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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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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<b>GEOTILIN</b><b><sup>®</sup></b><b> P</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>medicated additive</i> |
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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>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 kg 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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Oxytetracycline as oxytetracycline hydrochloride 60 g |
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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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Tiamulin as tiamulin hydrogen fumarate 20 g |
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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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Carrier and adjuvants up to 1000 g |
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</p> |
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</div> |
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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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GEOTILIN<b><sup>®</sup></b> P is a combination of broad-spectrum antimicrobial antibiotics. In sensitive organisms both antibiotics inhibit protein synthesis. GEOTILIN<b><sup>®</sup></b> P is very potent against mycoplasmas (<i>Mycoplasma</i> <i>hyopneumoniae</i>, <i>M. hyorhinis</i> and <i>M.</i> <i>hyosynoviae</i>) and the species causing bloody scours in swine (<i>Serpulina</i> <i>hyodysenteriae</i>). It also inhibits the growth and multiplication of many gram-positive (<i>Staphylococcus </i>spp., <i>Streptococcus</i> spp., <i>Clostridium perfringens</i>, <i>Listeria monocytogenes</i>, <i>Erysipelothrix</i> <i>insidiosa</i>, <i>Actinomyces pyogenes</i>) and gram-negative bacteria (<i>Pasteurella</i> spp., <i>Klebsiella pneumoniae</i>, <i>Actinobacillus</i> and <i>Haemophylus</i> spp., <i>Fusobacterium necrophorum</i>, <i>Bacteroides</i> spp. and <i>Campylobacter</i> <i>coli</i>) as well as spirochettes (<i>Leptospira</i> spp.), rickettsiae (<i>Eperythrozoon suis</i>) and chlamydiae. Gram-negative intestinal bacteria are not usually sensitive to tiamulin- oxytetracycline combination. When taken orally both active ingredients are very rapidly resorbed and achieve peak plasma-levels in 60-90 minutes. Oxytetracycline and tiamulin are excreted mostly in bile and only partly via urine. |
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</p> |
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</div> |
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</div> |
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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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Control and treatment of the following diseases in swine: |
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</p> |
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</div> |
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mycoplasmal pneumonia; |
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</p> |
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</div> |
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<li> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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mycoplasmal arthritis caused by <i>Mycoplasma hyosynoviae</i> (treatment alleviates the symptoms of lameness and improves gain and feed conversion); |
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</p> |
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</div> |
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<li> |
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<div align="justify"> |
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atrophic rhinitis in swine; |
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</p> |
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</div> |
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<li> |
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<div align="justify"> |
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bloody scours (swine dysentery); |
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</p> |
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</div> |
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<li> |
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bacterial and necrotic enteritis in swine; |
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</p> |
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</div> |
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<li> |
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secondary respiratory and gastrointestinal bacterial infections. |
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</p> |
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</div> |
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</ul> |
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</p> |
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</div> |
