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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>PLIVACOR</b><b><sup>®</sup></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 suspension</i> |
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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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<p style="text-align: justify;"> |
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<b><i>Composition</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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1 mL contains: |
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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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Dexamethasone as dexamethasone pivalate 1 mg |
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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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Dexamethasone as dexamethasone sodium phosphate 1 mg |
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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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<div align="justify"> |
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<p style="text-align: justify;"> |
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<b><i>Action</i></b> |
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</p> |
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</div> |
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Dexamethasone is a potent glucocorticoidal synthetic steroid. Dexamethasone phosphate rapidly exerts therapeutic effect and maintains it over about 48 hours. Dexamethasone pivalate has a prolonged action lasting over 7 days. Therefore, Plivacor<b><sup>®</sup></b> is indicated whenever rapid and prolonged effect (ketosis) is required. Glucocorticoids inhibit inflammatory response by preventing formation of the inflammatory mediators (prostaglandins), stabilise biological membranes, suppress migration of leukocytes, reduce calibre of blood vessels and the resulting extravasation, suppress formation of cartilage and alleviate fever and toxaemia. Anti-inflammatory and anti-shock effect of Plivacor<b><sup>®</sup></b> is comparable with its gluconeogenetic action. Mineralocorticoidal effects of this synthetic hormone are negligible. Therefore, therapeutic doses of Plivacor<b><sup>®</sup></b> do not affect the balance of water and electrolytes. |
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</p> |
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</div> |
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<p style="text-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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<p style="text-align: justify;"> |
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Major diseases managed by glucocorticoids in supportive treatment:<b></b> |
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</p> |
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</div> |
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<i>Nutritional, metabolic and other disorders:</i> |
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</p> |
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</div> |
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ketosis, puerperal paresis, tetanic conditions, agalaxia in sows - MMA syndrome, edemic disease in piglets, acute circulatory collapse and shock, intoxication, snake bite, thermal and chemical burns, induction of appetite in general exhaustion. |
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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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<p style="text-align: justify;"> |
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<i>Inflammations of muscular-skeletal system:</i> |
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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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arthritis, osteoarthritis, panostitis, myozsitis, tendinitis, bursitis, sinovitis, laminitis, sacroiliac subluxation, protrusion of intervertebral disk, craniocerebral or spinal wounds, etc. |
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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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<div align="justify"> |
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<p style="text-align: justify;"> |
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<i>Mostly allergic conditions:</i> |
