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Revision 1.1 - (show annotations)
Thu Apr 5 12:26:37 2001 UTC (18 years, 4 months 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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7
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9
10 <div align="justify">
11 <p style="text-align: justify;">
12
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15 </p>
16 </div>
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24
25
26
27
28
29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>BRONHIKAL</b><b><sup>®</sup></b><b> I SPF and BRONHIKAL</b><b><sup>®</sup></b><b> II 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 infectious bronchitis in poultry</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
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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
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99
100
101
102
103
104
105 <div align="justify">
106 <p style="text-align: justify;">
107
108 One dose of BRONHIKAL<sup>®</sup> I SPF<b> </b>vaccine<b> </b>for chicks<b> </b>contains at least 10<sup>3.5 </sup>EID<sub>50</sub> of attenuated live infectious bronchitis virus (H-120) grown in chick' embryos obtained from SPF eggs.
109
110 </p>
111 </div>
112
113
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115
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120
121
122
123
124 <div align="justify">
125 <p style="text-align: justify;">
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127
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129 </p>
130 </div>
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137
138
139
140
141
142
143 <div align="justify">
144 <p style="text-align: justify;">
145
146 One dose of Bronhikal<sup>®</sup> II SPF vaccine for hens contains at least 10<sup>3.5 </sup>EID<sub>50</sub> of attenuated live infectious bronchitis virus (H-52) grown in chick' embryos obtained from SPF eggs.
147
148 </p>
149 </div>
150
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157
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160
161
162 <div align="justify">
163 <p style="text-align: justify;">
164
165
166
167 </p>
168 </div>
169
170
171
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174
175
176
177
178
179
180
181 <div align="justify">
182 <p style="text-align: justify;">
183
184 H-120 strain has been more attenuated than H-52 strain.
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
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 <b><i>Action</i></b><b></b>
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 The vaccine stimulates formation of specific antibodies for bronchitis virus in poultry.
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
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 <b><i>Indications</i></b>
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 Immunisation of healthy chicks and hens against infectious bronchitis. The chicks are vaccinated with Bronhikal<b><sup>®</sup></b> I (H-120) and the hens, relevant to epizootiologic situation, with Bronhikal<b><sup>®</sup></b> I (H-120) and Bronhikal<b><sup>®</sup></b> II (H-52).
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
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 <b><i>Contraindications</i></b><b></b>
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 Bronhikal<b><sup>®</sup></b> II (H-52) is not used in primary immunisation of poultry.
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
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 <b><i>Administration and dosage</i></b><b></b>
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 Bronhikal<b><sup>®</sup></b>I SPF and Bronhikal<b><sup>®</sup></b> II SPF may be administered by the following routes:
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 <b><i>1. Oculonasally</i></b><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 One dose of the diluted vaccine, irrespective of the age and body weight, is 0.1 mL, i. e. two drops/bird. The vaccine is administered dropwise into the eye and nostril.
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
489
490 </p>
491 </div>
492
493
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495
496
497
498
499
500
501
502
503
504 <div align="justify">
505 <p style="text-align: justify;">
506
507 <b><i>2. In drinking water</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 Immediately before use reconstitute the vaccine in cold and clean water without chlorine or other disinfectants, in the dosage equivalent to the number of birds to be vaccinated. The number of doses should not be less than the number of birds.
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
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 Use 10 L of water to reconstitute 1000 vaccinal doses for the chicks in the first week of life and 40 L of water for the chicks aged two months and for older poultry.
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
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593
594
595
596
597
598
599 <div align="justify">
600 <p style="text-align: justify;">
601
602 To ensure the intake of medicated drinking water, the animals should be restricted from other sources of liquid 3 hours prior to treatment. Waterers should be clean, with no traces of food or disinfectant. Sufficient number of waterers should be provided, i. e. about 30% more than required for that age, to ensure that all birds take the water with the vaccine within one hour.
603
604 </p>
605 </div>
606
607
608
609
610
611
612
613
614
615
616
617
618 <div align="justify">
619 <p style="text-align: justify;">
620
621
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 <b><i>3. Spraying</i></b>
641
642 </p>
643 </div>
644
645
646
647
648
649
650
651
652
653
654
655
656 <div align="justify">
657 <p style="text-align: justify;">
658
659 Vaccination of the one-day old chicks is performed preferably in the hatchery or in the transport boxes. Use 100-150 mL of water, preferably distilled, to resuspend 1000 vaccinal doses. Use a sprayer forming 30-100 mm size particles. The particles for young birds are larger than for the old ones. First vaccination can be performed already in the hatchery, or later, relevant to other immunoprophylactic procedures. If the hens are already vaccinated with Bronhikal<b><sup>®</sup></b> I SPF, then Bronhikal<b><sup>®</sup></b>II SPF can be administered one month before the animals are mature.
