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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
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9
10 <div align="justify">
11 <p style="text-align: justify;">
12
13
14
15 </p>
16 </div>
17
18
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24
25
26
27
28
29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>PLIVACOR</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 Dexamethasone as dexamethasone pivalate 1 mg
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 Dexamethasone as dexamethasone sodium phosphate 1 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>
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 Dexamethasone is a potent glucocorticoidal synthetic steroid. Dexamethasone phosphate rapidly exerts therapeutic effect and maintains it over about 48 hours. Dexamethasone pivalate has a prolonged action lasting over 7 days. Therefore, Plivacor<b><sup>®</sup></b> is indicated whenever rapid and prolonged effect (ketosis) is required. Glucocorticoids inhibit inflammatory response by preventing formation of the inflammatory mediators (prostaglandins), stabilise biological membranes, suppress migration of leukocytes, reduce calibre of blood vessels and the resulting extravasation, suppress formation of cartilage and alleviate fever and toxaemia. Anti-inflammatory and anti-shock effect of Plivacor<b><sup>®</sup></b> is comparable with its gluconeogenetic action. Mineralocorticoidal effects of this synthetic hormone are negligible. Therefore, therapeutic doses of Plivacor<b><sup>®</sup></b> do not affect the balance of water and electrolytes.
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 Major diseases managed by glucocorticoids in supportive treatment:<b></b>
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 <i>Nutritional, metabolic and other disorders:</i>
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 ketosis, puerperal paresis, tetanic conditions, agalaxia in sows - MMA syndrome, edemic disease in piglets, acute circulatory collapse and shock, intoxication, snake bite, thermal and chemical burns, induction of appetite in general exhaustion.
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 <i>Inflammations of muscular-skeletal system:</i>
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 arthritis, osteoarthritis, panostitis, myozsitis, tendinitis, bursitis, sinovitis, laminitis, sacroiliac subluxation, protrusion of intervertebral disk, craniocerebral or spinal wounds, etc.
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
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 <i>Mostly allergic conditions:</i>
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 eczematous and other non-specific dermatoses, allergic dermatitis following flea bites, oedemas of allergic origin, alimentary exanthem, otitis, chronic alveolar emphysema, asthma in cats, autoimmune diseases, etc.
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></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 <b><i>Contraindications</i></b>
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 Osteoporosis, renal insufficiency, hypertension and chronic heart failure, one week pre- and one week post vaccination, injecting into infected tissue, gastric ulcer and paratuberculosis. Intravenous or intra-articular administration should be avoided.
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></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 Administration and dosage
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 Plivacor<b><sup>®</sup></b> is given by i.m. or s.c. route. Shake well before use.
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
584
585 </p>
586 </div>
587
588
589
590
591
592
593
594
595 <table width="59.06%" border="1" cols="2" rows="5">
596 <tr>
597 <td bgcolor="White" width="63.90%" rowspan="1" colspan="1">
