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dpavlin |
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<!--Section Begins--><br> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<b>SIDERANEM</b><b><sup>®</sup></b><b> 100</b> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<i>injection solution</i> |
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</p> |
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</div> |
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</p> |
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<div align="justify"> |
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<b><i>Composition</i></b> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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1 mL contains 100 mg of trivalent iron as ferric (III)-dextran. |
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</p> |
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</div> |
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<b><i>Action</i></b><b></b> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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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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</p> |
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</div> |
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</p> |
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</div> |
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<div align="justify"> |
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<b><i>Indications </i></b> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Prophylaxis and treatment of sideropenic anemia in piglets. |
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</p> |
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</div> |
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<div align="justify"> |
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</p> |
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</div> |
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<b><i>Contraindications</i></b><b></b> |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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Preparations of dextran-iron should not be given to the piglets with colibacillosis, particularly diarrheal. |
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</p> |
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</div> |
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</p> |
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Concomitant p. o. administration of iron preparations or i. m. injections of dextran/iron should be avoided. |
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</p> |
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</div> |
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</p> |
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Sideranem<b><sup>®</sup></b> 100 should not be given intravenously. |
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</p> |
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</div> |
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<b></b> |
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<div align="justify"> |
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<b><i>Administration and dosage</i></b> |
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</p> |
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</div> |
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Sideranem<b><sup>®</sup></b> is given by deep i. m. injection, posteriorly to the auricular basis. |
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</p> |
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</div> |
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<i>Prophylaxis</i>: a single dose of 1 mL between days 1-4 of life. |
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</p> |
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</div> |
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<div align="justify"> |
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<i>Treatment</i>: a single dose of 2 mL. |
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</p> |
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</div> |
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</p> |
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</div> |
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<div align="justify"> |
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<b><i>Warnings and precautions</i></b> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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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> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
544 |
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|
545 |
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546 |
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|
547 |
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</p> |
548 |
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</div> |
549 |
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550 |
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551 |
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|
561 |
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<div align="justify"> |
562 |
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<p style="text-align: justify;"> |
563 |
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|
564 |
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|
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>. |
565 |
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566 |
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</p> |
567 |
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</div> |
568 |
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569 |
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570 |
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579 |
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<div align="justify"> |
581 |
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<p style="text-align: justify;"> |
582 |
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|
583 |
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<b></b> |
584 |
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|
585 |
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</p> |
586 |
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</div> |
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596 |
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597 |
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598 |
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599 |
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<div align="justify"> |
600 |
|
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<p style="text-align: justify;"> |
601 |
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|
602 |
|
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<b><i>Withdrawal</i></b><b></b> |
603 |
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604 |
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</p> |
605 |
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</div> |
606 |
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607 |
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608 |
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610 |
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614 |
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616 |
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617 |
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618 |
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<div align="justify"> |
619 |
|
|
<p style="text-align: justify;"> |
620 |
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|
621 |
|
|
Swine - meat, organs and other edible tissues<b> - </b>0 days.<b></b> |
622 |
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|
623 |
|
|
</p> |
624 |
|
|
</div> |
625 |
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626 |
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627 |
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628 |
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629 |
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630 |
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631 |
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632 |
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634 |
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635 |
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636 |
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637 |
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<div align="justify"> |
638 |
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<p style="text-align: justify;"> |
639 |
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|
640 |
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|
641 |
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|
642 |
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</p> |
643 |
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</div> |
644 |
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645 |
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646 |
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647 |
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648 |
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649 |
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650 |
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651 |
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652 |
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653 |
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654 |
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655 |
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656 |
|
|
<div align="justify"> |
657 |
|
|
<p style="text-align: justify;"> |
658 |
|
|
|
659 |
|
|
<b><i>Storage</i></b> |
660 |
|
|
|
661 |
|
|
</p> |
662 |
|
|
</div> |
663 |
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|
664 |
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665 |
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666 |
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667 |
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668 |
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669 |
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670 |
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671 |
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672 |
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|
673 |
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|
674 |
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|
675 |
|
|
<div align="justify"> |
676 |
|
|
<p style="text-align: justify;"> |
677 |
|
|
|
678 |
|
|
Store in a dark and cool place at 8-15°C. Keep away from children. Avoid freezing. |
679 |
|
|
|
680 |
|
|
</p> |
681 |
|
|
</div> |
682 |
|
|
|
683 |
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684 |
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685 |
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686 |
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687 |
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688 |
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689 |
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690 |
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691 |
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692 |
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|
693 |
|
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|
694 |
|
|
<div align="justify"> |
695 |
|
|
<p style="text-align: justify;"> |
696 |
|
|
|
697 |
|
|
|
698 |
|
|
|
699 |
|
|
</p> |
700 |
|
|
</div> |
701 |
|
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|
702 |
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|
703 |
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704 |
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705 |
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706 |
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707 |
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708 |
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709 |
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710 |
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711 |
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712 |
|
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|
713 |
|
|
<div align="justify"> |
714 |
|
|
<p style="text-align: justify;"> |
715 |
|
|
|
716 |
|
|
<b><i>Shelf life</i></b> |
717 |
|
|
|
718 |
|
|
</p> |
719 |
|
|
</div> |
720 |
|
|
|
721 |
|
|
|
722 |
|
|
|
723 |
|
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|
724 |
|
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725 |
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|
726 |
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|
727 |
|
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|
728 |
|
|
|
729 |
|
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|
730 |
|
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|
731 |
|
|
|
732 |
|
|
<div align="justify"> |
733 |
|
|
<p style="text-align: justify;"> |
734 |
|
|
|
735 |
|
|
Denoted on the packaging (5 years in the original pack). |
736 |
|
|
|
737 |
|
|
</p> |
738 |
|
|
</div> |
739 |
|
|
|
740 |
|
|
|
741 |
|
|
|
742 |
|
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|
743 |
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744 |
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745 |
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|
746 |
|
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|
747 |
|
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|
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>Legal category</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 |
|
|
On prescription only. |
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 |
|
|
<b><i></i></b> |
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 |
|
|
Supply |
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 |
|
|
Pierced bottle of 200 mL. |
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>Manufacturer</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 |
|
|
VETERINA Animal Health Ltd., Croatia |
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="left"> |
942 |
|
|
<p style="text-align: left;"> |
943 |
|
|
|
944 |
|
|
|
945 |
|
|
|
946 |
|
|
</p> |
947 |
|
|
</div> |
948 |
|
|
|
949 |
|
|
|
950 |
|
|
|
951 |
|
|
|
952 |
|
|
|
953 |
|
|
|
954 |
|
|
|
955 |
|
|
<!--Section Ends--> |
956 |
|
|
|
957 |
|
|
|
958 |
|
|
|
959 |
|
|
|
960 |
|
|
|
961 |
|
|
|
962 |
|
|
|
963 |
|
|
|