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Contents of /vet/1018.html

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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>
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10 <div align="justify">
11 <p style="text-align: justify;">
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15 </p>
16 </div>
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29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>DIZEVAK</b><b><sup>®</sup></b><b></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>inactivated adsorbate vaccine against dysentery and enterotoxaemia in domestic animals </i>
52
53 </p>
54 </div>
55
56
57
58
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61
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64
65
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67 <div align="justify">
68 <p style="text-align: justify;">
69
70 <b><i></i></b>
71
72 </p>
73 </div>
74
75
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84
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86 <div align="justify">
87 <p style="text-align: justify;">
88
89 Composition
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 The vaccine contains anacultures of toxogenic strains of <i>Clostridium perfringens</i>, types C and D adsorbed in aluminium hydroxide gel and preserved with phenol.
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;">
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129 </p>
130 </div>
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132
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135
136
137
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139
140
141
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143 <div align="justify">
144 <p style="text-align: justify;">
145
146 <b><i>Action</i></b>
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 The vaccine stimulates formation of specific antibodies for the toxins of <i>Clostridium</i> <i>perfringens</i> types B, C and D (toxins b and e). It protects the animals against the infections caused by toxotypes of <i>C.</i> <i>perfringens</i>, i. e. against lamb dysentery (and of other young animals) and against enterotoxaemia caused by <i>C.</i> <i>perfringens,</i> types C and D.
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 Immunisation of sheep, goats, cattle and sows against:
223
224 </p>
225 </div>
226
227
228
229
230
231
232
233
234
235
236 <ul>
237 <li>
238
239 <div align="justify">
240 <p style="text-align: justify;">
241
242 Sheep and goats:
243
244 </p>
245 </div>
246
247
248
249
250
251
252
253
254
255
256 </ul>
257
258 <div align="justify">
259 <p style="text-align: justify;">
260
261 Lamb and kids dysentery - protection of young animals via colostrum;
262
263 </p>
264 </div>
265
266
267
268
269
270
271
272
273
274
275
276
277 <div align="justify">
278 <p style="text-align: justify;">
279
280 Enterotoxaemia in sheep caused by <i>C.</i> <i>perfringens</i> type C (Struck);
281
282 </p>
283 </div>
284
285
286
287
288
289
290
291
292
293
294
295
296 <div align="justify">
297 <p style="text-align: justify;">
298
299 Enterotoxaemia in sheep of all ages caused by <i>C.</i> <i>perfringens </i>type D (&quot;Pulpy kidney disease&quot;);<i> </i>
