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Revision 1.1 - (show annotations)
Thu Apr 5 12:26:37 2001 UTC (18 years, 1 month ago) by dpavlin
Branch: MAIN
CVS Tags: HEAD
File MIME type: text/html
smpc for veterina

1
2
3 <!--Section Begins--><br>
4
5
6
7
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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18
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23
24
25
26
27
28
29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>GUMBOKAL</b><b><sup>®</sup></b><b> SPF</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>lyophilised vaccine against Gumboro disease Winterfield 2512 strain</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
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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 The vaccine contains attenuated Gumboro disease virus, strain Winterfield 2512 grown in embryonated chicks' SPF eggs. One vaccinal dose contains at least 10<sup>3.5</sup> EID<sub>50 </sub>of this virus strain.
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 formation of specific antibodies against Gumboro disease in chicks.
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 healthy chicks against Gumboro disease.
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
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 <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 Unknown.
280
281 </p>
282 </div>
283
284
285
286
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288
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, dosage and vaccination programme</i></b>
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 The vaccine is given resuspended in cold and clean drinking water without chlorine or other disinfectant.
337
338 </p>
339 </div>
340
341
342
343
344
345
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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 Resuspend 1000 vaccinal doses in 10 L of water.
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 Chicks are given a single dose at the age of 10-20 days. Relevant to epizootiologic status, the vaccine may be given in two doses at the age of 8-12 days and 18-20 days.
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
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 A single dose already establishes sound immunity against bursal disease.
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
470
471 </p>
472 </div>
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474
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476
477
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479
480
481
482
483
484
485 <div align="justify">
486 <p style="text-align: justify;">
487
488 Immunisation programme against Gumboro disease is established relevant to the titer of maternal antibodies.
489
490 </p>
491 </div>
492
493
494
495
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500
501
502
503
504 <div align="justify">
505 <p style="text-align: justify;">
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507
508
509 </p>
510 </div>
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519
520
521
522
523 <div align="justify">
524 <p style="text-align: justify;">
525
526 To make the birds thirsty withhold the supplies of drinking water 3 hours prior to immunisation. Drinking system should be clean, without traces of feed or disinfectants. Provide sufficient number of waterers, i. e. about 30% more than required, to ensure water intake to all birds within one hour.
527
528 </p>
529 </div>
530
531
532
533
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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 <b><i>Immunity</i></b><b></b>
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 Immunity in the vaccinated birds is established 4-5 days post vaccination.
584
585 </p>
586 </div>
587
588
589
590
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594
595
596
597
598
599 <div align="justify">
600 <p style="text-align: justify;">
601
602
603
604 </p>
605 </div>
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607
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609
610
611
612
613
614
615
616
617
618 <div align="justify">
619 <p style="text-align: justify;">
620
621 <b><i>Warnings and precautions</i></b><b></b>
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 Dishes for preparation and administration of the vaccine should be perfectly clean.
641
642 </p>
643 </div>
644
645
646
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649
650
651
652
653
654
655
656 <div align="justify">
657 <p style="text-align: justify;">
658
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661 </p>
662 </div>
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664
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666
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669
670
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672
673
674
675 <div align="justify">
676 <p style="text-align: justify;">
677
678 The vaccine is administered to all birds in the flock.
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
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707
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709
710
711
712
713 <div align="justify">
714 <p style="text-align: justify;">
715
716 Avoid exposure to direct sunlight.
717
718 </p>
719 </div>
720
721
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726
727
728
729
730
731
732 <div align="justify">
733 <p style="text-align: justify;">
734
735
736
737 </p>
738 </div>
739
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746
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748
749
750
751 <div align="justify">
752 <p style="text-align: justify;">
753
754 Once prepared use within 3 hours.
755
756 </p>
757 </div>
758
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764
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766
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769
770 <div align="justify">
771 <p style="text-align: justify;">
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775 </p>
776 </div>
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786
787
788
789 <div align="justify">
790 <p style="text-align: justify;">
791
792 GUMBOKAL<b><sup>®</sup></b> SPF vaccine should not be given 4 days before and 4 days after vaccination against Newcastle disease and avian infectious bronchitis.