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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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eczematous and other non-specific dermatoses, allergic dermatitis following flea bites, oedemas of allergic origin, alimentary exanthem, otitis, chronic alveolar emphysema, asthma in cats, autoimmune diseases, etc. |
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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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<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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<b><i>Contraindications</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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Osteoporosis, renal insufficiency, hypertension and chronic heart failure, one week pre- and one week post vaccination, injecting into infected tissue, gastric ulcer and paratuberculosis. Intravenous or intra-articular administration should be avoided. |
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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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<b><i></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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Administration and dosage |
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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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Plivacor<b><sup>®</sup></b> is given by i.m. or s.c. route. Shake well before use. |
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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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</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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</p> |
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</div> |
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<table width="59.06%" border="1" cols="2" rows="5"> |
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<tr> |
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<td bgcolor="White" width="63.90%" rowspan="1" colspan="1"> |
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<div align="left"> |
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<p style="text-align: left;"> |
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Species |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="36.10%" rowspan="1" colspan="1"> |
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<div align="left"> |
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<p style="text-align: left;"> |
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|
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Dose |
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</p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="63.90%" rowspan="1" colspan="1"> |
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<div align="left"> |
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<p style="text-align: left;"> |
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Horses, cattle |
648 |
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</p> |
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</div> |
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653 |
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654 |
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655 |
</td> |
656 |
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657 |
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658 |
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659 |
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660 |
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661 |
<td bgcolor="White" width="36.10%" rowspan="1" colspan="1"> |
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<div align="left"> |
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<p style="text-align: left;"> |
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|
666 |
10-25 mL |
667 |
|
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</p> |
669 |
</div> |
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671 |
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672 |
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673 |
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674 |
</td> |
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679 |
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680 |
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681 |
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</tr> |
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<tr> |
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<td bgcolor="White" width="63.90%" rowspan="1" colspan="1"> |