300
301 </p>
302 </div>
303
304
305
306
307
308
309
310
311
312
313 <ul>
314 <li>
315
316 <div align="justify">
317 <p style="text-align: justify;">
318
319 Cattle:
320
321 </p>
322 </div>
323
324
325
326
327
328
329
330
331
332
333 </ul>
334
335 <div align="justify">
336 <p style="text-align: justify;">
337
338 Enterotoxaemia caused by <i>C.</i> <i>perfringens</i> types C and D;
339
340 </p>
341 </div>
342
343
344
345
346
347
348
349
350
351
352 <ul>
353 <li>
354
355 <div align="justify">
356 <p style="text-align: justify;">
357
358 Sows:
359
360 </p>
361 </div>
362
363
364
365
366
367
368
369
370
371
372 </ul>
373
374 <div align="justify">
375 <p style="text-align: justify;">
376
377 Necrotic enteritis in piglets caused by <i>C.</i> <i>perfringens</i> type C.
378
379 </p>
380 </div>
381
382
383
384
385
386
387
388
389
390
391
392
393 <div align="justify">
394 <p style="text-align: justify;">
395
396
397
398 </p>
399 </div>
400
401
402
403
404
405
406
407
408
409
410
411
412 <div align="justify">
413 <p style="text-align: justify;">
414
415 <b><i>Contraindications</i></b>
416
417 </p>
418 </div>
419
420
421
422
423
424
425
426
427
428
429
430
431 <div align="justify">
432 <p style="text-align: justify;">
433
434 Sick animals should not be vaccinated. Other contraindications have not been reported.
435
436 </p>
437 </div>
438
439
440
441
442
443
444
445
446
447
448
449
450 <div align="justify">
451 <p style="text-align: justify;">
452
453
454
455 </p>
456 </div>
457
458
459
460
461
462
463
464
465
466
467
468
469 <div align="justify">
470 <p style="text-align: justify;">
471
472 Administration, dosage and vaccination programme<b></b>
473
474 </p>
475 </div>
476
477
478
479
480
481
482
483
484
485
486
487
488 <div align="justify">
489 <p style="text-align: justify;">
490
491
492
493 </p>
494 </div>
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496
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500
501
502
503
504
505
506
507 <div align="justify">
508 <p style="text-align: justify;">
509
510
511
512 </p>
513 </div>
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517
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519
520
521
522
523
524
525
526 <div align="justify">
527 <p style="text-align: justify;">
528
529
530
531 </p>
532 </div>
533
534
535
536
537
538
539
540
541 <table width="52.50%" border="1" cols="2" rows="4">
542 <tr>
543 <td bgcolor="White" width="37.50%" rowspan="1" colspan="1">
544
545 <div align="left">
546 <p style="text-align: left;">
547
548 Species
549
550 </p>
551 </div>
552
553
554
555
556 </td>
557
558
559
560
561
562 <td bgcolor="White" width="62.50%" rowspan="1" colspan="1">
563
564 <div align="left">
565 <p style="text-align: left;">
566
567 Dosage and administration
568
569 </p>
570 </div>
571
572
573
574
575 </td>
576
577
578
579
580
581
582
583 </tr>
584
585
586
587 <tr>
588 <td bgcolor="White" width="37.50%" rowspan="1" colspan="1">
589
590 <div align="left">
591 <p style="text-align: left;">
592
593 Sheep, goats
594
595 </p>
596 </div>
597
598
599
600
601 </td>
602
603
604
605
606
607 <td bgcolor="White" width="62.50%" rowspan="1" colspan="1">
608
609 <div align="left">
610 <p style="text-align: left;">
611
612 2 mL s. c.
613
614 </p>
615 </div>
616
617
618
619
620 </td>
621
622
623
624
625
626
627
628 </tr>
629
630
631
632 <tr>
633 <td bgcolor="White" width="37.50%" rowspan="1" colspan="1">
634
635 <div align="left">
636 <p style="text-align: left;">
637
638 Cattle
639
640 </p>
641 </div>
642
643
644
645
646 </td>
647
648
649
650
651
652 <td bgcolor="White" width="62.50%" rowspan="1" colspan="1">
653
654 <div align="left">
655 <p style="text-align: left;">
656
657 4 mL s. c.
658
659 </p>
660 </div>
661
662
663
664
665 </td>
666
667
668
669
670
671
672
673 </tr>
674
675
676
677 <tr>
678 <td bgcolor="White" width="37.50%" rowspan="1" colspan="1">
679
680 <div align="left">
681 <p style="text-align: left;">
682
683 Sows
684
685 </p>
686 </div>
687
688
689
690
691 </td>
692
693
694
695
696
697 <td bgcolor="White" width="62.50%" rowspan="1" colspan="1">
698
699 <div align="left">
700 <p style="text-align: left;">
701
702 5 mL i. m.
703
704 </p>
705 </div>
706
707
708
709
710 </td>
711
712
713
714
715
716
717
718 </tr>
719
720 </table>
721
722
723
724
725 <div align="justify">
726 <p style="text-align: justify;">
727
728 Pregnant/sheep and does are vaccinated two times: in the second half of pregnancy and then at least 20-30 before lambing/kidding.
729
730 </p>
731 </div>
732
733
734
735
736
737
738
739
740
741
742
743
744 <div align="justify">
745 <p style="text-align: justify;">
746
747
748
749 </p>
750 </div>
751
752
753
754
755
756
757
758
759
760
761
762
763 <div align="justify">
764 <p style="text-align: justify;">
765
766 Lambs and kids to non-vaccinated mothers may be vaccinated at the age of 4 weeks.
767
768 </p>
769 </div>
770
771
772
773
774
775
776
777
778
779
780
781
782 <div align="justify">
783 <p style="text-align: justify;">
784
785
786
787 </p>
788 </div>
789
790
791
792
793
794
795
796
797
798
799
800
801 <div align="justify">
802 <p style="text-align: justify;">
803
804 Lambs and kids to the vaccinated mothers are immunised via colostrum and are, therefore, to be vaccinated when 2 months old.
805
806 </p>
807 </div>
808
809
810
811
812
813
814
815
816
817
818
819
820 <div align="justify">
821 <p style="text-align: justify;">
822
823
824
825 </p>
826 </div>
827
828
829
830
831
832
833
834
835
836
837
838
839 <div align="justify">
840 <p style="text-align: justify;">
841
842 Cattle are vaccinated twice in 4-6 weeks interval. Pregnant cows are given booster vaccine not later than 20 days prior to calving.
843
844 </p>
845 </div>
846
847
848
849
850
851
852
853
854
855
856
857
858 <div align="justify">
859 <p style="text-align: justify;">
860
861
862
863 </p>
864 </div>
865
866
867
868
869
870
871
872
873
874
875
876
877 <div align="justify">
878 <p style="text-align: justify;">
879
880 Sows are vaccinated twice: 30 and 14 days before farrowing.
881
882 </p>
883 </div>
884
885
886
887
888
889
890
891
892
893
894
895
896 <div align="justify">
897 <p style="text-align: justify;">
898
899
900
901 </p>
902 </div>
903
904
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906
907
908
909
910
911
912
913
914
915 <div align="justify">
916 <p style="text-align: justify;">
917
918 <b><i>Immunity</i></b>
919
920 </p>
921 </div>
922
923
924
925
926
927
928
929
930
931
932
933
934 <div align="justify">
935 <p style="text-align: justify;">
936
937 Specific antibodies transmitted to the young via colostrum render immunity during first days of their life, when the incidence of the disease is the highest.