598
599 <div align="left">
600 <p style="text-align: left;">
601
602 Species
603
604 </p>
605 </div>
606
607
608
609
610 </td>
611
612
613
614
615
616 <td bgcolor="White" width="36.10%" rowspan="1" colspan="1">
617
618 <div align="left">
619 <p style="text-align: left;">
620
621 Dose
622
623 </p>
624 </div>
625
626
627
628
629 </td>
630
631
632
633
634
635
636
637 </tr>
638
639
640
641 <tr>
642 <td bgcolor="White" width="63.90%" rowspan="1" colspan="1">
643
644 <div align="left">
645 <p style="text-align: left;">
646
647 Horses, cattle
648
649 </p>
650 </div>
651
652
653
654
655 </td>
656
657
658
659
660
661 <td bgcolor="White" width="36.10%" rowspan="1" colspan="1">
662
663 <div align="left">
664 <p style="text-align: left;">
665
666 10-25 mL
667
668 </p>
669 </div>
670
671
672
673
674 </td>
675
676
677
678
679
680
681
682 </tr>
683
684
685
686 <tr>
687 <td bgcolor="White" width="63.90%" rowspan="1" colspan="1">
688
689 <div align="left">
690 <p style="text-align: left;">
691
692 Foals, calves, sheep, goats, swine
693
694 </p>
695 </div>
696
697
698
699
700 </td>
701
702
703
704
705
706 <td bgcolor="White" width="36.10%" rowspan="1" colspan="1">
707
708 <div align="left">
709 <p style="text-align: left;">
710
711 1-5 mL
712
713 </p>
714 </div>
715
716
717
718
719 </td>
720
721
722
723
724
725
726
727 </tr>
728
729
730
731 <tr>
732 <td bgcolor="White" width="63.90%" rowspan="1" colspan="1">
733
734 <div align="left">
735 <p style="text-align: left;">
736
737 Dogs
738
739 </p>
740 </div>
741
742
743
744
745 </td>
746
747
748
749
750
751 <td bgcolor="White" width="36.10%" rowspan="1" colspan="1">
752
753 <div align="left">
754 <p style="text-align: left;">
755
756 0.25-2 mL
757
758 </p>
759 </div>
760
761
762
763
764 </td>
765
766
767
768
769
770
771
772 </tr>
773
774
775
776 <tr>
777 <td bgcolor="White" width="63.90%" rowspan="1" colspan="1">
778
779 <div align="left">
780 <p style="text-align: left;">
781
782 Cats
783
784 </p>
785 </div>
786
787
788
789
790 </td>
791
792
793
794
795
796 <td bgcolor="White" width="36.10%" rowspan="1" colspan="1">
797
798 <div align="left">
799 <p style="text-align: left;">
800
801 0.25-0.5 mL
802
803 </p>
804 </div>
805
806
807
808
809 </td>
810
811
812
813
814
815
816
817 </tr>
818
819 </table>
820
821
822
823
824 <div align="justify">
825 <p style="text-align: justify;">
826
827
828
829 </p>
830 </div>
831
832
833
834
835
836
837
838
839
840
841
842
843 <div align="justify">
844 <p style="text-align: justify;">
845
846 Treatment of primary ketosis frequently requires a single dose only, as shortly upon administration of Plivacor<b><sup>®</sup></b> cows appetite and lactation are improved and the relapse is rare.
847
848 </p>
849 </div>
850
851
852
853
854
855
856
857
858
859
860
861
862 <div align="justify">
863 <p style="text-align: justify;">
864
865 <b></b>
866
867 </p>
868 </div>
869
870
871
872
873
874
875
876
877
878
879
880
881 <div align="justify">
882 <p style="text-align: justify;">
883
884 <b><i>Warnings and precautions</i></b>
885
886 </p>
887 </div>
888
889
890
891
892
893
894
895
896
897
898
899
900 <div align="justify">
901 <p style="text-align: justify;">
902
903 In experimental animals at the early stage of pregnancy corticosteroids may cause foetal abnormalities and in the last trimester the abortion or early parturition accompanied by retained placenta (cows and sheep).
904
905 </p>
906 </div>
907
908
909
910
911
912
913
914
915
916
917
918
919 <div align="justify">
920 <p style="text-align: justify;">
921
922
923
924 </p>
925 </div>
926
927
928
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930
931
932
933
934
935
936
937
938 <div align="justify">
939 <p style="text-align: justify;">
940
941 When treating infectious diseases and impairment of the organs, due to the presence of the infection always give corticosteroids concomitantly with an antibiotic or other antimicrobial.
