1087
1088 <b><i>Warnings and precautions</i></b>
1089
1090 </p>
1091 </div>
1092
1093
1094
1095
1096
1097
1098
1099
1100
1101
1102
1103
1104 <div align="justify">
1105 <p style="text-align: justify;">
1106
1107 High doses of dexamethasone may in the early pregnancy cause foetal abnormalities (rats and mice) and in the late pregnancy induce abortion or early parturition (particularly in ruminants).
1108
1109 </p>
1110 </div>
1111
1112
1113
1114
1115
1116
1117
1118
1119
1120
1121
1122
1123 <div align="justify">
1124 <p style="text-align: justify;">
1125
1126
1127
1128 </p>
1129 </div>
1130
1131
1132
1133
1134
1135
1136
1137
1138
1139
1140
1141
1142 <div align="justify">
1143 <p style="text-align: justify;">
1144
1145 Because cats and dogs are given rather low dose, for accurate dosage precisely determine the animal's weight and use the syringes with the marks at least at 0.1.
1146
1147 </p>
1148 </div>
1149
1150
1151
1152
1153
1154
1155
1156
1157
1158
1159
1160
1161 <div align="justify">
1162 <p style="text-align: justify;">
1163
1164
1165
1166 </p>
1167 </div>
1168
1169
1170
1171
1172
1173
1174
1175
1176
1177
1178
1179
1180 <div align="justify">
1181 <p style="text-align: justify;">
1182
1183 Given concomitantly with general anaesthesia dihydrostreptomycin may enhance neuromuscular blockade induced by halothane and myorelaxant.
1184
1185 </p>
1186 </div>
1187
1188
1189
1190
1191
1192
1193
1194
1195
1196
1197
1198
1199 <div align="justify">
1200 <p style="text-align: justify;">
1201
1202
1203
1204 </p>
1205 </div>
1206
1207
1208
1209
1210
1211
1212
1213
1214
1215
1216
1217
1218 <div align="justify">
1219 <p style="text-align: justify;">
1220
1221 Dexamethasone diminishes immune response. Therefore, Sustrepen<b><sup>®</sup></b> D should not be instituted at least 7 days prior and 7 days after vaccination.