938
939 </p>
940 </div>
941
942
943
944
945
946
947
948
949
950
951
952
953 <div align="justify">
954 <p style="text-align: justify;">
955
956
957
958 </p>
959 </div>
960
961
962
963
964
965
966
967
968
969
970
971
972 <div align="justify">
973 <p style="text-align: justify;">
974
975 <b><i>Warnings and precautions</i></b>
976
977 </p>
978 </div>
979
980
981
982
983
984
985
986
987
988
989
990
991 <div align="justify">
992 <p style="text-align: justify;">
993
994 Shake well before use.
995
996 </p>
997 </div>
998
999
1000
1001
1002
1003
1004
1005
1006
1007
1008
1009
1010 <div align="justify">
1011 <p style="text-align: justify;">
1012
1013
1014
1015 </p>
1016 </div>
1017
1018
1019
1020
1021
1022
1023
1024
1025
1026
1027
1028
1029 <div align="justify">
1030 <p style="text-align: justify;">
1031
1032 Use sterile and dry needles and syringes. Do not use the vaccination needle to withdraw the vaccine from the bottle.
1033
1034 </p>
1035 </div>
1036
1037
1038
1039
1040
1041
1042
1043
1044
1045
1046
1047
1048 <div align="justify">
1049 <p style="text-align: justify;">
1050
1051
1052
1053 </p>
1054 </div>
1055
1056
1057
1058
1059
1060
1061
1062
1063
1064
1065
1066
1067 <div align="justify">
1068 <p style="text-align: justify;">
1069
1070 A palpable swelling might develop at the site of injection, which disappears after several days.
1071
1072 </p>
1073 </div>
1074
1075
1076
1077
1078
1079
1080
1081
1082
1083
1084
1085
1086 <div align="justify">
1087 <p style="text-align: justify;">
1088
1089
1090
1091 </p>
1092 </div>
1093
1094
1095
1096
1097
1098
1099
1100
1101
1102
1103
1104
1105 <div align="justify">
1106 <p style="text-align: justify;">
1107
1108 If case of allergic reactions, particularly of anaphylactic condition, instantaneously administer intravenous soluble glucocorticoid (e. g. dexamethasone sodium phosphate) and intramuscular adrenaline and antihistaminic.
1109
1110 </p>
1111 </div>
1112
1113
1114
1115
1116
1117
1118
1119
1120
1121
1122
1123
1124 <div align="justify">
1125 <p style="text-align: justify;">
1126
1127
1128
1129 </p>
1130 </div>
1131
1132
1133
1134
1135
1136
1137
1138
1139
1140
1141
1142
1143 <div align="justify">
1144 <p style="text-align: justify;">
1145
1146 The animals given immunosuppressants (e. g. glucocorticoids) should not be vaccinated within 4 weeks of their administration.
1147
1148 </p>
1149 </div>
1150
1151
1152
1153
1154
1155
1156
1157
1158
1159
1160
1161
1162 <div align="justify">
1163 <p style="text-align: justify;">
1164
1165
1166
1167 </p>
1168 </div>
1169
1170
1171
1172
1173
1174
1175
1176
1177
1178
1179
1180
1181 <div align="justify">
1182 <p style="text-align: justify;">
1183
1184 Packaging and vaccine leftovers must be disposed of in a safe way, preferably by boiling in water.
1185
1186 </p>
1187 </div>
1188
1189
1190
1191
1192
1193
1194
1195
1196
1197
1198
1199
1200 <div align="justify">
1201 <p style="text-align: justify;">
1202
1203
1204
1205 </p>
1206 </div>
1207
1208
1209
1210
1211
1212
1213
1214
1215
1216
1217
1218
1219 <div align="justify">
1220 <p style="text-align: justify;">
1221
1222 In every animal population there are some with poorer response to vaccination. Immune reaction is affected by hereditary factors, subclinical diseases, health condition, stress, concurrent administration of other medicines, storage and administration of the vaccine.
