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8 |
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9 |
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10 |
<div align="left"> |
<div align="justify"> |
11 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
12 |
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13 |
<b>PLIVAK</b><b><sup>®</sup></b><b> - KS</b> |
<b>PLIVAK</b><b><sup>®</sup></b><b> - KS</b> |
14 |
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26 |
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27 |
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28 |
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29 |
<div align="left"> |
<div align="justify"> |
30 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
31 |
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32 |
<i>lyophilised live vaccine against classical swine fever, strain China virus multiplied in cell culture</i> |
<i>a live, freeze-dried vaccine against classical swine fever, strain China, grown in cell culture</i> |
33 |
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34 |
</p> |
</p> |
35 |
</div> |
</div> |
45 |
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46 |
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47 |
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48 |
<div align="left"> |
<div align="justify"> |
49 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
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50 |
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51 |
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<b></b> |
52 |
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53 |
</p> |
</p> |
54 |
</div> |
</div> |
64 |
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65 |
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66 |
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67 |
<div align="left"> |
<div align="justify"> |
68 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
69 |
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70 |
<b><i>Composition</i></b> |
<b><i>Composition</i></b> |
71 |
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83 |
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84 |
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85 |
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86 |
<div align="left"> |
<div align="justify"> |
87 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
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Lyophilised vaccine contains live modified virus of classical swine fever, strain China, multiplied in MPK (minipig kidney) cell culture. |
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</p> |
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</div> |
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<div align="left"> |
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<p style="text-align: left;"> |
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88 |
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89 |
Each vaccine dose (1ml) contains at least 100 PD<sub>50</sub> per each pig. |
Freeze-dried vaccine contains a live, modified virus of classical swine fever, strain China, grown in MPK (minipig kidney) cell culture. |
90 |
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91 |
</p> |
</p> |
92 |
</div> |
</div> |
102 |
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103 |
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104 |
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105 |
<div align="left"> |
<div align="justify"> |
106 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
107 |
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108 |
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109 |
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121 |
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122 |
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123 |
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124 |
<div align="left"> |
<div align="justify"> |
125 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
126 |
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127 |
<b><i>Action</i></b> |
<b><i>Action</i></b> |
128 |
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140 |
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141 |
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142 |
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143 |
<div align="left"> |
<div align="justify"> |
144 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
145 |
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146 |
The vaccine enhances formation of specific antibodies against classical swine fever virus in vaccinated pigs. |
The vaccine induces in vaccinated pigs the formation of specific antibodies to classical swine fever virus. |
147 |
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148 |
</p> |
</p> |
149 |
</div> |
</div> |
159 |
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160 |
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161 |
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162 |
<div align="left"> |
<div align="justify"> |
163 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
164 |
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165 |
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166 |
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178 |
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179 |
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180 |
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181 |
<div align="left"> |
<div align="justify"> |
182 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
183 |
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184 |
<b><i>Indication</i></b> |
<b><i>Indications</i></b> |
185 |
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186 |
</p> |
</p> |
187 |
</div> |
</div> |
197 |
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198 |
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199 |
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200 |
<div align="left"> |
<div align="justify"> |
201 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
202 |
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203 |
Active immunization of pigs against classical swine fever. |
Active immunisation of pigs against classical swine fever. |
204 |
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205 |
</p> |
</p> |
206 |
</div> |
</div> |
216 |
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217 |
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218 |
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219 |
<div align="left"> |
<div align="justify"> |
220 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
221 |
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222 |
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223 |
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235 |
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236 |
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237 |
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238 |
<div align="left"> |
<div align="justify"> |
239 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
240 |
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241 |
<b><i>Contraindications</i></b> |
<b><i>Contraindications</i></b> |
242 |
