1 |
|
2 |
|
3 |
<!--Section Begins--><br> |
4 |
|
5 |
|
6 |
|
7 |
|
8 |
|
9 |
|
10 |
<div align="justify"> |
11 |
<p style="text-align: justify;"> |
12 |
|
13 |
|
14 |
|
15 |
</p> |
16 |
</div> |
17 |
|
18 |
|
19 |
|
20 |
|
21 |
|
22 |
|
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> IM 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 VMG-91 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 |
|
78 |
|
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 live attenuated Gumboro disease virus, intermediary type (strain VMG-91) grown in embryonated chicks' SPF eggs. One vaccinal dose contains at least 10<sup>3</sup> TCID<sub>50.</sub> The vaccine is lyophilised with the addition of PPGF (PLIVA) stabiliser. |
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 (infectious bursal disease). |
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 |
Active immunoprophylaxis against infectious bursal disease in healthy chicks. |
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 |
Clinically sick and exhausted chicks should not be vaccinated as well as those under stress. |
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 |
|
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. Resuspend 1000 vaccinal doses in 10 L of water. 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. |
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 |
|
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 |
It is recommended to vaccinate the chicks to vaccinated mothers with born immunity to Gumboro disease or who were inoculated with a mild strain of infectious bursal disease. |
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. A single dose already establishes sound immunity against bursal disease. |
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>Immunity</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 |
Immunity in the vaccinated birds is established 4-5 days post vaccination. |
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 |
|
494 |
|
495 |
|
496 |
|
497 |
|
498 |
|
499 |
|
500 |
|
501 |
|
502 |
|
503 |
|
504 |
<div align="justify"> |
505 |
<p style="text-align: justify;"> |
506 |
|
507 |
<b><i>Warnings and precautions</i></b><b></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 |
To avoid possible interaction in the immune response, GUMBOKAL<b><sup>®</sup></b> IM SPF vaccine should not be given 4 days before to 4 days after vaccination against Newcastle disease and infectious bronchitis in hens. |
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 |
Dishes for preparation and administration of the vaccine should be perfectly clean and the water free of disinfectants. |
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 |
|
592 |
|
593 |
|
594 |
|
595 |
|
596 |
|
597 |
|
598 |
|
599 |
<div align="justify"> |
600 |
<p style="text-align: justify;"> |
601 |
|
602 |
The vaccine is administered to all birds in the flock. |
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 |
Avoid exposure to direct sunlight. |
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 |
|
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 |
Packaging and vaccine leftovers must be disposed of in a safe way, preferably by boiling in water. |
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 |
|
702 |
|
703 |
|
704 |
|
705 |
|
706 |
|
707 |
|
708 |
|
709 |
|
710 |
|
711 |
|
712 |
|
713 |
<div align="justify"> |
714 |
<p style="text-align: justify;"> |
715 |
|
716 |
<b><i>Withdrawal</i></b><b></b> |
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 |
Meat and other edible tissues of poultry - 0 days.<b></b> |
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 |
|
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 |
<b><i>Storage</i></b> |
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 |
Store in a dark place, at 2-8°C (refrigerator). Keep away from children. |
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 |
|
812 |
|
813 |
</p> |
814 |
</div> |
815 |
|
816 |
|
817 |
|
818 |
|
819 |
|
820 |
|
821 |
|
822 |
|
823 |
|
824 |
|
825 |
|
826 |
|
827 |
<div align="justify"> |
828 |
<p style="text-align: justify;"> |
829 |
|
830 |
<b><i>Shelf life</i></b> |
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 |
Denoted on the packaging (18 months).<b></b> |
850 |
|
851 |
</p> |
852 |
</div> |
853 |
|
854 |
|
855 |
|
856 |
|
857 |
|
858 |
|
859 |
|
860 |
|
861 |
|
862 |
|
863 |
|
864 |
|
865 |
<div align="justify"> |
866 |
<p style="text-align: justify;"> |
867 |
|
868 |
|
869 |
|
870 |
</p> |
871 |
</div> |
872 |
|
873 |
|
874 |
|
875 |
|
876 |
|
877 |
|
878 |
|
879 |
|
880 |
|
881 |
|
882 |
|
883 |
|
884 |
<div align="justify"> |
885 |
<p style="text-align: justify;"> |
886 |
|
887 |
<b><i>Legal category</i></b> |
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 |
On prescription only. |
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 |
|
926 |
|
927 |
</p> |
928 |
</div> |
929 |
|
930 |
|
931 |
|
932 |
|
933 |
|
934 |
|
935 |
|
936 |
|
937 |
|
938 |
|
939 |
|
940 |
|
941 |
<div align="justify"> |
942 |
<p style="text-align: justify;"> |
943 |
|
944 |
<b><i>Supply</i></b> |
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 |
Boxes with 10x1000 and 10x2000 vaccinal doses. |
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 |
|
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 |
<b><i>Manufacturer</i></b><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 |
VETERINA Animal Health Ltd., Croatia |
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 |
|
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 |
<b><i>Important note</i></b><b></b> |
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 |
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. |
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 |
|
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 |
Given the variations in vaccination programmes, before vaccinating the whole flock it is recommended to consult the veterinarian who is an expert in poultry. |
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="left"> |
1151 |
<p style="text-align: left;"> |
1152 |
|
1153 |
|
1154 |
|
1155 |
</p> |
1156 |
</div> |
1157 |
|
1158 |
|
1159 |
|
1160 |
|
1161 |
|
1162 |
|
1163 |
|
1164 |
<!--Section Ends--> |
1165 |
|
1166 |
|
1167 |
|
1168 |
|
1169 |
|
1170 |
|
1171 |
|
1172 |
|