1223
1224 </p>
1225 </div>
1226
1227
1228
1229
1230
1231
1232
1233
1234
1235
1236
1237
1238 <div align="justify">
1239 <p style="text-align: justify;">
1240
1241
1242
1243 </p>
1244 </div>
1245
1246
1247
1248
1249
1250
1251
1252
1253
1254
1255
1256
1257 <div align="justify">
1258 <p style="text-align: justify;">
1259
1260 <b><i>Withdrawal</i></b>
1261
1262 </p>
1263 </div>
1264
1265
1266
1267
1268
1269
1270
1271
1272
1273
1274
1275
1276 <div align="justify">
1277 <p style="text-align: justify;">
1278
1279 Meat, organs and other edible tissues 0 days
1280
1281 </p>
1282 </div>
1283
1284
1285
1286
1287
1288
1289
1290
1291
1292
1293
1294
1295 <div align="justify">
1296 <p style="text-align: justify;">
1297
1298 Milk 0 days
1299
1300 </p>
1301 </div>
1302
1303
1304
1305
1306
1307
1308
1309
1310
1311
1312
1313
1314 <div align="justify">
1315 <p style="text-align: justify;">
1316
1317
1318
1319 </p>
1320 </div>
1321
1322
1323
1324
1325
1326
1327
1328
1329
1330
1331
1332
1333 <div align="justify">
1334 <p style="text-align: justify;">
1335
1336 <b><i>Storage</i></b>
1337
1338 </p>
1339 </div>
1340
1341
1342
1343
1344
1345
1346
1347
1348
1349
1350
1351
1352 <div align="justify">
1353 <p style="text-align: justify;">
1354
1355 Store in a dark place at 2-8°C (refrigerator). Keep away from children. Avoid freezing.
1356
1357 </p>
1358 </div>
1359
1360
1361
1362
1363
1364
1365
1366
1367
1368
1369
1370
1371 <div align="justify">
1372 <p style="text-align: justify;">
1373
1374
1375
1376 </p>
1377 </div>
1378
1379
1380
1381
1382
1383
1384
1385
1386
1387
1388
1389
1390 <div align="justify">
1391 <p style="text-align: justify;">
1392
1393 <b><i>Shelf life</i></b>
1394
1395 </p>
1396 </div>
1397
1398
1399
1400
1401
1402
1403
1404
1405
1406
1407
1408
1409 <div align="justify">
1410 <p style="text-align: justify;">
1411
1412 Denoted on the packaging (18 months in original pack).
1413
1414 </p>
1415 </div>
1416
1417
1418
1419
1420
1421
1422
1423
1424
1425
1426
1427
1428 <div align="justify">
1429 <p style="text-align: justify;">
1430
1431
1432
1433 </p>
1434 </div>
1435
1436
1437
1438
1439
1440
1441
1442
1443
1444
1445
1446
1447 <div align="justify">
1448 <p style="text-align: justify;">
1449
1450 <b><i>Legal category</i></b>
1451
1452 </p>
1453 </div>
1454
1455
1456
1457
1458
1459
1460
1461
1462
1463
1464
1465
1466 <div align="justify">
1467 <p style="text-align: justify;">
1468
1469 On prescription only.
1470
1471 </p>
1472 </div>
1473
1474
1475
1476
1477
1478
1479
1480
1481
1482
1483
1484
1485 <div align="justify">
1486 <p style="text-align: justify;">
1487
1488
1489
1490 </p>
1491 </div>
1492
1493
1494
1495
1496
1497
1498
1499
1500
1501
1502
1503
1504 <div align="justify">
1505 <p style="text-align: justify;">
1506
1507 <b><i>Supply </i></b>
1508
1509 </p>
1510 </div>
1511
1512
1513
1514
1515
1516
1517
1518
1519
1520
1521
1522
1523 <div align="justify">
1524 <p style="text-align: justify;">
1525
1526 Bottle of 100 mL
1527
1528 </p>
1529 </div>
1530
1531
1532
1533
1534
1535
1536
1537
1538
1539
1540
1541
1542 <div align="justify">
1543 <p style="text-align: justify;">
1544
1545
1546
1547 </p>
1548 </div>
1549
1550
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1552
1553
1554
1555
1556
1557
1558
1559
1560
1561 <div align="justify">
1562 <p style="text-align: justify;">
1563
1564 <b><i>Manufacturer</i></b>
1565
1566 </p>
1567 </div>
1568
1569
1570
1571
1572
1573
1574
1575
1576
1577
1578
1579
1580 <div align="justify">
1581 <p style="text-align: justify;">
1582
1583 VETERINA Animal Health Ltd., Croatia
1584
1585 </p>
1586 </div>
1587
1588
1589
1590
1591
1592
1593
1594
1595
1596
1597
1598
1599 <div align="justify">
1600 <p style="text-align: justify;">
1601
1602
1603
1604 </p>
1605 </div>
1606
1607
1608
1609
1610
1611
1612
1613
1614
1615
1616
1617
1618 <div align="left">
1619 <p style="text-align: left;">
1620
1621
1622
1623 </p>
1624 </div>
1625
1626
1627
1628
1629
1630
1631
1632 <!--Section Ends-->
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