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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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Concomitant administration of ionofore antibiotics (e. g. lasalocid, monensin, maduramicin and semduramicin) with tiamulin, or their intake 7 days before and 7 after tiamulin, should be avoided. |
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</p> |
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</div> |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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The preparation is contraindicated in severe hepatic and renal impairment. |
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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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Medicated additives containing tiamulin are not recommended to sows and primiparous sows in the first third of pregnancy (approximately during first 5 weeks of pregnancy). |
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</p> |
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</div> |
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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>Administration, dosage and metaphylactic programme</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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Medicated additive is given mixed in feed over 5 consecutive days. For metaphylactic purpose during stress situations administration may be prolonged, relevant to the risk 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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Therapeutic dose of Geotilin<b><sup>®</sup></b> P for swine is 0.5 kg/100 kg of feed (oxytetracycline 300 ppm and tiamulin 100 ppm). Usually the treatment lasts for 5 days. |
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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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Metaphylaxis of dysentery and enzootic pneumonia: 0.125-0.250 kg of Geotilin<b><sup>®</sup></b> P/100 kg of feed. |
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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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Dose and duration of treatment are relevant to severity of the disease and the risk of infection. Medicated additive should be given when clinical manifestations of the disease are most frequent. |
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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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It is recommended to introduce Geotilin<b><sup>®</sup></b> P during first 10 days post weaning, i. e. to administer therapeutic dose over 5 days (0.5 kg/100 kg of feed), and metaphylactic dose over next 5 days (0.250 kg/100 kg of feed). |
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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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The procedure should be repeated and applied in the same manner on the admittance of swine to the fattening. |
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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;"> |
811 |
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Geotilin<b><sup>®</sup></b> P premix may be instituted metaphylactically, i. e. prophylactically before or after the above periods. Duration of treatment may be prolonged relevant to the degree and scope of the risk to swine. As a rule, metaphylaxis should be introduced during fattening period, when the animals are 20-50 kg of b. w. In such instances the dose during first 10 days is 0.250 kg/100 kg of feed. |
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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"> |
848 |
<p style="text-align: justify;"> |
849 |
|
850 |
<b><i>Side effects</i></b> |
851 |
|
852 |
</p> |
853 |
</div> |
854 |
|
855 |
|
856 |
|
857 |
|
858 |
|
859 |
|
860 |
|
861 |
|
862 |
|
863 |
|
864 |
|
865 |
|
866 |
<div align="justify"> |
867 |
<p style="text-align: justify;"> |
868 |
|
869 |
Vomiting has been reported on very rare occasions. |
870 |
|
871 |
</p> |
872 |
</div> |
873 |
|
874 |
|
875 |
|
876 |
|
877 |
|
878 |
|
879 |
|
880 |
|
881 |
|
882 |
|
883 |
|
884 |
|
885 |
<div align="justify"> |
886 |
<p style="text-align: justify;"> |
887 |
|
888 |
|
889 |
|
890 |
</p> |
891 |
</div> |
892 |
|
893 |
|
894 |
|
895 |
|
896 |
|
897 |
|
898 |
|
899 |
|
900 |
|
901 |
|
902 |
|
903 |
|
904 |
<div align="justify"> |
905 |
<p style="text-align: justify;"> |
906 |
|
907 |
If during administration rubor develops in the area of anus and/or genitalia, Geotilin<b><sup>®</sup></b> P should be discontinued and the animals thoroughly washed with water in order to remove the traces of faeces and urine containing active ingredients. |
908 |
|
909 |
</p> |
910 |
</div> |
911 |
|
912 |
|
913 |
|
914 |
|
915 |
|
916 |
|
917 |
|
918 |
|
919 |
|
920 |
|
921 |
|
922 |
|
923 |
<div align="justify"> |
924 |
<p style="text-align: justify;"> |
925 |
|
926 |
|
927 |
|
928 |
</p> |
929 |
</div> |
930 |
|
931 |
|
932 |
|
933 |
|
934 |
|
935 |
|
936 |
|
937 |
|
938 |
