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<!--Section Begins--><br> |
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<div align="justify"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<b>SUSTREPEN</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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</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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Procaine benzylpenicillin 250,000 iu. |
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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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Dihydrostreptomycin as sulfate 250 mg |
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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>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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A combination of penicillin, acting primarily on gram-positive bacteria, and dihydrostreptomycin, acting mostly on gram-negative bacteria, has broadened antibacterial spectrum of Sustrepen<b><sup>®</sup></b> which acts bactericidally and bacteriostatically against commonest causes of infections in domestic animals: <i>Staphylococcus</i> spp., <i>Streptococcus</i> spp., <i>Pasteurella</i> spp., <i>Salmonella</i> spp., <i>Actinobacillus</i> spp., <i>B. anthracis</i>, <i>Diplococcus</i> spp., <i>Erysipelothrix insidiosa</i>, <i>E. coli</i>, <i>Clostridium</i> spp., <i>Leptospira</i> spp., <i>Proteus</i> spp., <i>Corynebacterium renale</i>, <i>Campylobacter</i> spp. 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><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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Treatment of acute and chronic, primary and secondary, general and local infections caused by penicillin- and dihydrostreptomycin-sensitive organisms: respiratory infections, urinary infections, prophylaxis of postoperative infections, suppurative inflammation of wounds, phlegmon, paronychia, panarthritis, umbilical inflammations, puerperal infections, septicemia, mastitis (accompanied by local therapy), infections secondary to distemper, parvovirosis, panleukopenia, influenza, etc. |
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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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<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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The drug should not be given by i. v. route. |
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</p> |
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</div> |
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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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Penicillin antibiotics are contraindicated in guinea-pigs, hamsters and other small monogastric herbivore due to clostridiotoxicosis and fatal enterocolitis. |
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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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Hypersensitivity to the ingredients, which is very rare. |
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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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<b><i>Administration and dosage</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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Shake well before use. Administer by deep intramuscular injection. Dogs and cats may be given s. c. injection as well. |
