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Revision 1.1 - (show annotations)
Thu Apr 5 12:26:37 2001 UTC (18 years ago) by dpavlin
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CVS Tags: HEAD
File MIME type: text/html
smpc for veterina

1
2
3 <!--Section Begins--><br>
4
5
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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>DAVAK</b><b><sup>®</sup></b><b> gI</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>inactivated oily vaccine against Aujeszky's disease in swine</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
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72 </p>
73 </div>
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75
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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
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99
100
101
102
103
104
105 <div align="justify">
106 <p style="text-align: justify;">
107
108 The vaccine contains Aujeszky's disease virus 53p2 (gI<sup>-</sup>) strain grown in the cell line culture PK-15, dissociated with non-ionic detergent, inactivated with formaldehyde. A sub-unit antigen has been adsorbed in aluminium hydroxide gel, emulsified and resuspended in mineral oil as a multiple emulsion water/oil/water type.
109
110 </p>
111 </div>
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113
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119
120
121
122
123
124 <div align="justify">
125 <p style="text-align: justify;">
126
127
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129 </p>
130 </div>
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133
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135
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137
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139
140
141
142
143 <div align="justify">
144 <p style="text-align: justify;">
145
146 <b><i>Action</i></b><b></b>
147
148 </p>
149 </div>
150
151
152
153
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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 Aujeszky's disease virus.
166
167 </p>
168 </div>
169
170
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179
180
181 <div align="justify">
182 <p style="text-align: justify;">
183
184
185
186 </p>
187 </div>
188
189
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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
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213
214
215
216
217
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219 <div align="justify">
220 <p style="text-align: justify;">
221
222 Active immunisation of healthy swine against Aujeszky's disease.
223
224 </p>
225 </div>
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227
228
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231
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234
235
236
237
238 <div align="justify">
239 <p style="text-align: justify;">
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241
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243 </p>
244 </div>
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251
252
253
254
255
256
257 <div align="justify">
258 <p style="text-align: justify;">
259
260 <b><i>Contraindications</i></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 Sick animals should not be vaccinated.
280
281 </p>
282 </div>
283
284
285
286
287
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289
290
291
292
293
294
295 <div align="justify">
296 <p style="text-align: justify;">
297
298
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 <b><i>Administration and dosage</i></b><b></b>
318
319 </p>
320 </div>
321
322
323
324
325
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327
328
329
330
331
332
333 <div align="justify">
334 <p style="text-align: justify;">
335
336 Before administration heat the vaccine to room temperature (18-20°C). Shake before and occasionally during administration.
337
338 </p>
339 </div>
340
341
342
343
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345
346
347
348
349
350
351
352 <div align="justify">
353 <p style="text-align: justify;">
354
355
356
357 </p>
358 </div>
359
360
361
362
363
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365
366
367
368
369
370
371 <div align="justify">
372 <p style="text-align: justify;">
373
374 The vaccine is given by i. m. route behind the ear in the dose of 2 mL irrespective of the age, body weight and breed.
375
376 </p>
377 </div>
378
379
380
381
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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 <b><i>Vaccination programme</i></b>
413
414 </p>
415 </div>
416
417
418
419
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421
422
423
424
425
426
427
428 <div align="justify">
429 <p style="text-align: justify;">
430
431 Piglets having obtained maternal antibodies via colostrum are protected in the first weeks of life and are, therefore, vaccinated for the first time at the age of 8-12 weeks.
432
433 </p>
434 </div>
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436
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446
447 <div align="justify">
448 <p style="text-align: justify;">
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452 </p>
453 </div>
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460
461
462
463
464
465
466 <div align="justify">
467 <p style="text-align: justify;">
468
469 Piglets to non-vaccinated sows may be vaccinated already at the age of 14 days. Booster dose is given after 4-6 weeks. Thus vaccinated animals are protected till the end of the fattening period.
