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Revision 1.1 - (show annotations)
Thu Apr 5 12:26:37 2001 UTC (18 years ago) by dpavlin
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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">
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32 <b>SIDERANEM</b><b><sup>®</sup></b><b> 100</b>
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34 </p>
35 </div>
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48 <div align="justify">
49 <p style="text-align: justify;">
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51 <i>injection solution</i>
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53 </p>
54 </div>
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72 </p>
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86 <div align="justify">
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89 <b><i>Composition</i></b>
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91 </p>
92 </div>
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105 <div align="justify">
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108 1 mL contains 100 mg of trivalent iron as ferric (III)-dextran.
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110 </p>
111 </div>
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143 <div align="justify">
144 <p style="text-align: justify;">
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146 <b><i>Action</i></b><b></b>
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148 </p>
149 </div>
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162 <div align="justify">
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165 Functional iron is indispensable for intracellular oxidation and regulation and for normal cell and tissue function. Young animals, particularly piglets, grow rapidly and so is with the increase in their muscle and blood volume. These processes cause very rapid depletion of iron stores, which results in anemia, decreased immunity and appetite, retarded growth and development. Iron deficiency is most efficiently compensated by i. m. injections. So administered, it is rapidly resorbed, in the first place in the lymphatic vessels, and transported to the liver, spleen and bone marrow where it participates in haemoglobin synthesis. Sideranem<b><sup>®</sup></b> 100 injections prevent, i. e. eliminate the signs of sideropenic anemia in piglets.
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167 </p>
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181 <div align="justify">
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186 </p>
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200 <div align="justify">
201 <p style="text-align: justify;">
202
203 <b><i>Indications </i></b>
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205 </p>
206 </div>
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219 <div align="justify">
220 <p style="text-align: justify;">
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222 Prophylaxis and treatment of sideropenic anemia in piglets.
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224 </p>
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238 <div align="justify">
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243 </p>
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257 <div align="justify">
258 <p style="text-align: justify;">
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260 <b><i>Contraindications</i></b><b></b>
261
262 </p>
263 </div>
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276 <div align="justify">
277 <p style="text-align: justify;">
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279 Preparations of dextran-iron should not be given to the piglets with colibacillosis, particularly diarrheal.
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281 </p>
282 </div>
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295 <div align="justify">
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300 </p>
301 </div>
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314 <div align="justify">
315 <p style="text-align: justify;">
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317 Concomitant p. o. administration of iron preparations or i. m. injections of dextran/iron should be avoided.
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319 </p>
320 </div>
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333 <div align="justify">
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338 </p>
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352 <div align="justify">
353 <p style="text-align: justify;">
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355 Sideranem<b><sup>®</sup></b> 100 should not be given intravenously.
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357 </p>
358 </div>
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371 <div align="justify">
372 <p style="text-align: justify;">
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374 <b></b>
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376 </p>
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390 <div align="justify">
391 <p style="text-align: justify;">
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393 <b><i>Administration and dosage</i></b>
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395 </p>
396 </div>
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409 <div align="justify">
410 <p style="text-align: justify;">
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412 Sideranem<b><sup>®</sup></b> is given by deep i. m. injection, posteriorly to the auricular basis.
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414 </p>
415 </div>
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428 <div align="justify">
429 <p style="text-align: justify;">
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431 <b></b>
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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 <i>Prophylaxis</i>: a single dose of 1 mL between days 1-4 of life.
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452 </p>
453 </div>
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466 <div align="justify">
467 <p style="text-align: justify;">
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469 <i>Treatment</i>: a single dose of 2 mL.
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471 </p>
472 </div>
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485 <div align="justify">
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490 </p>
491 </div>
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504 <div align="justify">
505 <p style="text-align: justify;">
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507 <b><i>Warnings and precautions</i></b>
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509 </p>
510 </div>
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523 <div align="justify">
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526 More than 100 mg of iron given in a single dose to newborn piglets may contribute to colibacillosis. Therefore, the dose should be determined meticulously, relevant to local conditions. <b></b>
527
528 </p>
529 </div>
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542 <div align="justify">
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547 </p>
548 </div>
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561 <div align="justify">
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564 Deficiency in vitamin E and selenium may contribute to development of intolerance to dextran-iron preparations. In newly born piglets it occurs very rapidly or several hours from the injection, in the form of muscular twitches, staggering, choking and sometimes fatality. If this is assumed to be the deficiency in vitamin E and/or selenium, the sows and primiparous sows should be given prophylactically in the last trimester of pregnancy the preparations like Muvisel<b><sup>®</sup></b>, Becekasel<b><sup>®</sup></b>, etc. Every piglet may as well be given at least one day before administration of Sideranem<b><sup>®</sup></b> 100, a single i. m. dose of 1 mL of Tokoselen<b><sup>®</sup></b>.
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566 </p>
567 </div>
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580 <div align="justify">
581 <p style="text-align: justify;">
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583 <b></b>
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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 <b><i>Withdrawal</i></b><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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621 Swine - meat, organs and other edible tissues<b> - </b>0 days.<b></b>
622
623 </p>
624 </div>
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642 </p>
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656 <div align="justify">
657 <p style="text-align: justify;">
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659 <b><i>Storage</i></b>
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661 </p>
662 </div>
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675 <div align="justify">
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678 Store in a dark and cool place at 8-15°C. Keep away from children. Avoid freezing.
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680 </p>
681 </div>
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699 </p>
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716 <b><i>Shelf life</i></b>
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718 </p>
719 </div>
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735 Denoted on the packaging (5 years in the original pack).
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737 </p>
738 </div>
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773 <b><i>Legal category</i></b>
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775 </p>
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792 On prescription only.
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794 </p>
795 </div>
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808 <div align="justify">
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811 <b><i></i></b>
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813 </p>
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830 Supply
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832 </p>
833 </div>
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846 <div align="justify">
847 <p style="text-align: justify;">
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849 Pierced bottle of 200 mL.
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851 </p>
852 </div>
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884 <div align="justify">
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887 <b><i>Manufacturer</i></b>
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889 </p>
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906 VETERINA Animal Health Ltd., Croatia
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908 </p>
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941 <div align="left">
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947 </div>
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955 <!--Section Ends-->
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