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254 |
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255 |
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256 |
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257 |
<div align="left"> |
<div align="justify"> |
258 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
259 |
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260 |
Diseased animals shouldn't be vaccinated. |
Only healthy animals should be vaccinated. |
261 |
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262 |
</p> |
</p> |
263 |
</div> |
</div> |
273 |
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274 |
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275 |
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276 |
<div align="left"> |
<div align="justify"> |
277 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
278 |
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279 |
It is not recommended to vaccinate gravid gilts or sows, except in directly affected breeding lots. |
It is not recommended to vaccinate gravid gilts or sows, except in case of an imminent risk. |
280 |
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|
281 |
</p> |
</p> |
282 |
</div> |
</div> |
292 |
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293 |
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294 |
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295 |
<div align="left"> |
<div align="justify"> |
296 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
297 |
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298 |
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299 |
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311 |
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312 |
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313 |
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314 |
<div align="left"> |
<div align="justify"> |
315 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
316 |
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|
317 |
<b><i>Administration and dosage</i></b> |
<b><i>Administration and dosage</i></b> |
318 |
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330 |
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331 |
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332 |
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333 |
<div align="left"> |
<div align="justify"> |
334 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
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Vaccine dose is 1 ml, regardless of age, body weight and breed; it is administered deeply intramuscularly in the neck muscles (directly behind ear base) or in the thigh. |
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</p> |
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</div> |
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<div align="left"> |
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<p style="text-align: left;"> |
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</p> |
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</div> |
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<div align="left"> |
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<p style="text-align: left;"> |
|
335 |
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336 |
<b><i>Vaccination programme</i></b> |
The dose is 1 ml, irrespective of the animal age, body weight and breed, and it is administered by a deep intramuscular injection in the neck (behind the ear base) or thigh muscles. |
337 |
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|
338 |
</p> |
</p> |
339 |
</div> |
</div> |
349 |
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350 |
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351 |
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352 |
<div align="left"> |
<div align="justify"> |
353 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
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Piglets from non-vaccinated sows: |
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</p> |
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</div> |
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354 |
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355 |
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356 |
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<div align="left"> |
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<p style="text-align: left;"> |
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- may be vaccinated already when 7-14 days old and re-vaccinated 3-4 weeks after vaccination. |
|
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357 |
</p> |
</p> |
358 |
</div> |
</div> |
359 |
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368 |
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369 |
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370 |
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371 |
<div align="left"> |
<div align="justify"> |
372 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
373 |
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|
374 |
Piglets from vaccinated sows: |
- the first dose of the vaccine is administered at the age of 6-8 weeks and the booster dose 3-4 weeks later. |
375 |
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|
376 |
</p> |
</p> |
377 |
</div> |
</div> |
390 |
<div align="left"> |
<div align="left"> |
391 |
<p style="text-align: left;"> |
<p style="text-align: left;"> |
392 |
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|
|
- are vaccinated when 6-8 weeks old and re-vaccinated 3-4 weeks after vaccination. |
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</p> |
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</div> |
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393 |
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394 |
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<div align="left"> |
|
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<p style="text-align: left;"> |
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Piglets in directly affected breeding lots: |
|
|
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|
395 |
</p> |
</p> |
396 |
</div> |
</div> |
397 |
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|
406 |
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|
407 |
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|
408 |
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|
409 |
<div align="left"> |
<div align="justify"> |
410 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
411 |
|
|
412 |
- may be vaccinated when 3 weeks old and re-vaccinated 3-4 weeks after vaccination. |
Piglets in herds exposed to imminent risk may be vaccinated at 3 weeks of age and revaccinated 3-4 weeks later. |
413 |
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|
414 |
</p> |
</p> |
415 |
</div> |
</div> |
425 |
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|
426 |
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|
427 |
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|
428 |
<div align="left"> |
<div align="justify"> |
429 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
430 |
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|
431 |
Sows and gilts: |
Sows and gilts: |
432 |
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444 |