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<div align="left"> |
690 |
<p style="text-align: left;"> |
691 |
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692 |
Foals, calves, sheep, goats, swine |
693 |
|
694 |
</p> |
695 |
</div> |
696 |
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697 |
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698 |
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699 |
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700 |
</td> |
701 |
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702 |
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703 |
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704 |
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705 |
|
706 |
<td bgcolor="White" width="36.10%" rowspan="1" colspan="1"> |
707 |
|
708 |
<div align="left"> |
709 |
<p style="text-align: left;"> |
710 |
|
711 |
1-5 mL |
712 |
|
713 |
</p> |
714 |
</div> |
715 |
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716 |
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717 |
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718 |
|
719 |
</td> |
720 |
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721 |
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722 |
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723 |
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724 |
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725 |
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726 |
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727 |
</tr> |
728 |
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729 |
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730 |
|
731 |
<tr> |
732 |
<td bgcolor="White" width="63.90%" rowspan="1" colspan="1"> |
733 |
|
734 |
<div align="left"> |
735 |
<p style="text-align: left;"> |
736 |
|
737 |
Dogs |
738 |
|
739 |
</p> |
740 |
</div> |
741 |
|
742 |
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743 |
|
744 |
|
745 |
</td> |
746 |
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747 |
|
748 |
|
749 |
|
750 |
|
751 |
<td bgcolor="White" width="36.10%" rowspan="1" colspan="1"> |
752 |
|
753 |
<div align="left"> |
754 |
<p style="text-align: left;"> |
755 |
|
756 |
0.25-2 mL |
757 |
|
758 |
</p> |
759 |
</div> |
760 |
|
761 |
|
762 |
|
763 |
|
764 |
</td> |
765 |
|
766 |
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767 |
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768 |
|
769 |
|
770 |
|
771 |
|
772 |
</tr> |
773 |
|
774 |
|
775 |
|
776 |
<tr> |
777 |
<td bgcolor="White" width="63.90%" rowspan="1" colspan="1"> |
778 |
|
779 |
<div align="left"> |
780 |
<p style="text-align: left;"> |
781 |
|
782 |
Cats |
783 |
|
784 |
</p> |
785 |
</div> |
786 |
|
787 |
|
788 |
|
789 |
|
790 |
</td> |
791 |
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792 |
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793 |
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794 |
|
795 |
|
796 |
<td bgcolor="White" width="36.10%" rowspan="1" colspan="1"> |
797 |
|
798 |
<div align="left"> |
799 |
<p style="text-align: left;"> |
800 |
|
801 |
0.25-0.5 mL |
802 |
|
803 |
</p> |
804 |
</div> |
805 |
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806 |
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807 |
|
808 |
|
809 |
</td> |
810 |
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811 |
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812 |
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813 |
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814 |
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815 |
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816 |
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817 |
</tr> |
818 |
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819 |
</table> |
820 |
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821 |
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822 |
|
823 |
|
824 |
<div align="justify"> |
825 |
<p style="text-align: justify;"> |
826 |
|
827 |
|
828 |
|
829 |
</p> |
830 |
</div> |
831 |
|
832 |
|
833 |
|
834 |
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835 |
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836 |
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837 |
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838 |
|
839 |
|
840 |
|
841 |
|
842 |
|
843 |
<div align="justify"> |
844 |
<p style="text-align: justify;"> |
845 |
|
846 |
Treatment of primary ketosis frequently requires a single dose only, as shortly upon administration of Plivacor<b><sup>®</sup></b> cows appetite and lactation are improved and the relapse is rare. |
847 |
|
848 |
</p> |
849 |
</div> |
