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Revision 1.2 - (show annotations)
Tue Apr 10 11:02:10 2001 UTC (22 years, 11 months ago) by dpavlin
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1
2
3 <!--Section Begins--><br>
4
5
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8
9
10 <div align="justify">
11 <p style="text-align: justify;">
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13
14
15 </p>
16 </div>
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24
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26
27
28
29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>GUMPESKAL</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 bivalent oily vaccine against Gumboro and Newcastle disease</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
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81
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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 The vaccine contains inactivated Newcastle disease virus (NDV) and Gumboro disease virus inactivated with formaldehyde. NDV is also dissociated with non-ionic detergent. Both immunogens are and resuspended with the addition of an emulsifier, in mineral oil as a multiple emulsion water/oil/water type.
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
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 <b><i>Action</i></b><b></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 the formation of specific antibodies for Gumboro and Newcastle disease viruses.
166
167 </p>
168 </div>
169
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180
181 <div align="justify">
182 <p style="text-align: justify;">
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184
185
186 </p>
187 </div>
188
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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 Immunoprophylaxis of heavy and light hybrids against Gumboro and Newcastle disease and immunisation of their offspring against infectious bursal disease during their first 2-4 weeks of life.
223
224 </p>
225 </div>
226
227
228
229
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231
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233
234
235
236
237
238 <div align="justify">
239 <p style="text-align: justify;">
240
241
242
243 </p>
244 </div>
245
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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
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269
270
271
272
273
274
275
276 <div align="justify">
277 <p style="text-align: justify;">
278
279 Unknown.
280
281 </p>
282 </div>
283
284
285
286
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289
290
291
292
293
294
295 <div align="justify">
296 <p style="text-align: justify;">
297
298 <b><i></i></b>
299
300 </p>
301 </div>
302
303
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305
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307
308
309
310
311
312
313
314 <div align="justify">
315 <p style="text-align: justify;">
316
317 Administration, dosage and vaccination programme<b></b>
318
319 </p>
320 </div>
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323
324
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327
328
329
330
331
332
333 <div align="justify">
334 <p style="text-align: justify;">
335
336 Before administration the vaccine should be heated to room temperature and shaken well prior to and occasionally during administration. GUMPESKAL<b><sup>®</sup></b> is given by i. m<i>.</i> route into the breast muscle or s. c. into the skin fold at the dorsal neck side.
337
338 </p>
339 </div>
340
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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
364
365
366
367
368
369
370
371 <div align="justify">
372 <p style="text-align: justify;">
373
374 The dose per bird is 0.5 mL.
375
376 </p>
377 </div>
378
379
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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>
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405
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407
408
409 <div align="justify">
410 <p style="text-align: justify;">
411
412 As a rule, healthy birds are vaccinated at the age of 16-20 weeks.
413
414 </p>
415 </div>
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421
422
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424
425
426
427
428 <div align="justify">
429 <p style="text-align: justify;">
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431
432
433 </p>
434 </div>
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441
442
443
444
445
446
447 <div align="justify">
448 <p style="text-align: justify;">
449
450 Before being vaccinated with GUMPESKAL<b><sup>®</sup></b> the birds should be given live attenuated vaccine against Gumboro and Newcastle diseases. Time between these two vaccinations and administration of GUMPESKAL<b><sup>®</sup></b> should not be shorter than 2 weeks. Optimum effect is achieved with an interval of 6 weeks.
451
452 </p>
453 </div>
454
455
456
457
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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 <b><i>Immunity</i></b>
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 In healthy chicks the immunity is established 2-3 weeks after vaccination and is maintained till the end of the production cycle. This ensures immunity of their offspring against infectious bursal disease during their first 2-4 weeks of life.
