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>GUMPESKAL</b><b><sup>®</sup></b><b>+IB+EDS</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 tetravalent oily vaccine against Gumboro disease, Newcastle disease, avian infectious bronchitis and egg-drop syndrome</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 infectious bursal disease virus (Gumboro disease), Newcastle disease virus (NDV), avian infectious bronchitis virus (AIBV) and egg-drop syndrome virus, each inactivated with formaldehyde. NDV and AIBV are also dissociated with non-ionic detergent. All four immunogens are re-suspended, 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 formation of specific antibodies for Gumboro disease, Newcastle disease, avian infectious bronchitis and egg-drop syndrome viruses. |
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 light and heavy hybrids against Gumboro disease, Newcastle disease, avian infectious bronchitis and egg-drop syndrome. |
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 |
|
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 and dosage</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 birds are vaccinated at the age of 16-20 weeks, but not later than 4 weeks before the onset of the egg production. Before being vaccinated with GUMPESKAL<b><sup>®</sup></b>+IB+EDS, the birds should be given live vaccine against Gumboro and Newcastle disease and avian infectious bronchitis. Time between these two vaccinations and administration of GUMPESKAL<b><sup>® </sup></b>+IB+EDS should not be shorter than 2 weeks. Optimum effect is achieved with an interval of 6 weeks. |
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 |
The dose per bird is 0.5 mL given by i. m. route in the breast muscle or s. c. into the skin fold at the dorsal neck side. |
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></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 |
<b><i>Warnings and precautions</i></b><b></b> |
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 |
Before administration the vaccine should be heated to room temperature (18-20°C) and shaken prior to and during administration. <b></b> |
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 |
|
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 |
Vaccination equipment should be sterile.<b></b> |
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></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 |
Once opened use within 24 hours.<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 |
|
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 |
The vaccine is administered to healthy birds only. |
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 |
|
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 |
Do not administer by i. v. route. |
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 |
|
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 |
In every animal population there are some with poorer response to vaccination. Immune reaction is affected by hereditary factors, age of the animal, subclinical diseases, condition of the animal, stress factors and concurrent administration of other drugs. |
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 |
|
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 |
Packaging and vaccine leftovers must be sterilised by heating. |
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 |
Accidental self-administration may cause local reaction. |
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 |
|
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 |
<b><i>Withdrawal</i></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 |
Meat, organs and other edible tissues - 0 days. |
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></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 |
<b><i>Storage</i></b> |
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 |
Store in a dark place at 2-8°C (refrigerator). Keep away from children. Avoid freezing. |
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 |
|
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 |
<b><i>Shelf life</i></b><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 |
Denoted on the packaging (18 months). |
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 |
|
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 |
<b><i>Legal category</i></b><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 |
On prescription only. |
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 |
|
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>Supply</i></b><b></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 |
Bottles of 500 mL (1000 doses). |
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>Manufacturer</i></b><b></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 |
VETERINA Animal Health Ltd., Croatia |
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="left"> |
1075 |
<p style="text-align: left;"> |
1076 |
|
1077 |
|
1078 |
|
1079 |
</p> |
1080 |
</div> |
1081 |
|
1082 |
|
1083 |
|
1084 |
|
1085 |
|
1086 |
|
1087 |
|
1088 |
<!--Section Ends--> |
1089 |
|
1090 |
|
1091 |
|
1092 |
|
1093 |
|
1094 |
|
1095 |
|
1096 |
|