850 |
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851 |
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852 |
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853 |
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854 |
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855 |
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856 |
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857 |
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858 |
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859 |
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860 |
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861 |
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862 |
<div align="justify"> |
863 |
<p style="text-align: justify;"> |
864 |
|
865 |
<b></b> |
866 |
|
867 |
</p> |
868 |
</div> |
869 |
|
870 |
|
871 |
|
872 |
|
873 |
|
874 |
|
875 |
|
876 |
|
877 |
|
878 |
|
879 |
|
880 |
|
881 |
<div align="justify"> |
882 |
<p style="text-align: justify;"> |
883 |
|
884 |
<b><i>Warnings and precautions</i></b> |
885 |
|
886 |
</p> |
887 |
</div> |
888 |
|
889 |
|
890 |
|
891 |
|
892 |
|
893 |
|
894 |
|
895 |
|
896 |
|
897 |
|
898 |
|
899 |
|
900 |
<div align="justify"> |
901 |
<p style="text-align: justify;"> |
902 |
|
903 |
In experimental animals at the early stage of pregnancy corticosteroids may cause foetal abnormalities and in the last trimester the abortion or early parturition accompanied by retained placenta (cows and sheep). |
904 |
|
905 |
</p> |
906 |
</div> |
907 |
|
908 |
|
909 |
|
910 |
|
911 |
|
912 |
|
913 |
|
914 |
|
915 |
|
916 |
|
917 |
|
918 |
|
919 |
<div align="justify"> |
920 |
<p style="text-align: justify;"> |
921 |
|
922 |
|
923 |
|
924 |
</p> |
925 |
</div> |
926 |
|
927 |
|
928 |
|
929 |
|
930 |
|
931 |
|
932 |
|
933 |
|
934 |
|
935 |
|
936 |
|
937 |
|
938 |
<div align="justify"> |
939 |
<p style="text-align: justify;"> |
940 |
|
941 |
When treating infectious diseases and impairment of the organs, due to the presence of the infection always give corticosteroids concomitantly with an antibiotic or other antimicrobial. |
942 |
|
943 |
</p> |
944 |
</div> |
945 |
|
946 |
|
947 |
|
948 |
|
949 |
|
950 |
|
951 |
|
952 |
|
953 |
|
954 |
|
955 |
|
956 |
|
957 |
<div align="justify"> |
958 |
<p style="text-align: justify;"> |
959 |
|
960 |
|
961 |
|
962 |
</p> |
963 |
</div> |
964 |
|
965 |
|
966 |
|
967 |
|
968 |
|
969 |
|
970 |
|
971 |
|
972 |
|
973 |
|
974 |
|
975 |
|
976 |
<div align="justify"> |
977 |
<p style="text-align: justify;"> |
978 |
|
979 |
Corticosteroids prolong wound healing. |
980 |
|
981 |
</p> |
982 |
</div> |
983 |
|
984 |
|
985 |
|
986 |
|
987 |
|
988 |
|
989 |
|
990 |
|
991 |
|
992 |
|
993 |
|
994 |
|
995 |
<div align="justify"> |
996 |
<p style="text-align: justify;"> |
997 |
|
998 |
|
999 |
|
1000 |
</p> |
1001 |
</div> |
1002 |
|
1003 |
|
1004 |
|
1005 |
|
1006 |
|
1007 |
|
1008 |
|
1009 |
|
1010 |
|
1011 |
|
1012 |
|
1013 |
|
1014 |
<div align="justify"> |
1015 |
<p style="text-align: justify;"> |
1016 |
|
1017 |
Prolonged administration of corticosteroids should be avoided, unless necessary. |
1018 |
|
1019 |
</p> |
1020 |
</div> |
1021 |
|
1022 |
|
1023 |
|
1024 |
|
1025 |
|
1026 |
|
1027 |
|
1028 |
|
1029 |
|
1030 |
|
1031 |
|
1032 |
|
1033 |
<div align="justify"> |
1034 |
<p style="text-align: justify;"> |
1035 |
|
1036 |
|
1037 |
|
1038 |
</p> |
1039 |
</div> |
1040 |
|
1041 |
|
1042 |
|
1043 |
|
1044 |
|
1045 |
|
1046 |
|
1047 |
|
1048 |
|
1049 |
|
1050 |
|
1051 |
|
1052 |
<div align="justify"> |
1053 |
<p style="text-align: justify;"> |
1054 |
|
1055 |
Needles and syringes should be sterilised by boiling in water, rather than with alcohol or other disinfectants.<b></b> |
1056 |
|
1057 |
</p> |
1058 |
</div> |
1059 |
|
1060 |
|
1061 |
|
1062 |
|
1063 |
|
1064 |
|
1065 |
|
1066 |
|
1067 |
|
1068 |
|
1069 |
|
1070 |
|
1071 |
<div align="justify"> |
1072 |
<p style="text-align: justify;"> |
1073 |
|
1074 |
<i></i> |
1075 |
|
1076 |
</p> |
1077 |
</div> |
1078 |
|
1079 |
|
1080 |
|
1081 |
|
1082 |
|
1083 |
|
1084 |
|
1085 |
|
1086 |
|
1087 |
|
1088 |
|
1089 |
|
1090 |
<div align="justify"> |
1091 |
<p style="text-align: justify;"> |
1092 |
|
1093 |
<b><i>Withdrawal</i></b> |
1094 |
|
1095 |
</p> |
1096 |
</div> |
1097 |
|
1098 |
|
1099 |
|
1100 |
|
1101 |
|
1102 |
|
1103 |
|
1104 |
|
1105 |
|
1106 |
|
1107 |
|
1108 |
|
1109 |
<div align="justify"> |
1110 |
<p style="text-align: justify;"> |
1111 |
|
1112 |
Meat and other edible tissues<b> </b>8 days<b></b> |
1113 |
|
1114 |
</p> |
1115 |
</div> |
1116 |
|
1117 |
|
1118 |
|
1119 |
|
1120 |
|
1121 |
|
1122 |
|
1123 |
|
1124 |
|
1125 |
|
1126 |
|
1127 |
|
1128 |
<div align="justify"> |
1129 |
