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smpc for veterina

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3 <!--Section Begins--><br>
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15 </p>
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29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>BODIKAL</b><b><sup>®</sup></b><b> SPF</b>
33
34 </p>
35 </div>
36
37
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39
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41
42
43
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45
46
47
48 <div align="justify">
49 <p style="text-align: justify;">
50
51 <i>lyophilised vaccine against fowl pox (chicken strain)</i>
52
53 </p>
54 </div>
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67 <div align="justify">
68 <p style="text-align: justify;">
69
70 <b></b>
71
72 </p>
73 </div>
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86 <div align="justify">
87 <p style="text-align: justify;">
88
89 <b><i>Composition</i></b><b></b>
90
91 </p>
92 </div>
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105 <div align="justify">
106 <p style="text-align: justify;">
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108 The vaccine contains attenuated chicken strain of fowl pox virus grown in chick' embryos obtained from SPF eggs.
109
110 </p>
111 </div>
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124 <div align="justify">
125 <p style="text-align: justify;">
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129 </p>
130 </div>
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143 <div align="justify">
144 <p style="text-align: justify;">
145
146 <b><i>Action</i></b><b></b>
147
148 </p>
149 </div>
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160
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162 <div align="justify">
163 <p style="text-align: justify;">
164
165 The vaccine stimulates formation of specific antibodies for fowl pox virus in poultry.
166
167 </p>
168 </div>
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181 <div align="justify">
182 <p style="text-align: justify;">
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186 </p>
187 </div>
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200 <div align="justify">
201 <p style="text-align: justify;">
202
203 <b><i>Indications</i></b>
204
205 </p>
206 </div>
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219 <div align="justify">
220 <p style="text-align: justify;">
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222 Immunisation of poultry against fowl pox. The vaccine is given to all poultry looking healthy at the age of 8 weeks. In imminent risk of the infection, young birds, even the chicks aged one week, are also vaccinated. Already infected flocks may also be vaccinated, as vaccination shortens the course of infection.
223
224 </p>
225 </div>
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238 <div align="justify">
239 <p style="text-align: justify;">
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243 </p>
244 </div>
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257 <div align="justify">
258 <p style="text-align: justify;">
259
260 <b><i>Contraindications</i></b><b></b>
261
262 </p>
263 </div>
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265
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269
270
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272
273
274
275
276 <div align="justify">
277 <p style="text-align: justify;">
278
279 Layers should not be vaccinated.
280
281 </p>
282 </div>
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291
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293
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295 <div align="justify">
296 <p style="text-align: justify;">
297
298 <b></b>
299
300 </p>
301 </div>
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307
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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>
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329
330
331
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333 <div align="justify">
334 <p style="text-align: justify;">
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336 Vaccination is performed with the provided applicator.
337
338 </p>
339 </div>
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352 <div align="justify">
353 <p style="text-align: justify;">
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357 </p>
358 </div>
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369
370
371 <div align="justify">
372 <p style="text-align: justify;">
373
374 Immediately prior to administration reconstitute the vaccine with the enclosed diluent and shake well. Dip the applicator into the vaccine and punctured the bird in the inner side of the wing fold. Avoid administration into blood vessels, bones, muscles or feathers. If there are many feathers at the site of administration, remove them beforehand.
375
376 </p>
377 </div>
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390 <div align="justify">
391 <p style="text-align: justify;">
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395 </p>
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409 <div align="justify">
410 <p style="text-align: justify;">
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412 Poults are vaccinated in the external side of the thigh after removal of some feathers. Vaccination into the wing fold is not recommended because keeping the head under the wing during sleep may cause vaccinal lesions on the head.
413
414 </p>
415 </div>
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428 <div align="justify">
429 <p style="text-align: justify;">
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433 </p>
434 </div>
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447 <div align="justify">
448 <p style="text-align: justify;">
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450 Once reconstituted use within 2 hours.
451
452 </p>
453 </div>
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466 <div align="justify">
467 <p style="text-align: justify;">
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471 </p>
472 </div>
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483
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485 <div align="justify">
486 <p style="text-align: justify;">
487
488 <b><i>Immunity</i></b><b></b>
489
490 </p>
491 </div>
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498
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501
502
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504 <div align="justify">
505 <p style="text-align: justify;">
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507 Immunity is developed 14-18 days following vaccination. It is fully established after 4 weeks and is maintained for at least one year. In the birds below 8 weeks of age the immunity lasts for a shorter period. Therefore, they must be revaccinated after 2 months. The degree of immunity varies between birds and flocks.
508
509 </p>
510 </div>
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523 <div align="justify">
524 <p style="text-align: justify;">
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528 </p>
529 </div>
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542 <div align="justify">
543 <p style="text-align: justify;">
544
545 <b><i>Warnings and precautions</i></b>
546
547 </p>
548 </div>
549
550
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554
555
556
557
558
559
560
561 <div align="justify">
562 <p style="text-align: justify;">
563
564 After 6-8 days of administration a reaction develops at inoculation site in the form of two clearly marked nodes and then a small scab which gradually disappear.