942
943 </p>
944 </div>
945
946
947
948
949
950
951
952
953
954
955
956
957 <div align="justify">
958 <p style="text-align: justify;">
959
960
961
962 </p>
963 </div>
964
965
966
967
968
969
970
971
972
973
974
975
976 <div align="justify">
977 <p style="text-align: justify;">
978
979 Corticosteroids prolong wound healing.
980
981 </p>
982 </div>
983
984
985
986
987
988
989
990
991
992
993
994
995 <div align="justify">
996 <p style="text-align: justify;">
997
998
999
1000 </p>
1001 </div>
1002
1003
1004
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014 <div align="justify">
1015 <p style="text-align: justify;">
1016
1017 Prolonged administration of corticosteroids should be avoided, unless necessary.
1018
1019 </p>
1020 </div>
1021
1022
1023
1024
1025
1026
1027
1028
1029
1030
1031
1032
1033 <div align="justify">
1034 <p style="text-align: justify;">
1035
1036
1037
1038 </p>
1039 </div>
1040
1041
1042
1043
1044
1045
1046
1047
1048
1049
1050
1051
1052 <div align="justify">
1053 <p style="text-align: justify;">
1054
1055 Needles and syringes should be sterilised by boiling in water, rather than with alcohol or other disinfectants.<b></b>
1056
1057 </p>
1058 </div>
1059
1060
1061
1062
1063
1064
1065
1066
1067
1068
1069
1070
1071 <div align="justify">
1072 <p style="text-align: justify;">
1073
1074 <i></i>
1075
1076 </p>
1077 </div>
1078
1079
1080
1081
1082
1083
1084
1085
1086
1087
1088
1089
1090 <div align="justify">
1091 <p style="text-align: justify;">
1092
1093 <b><i>Withdrawal</i></b>
1094
1095 </p>
1096 </div>
1097
1098
1099
1100
1101
1102
1103
1104
1105
1106
1107
1108
1109 <div align="justify">
1110 <p style="text-align: justify;">
1111
1112 Meat and other edible tissues<b> </b>8 days<b></b>
1113
1114 </p>
1115 </div>
1116
1117
1118
1119
1120
1121
1122
1123
1124
1125
1126
1127
1128 <div align="justify">
1129 <p style="text-align: justify;">
1130
1131 Milk<b> </b>7 days<b></b>
1132
1133 </p>
1134 </div>
1135
1136
1137
1138
1139
1140
1141
1142
1143
1144
1145
1146
1147 <div align="justify">
1148 <p style="text-align: justify;">
1149
1150
1151
1152 </p>
1153 </div>
1154
1155
1156
1157
1158
1159
1160
1161
1162
1163
1164
1165
1166 <div align="justify">
1167 <p style="text-align: justify;">
1168
1169 <b><i>Storage</i></b>
1170
1171 </p>
1172 </div>
1173
1174
1175
1176
1177
1178
1179
1180
1181
1182
1183
1184
1185 <div align="justify">
1186 <p style="text-align: justify;">
1187
1188 Store in a dark place at room temperature (up to 25°C). Keep away from children. Avoid freezing.
1189
1190 </p>
1191 </div>
1192
1193
1194
1195
1196
1197
1198
1199
1200
1201
1202
1203
1204 <div align="justify">
1205 <p style="text-align: justify;">
1206
1207
1208
1209 </p>
1210 </div>
1211
1212
1213
1214
1215
1216
1217
1218
1219
1220
1221
1222
1223 <div align="justify">
1224 <p style="text-align: justify;">
1225
1226 <b><i>Legal category</i></b>
1227
1228 </p>
1229 </div>
1230
1231
1232
1233
1234
1235
1236
1237
1238
1239
1240
1241
1242 <div align="justify">
1243 <p style="text-align: justify;">
1244
1245 On prescription only.
1246
1247 </p>
1248 </div>
1249
1250
1251
1252
1253
1254
1255
1256
1257
1258
1259
1260
1261 <div align="justify">
1262 <p style="text-align: justify;">
1263
1264 <b><i></i></b>
1265
1266 </p>
1267 </div>
1268
1269
1270
1271
1272
1273
1274
1275
1276
1277
1278
1279
1280 <div align="justify">
1281 <p style="text-align: justify;">
1282
1283 Shelf life
1284
1285 </p>
1286 </div>
1287
1288
1289
1290
1291
1292
1293
1294
1295
1296
1297
1298
1299 <div align="justify">
1300 <p style="text-align: justify;">
1301
1302 Denoted on the packaging (2 years in the original pack).
1303
1304 </p>
1305 </div>
1306
1307
1308
1309
1310
1311
1312
1313
1314
1315
1316
1317
1318 <div align="justify">
1319 <p style="text-align: justify;">
1320
1321 <b></b>
1322
1323 </p>
1324 </div>
1325
1326
1327
1328
1329
1330
1331
1332
1333
1334
1335
1336
1337 <div align="justify">
1338 <p style="text-align: justify;">
1339
1340 <b><i>Supply</i></b>
1341
1342 </p>
1343 </div>
1344
1345
1346
1347
1348
1349
1350
1351
1352
1353
1354
1355
1356 <div align="justify">
1357 <p style="text-align: justify;">
1358
1359 Bottle of 50 mL and 100 mL.
1360
1361 </p>
1362 </div>
1363
1364
1365
1366
1367
1368
1369
1370
1371
1372
1373
1374
1375 <div align="justify">
1376 <p style="text-align: justify;">
1377
1378 <b></b>
1379
1380 </p>
1381 </div>
1382
1383
1384
1385
1386
1387
1388
1389
1390
1391
1392
1393
1394 <div align="justify">
1395 <p style="text-align: justify;">
1396
1397 <b><i>Manufacturer</i></b><b></b>
1398
1399 </p>
1400 </div>
1401
1402
1403
1404
1405
1406
1407
1408
1409
1410
1411
1412
1413 <div align="justify">
1414 <p style="text-align: justify;">
1415
1416 VETERINA Animal Health Ltd., Croatia
1417
1418 </p>
1419 </div>
1420
1421
1422
1423
1424
1425
1426
1427
1428
1429
1430
1431
1432 <div align="justify">
1433 <p style="text-align: justify;">
1434
1435
1436
1437 </p>
1438 </div>
1439
1440
1441
1442
1443
1444
1445
1446
1447
1448
1449
1450
1451 <div align="left">
1452 <p style="text-align: left;">
1453
1454
1455
1456 </p>
1457 </div>
1458
1459
1460
1461
1462
1463
1464
1465 <!--Section Ends-->
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