<p style="text-align: justify;"> |
1130 |
|
1131 |
Milk<b> </b>7 days<b></b> |
1132 |
|
1133 |
</p> |
1134 |
</div> |
1135 |
|
1136 |
|
1137 |
|
1138 |
|
1139 |
|
1140 |
|
1141 |
|
1142 |
|
1143 |
|
1144 |
|
1145 |
|
1146 |
|
1147 |
<div align="justify"> |
1148 |
<p style="text-align: justify;"> |
1149 |
|
1150 |
|
1151 |
|
1152 |
</p> |
1153 |
</div> |
1154 |
|
1155 |
|
1156 |
|
1157 |
|
1158 |
|
1159 |
|
1160 |
|
1161 |
|
1162 |
|
1163 |
|
1164 |
|
1165 |
|
1166 |
<div align="justify"> |
1167 |
<p style="text-align: justify;"> |
1168 |
|
1169 |
<b><i>Storage</i></b> |
1170 |
|
1171 |
</p> |
1172 |
</div> |
1173 |
|
1174 |
|
1175 |
|
1176 |
|
1177 |
|
1178 |
|
1179 |
|
1180 |
|
1181 |
|
1182 |
|
1183 |
|
1184 |
|
1185 |
<div align="justify"> |
1186 |
<p style="text-align: justify;"> |
1187 |
|
1188 |
Store in a dark place at room temperature (up to 25°C). Keep away from children. Avoid freezing. |
1189 |
|
1190 |
</p> |
1191 |
</div> |
1192 |
|
1193 |
|
1194 |
|
1195 |
|
1196 |
|
1197 |
|
1198 |
|
1199 |
|
1200 |
|
1201 |
|
1202 |
|
1203 |
|
1204 |
<div align="justify"> |
1205 |
<p style="text-align: justify;"> |
1206 |
|
1207 |
|
1208 |
|
1209 |
</p> |
1210 |
</div> |
1211 |
|
1212 |
|
1213 |
|
1214 |
|
1215 |
|
1216 |
|
1217 |
|
1218 |
|
1219 |
|
1220 |
|
1221 |
|
1222 |
|
1223 |
<div align="justify"> |
1224 |
<p style="text-align: justify;"> |
1225 |
|
1226 |
<b><i>Legal category</i></b> |
1227 |
|
1228 |
</p> |
1229 |
</div> |
1230 |
|
1231 |
|
1232 |
|
1233 |
|
1234 |
|
1235 |
|
1236 |
|
1237 |
|
1238 |
|
1239 |
|
1240 |
|
1241 |
|
1242 |
<div align="justify"> |
1243 |
<p style="text-align: justify;"> |
1244 |
|
1245 |
On prescription only. |
1246 |
|
1247 |
</p> |
1248 |
</div> |
1249 |
|
1250 |
|
1251 |
|
1252 |
|
1253 |
|
1254 |
|
1255 |
|
1256 |
|
1257 |
|
1258 |
|
1259 |
|
1260 |
|
1261 |
<div align="justify"> |
1262 |
<p style="text-align: justify;"> |
1263 |
|
1264 |
<b><i></i></b> |
1265 |
|
1266 |
</p> |
1267 |
</div> |
1268 |
|
1269 |
|
1270 |
|
1271 |
|
1272 |
|
1273 |
|
1274 |
|
1275 |
|
1276 |
|
1277 |
|
1278 |
|
1279 |
|
1280 |
<div align="justify"> |
1281 |
<p style="text-align: justify;"> |
1282 |
|
1283 |
Shelf life |
1284 |
|
1285 |
</p> |
1286 |
</div> |
1287 |
|
1288 |
|
1289 |
|
1290 |
|
1291 |
|
1292 |
|
1293 |
|
1294 |
|
1295 |
|
1296 |
|
1297 |
|
1298 |
|
1299 |
<div align="justify"> |
1300 |
<p style="text-align: justify;"> |
1301 |
|
1302 |
Denoted on the packaging (2 years in the original pack). |
1303 |
|
1304 |
</p> |
1305 |
</div> |
1306 |
|
1307 |
|
1308 |
|
1309 |
|
1310 |
|
1311 |
|
1312 |
|
1313 |
|
1314 |
|
1315 |
|
1316 |
|
1317 |
|
1318 |
<div align="justify"> |
1319 |
<p style="text-align: justify;"> |
1320 |
|
1321 |
<b></b> |
1322 |
|
1323 |
</p> |
1324 |
</div> |
1325 |
|
1326 |
|
1327 |
|
1328 |
|
1329 |
|
1330 |
|
1331 |
|
1332 |
|
1333 |
|
1334 |
|
1335 |
|
1336 |
|
1337 |
<div align="justify"> |
1338 |
<p style="text-align: justify;"> |
1339 |
|
1340 |
<b><i>Supply</i></b> |
1341 |
|
1342 |
</p> |
1343 |
</div> |
1344 |
|
1345 |
|
1346 |
|
1347 |
|
1348 |
|
1349 |
|
1350 |
|
1351 |
|
1352 |
|
1353 |
|
1354 |
|
1355 |
|
1356 |
<div align="justify"> |
1357 |
<p style="text-align: justify;"> |
1358 |
|
1359 |
Bottle of 50 mL and 100 mL. |
1360 |
|
1361 |
</p> |
1362 |
</div> |
1363 |
|
1364 |
|
1365 |
|
1366 |
|
1367 |
|
1368 |
|
1369 |
|
1370 |
|
1371 |
|
1372 |
|
1373 |
|
1374 |
|
1375 |
<div align="justify"> |
1376 |
<p style="text-align: justify;"> |
1377 |
|
1378 |
<b></b> |
1379 |
|
1380 |
</p> |
1381 |
</div> |
1382 |
|
1383 |
|
1384 |
|
1385 |
|
1386 |
|
1387 |
|
1388 |
|
1389 |
|
1390 |
|
1391 |
|
1392 |
|
1393 |
|
1394 |
<div align="justify"> |
1395 |
<p style="text-align: justify;"> |
1396 |
|
1397 |
<b><i>Manufacturer</i></b><b></b> |
1398 |
|
1399 |
</p> |
1400 |
</div> |
1401 |
|
1402 |
|
1403 |
|
1404 |
|
1405 |
|
1406 |
|
1407 |
|
1408 |
|
1409 |
|
1410 |
|
1411 |
|
1412 |
|
1413 |
<div align="justify"> |
1414 |
<p style="text-align: justify;"> |
1415 |
|
1416 |
VETERINA Animal Health Ltd., Croatia |
1417 |
|
1418 |
</p> |
1419 |
</div> |
1420 |
|
1421 |
|
1422 |
|
1423 |
|
1424 |
|
1425 |
|
1426 |
|
1427 |
|
1428 |
|
1429 |
|
1430 |
|
1431 |
|
1432 |
<div align="justify"> |
1433 |
<p style="text-align: justify;"> |
1434 |
|
1435 |
|
1436 |
|
1437 |
</p> |
1438 |
</div> |
1439 |
|
1440 |
|
1441 |
|
1442 |
|
1443 |
|
1444 |
|
1445 |
|
1446 |
|
1447 |
|
1448 |
|
1449 |
|
1450 |
|
1451 |
<div align="left"> |
1452 |
<p style="text-align: left;"> |
1453 |
|
1454 |
|
1455 |
|
1456 |
</p> |
1457 |
</div> |
1458 |
|
1459 |
|
1460 |
|
1461 |
|
1462 |
|
1463 |
|
1464 |
|
1465 |
<!--Section Ends--> |
1466 |
|
1467 |
|
1468 |
|
1469 |
|
1470 |
|
1471 |
|
1472 |
|
1473 |
|