470
471 </p>
472 </div>
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483
484
485 <div align="justify">
486 <p style="text-align: justify;">
487
488
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490 </p>
491 </div>
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502
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504 <div align="justify">
505 <p style="text-align: justify;">
506
507 Sows and gilts are vaccinated 4-8 weeks prior to farrowing to establish optimum passive immunity in the piglets.
508
509 </p>
510 </div>
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512
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519
520
521
522
523 <div align="justify">
524 <p style="text-align: justify;">
525
526
527
528 </p>
529 </div>
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533
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539
540
541
542 <div align="justify">
543 <p style="text-align: justify;">
544
545 Boars are vaccinated 2 times yearly.
546
547 </p>
548 </div>
549
550
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555
556
557
558
559
560
561 <div align="justify">
562 <p style="text-align: justify;">
563
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565
566 </p>
567 </div>
568
569
570
571
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577
578
579
580 <div align="justify">
581 <p style="text-align: justify;">
582
583 <b><i>Immunity</i></b><b></b>
584
585 </p>
586 </div>
587
588
589
590
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593
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595
596
597
598
599 <div align="justify">
600 <p style="text-align: justify;">
601
602 Immunity is developed 14 days post vaccination and after booster dose it is maintained over 6-8 months.
603
604 </p>
605 </div>
606
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612
613
614
615
616
617
618 <div align="justify">
619 <p style="text-align: justify;">
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621
622
623 </p>
624 </div>
625
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629
630
631
632
633
634
635
636
637 <div align="justify">
638 <p style="text-align: justify;">
639
640 <b><i>Warnings and precautions</i></b>
641
642 </p>
643 </div>
644
645
646
647
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649
650
651
652
653
654
655
656 <div align="justify">
657 <p style="text-align: justify;">
658
659 Once opened use within 24 hours.
660
661 </p>
662 </div>
663
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669
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675 <div align="justify">
676 <p style="text-align: justify;">
677
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680 </p>
681 </div>
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690
691
692
693
694 <div align="justify">
695 <p style="text-align: justify;">
696
697 The period between two vaccinations should not be longer than 5-6 months.
698
699 </p>
700 </div>
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713 <div align="justify">
714 <p style="text-align: justify;">
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718 </p>
719 </div>
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732 <div align="justify">
733 <p style="text-align: justify;">
734
735 Use sterile and dry needles and syringes. Do not sterilise with chemicals. Do not use the vaccination needle to withdraw the vaccine from the bottle.
736
737 </p>
738 </div>
739
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751 <div align="justify">
752 <p style="text-align: justify;">
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756 </p>
757 </div>
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769
770 <div align="justify">
771 <p style="text-align: justify;">
772
773 Packaging and vaccine leftovers must be disposed in a safe way, preferably by boiling in water.
774
775 </p>
776 </div>
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789 <div align="justify">
790 <p style="text-align: justify;">
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794 </p>
795 </div>
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808 <div align="justify">
809 <p style="text-align: justify;">
810
811 In case of allergic reactions, particularly of anaphylactic condition, instantaneously administer intravenous soluble glucocorticoid (e. g. dexamethasone sodium phosphate) and intramuscular adrenaline and antihistaminic.
812
813 </p>
814 </div>
815
816
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825
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827 <div align="justify">
828 <p style="text-align: justify;">
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832 </p>
833 </div>
834
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845
846 <div align="justify">
847 <p style="text-align: justify;">
848
849 The animals given immunosuppressants (e. g. glucocorticoids) should not be vaccinated within 4 weeks of their administration.
850
851 </p>
852 </div>
853
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864
865 <div align="justify">
866 <p style="text-align: justify;">
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870 </p>
871 </div>
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884 <div align="justify">
885 <p style="text-align: justify;">
886
887 In every animal population there are some with poorer response to vaccination. Immune response is affected by hereditary factors, subclinical diseases, health condition, stress, concurrent administration of other medicines, storage and administration of the vaccine.