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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="57.43%" border="1" cols="2" rows="4"> |
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<tr> |
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<td bgcolor="White" width="62.86%" 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 and class |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="37.14%" rowspan="1" colspan="1"> |
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<div align="left"> |
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<p style="text-align: left;"> |
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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="62.86%" 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 |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="37.14%" rowspan="1" colspan="1"> |
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<div align="left"> |
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<p style="text-align: left;"> |
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4 mL/100 kg b.w. |
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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="62.86%" rowspan="1" colspan="1"> |
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<div align="left"> |
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<p style="text-align: left;"> |
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Foals, calves, swine sheep, goats |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="37.14%" rowspan="1" colspan="1"> |
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<div align="left"> |
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<p style="text-align: left;"> |
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2 mL/50 kg b.w. |
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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="62.86%" rowspan="1" colspan="1"> |
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<div align="left"> |
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<p style="text-align: left;"> |
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Dogs, cats |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="37.14%" rowspan="1" colspan="1"> |
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<div align="left"> |
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<p style="text-align: left;"> |
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0.1 mL/1 kg b.w. |
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</p> |
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</div> |
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</td> |
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</tr> |
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</table> |
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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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Repeat administration every 24 hours till remission of the symptoms and then continue for at least 48 hours from the establishment of normal body temperature and remission of all sings of infection. |
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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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In severe infections the dose may be doubled. |
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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"> |
| 780 |
<p style="text-align: justify;"> |
| 781 |
|
| 782 |
<b><i>Warnings and precautions</i></b> |
| 783 |
|
| 784 |
</p> |
| 785 |
</div> |
| 786 |
|
| 787 |
|
| 788 |
|
| 789 |
|
| 790 |
|
| 791 |