508
509 </p>
510 </div>
511
512
513
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519
520
521
522
523 <div align="justify">
524 <p style="text-align: justify;">
525
526 <b></b>
527
528 </p>
529 </div>
530
531
532
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538
539
540
541
542 <div align="justify">
543 <p style="text-align: justify;">
544
545 <b><i>Warnings and precautions</i></b><b></b>
546
547 </p>
548 </div>
549
550
551
552
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554
555
556
557
558
559
560
561 <div align="justify">
562 <p style="text-align: justify;">
563
564 The vaccine is administered to all healthy birds and the whole flock.
565
566 </p>
567 </div>
568
569
570
571
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574
575
576
577
578
579
580 <div align="justify">
581 <p style="text-align: justify;">
582
583
584
585 </p>
586 </div>
587
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590
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593
594
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596
597
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599 <div align="justify">
600 <p style="text-align: justify;">
601
602 Vaccination equipment should be sterile.
603
604 </p>
605 </div>
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612
613
614
615
616
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618 <div align="justify">
619 <p style="text-align: justify;">
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623 </p>
624 </div>
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632
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637 <div align="justify">
638 <p style="text-align: justify;">
639
640 During vaccination care should be taken to avoid transmission of the infection from one flock to another.
641
642 </p>
643 </div>
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656 <div align="justify">
657 <p style="text-align: justify;">
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661 </p>
662 </div>
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674
675 <div align="justify">
676 <p style="text-align: justify;">
677
678 Once opened use within 24 hours.
679
680 </p>
681 </div>
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689
690
691
692
693
694 <div align="justify">
695 <p style="text-align: justify;">
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699 </p>
700 </div>
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711
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713 <div align="justify">
714 <p style="text-align: justify;">
715
716 The vaccine should not be administered by i. v. route.
717
718 </p>
719 </div>
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732 <div align="justify">
733 <p style="text-align: justify;">
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737 </p>
738 </div>
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750
751 <div align="justify">
752 <p style="text-align: justify;">
753
754 Avoid direct exposure to sunlight and high temperatures.
755
756 </p>
757 </div>
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770 <div align="justify">
771 <p style="text-align: justify;">
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775 </p>
776 </div>
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788
789 <div align="justify">
790 <p style="text-align: justify;">
791
792 Packaging and vaccine leftovers must be disposed of in a safe way, e. g. sterilised by heat.
793
794 </p>
795 </div>
796
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808 <div align="justify">
809 <p style="text-align: justify;">
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813 </p>
814 </div>
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825
826
827 <div align="justify">
828 <p style="text-align: justify;">
829
830 Beware of accidental injecting into the hand. In severe local reaction, seek medical advice (surgeon).
831
832 </p>
833 </div>
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846 <div align="justify">
847 <p style="text-align: justify;">
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850
851 </p>
852 </div>
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864
865 <div align="justify">
866 <p style="text-align: justify;">
867
868 <b><i>Withdrawal</i></b>
869
870 </p>
871 </div>
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883
884 <div align="justify">
885 <p style="text-align: justify;">
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887 Meat, and edible tissues of the vaccinated chicks - 0 days.
888
889 </p>
890 </div>
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901
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903 <div align="justify">
904 <p style="text-align: justify;">
905
906 <b></b>
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908 </p>
909 </div>
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920
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922 <div align="justify">
923 <p style="text-align: justify;">
924
925 <b><i>Storage</i></b>
926
927 </p>
928 </div>
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940
941 <div align="justify">
942 <p style="text-align: justify;">
943
944 Store in a dark place at 2-8°C (refrigerator). Keep away from children. Avoid freezing.
945
946 </p>
947 </div>
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960 <div align="justify">
961 <p style="text-align: justify;">
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965 </p>
966 </div>
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979 <div align="justify">
980 <p style="text-align: justify;">
981
982 <b><i>Shelf life</i></b><b></b>
983
984 </p>
985 </div>
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998 <div align="justify">
999 <p style="text-align: justify;">
1000
1001 Denoted on the packaging (18 months).
1002
1003 </p>
1004 </div>
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1007
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1016
1017 <div align="justify">
1018 <p style="text-align: justify;">
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1021
1022 </p>
1023 </div>
1024
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1035
1036 <div align="justify">
1037 <p style="text-align: justify;">
1038
1039 <b><i>Legal category</i></b><b></b>
1040
1041 </p>
1042 </div>
1043
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1050
1051
1052
1053
1054
1055 <div align="justify">
1056 <p style="text-align: justify;">
1057
1058 On prescription only.
1059
1060 </p>
1061 </div>
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1072
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1074 <div align="justify">
1075 <p style="text-align: justify;">
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1079 </p>
1080 </div>
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1091
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1093 <div align="justify">
1094 <p style="text-align: justify;">
1095
1096 <b><i>Supply</i></b><b></b>
1097
1098 </p>
1099 </div>
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1103
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1109
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1111
1112 <div align="justify">
1113 <p style="text-align: justify;">
1114
1115 Bottles of 100 mL (200 doses) and 500 mL (1000 doses).
1116
1117 </p>
1118 </div>
1119
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1125
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1128
1129
1130
1131 <div align="justify">
1132 <p style="text-align: justify;">
1133
1134
1135
1136 </p>
1137 </div>
1138
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1144
1145
1146
1147
1148
1149
1150 <div align="justify">
1151 <p style="text-align: justify;">
1152
1153 <b><i>Manufacturer</i></b><b></b>
1154
1155 </p>
1156 </div>
1157
1158
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1163
1164
1165
1166
1167
1168
1169 <div align="justify">
1170 <p style="text-align: justify;">
1171
1172 VETERINA Animal Health Ltd., Croatia
1173
1174 </p>
1175 </div>
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1177
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1185
1186
1187
1188 <div align="justify">
1189 <p style="text-align: justify;">
1190
1191
1192
1193 </p>
1194 </div>
1195
1196
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1198
1199
1200
1201
1202
1203
1204
1205
1206
1207 <div align="justify">
1208 <p style="text-align: justify;">
1209
1210 <b><i>Important note</i></b><b></b>
1211
1212 </p>
1213 </div>
1214
1215
1216
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1218
1219
1220
1221
1222
1223
1224
1225
1226 <div align="justify">
1227 <p style="text-align: justify;">
1228
1229 The vaccine ensures sound immunisation against classical serotype of Gumboro disease virus.
1230
1231 </p>
1232 </div>
1233
1234
1235
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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>
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1253
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1259
1260
1261
1262
1263
1264 <div align="justify">
1265 <p style="text-align: justify;">
1266
1267 In every animal population there are some with poorer response to vaccination. In addition to proper storage and administration, success of vaccination depends on immunocompetence, i. e. on hereditary factors, subclinical diseases, condition of the animal, stress factors, concurrent administration of other drugs, etc.
1268
1269 </p>
1270 </div>
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1283 <div align="justify">
1284 <p style="text-align: justify;">
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1287
1288 </p>
1289 </div>
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1300
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1302 <div align="left">
1303 <p style="text-align: left;">
1304
1305
1306
1307 </p>
1308 </div>
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1312
1313
1314
1315
1316 <!--Section Ends-->
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