888
889 </p>
890 </div>
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903 <div align="justify">
904 <p style="text-align: justify;">
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908 </p>
909 </div>
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922 <div align="justify">
923 <p style="text-align: justify;">
924
925 <b><i>Withdrawal</i></b>
926
927 </p>
928 </div>
929
930
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937
938
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940
941 <div align="justify">
942 <p style="text-align: justify;">
943
944 Meat, organs and other edible tissues - 0 days.
945
946 </p>
947 </div>
948
949
950
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960 <div align="justify">
961 <p style="text-align: justify;">
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964
965 </p>
966 </div>
967
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978
979 <div align="justify">
980 <p style="text-align: justify;">
981
982 <b><i>Storage</i></b><b></b>
983
984 </p>
985 </div>
986
987
988
989
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993
994
995
996
997
998 <div align="justify">
999 <p style="text-align: justify;">
1000
1001 Store in a dark place up to 2-8°C (refrigerator). Keep away from children. Avoid freezing.
1002
1003 </p>
1004 </div>
1005
1006
1007
1008
1009
1010
1011
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1015
1016
1017 <div align="justify">
1018 <p style="text-align: justify;">
1019
1020
1021
1022 </p>
1023 </div>
1024
1025
1026
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1029
1030
1031
1032
1033
1034
1035
1036 <div align="justify">
1037 <p style="text-align: justify;">
1038
1039 <b><i>Shelf life</i></b>
1040
1041 </p>
1042 </div>
1043
1044
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1049
1050
1051
1052
1053
1054
1055 <div align="justify">
1056 <p style="text-align: justify;">
1057
1058 Denoted on the packaging (18 months in the original pack).
1059
1060 </p>
1061 </div>
1062
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1069
1070
1071
1072
1073
1074 <div align="justify">
1075 <p style="text-align: justify;">
1076
1077
1078
1079 </p>
1080 </div>
1081
1082
1083
1084
1085
1086
1087
1088
1089
1090
1091
1092
1093 <div align="justify">
1094 <p style="text-align: justify;">
1095
1096 <b><i>Legal category</i></b><b></b>
1097
1098 </p>
1099 </div>
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1101
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1103
1104
1105
1106
1107
1108
1109
1110
1111
1112 <div align="justify">
1113 <p style="text-align: justify;">
1114
1115 On prescription only.
1116
1117 </p>
1118 </div>
1119
1120
1121
1122
1123
1124
1125
1126
1127
1128
1129
1130
1131 <div align="justify">
1132 <p style="text-align: justify;">
1133
1134
1135
1136 </p>
1137 </div>
1138
1139
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1141
1142
1143
1144
1145
1146
1147
1148
1149
1150 <div align="justify">
1151 <p style="text-align: justify;">
1152
1153 <b><i>Supply</i></b>
1154
1155 </p>
1156 </div>
1157
1158
1159
1160
1161
1162
1163
1164
1165
1166
1167
1168
1169 <div align="justify">
1170 <p style="text-align: justify;">
1171
1172 Bottle with 10 doses (20 mL) and with 50 doses (100 mL).
1173
1174 </p>
1175 </div>
1176
1177
1178
1179
1180
1181
1182
1183
1184
1185
1186
1187
1188 <div align="justify">
1189 <p style="text-align: justify;">
1190
1191
1192
1193 </p>
1194 </div>
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1196
1197
1198
1199
1200
1201
1202
1203
1204
1205
1206
1207 <div align="justify">
1208 <p style="text-align: justify;">
1209
1210 <b><i>Manufacturer</i></b>
1211
1212 </p>
1213 </div>
1214
1215
1216
1217
1218
1219
1220
1221
1222
1223
1224
1225
1226 <div align="justify">
1227 <p style="text-align: justify;">
1228
1229 VETERINA Animal Health Ltd., Croatia
1230
1231 </p>
1232 </div>
1233
1234
1235
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1237
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1239
1240
1241
1242
1243
1244
1245 <div align="justify">
1246 <p style="text-align: justify;">
1247
1248
1249
1250 </p>
1251 </div>
1252
1253
1254
1255
1256
1257
1258
1259
1260
1261
1262
1263
1264 <div align="left">
1265 <p style="text-align: left;">
1266
1267
1268
1269 </p>
1270 </div>
1271
1272
1273
1274
1275
1276
1277
1278 <!--Section Ends-->
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