565
566 </p>
567 </div>
568
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580 <div align="justify">
581 <p style="text-align: justify;">
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585 </p>
586 </div>
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599 <div align="justify">
600 <p style="text-align: justify;">
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602 The reaction occurs in approximately 90-95% of the vaccinated birds and fails in the infected or already immune ones.
603
604 </p>
605 </div>
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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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637 <div align="justify">
638 <p style="text-align: justify;">
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640 Healthy birds failing to react should be revaccinated.
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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675 <div align="justify">
676 <p style="text-align: justify;">
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678 Pullets and replacement chicks should be vaccinated at least one month before the point of lay.
679
680 </p>
681 </div>
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694 <div align="justify">
695 <p style="text-align: justify;">
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699 </p>
700 </div>
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713 <div align="justify">
714 <p style="text-align: justify;">
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716 Markedly lean and stressed birds should not be vaccinated.
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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751 <div align="justify">
752 <p style="text-align: justify;">
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754 Packaging and vaccine leftovers should be sterilised by heating.
755
756 </p>
757 </div>
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770 <div align="justify">
771 <p style="text-align: justify;">
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773 <b></b>
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775 </p>
776 </div>
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789 <div align="justify">
790 <p style="text-align: justify;">
791
792 <b><i>Withdrawal</i></b><b></b>
793
794 </p>
795 </div>
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808 <div align="justify">
809 <p style="text-align: justify;">
810
811 Meat, organs and other edible tissues of the poultry - 0 days.
812
813 </p>
814 </div>
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827 <div align="justify">
828 <p style="text-align: justify;">
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832 </p>
833 </div>
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846 <div align="justify">
847 <p style="text-align: justify;">
848
849 <b><i>Storage</i></b><b></b>
850
851 </p>
852 </div>
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865 <div align="justify">
866 <p style="text-align: justify;">
867
868 Store in a dark place at 2-88C (refrigerator). Keep away from children.
869
870 </p>
871 </div>
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884 <div align="justify">
885 <p style="text-align: justify;">
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889 </p>
890 </div>
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903 <div align="justify">
904 <p style="text-align: justify;">
905
906 <b><i>Shelf life</i></b>
907
908 </p>
909 </div>
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922 <div align="justify">
923 <p style="text-align: justify;">
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925 Denoted on the packaging (2 years in the original pack).
926
927 </p>
928 </div>
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941 <div align="justify">
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946 </p>
947 </div>
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960 <div align="justify">
961 <p style="text-align: justify;">
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963 <b><i>Legal category</i></b><b></b>
964
965 </p>
966 </div>
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979 <div align="justify">
980 <p style="text-align: justify;">
981
982 On prescription only.
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984 </p>
985 </div>
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998 <div align="justify">
999 <p style="text-align: justify;">
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1003 </p>
1004 </div>
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1017 <div align="justify">
1018 <p style="text-align: justify;">
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1020 <b><i>Supply</i></b>
1021
1022 </p>
1023 </div>
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1036 <div align="justify">
1037 <p style="text-align: justify;">
1038
1039 Box with 5 x 1000 vaccinal doses and 5 bottles with diluent.
1040
1041 </p>
1042 </div>
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1055 <div align="justify">
1056 <p style="text-align: justify;">
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1060 </p>
1061 </div>
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1074 <div align="justify">
1075 <p style="text-align: justify;">
1076
1077 <b><i>Manufacturer</i></b>
1078
1079 </p>
1080 </div>
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1093 <div align="justify">
1094 <p style="text-align: justify;">
1095
1096 VETERINA Animal Health Ltd., Croatia
1097
1098 </p>
1099 </div>
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1112 <div align="justify">
1113 <p style="text-align: justify;">
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1117 </p>
1118 </div>
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1125
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1131 <div align="justify">
1132 <p style="text-align: justify;">
1133
1134 <b><i>Additional information</i></b>
1135
1136 </p>
1137 </div>
1138
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1149
1150 <div align="justify">
1151 <p style="text-align: justify;">
1152
1153 Bodikal<b><sup>®</sup></b> SPF is a very potent vaccine for the growing poultry. It has been shown that the vaccine establishes sound immunity and that the reactions to it are mild.
1154
1155 </p>
1156 </div>
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1170 <p style="text-align: justify;">
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1174 </p>
1175 </div>
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1188 <div align="justify">
1189 <p style="text-align: justify;">
1190
1191 In every animal population there are some with poorer response to vaccination. Immune response is affected by hereditary factors, age, subclinical diseases, condition, diet, stress and concurrent administration of other drugs. It is very important that the vaccine is properly kept and administered.<b></b>
1192
1193 </p>
1194 </div>
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1212 </p>
1213 </div>
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1226 <div align="left">
1227 <p style="text-align: left;">
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1231 </p>
1232 </div>
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1234
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1238
1239
1240 <!--Section Ends-->
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