|
| 792 |
|
| 793 |
|
| 794 |
|
| 795 |
|
| 796 |
|
| 797 |
|
| 798 |
<div align="justify"> |
| 799 |
<p style="text-align: justify;"> |
| 800 |
|
| 801 |
Beta-lactamase producing organisms are resistant to Sustrepen<b><sup>®</sup></b>. |
| 802 |
|
| 803 |
</p> |
| 804 |
</div> |
| 805 |
|
| 806 |
|
| 807 |
|
| 808 |
|
| 809 |
|
| 810 |
|
| 811 |
|
| 812 |
|
| 813 |
|
| 814 |
|
| 815 |
|
| 816 |
|
| 817 |
<div align="justify"> |
| 818 |
<p style="text-align: justify;"> |
| 819 |
|
| 820 |
|
| 821 |
|
| 822 |
</p> |
| 823 |
</div> |
| 824 |
|
| 825 |
|
| 826 |
|
| 827 |
|
| 828 |
|
| 829 |
|
| 830 |
|
| 831 |
|
| 832 |
|
| 833 |
|
| 834 |
|
| 835 |
|
| 836 |
<div align="justify"> |
| 837 |
<p style="text-align: justify;"> |
| 838 |
|
| 839 |
Prolonged administration of high doses may impair hearing and equilibrium, particularly in cats. |
| 840 |
|
| 841 |
</p> |
| 842 |
</div> |
| 843 |
|
| 844 |
|
| 845 |
|
| 846 |
|
| 847 |
|
| 848 |
|
| 849 |
|
| 850 |
|
| 851 |
|
| 852 |
|
| 853 |
|
| 854 |
|
| 855 |
<div align="justify"> |
| 856 |
<p style="text-align: justify;"> |
| 857 |
|
| 858 |
|
| 859 |
|
| 860 |
</p> |
| 861 |
</div> |
| 862 |
|
| 863 |
|
| 864 |
|
| 865 |
|
| 866 |
|
| 867 |
|
| 868 |
|
| 869 |
|
| 870 |
|
| 871 |
|
| 872 |
|
| 873 |
|
| 874 |
<div align="left"> |
| 875 |
<p style="text-align: left;"> |
| 876 |
|
| 877 |
On very rare occasions the animals may develop allergic reactions (e. g. dyspnea, edema on the head, neck or extremities, ptyalism, erythema etc.). In such instances immediately withdraw the preparation and, if necessary, institute corresponding drugs (adrenaline, H1 receptor blokers and glucocorticoids). |
| 878 |
|
| 879 |
</p> |
| 880 |
</div> |
| 881 |
|
| 882 |
|
| 883 |
|
| 884 |
|
| 885 |
|
| 886 |
|
| 887 |
|
| 888 |
|
| 889 |
|
| 890 |
|
| 891 |
|
| 892 |
|
| 893 |
<div align="justify"> |
| 894 |
<p style="text-align: justify;"> |
| 895 |
|
| 896 |
|
| 897 |
|
| 898 |
</p> |
| 899 |
</div> |
| 900 |
|
| 901 |
|
| 902 |
|
| 903 |
|
| 904 |
|
| 905 |
|
| 906 |
|
| 907 |
|
| 908 |
|
| 909 |
|
| 910 |
|
| 911 |
|
| 912 |
<div align="justify"> |
| 913 |
<p style="text-align: justify;"> |
| 914 |
|
| 915 |
Do not mix Sustrepen<b><sup>®</sup></b> with other drugs in the same syringe. |
| 916 |
|
| 917 |
</p> |
| 918 |
</div> |
| 919 |
|
| 920 |
|
| 921 |
|
| 922 |
|
| 923 |
|
| 924 |
|
| 925 |
|
| 926 |
|
| 927 |
|
| 928 |
|
| 929 |
|
| 930 |
|
| 931 |
<div align="justify"> |
| 932 |
<p style="text-align: justify;"> |
| 933 |
|
| 934 |
|
| 935 |
|
| 936 |
</p> |
| 937 |
</div> |
| 938 |
|
| 939 |
|
| 940 |
|
| 941 |
|
| 942 |
|
| 943 |
|
| 944 |
|
| 945 |
|
| 946 |
|
| 947 |
|
| 948 |
|
| 949 |
|
| 950 |
<div align="justify"> |
| 951 |
<p style="text-align: justify;"> |
| 952 |
|
| 953 |
Concomitant administration of tetracyclines, macrolides, or chloramphenicol may diminish the effect of penicillin. |
| 954 |
|
| 955 |
</p> |
| 956 |
</div> |
| 957 |
|
| 958 |
|
| 959 |
|
| 960 |
|
| 961 |
|
| 962 |
|
| 963 |
|
| 964 |
|
| 965 |
|
| 966 |
|
| 967 |
|
| 968 |
|
| 969 |
<div align="justify"> |
| 970 |
<p style="text-align: justify;"> |
| 971 |
|
| 972 |
|
| 973 |
|
| 974 |
</p> |
| 975 |
</div> |
| 976 |
|
| 977 |
|
| 978 |
|
| 979 |
|
| 980 |
|
| 981 |
|
| 982 |
|
| 983 |
|
| 984 |
|
| 985 |
|
| 986 |
|
| 987 |
|
| 988 |
<div align="justify"> |
| 989 |
<p style="text-align: justify;"> |
| 990 |
|
| 991 |
It is not recommended to administer dihydrostreptomycin in renal impairment. |
| 992 |
|
| 993 |
</p> |
| 994 |
</div> |
| 995 |
|
| 996 |
|
| 997 |
|
| 998 |
|
| 999 |
|
| 1000 |
|
| 1001 |
|
| 1002 |
|
| 1003 |
|
| 1004 |
|
| 1005 |
|
| 1006 |