1222
1223 </p>
1224 </div>
1225
1226
1227
1228
1229
1230
1231
1232
1233
1234
1235
1236
1237 <div align="justify">
1238 <p style="text-align: justify;">
1239
1240
1241
1242 </p>
1243 </div>
1244
1245
1246
1247
1248
1249
1250
1251
1252
1253
1254
1255
1256 <div align="justify">
1257 <p style="text-align: justify;">
1258
1259 <b><i>Withdrawal</i></b><b></b>
1260
1261 </p>
1262 </div>
1263
1264
1265
1266
1267
1268
1269
1270
1271
1272
1273
1274
1275 <div align="justify">
1276 <p style="text-align: justify;">
1277
1278 Meat and other edible tissues -
1279
1280 </p>
1281 </div>
1282
1283
1284
1285
1286
1287
1288
1289
1290
1291
1292
1293
1294 <div align="justify">
1295 <p style="text-align: justify;">
1296
1297 ruminants, swine, horses 12 days
1298
1299 </p>
1300 </div>
1301
1302
1303
1304
1305
1306
1307
1308
1309
1310
1311
1312
1313 <div align="justify">
1314 <p style="text-align: justify;">
1315
1316 Kidneys 40 days
1317
1318 </p>
1319 </div>
1320
1321
1322
1323
1324
1325
1326
1327
1328
1329
1330
1331
1332 <div align="justify">
1333 <p style="text-align: justify;">
1334
1335 Milk 6 days
1336
1337 </p>
1338 </div>
1339
1340
1341
1342
1343
1344
1345
1346
1347
1348
1349
1350
1351 <div align="justify">
1352 <p style="text-align: justify;">
1353
1354
1355
1356 </p>
1357 </div>
1358
1359
1360
1361
1362
1363
1364
1365
1366
1367
1368
1369
1370 <div align="justify">
1371 <p style="text-align: justify;">
1372
1373 <b><i>Storage</i></b><b></b>
1374
1375 </p>
1376 </div>
1377
1378
1379
1380
1381
1382
1383
1384
1385
1386
1387
1388
1389 <div align="justify">
1390 <p style="text-align: justify;">
1391
1392 Store in a dark and cool place (8-15°C). Keep away from children. Avoid freezing.
1393
1394 </p>
1395 </div>
1396
1397
1398
1399
1400
1401
1402
1403
1404
1405
1406
1407
1408 <div align="justify">
1409 <p style="text-align: justify;">
1410
1411
1412
1413 </p>
1414 </div>
1415
1416
1417
1418
1419
1420
1421
1422
1423
1424
1425
1426
1427 <div align="justify">
1428 <p style="text-align: justify;">
1429
1430 <b><i>Shelf life</i></b>
1431
1432 </p>
1433 </div>
1434
1435
1436
1437
1438
1439
1440
1441
1442
1443
1444
1445
1446 <div align="justify">
1447 <p style="text-align: justify;">
1448
1449 Denoted on the packaging (2 years in the original pack).
1450
1451 </p>
1452 </div>
1453
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1457
1458
1459
1460
1461
1462
1463
1464
1465 <div align="justify">
1466 <p style="text-align: justify;">
1467
1468
1469
1470 </p>
1471 </div>
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1476
1477
1478
1479
1480
1481
1482
1483
1484 <div align="justify">
1485 <p style="text-align: justify;">
1486
1487 <b><i>Legal category</i></b><b></b>
1488
1489 </p>
1490 </div>
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1495
1496
1497
1498
1499
1500
1501
1502
1503 <div align="justify">
1504 <p style="text-align: justify;">
1505
1506 On prescription only.
1507
1508 </p>
1509 </div>
1510
1511
1512
1513
1514
1515
1516
1517
1518
1519
1520
1521
1522 <div align="justify">
1523 <p style="text-align: justify;">
1524
1525 <b><i></i></b>
1526
1527 </p>
1528 </div>
1529
1530
1531
1532
1533
1534
1535
1536
1537
1538
1539
1540
1541 <div align="justify">
1542 <p style="text-align: justify;">
1543
1544 Supply<b></b>
1545
1546 </p>
1547 </div>
1548
1549
1550
1551
1552
1553
1554
1555
1556
1557
1558
1559
1560 <div align="justify">
1561 <p style="text-align: justify;">
1562
1563 Pierced bottle with 50 mL suspension.
1564
1565 </p>
1566 </div>
1567
1568
1569
1570
1571
1572
1573
1574
1575
1576
1577
1578
1579 <div align="justify">
1580 <p style="text-align: justify;">
1581
1582
1583
1584 </p>
1585 </div>
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1587
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1589
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1591
1592
1593
1594
1595
1596
1597
1598 <div align="justify">
1599 <p style="text-align: justify;">
1600
1601 <b><i>Manufacturer</i></b><b></b>
1602
1603 </p>
1604 </div>
1605
1606
1607
1608
1609
1610
1611
1612
1613
1614
1615
1616
1617 <div align="justify">
1618 <p style="text-align: justify;">
1619
1620 VETERINA Animal Health Ltd., Croatia
1621
1622 </p>
1623 </div>
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1625
1626
1627
1628
1629
1630
1631
1632
1633
1634
1635
1636 <div align="justify">
1637 <p style="text-align: justify;">
1638
1639
1640
1641 </p>
1642 </div>
1643
1644
1645
1646
1647
1648
1649
1650
1651
1652
1653
1654
1655 <div align="left">
1656 <p style="text-align: left;">
1657
1658
1659
1660 </p>
1661 </div>
1662
1663
1664
1665
1666
1667
1668
1669 <!--Section Ends-->
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