793
794 </p>
795 </div>
796
797
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799
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802
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804
805
806
807
808 <div align="justify">
809 <p style="text-align: justify;">
810
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813 </p>
814 </div>
815
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820
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822
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825
826
827 <div align="justify">
828 <p style="text-align: justify;">
829
830 Packaging and vaccine leftovers must disposed of in a safe way.
831
832 </p>
833 </div>
834
835
836
837
838
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840
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842
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844
845
846 <div align="justify">
847 <p style="text-align: justify;">
848
849
850
851 </p>
852 </div>
853
854
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856
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859
860
861
862
863
864
865 <div align="justify">
866 <p style="text-align: justify;">
867
868 <b><i>Withdrawal</i></b><b></b>
869
870 </p>
871 </div>
872
873
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875
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877
878
879
880
881
882
883
884 <div align="justify">
885 <p style="text-align: justify;">
886
887 Meat, organs and other edible tissues of vaccinated chicks - 0 days.<b></b>
888
889 </p>
890 </div>
891
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898
899
900
901
902
903 <div align="justify">
904 <p style="text-align: justify;">
905
906 <b> </b>
907
908 </p>
909 </div>
910
911
912
913
914
915
916
917
918
919
920
921
922 <div align="justify">
923 <p style="text-align: justify;">
924
925 <b><i>Storage</i></b>
926
927 </p>
928 </div>
929
930
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936
937
938
939
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.
945
946 </p>
947 </div>
948
949
950
951
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956
957
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960 <div align="justify">
961 <p style="text-align: justify;">
962
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964
965 </p>
966 </div>
967
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972
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977
978
979 <div align="justify">
980 <p style="text-align: justify;">
981
982 <b><i>Shelf life</i></b>
983
984 </p>
985 </div>
986
987
988
989
990
991
992
993
994
995
996
997
998 <div align="justify">
999 <p style="text-align: justify;">
1000
1001 Denoted on the packaging (18 months).<b></b>
1002
1003 </p>
1004 </div>
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017 <div align="justify">
1018 <p style="text-align: justify;">
1019
1020
1021
1022 </p>
1023 </div>
1024
1025
1026
1027
1028
1029
1030
1031
1032
1033
1034
1035
1036 <div align="justify">
1037 <p style="text-align: justify;">
1038
1039 <b><i>Legal category</i></b>
1040
1041 </p>
1042 </div>
1043
1044
1045
1046
1047
1048
1049
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>
1062
1063
1064
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1066
1067
1068
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>Supply</i></b>
1097
1098 </p>
1099 </div>
1100
1101
1102
1103
1104
1105
1106
1107
1108
1109
1110
1111
1112 <div align="justify">
1113 <p style="text-align: justify;">
1114
1115 Boxes with 10x1000 and 10x2000 vaccinal doses (lyophilisate and solvent).
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
1140
1141
1142
1143
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
1159
1160
1161
1162
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>
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>
1195
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>Important note</i></b><b></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 In every animal population there are some with poorer response to vaccination. In addition to proper storage and administration, success of vaccination depends on hereditary factors, age of the animal, subclinical diseases, maternal antibodies, feed, stress factors and concurrent administration of other drugs.
1230
1231 </p>
1232 </div>
1233
1234
1235
1236
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="justify">
1265 <p style="text-align: justify;">
1266
1267 Given the variations in vaccination programmes, before vaccinating the whole flock it is recommended to consult the veterinarian who is an expert in poultry.
1268
1269 </p>
1270 </div>
1271
1272
1273
1274
1275
1276
1277
1278
1279
1280
1281
1282
1283 <div align="justify">
1284 <p style="text-align: justify;">
1285
1286
1287
1288 </p>
1289 </div>
1290
1291
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1297
1298
1299
1300
1301
1302 <div align="left">
1303 <p style="text-align: left;">
1304
1305
1306
1307 </p>
1308 </div>
1309
1310
1311
1312
1313
1314
1315
1316 <!--Section Ends-->
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