|
| 1007 |
<div align="justify"> |
| 1008 |
<p style="text-align: justify;"> |
| 1009 |
|
| 1010 |
|
| 1011 |
|
| 1012 |
</p> |
| 1013 |
</div> |
| 1014 |
|
| 1015 |
|
| 1016 |
|
| 1017 |
|
| 1018 |
|
| 1019 |
|
| 1020 |
|
| 1021 |
|
| 1022 |
|
| 1023 |
|
| 1024 |
|
| 1025 |
|
| 1026 |
<div align="justify"> |
| 1027 |
<p style="text-align: justify;"> |
| 1028 |
|
| 1029 |
Concurrent administration with halothane or myorelaxant may enhance neuromuscular blockade. |
| 1030 |
|
| 1031 |
</p> |
| 1032 |
</div> |
| 1033 |
|
| 1034 |
|
| 1035 |
|
| 1036 |
|
| 1037 |
|
| 1038 |
|
| 1039 |
|
| 1040 |
|
| 1041 |
|
| 1042 |
|
| 1043 |
|
| 1044 |
|
| 1045 |
<div align="justify"> |
| 1046 |
<p style="text-align: justify;"> |
| 1047 |
|
| 1048 |
|
| 1049 |
|
| 1050 |
</p> |
| 1051 |
</div> |
| 1052 |
|
| 1053 |
|
| 1054 |
|
| 1055 |
|
| 1056 |
|
| 1057 |
|
| 1058 |
|
| 1059 |
|
| 1060 |
|
| 1061 |
|
| 1062 |
|
| 1063 |
|
| 1064 |
<div align="justify"> |
| 1065 |
<p style="text-align: justify;"> |
| 1066 |
|
| 1067 |
<b><i>Withdrawal</i></b><b></b> |
| 1068 |
|
| 1069 |
</p> |
| 1070 |
</div> |
| 1071 |
|
| 1072 |
|
| 1073 |
|
| 1074 |
|
| 1075 |
|
| 1076 |
|
| 1077 |
|
| 1078 |
|
| 1079 |
|
| 1080 |
|
| 1081 |
|
| 1082 |
|
| 1083 |
<div align="justify"> |
| 1084 |
<p style="text-align: justify;"> |
| 1085 |
|
| 1086 |
Meat and other edible tissues 12 days |
| 1087 |
|
| 1088 |
</p> |
| 1089 |
</div> |
| 1090 |
|
| 1091 |
|
| 1092 |
|
| 1093 |
|
| 1094 |
|
| 1095 |
|
| 1096 |
|
| 1097 |
|
| 1098 |
|
| 1099 |
|
| 1100 |
|
| 1101 |
|
| 1102 |
<div align="justify"> |
| 1103 |
<p style="text-align: justify;"> |
| 1104 |
|
| 1105 |
Kidneys 45 days |
| 1106 |
|
| 1107 |
</p> |
| 1108 |
</div> |
| 1109 |
|
| 1110 |
|
| 1111 |
|
| 1112 |
|
| 1113 |
|
| 1114 |
|
| 1115 |
|
| 1116 |
|
| 1117 |
|
| 1118 |
|
| 1119 |
|
| 1120 |
|
| 1121 |
<div align="justify"> |
| 1122 |
<p style="text-align: justify;"> |
| 1123 |
|
| 1124 |
Milk 6 days |
| 1125 |
|
| 1126 |
</p> |
| 1127 |
</div> |
| 1128 |
|
| 1129 |
|
| 1130 |
|
| 1131 |
|
| 1132 |
|
| 1133 |
|
| 1134 |
|
| 1135 |
|
| 1136 |
|
| 1137 |
|
| 1138 |
|
| 1139 |
|
| 1140 |
<div align="justify"> |
| 1141 |
<p style="text-align: justify;"> |
| 1142 |
|
| 1143 |
|
| 1144 |
|
| 1145 |
</p> |
| 1146 |
</div> |
| 1147 |
|
| 1148 |
|
| 1149 |
|
| 1150 |
|
| 1151 |
|
| 1152 |
|
| 1153 |
|
| 1154 |
|
| 1155 |
|
| 1156 |
|
| 1157 |
|
| 1158 |
|
| 1159 |
<div align="justify"> |
| 1160 |
<p style="text-align: justify;"> |
| 1161 |
|
| 1162 |
<b><i>Storage</i></b><b></b> |
| 1163 |
|
| 1164 |
</p> |
| 1165 |
</div> |
| 1166 |
|
| 1167 |
|
| 1168 |
|
| 1169 |
|
| 1170 |
|
| 1171 |
|
| 1172 |
|
| 1173 |
|
| 1174 |
|
| 1175 |
|
| 1176 |
|
| 1177 |
|
| 1178 |
<div align="justify"> |
| 1179 |
<p style="text-align: justify;"> |
| 1180 |
|
| 1181 |
Store in a dark place at 8-15°C. Keep away from children. Avoid freezing. |
| 1182 |
|
| 1183 |
</p> |
| 1184 |
</div> |
| 1185 |
|
| 1186 |
|
| 1187 |
|
| 1188 |
|
| 1189 |
|
| 1190 |
|
| 1191 |
|
| 1192 |
|
| 1193 |
|
| 1194 |
|
| 1195 |
|
| 1196 |
|
| 1197 |
<div align="justify"> |
| 1198 |
<p style="text-align: justify;"> |
| 1199 |
|
| 1200 |
|
| 1201 |
|
| 1202 |
</p> |
| 1203 |
</div> |
| 1204 |
|
| 1205 |
|
| 1206 |
|
| 1207 |
|
| 1208 |
|
| 1209 |
|
| 1210 |
|
| 1211 |
|
| 1212 |
|
| 1213 |
|
| 1214 |
|
| 1215 |
|
| 1216 |
<div align="justify"> |
| 1217 |
<p style="text-align: justify;"> |
| 1218 |
|
| 1219 |
<b><i>Shelf life</i></b> |
| 1220 |
|
| 1221 |
</p> |
| 1222 |
</div> |
| 1223 |
|
| 1224 |
|
| 1225 |
|
| 1226 |
|
| 1227 |
|
| 1228 |
|
| 1229 |
|
| 1230 |
|
| 1231 |
|
| 1232 |
|
| 1233 |
|
| 1234 |
|
| 1235 |