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445 |
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446 |
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|
447 |
<div align="left"> |
<div align="justify"> |
448 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
449 |
|
|
450 |
- are vaccinated prior to mating. |
- before mating. |
451 |
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|
452 |
</p> |
</p> |
453 |
</div> |
</div> |
463 |
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|
464 |
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|
465 |
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|
466 |
<div align="left"> |
<div align="justify"> |
467 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
468 |
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|
469 |
Boars: |
Boars: |
470 |
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|
482 |
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|
483 |
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|
484 |
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|
485 |
<div align="left"> |
<div align="justify"> |
486 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
487 |
|
|
488 |
- are vaccinated once a year. |
- once a year. |
489 |
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|
490 |
</p> |
</p> |
491 |
</div> |
</div> |
501 |
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|
502 |
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|
503 |
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|
504 |
<div align="left"> |
<div align="justify"> |
505 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
506 |
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507 |
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508 |
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520 |
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521 |
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522 |
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|
523 |
<div align="left"> |
<div align="justify"> |
524 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
525 |
|
|
526 |
<b><i>Withdrawal period</i></b> |
<b><i>Withdrawal period</i></b> |
527 |
|
|
539 |
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|
540 |
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|
541 |
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|
542 |
<div align="left"> |
<div align="justify"> |
543 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
544 |
|
|
545 |
Meat, organs and other edible tissues of the vaccinated animals may be used without limitation, i.e. withdrawal period is 0 days. |
Meat, organs and other edible tissues of vaccinated animals may be used for human consumption without restriction, i.e. the withholding period is zero days. |
546 |
|
|
547 |
</p> |
</p> |
548 |
</div> |
</div> |
558 |
|
|
559 |
|
|
560 |
|
|
561 |
<div align="left"> |
<div align="justify"> |
562 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
563 |
|
|
564 |
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|
565 |
|
|
577 |
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|
578 |
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|
579 |
|
|
580 |
<div align="left"> |
<div align="justify"> |
581 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
582 |
|
|
583 |
<b><i>Important note</i></b> |
<b><i>Warnings</i></b> |
584 |
|
|
585 |
</p> |
</p> |
586 |
</div> |
</div> |
596 |
|
|
597 |
|
|
598 |
|
|
599 |
<div align="left"> |
<div align="justify"> |
600 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
601 |
|
|
602 |
Lyophilised vaccine should be suspended in the enclosed diluent immediately prior to administration. |
Freeze-dried vaccine should be suspended in enclosed diluent immediately before use. |
603 |
|
|
604 |
</p> |
</p> |
605 |
</div> |
</div> |
615 |
|
|
616 |
|
|
617 |
|
|
618 |
<div align="left"> |
<div align="justify"> |
619 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
620 |
|
|
621 |
After suspending, the vaccine should be used within 3 hours. |
Reconstituted vaccine should be used within 3 hours. |
622 |
|
|
623 |
</p> |
</p> |
624 |
</div> |
</div> |
634 |
|
|
635 |
|
|
636 |
|
|
637 |
<div align="left"> |
<div align="justify"> |
638 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
639 |
|
|
640 |
Non-consumed vaccine and empty bottles (vials) should be disposed of safely. |
Unused vaccine and empty vials should be disposed of safely. |
641 |
|
|
642 |
</p> |
</p> |
643 |
</div> |
</div> |
653 |
|
|
654 |
|
|
655 |
|
|
656 |
<div align="left"> |
<div align="justify"> |
657 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
658 |
|
|
659 |
Vaccination appliances should be sterile. |
Vaccination<b> </b>kit should be sterile. |
660 |
|
|
661 |
</p> |
</p> |
662 |
</div> |
</div> |
672 |
|
|
673 |
|
|
674 |
|
|
675 |
<div align="left"> |
<div align="justify"> |
676 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
677 |
|
|
678 |
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|
679 |
|
|
691 |
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|
692 |
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|
693 |
|
|
694 |
<div align="left"> |
<div align="justify"> |
695 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
696 |
|
|
697 |
<b><i>Storage</i></b> |
<b><i>Storage</i></b><i></i> |
698 |
|
|
699 |
</p> |
</p> |
700 |
</div> |
</div> |
710 |
|
|
711 |
|
|
712 |
|
|
713 |
<div align="left"> |
<div align="justify"> |
714 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
715 |
|
|
716 |
Store at a temperature of 2-8°C, away from light and out of the reach of children. |
The vaccine should be kept at 2-8Ëš C, protected from light and out of reach of children. |
717 |
|
|
718 |
</p> |
</p> |
719 |
</div> |
</div> |
729 |
|
|
730 |
|
|
731 |
|
|
732 |
<div align="left"> |
<div align="justify"> |
733 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
734 |
|
|
735 |
|
|
736 |
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|
748 |
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|
749 |
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|
750 |
|
|
751 |
<div align="left"> |
<div align="justify"> |
752 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
753 |
|
|
754 |
<b><i>Legal category</i></b> |
<b><i>Legal category</i></b><i></i> |
755 |
|
|
756 |
</p> |
</p> |
757 |
</div> |
</div> |
767 |
|
|
768 |
|
|
769 |
|
|
770 |
<div align="left"> |
<div align="justify"> |
771 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
772 |
|
|
773 |
On veterinary prescription. |
On veterinary prescription. |
774 |
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|
786 |
|
|
787 |
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|
788 |
|
|
789 |
<div align="left"> |
<div align="justify"> |
790 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
791 |
|
|
792 |
|
|
793 |
|
|
805 |
|
|
806 |
|
|
807 |
|
|
808 |
<div align="left"> |
<div align="justify"> |
809 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
810 |
|
|
811 |
<b><i>Shelf life</i></b> |
<b><i>Shelf life</i></b><i></i> |
812 |
|
|
813 |
</p> |
</p> |
814 |
</div> |
</div> |
824 |
|
|
825 |
|
|
826 |
|
|
827 |
<div align="left"> |
<div align="justify"> |
828 |
<p style="text-align: left;"> |
<p style="text-align: justify;"> |
829 |
|
|
830 |
Indicated on packaging. |
Indicated on the packing. |
831 |
|
|
832 |
</p> |
</p> |
833 |
</div> |
</div> |