660
661 </p>
662 </div>
663
664
665
666
667
668
669
670
671
672
673
674
675 <div align="justify">
676 <p style="text-align: justify;">
677
678
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 <b><i>Immunity</i></b><b></b>
698
699 </p>
700 </div>
701
702
703
704
705
706
707
708
709
710
711
712
713 <div align="justify">
714 <p style="text-align: justify;">
715
716 Immunity is established 4-5 days after vaccination. In revaccinated birds it is maintained for at least one year.
717
718 </p>
719 </div>
720
721
722
723
724
725
726
727
728
729
730
731
732 <div align="justify">
733 <p style="text-align: justify;">
734
735
736
737 </p>
738 </div>
739
740
741
742
743
744
745
746
747
748
749
750
751 <div align="justify">
752 <p style="text-align: justify;">
753
754 <b><i>Warnings and precautions</i></b>
755
756 </p>
757 </div>
758
759
760
761
762
763
764
765
766
767
768
769
770 <div align="justify">
771 <p style="text-align: justify;">
772
773 Bronhikal<b><sup>®</sup></b> II SPF is administered exclusively to the poultry already vaccinated with Bronhikal<b><sup>®</sup></b> I SPF, irrespective of its age.
774
775 </p>
776 </div>
777
778
779
780
781
782
783
784
785
786
787
788
789 <div align="justify">
790 <p style="text-align: justify;">
791
792
793
794 </p>
795 </div>
796
797
798
799
800
801
802
803
804
805
806
807
808 <div align="justify">
809 <p style="text-align: justify;">
810
811 If given as the first vaccine Bronhikal<b><sup>®</sup></b> II SPF produces severe vaccinal reactions. In the laying hens it may cause a transient drop in egg production.
812
813 </p>
814 </div>
815
816
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818
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820
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822
823
824
825
826
827 <div align="justify">
828 <p style="text-align: justify;">
829
830
831
832 </p>
833 </div>
834
835
836
837
838
839
840
841
842
843
844
845
846 <div align="justify">
847 <p style="text-align: justify;">
848
849 Once reconstituted use within 3 hours.
850
851 </p>
852 </div>
853
854
855
856
857
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859
860
861
862
863
864
865 <div align="justify">
866 <p style="text-align: justify;">
867
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869
870 </p>
871 </div>
872
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876
877
878
879
880
881
882
883
884 <div align="justify">
885 <p style="text-align: justify;">
886
887 Packaging and vaccine leftovers must be disposed of in a safe way, preferably by boiling in water.
888
889 </p>
890 </div>
891
892
893
894
895
896
897
898
899
900
901
902
903 <div align="justify">
904 <p style="text-align: justify;">
905
906
907
908 </p>
909 </div>
910
911
912
913
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919
920
921
922 <div align="justify">
923 <p style="text-align: justify;">
924
925 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.
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
945
946 </p>
947 </div>
948
949
950
951
952
953
954
955
956
957
958
959
960 <div align="justify">
961 <p style="text-align: justify;">
962
963 <b><i>Withdrawal</i></b>
964
965 </p>
966 </div>
967
968
969
970
971
972
973
974
975
976
977
978
979 <div align="justify">
980 <p style="text-align: justify;">
981
982 Meat, organs and other edible tissues - 0 days.
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
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 <b><i>Storage</i></b>
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 Store in a dark place at 2-8°C (refrigerator). Keep away from children.
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
1059
1060 </p>
1061 </div>
1062
1063
1064
1065
1066
1067
1068
1069
1070
1071
1072
1073
1074 <div align="justify">
1075 <p style="text-align: justify;">
1076
1077 <b><i>Shelf life</i></b>
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 Denoted on the packaging (18 months).
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
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 <b><i>Legal category</i></b>
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 On prescription only.
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
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 <b><i>Supply</i></b><b></b>
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 Bottles with 1000 and 2000 vaccinal doses with diluent.
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
1230
1231 </p>
1232 </div>
1233
1234
1235
1236
1237
1238
1239
1240
1241
1242
1243
1244
1245 <div align="justify">
1246 <p style="text-align: justify;">
1247
1248 <b><i>Manufacturer</i></b>
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 VETERINA Animal Health Ltd., Croatia
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
1292
1293
1294
1295
1296
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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