<div align="justify"> |
| 1236 |
<p style="text-align: justify;"> |
| 1237 |
|
| 1238 |
Denoted on the packaging (2 years in the original pack). |
| 1239 |
|
| 1240 |
</p> |
| 1241 |
</div> |
| 1242 |
|
| 1243 |
|
| 1244 |
|
| 1245 |
|
| 1246 |
|
| 1247 |
|
| 1248 |
|
| 1249 |
|
| 1250 |
|
| 1251 |
|
| 1252 |
|
| 1253 |
|
| 1254 |
<div align="justify"> |
| 1255 |
<p style="text-align: justify;"> |
| 1256 |
|
| 1257 |
|
| 1258 |
|
| 1259 |
</p> |
| 1260 |
</div> |
| 1261 |
|
| 1262 |
|
| 1263 |
|
| 1264 |
|
| 1265 |
|
| 1266 |
|
| 1267 |
|
| 1268 |
|
| 1269 |
|
| 1270 |
|
| 1271 |
|
| 1272 |
|
| 1273 |
<div align="justify"> |
| 1274 |
<p style="text-align: justify;"> |
| 1275 |
|
| 1276 |
<b><i>Legal category</i></b><b></b> |
| 1277 |
|
| 1278 |
</p> |
| 1279 |
</div> |
| 1280 |
|
| 1281 |
|
| 1282 |
|
| 1283 |
|
| 1284 |
|
| 1285 |
|
| 1286 |
|
| 1287 |
|
| 1288 |
|
| 1289 |
|
| 1290 |
|
| 1291 |
|
| 1292 |
<div align="justify"> |
| 1293 |
<p style="text-align: justify;"> |
| 1294 |
|
| 1295 |
On prescription only. |
| 1296 |
|
| 1297 |
</p> |
| 1298 |
</div> |
| 1299 |
|
| 1300 |
|
| 1301 |
|
| 1302 |
|
| 1303 |
|
| 1304 |
|
| 1305 |
|
| 1306 |
|
| 1307 |
|
| 1308 |
|
| 1309 |
|
| 1310 |
|
| 1311 |
<div align="justify"> |
| 1312 |
<p style="text-align: justify;"> |
| 1313 |
|
| 1314 |
|
| 1315 |
|
| 1316 |
</p> |
| 1317 |
</div> |
| 1318 |
|
| 1319 |
|
| 1320 |
|
| 1321 |
|
| 1322 |
|
| 1323 |
|
| 1324 |
|
| 1325 |
|
| 1326 |
|
| 1327 |
|
| 1328 |
|
| 1329 |
|
| 1330 |
<div align="justify"> |
| 1331 |
<p style="text-align: justify;"> |
| 1332 |
|
| 1333 |
<b><i>Supply</i></b><b></b> |
| 1334 |
|
| 1335 |
</p> |
| 1336 |
</div> |
| 1337 |
|
| 1338 |
|
| 1339 |
|
| 1340 |
|
| 1341 |
|
| 1342 |
|
| 1343 |
|
| 1344 |
|
| 1345 |
|
| 1346 |
|
| 1347 |
|
| 1348 |
|
| 1349 |
<div align="justify"> |
| 1350 |
<p style="text-align: justify;"> |
| 1351 |
|
| 1352 |
Pierced bottle of 100 mL. |
| 1353 |
|
| 1354 |
</p> |
| 1355 |
</div> |
| 1356 |
|
| 1357 |
|
| 1358 |
|
| 1359 |
|
| 1360 |
|
| 1361 |
|
| 1362 |
|
| 1363 |
|
| 1364 |
|
| 1365 |
|
| 1366 |
|
| 1367 |
|
| 1368 |
<div align="justify"> |
| 1369 |
<p style="text-align: justify;"> |
| 1370 |
|
| 1371 |
<b><i></i></b> |
| 1372 |
|
| 1373 |
</p> |
| 1374 |
</div> |
| 1375 |
|
| 1376 |
|
| 1377 |
|
| 1378 |
|
| 1379 |
|
| 1380 |
|
| 1381 |
|
| 1382 |
|
| 1383 |
|
| 1384 |
|
| 1385 |
|
| 1386 |
|
| 1387 |
<div align="justify"> |
| 1388 |
<p style="text-align: justify;"> |
| 1389 |
|
| 1390 |
Manufacturer |
| 1391 |
|
| 1392 |
</p> |
| 1393 |
</div> |
| 1394 |
|
| 1395 |
|
| 1396 |
|
| 1397 |
|
| 1398 |
|
| 1399 |
|
| 1400 |
|
| 1401 |
|
| 1402 |
|
| 1403 |
|
| 1404 |
|
| 1405 |
|
| 1406 |
<div align="justify"> |
| 1407 |
<p style="text-align: justify;"> |
| 1408 |
|
| 1409 |
VETERINA Animal Health Ltd., Croatia |
| 1410 |
|
| 1411 |
</p> |
| 1412 |
</div> |
| 1413 |
|
| 1414 |
|
| 1415 |
|
| 1416 |
|
| 1417 |
|
| 1418 |
|
| 1419 |
|
| 1420 |
|
| 1421 |
|
| 1422 |
|
| 1423 |
|
| 1424 |
|
| 1425 |
<div align="justify"> |
| 1426 |
<p style="text-align: justify;"> |
| 1427 |
|
| 1428 |
|
| 1429 |
|
| 1430 |
</p> |
| 1431 |
</div> |
| 1432 |
|
| 1433 |
|
| 1434 |
|
| 1435 |
|
| 1436 |
|
| 1437 |
|
| 1438 |
|
| 1439 |
|
| 1440 |
|
| 1441 |
|
| 1442 |
|
| 1443 |
|
| 1444 |
<div align="left"> |
| 1445 |
<p style="text-align: left;"> |
| 1446 |
|
| 1447 |
|
| 1448 |
|
| 1449 |
</p> |
| 1450 |
</div> |
| 1451 |
|
| 1452 |
|
| 1453 |
|
| 1454 |
|
| 1455 |
|
| 1456 |
|
| 1457 |
|
| 1458 |
<!--Section Ends--> |
| 1459 |
|
| 1460 |
|
| 1461 |
|
| 1462 |
|
| 1463 |
|
| 1464 |
|
| 1465 |
|
| 1466 |
|
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