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Revision 1.1 - (show annotations)
Thu Apr 5 12:26:37 2001 UTC (22 years, 11 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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10 <div align="justify">
11 <p style="text-align: justify;">
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15 </p>
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29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>PESTIKAL</b><b><sup>®</sup></b><b>+EDS</b>
33
34 </p>
35 </div>
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37
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45
46
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48 <div align="justify">
49 <p style="text-align: justify;">
50
51 <i>inactivated bivalent oily vaccine against Newcastle disease and egg-drop syndrome</i>
52
53 </p>
54 </div>
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56
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61
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67 <div align="justify">
68 <p style="text-align: justify;">
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70 <b></b>
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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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103
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105 <div align="justify">
106 <p style="text-align: justify;">
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108 The vaccine contains infectious virus of Newcastle disease (NDV) grown in the chicks' embryonated eggs and egg-drop syndrome virus grown in the duck's embryonated eggs. Each virus is inactivated with formaldehyde. NDV is also dissociated with non-ionic detergent. Both immunogens are resuspended, with the addition of an emulsifier, in mineral oil as a multiple emulsion water/oil/water type.
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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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141
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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 induces formation of specific antibodies for Newcastle disease and egg-drop syndrome viruses.
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;">
221
222 Immunoprophylaxis of Newcastle disease and egg-drop syndrome in healthy layers of light and heavy breeds.
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>
261
262 </p>
263 </div>
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265
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276 <div align="justify">
277 <p style="text-align: justify;">
278
279 Unknown.
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281 </p>
282 </div>
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295 <div align="justify">
296 <p style="text-align: justify;">
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298
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300 </p>
301 </div>
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309
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311
312
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314 <div align="justify">
315 <p style="text-align: justify;">
316
317 <b><i>Administration and dosage</i></b>
318
319 </p>
320 </div>
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330
331
332
333 <div align="justify">
334 <p style="text-align: justify;">
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336 Healthy layers are vaccinated at the age of 16-20 weeks, but not later than 4 weeks before the onset of egg production. Before being vaccinated, the hens should be given live vaccine against Newcastle disease. Time between these two vaccinations should not be shorter than 2 weeks. Optimum effect is achieved with an interval of 6 weeks.
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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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. at dorsal side of the neck.
375
376 </p>
377 </div>
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385
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389
390 <div align="justify">
391 <p style="text-align: justify;">
392
393 <b></b>
394
395 </p>
396 </div>
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399
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401
402
403
404
405
406
407
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409 <div align="justify">
410 <p style="text-align: justify;">
411
412 <b><i>Immunity</i></b><b></b>
413
414 </p>
415 </div>
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425
426
427
428 <div align="justify">
429 <p style="text-align: justify;">
430
431 In healthy hens immunity is established 2-3 weeks after vaccination and is maintained till the end of the production cycle.<b></b>
432
433 </p>
434 </div>
435
436
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442
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444
445
446
447 <div align="justify">
448 <p style="text-align: justify;">
449
450 <b><i> </i></b><b></b>
451
452 </p>
453 </div>
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459
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461
462
463
464
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466 <div align="justify">
467 <p style="text-align: justify;">
468
469 <b><i>Warnings and precautions</i></b><b></b>
470
471 </p>
472 </div>
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477
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483
484
485 <div align="justify">
486 <p style="text-align: justify;">
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488 Before administration the vaccine should be heated to room temperature (18-20°C) and shaken prior to and occasionally during administration. <b></b>
489
490 </p>
491 </div>
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504 <div align="justify">
505 <p style="text-align: justify;">
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509 </p>
510 </div>
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523 <div align="justify">
524 <p style="text-align: justify;">
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526 Vaccination equipment should be sterile.<b></b>
527
528 </p>
529 </div>
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542 <div align="justify">
543 <p style="text-align: justify;">
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545 <b></b>
546
547 </p>
548 </div>
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557
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559
560
561 <div align="justify">
562 <p style="text-align: justify;">
563
564 Once opened use within 24 hours.<b></b>
565
566 </p>
567 </div>
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580 <div align="justify">
581 <p style="text-align: justify;">
582
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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 Accidental self-administration may cause local reaction. If necessary seek medical (surgeon's) advice.<b></b>
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;">
639
640 <b><i>Withdrawal</i></b>
641
642 </p>
643 </div>
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656 <div align="justify">
657 <p style="text-align: justify;">
658
659 Meat and edible tissues - 0 days.<b></b>
660
661 </p>
662 </div>
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675 <div align="justify">
676 <p style="text-align: justify;">
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680 </p>
681 </div>
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694 <div align="justify">
695 <p style="text-align: justify;">
696
697 <b><i> Storage</i></b>
698
699 </p>
700 </div>
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713 <div align="justify">
714 <p style="text-align: justify;">
715
716 Store in a dark place at 2-8°C (refrigerator). Keep away from children. Avoid freezing.<b></b>
717
718 </p>
719 </div>
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737 </p>
738 </div>
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751 <div align="justify">
752 <p style="text-align: justify;">
753
754 <b><i>Shelf life</i></b><b></b>
755
756 </p>
757 </div>
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770 <div align="justify">
771 <p style="text-align: justify;">
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773 Denoted on the packaging (18 months in the original pack).<b></b>
774
775 </p>
776 </div>
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789 <div align="justify">
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794 </p>
795 </div>
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808 <div align="justify">
809 <p style="text-align: justify;">
810
811 <b><i>Legal category</i></b><b></b>
812
813 </p>
814 </div>
815
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820
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822
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825
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827 <div align="justify">
828 <p style="text-align: justify;">
829
830 On prescription only.<b></b>
831
832 </p>
833 </div>
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846 <div align="justify">
847 <p style="text-align: justify;">
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851 </p>
852 </div>
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865 <div align="justify">
866 <p style="text-align: justify;">
867
868 <b><i>Supply</i></b><b></b>
869
870 </p>
871 </div>
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881
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883
884 <div align="justify">
885 <p style="text-align: justify;">
886
887 Bottles of 200 and 1000 doses.
888
889 </p>
890 </div>
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903 <div align="justify">
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909 </div>
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922 <div align="justify">
923 <p style="text-align: justify;">
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925 <b><i>Manufacturer</i></b><b></b>
926
927 </p>
928 </div>
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941 <div align="justify">
942 <p style="text-align: justify;">
943
944 VETERINA Animal Health Ltd., Croatia
945
946 </p>
947 </div>
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960 <div align="justify">
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965 </p>
966 </div>
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979 <div align="justify">
980 <p style="text-align: justify;">
981
982 <b><i>Important note</i></b>
983
984 </p>
985 </div>
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998 <div align="justify">
999 <p style="text-align: justify;">
1000
1001 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, condition of the animal, stress factors and concurrent administration of other medicines.
1002
1003 </p>
1004 </div>
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1022 </p>
1023 </div>
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1036 <div align="justify">
1037 <p style="text-align: justify;">
1038
1039 Given the difference between the vaccination programmes, before vaccinating the whole flock it is recommended to consult the veterinarian - a poultry specialist.
1040
1041 </p>
1042 </div>
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1061 </div>
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1074 <div align="left">
1075 <p style="text-align: left;">
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1079 </p>
1080 </div>
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1088 <!--Section Ends-->
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