|
939 |
|
940 |
|
941 |
|
942 |
<div align="justify"> |
943 |
<p style="text-align: justify;"> |
944 |
|
945 |
<b><i>Warnings and precautions</i></b><b></b> |
946 |
|
947 |
</p> |
948 |
</div> |
949 |
|
950 |
|
951 |
|
952 |
|
953 |
|
954 |
|
955 |
|
956 |
|
957 |
|
958 |
|
959 |
|
960 |
|
961 |
<div align="justify"> |
962 |
<p style="text-align: justify;"> |
963 |
|
964 |
Sick animals taking scarce feed should be treated via drinking water or, preferably by parenteral administration of Geotilin<b><sup>® </sup></b>P. |
965 |
|
966 |
</p> |
967 |
</div> |
968 |
|
969 |
|
970 |
|
971 |
|
972 |
|
973 |
|
974 |
|
975 |
|
976 |
|
977 |
|
978 |
|
979 |
|
980 |
<div align="justify"> |
981 |
<p style="text-align: justify;"> |
982 |
|
983 |
|
984 |
|
985 |
</p> |
986 |
</div> |
987 |
|
988 |
|
989 |
|
990 |
|
991 |
|
992 |
|
993 |
|
994 |
|
995 |
|
996 |
|
997 |
|
998 |
|
999 |
<div align="justify"> |
1000 |
<p style="text-align: justify;"> |
1001 |
|
1002 |
To avoid interference, with other antimicrobials or medicated additives, Geotilin<b><sup>®</sup></b> P should not be mixed with other antimicrobials or medicated additives. |
1003 |
|
1004 |
</p> |
1005 |
</div> |
1006 |
|
1007 |
|
1008 |
|
1009 |
|
1010 |
|
1011 |
|
1012 |
|
1013 |
|
1014 |
|
1015 |
|
1016 |
|
1017 |
|
1018 |
<div align="justify"> |
1019 |
<p style="text-align: justify;"> |
1020 |
|
1021 |
|
1022 |
|
1023 |
</p> |
1024 |
</div> |
1025 |
|
1026 |
|
1027 |
|
1028 |
|
1029 |
|
1030 |
|
1031 |
|
1032 |
|
1033 |
|
1034 |
|
1035 |
|
1036 |
|
1037 |
<div align="justify"> |
1038 |
<p style="text-align: justify;"> |
1039 |
|
1040 |
Like with other medicated additives, when using wear face/eyes protection, suitable protective clothing and shoes. Avoid contact with mucosa and skin. After handling in feed mills wash thoroughly with water. |
1041 |
|
1042 |
</p> |
1043 |
</div> |
1044 |
|
1045 |
|
1046 |
|
1047 |
|
1048 |
|
1049 |
|
1050 |
|
1051 |
|
1052 |
|
1053 |
|
1054 |
|
1055 |
|
1056 |
<div align="justify"> |
1057 |
<p style="text-align: justify;"> |
1058 |
|
1059 |
|
1060 |
|
1061 |
</p> |
1062 |
</div> |
1063 |
|
1064 |
|
1065 |
|
1066 |
|
1067 |
|
1068 |
|
1069 |
|
1070 |
|
1071 |
|
1072 |
|
1073 |
|
1074 |
|
1075 |
<div align="justify"> |
1076 |
<p style="text-align: justify;"> |
1077 |
|
1078 |
Usual pelleting procedure does not diminish potency of Geotilin<b><sup>®</sup></b> P. |
1079 |
|
1080 |
</p> |
1081 |
</div> |
1082 |
|
1083 |
|
1084 |
|
1085 |
|
1086 |
|
1087 |
|
1088 |
|
1089 |
|
1090 |
|
1091 |
|
1092 |
|
1093 |
|
1094 |
<div align="justify"> |
1095 |
<p style="text-align: justify;"> |
1096 |
|
1097 |
|
1098 |
|
1099 |
</p> |
1100 |
</div> |
1101 |
|
1102 |
|
1103 |
|
1104 |
|
1105 |
|
1106 |
|
1107 |
|
1108 |
|
1109 |
|
1110 |
|
1111 |
|
1112 |
|
1113 |
<div align="justify"> |
1114 |
<p style="text-align: justify;"> |
1115 |
|
1116 |
<b><i>Withdrawal</i></b> |
1117 |
|
1118 |
</p> |
1119 |
</div> |
1120 |
|
1121 |
|
1122 |
|
1123 |
|
1124 |
|
1125 |
|
1126 |
|
1127 |
|
1128 |
|
1129 |
|
1130 |
|
1131 |
|
1132 |
<div align="justify"> |
1133 |
<p style="text-align: justify;"> |
1134 |
|
1135 |
Swine: meat, organs and other edible tissues - 5 days. |
1136 |
|
1137 |
</p> |
1138 |
</div> |
1139 |
|
1140 |
|
1141 |
|
1142 |
|
1143 |
|
1144 |
|
1145 |
|
1146 |
|
1147 |
|
1148 |
|
1149 |
|
1150 |
|
1151 |
<div align="justify"> |
1152 |
<p style="text-align: justify;"> |
1153 |
|
1154 |
|
1155 |
|
1156 |
</p> |
1157 |
</div> |
1158 |
|
1159 |
|
1160 |
|
1161 |
|
1162 |
|
1163 |
|
1164 |
|
1165 |
|
1166 |
|
1167 |
|
1168 |
|
1169 |
|
1170 |
<div align="justify"> |
1171 |
<p style="text-align: justify;"> |
1172 |
|
1173 |
<b><i>Storage</i></b> |
1174 |
|
1175 |
</p> |
1176 |
</div> |
1177 |
|
1178 |
|
1179 |
|
1180 |
|
1181 |
|
1182 |
|
1183 |
|
1184 |
|
1185 |
|
1186 |
|
1187 |
|
1188 |
|
1189 |
<div align="justify"> |
1190 |
<p style="text-align: justify;"> |
1191 |
|
1192 |
Store in a dry and ventilated place at room temperature (up to 25°C). Keep away from children. |
1193 |
|
1194 |
</p> |
1195 |
</div> |
1196 |
|
1197 |
|
1198 |
|
1199 |
|
1200 |
|
1201 |
|
1202 |
|
1203 |
|
1204 |
|
1205 |
|
1206 |
|
1207 |
|
1208 |
<div align="justify"> |
1209 |
<p style="text-align: justify;"> |
1210 |
|
1211 |
|
1212 |
|
1213 |
</p> |
1214 |
</div> |
1215 |
|
1216 |
|
1217 |
|
1218 |
|
1219 |
|
1220 |
|
1221 |
|
1222 |
|
1223 |
|
1224 |
|
1225 |
|
1226 |
|
1227 |
<div align="justify"> |
1228 |
<p style="text-align: justify;"> |
1229 |
|
1230 |
<b><i>Shelf life</i></b> |
1231 |
|
1232 |
</p> |
1233 |
</div> |
1234 |
|
1235 |
|
1236 |
|
1237 |
|
1238 |
|
1239 |
|
1240 |
|
1241 |
|
1242 |
|
1243 |
|
1244 |
|
1245 |
|
1246 |
<div align="justify"> |
1247 |
<p style="text-align: justify;"> |
1248 |
|
1249 |
Denoted on the packaging (18 months in the original pack). |
1250 |
|
1251 |
</p> |
1252 |
</div> |
1253 |
|
1254 |
|
1255 |
|
1256 |
|
1257 |
|
1258 |
|
1259 |
|
1260 |
|
1261 |
|
1262 |
|
1263 |
|
1264 |
|
1265 |
<div align="justify"> |
1266 |
<p style="text-align: justify;"> |
1267 |
|
1268 |
|
1269 |
|
1270 |
</p> |
1271 |
</div> |
1272 |
|
1273 |
|
1274 |
|
1275 |
|
1276 |
|
1277 |
|
1278 |
|
1279 |
|
1280 |
|
1281 |
|
1282 |
|
1283 |
|
1284 |
<div align="justify"> |
1285 |
<p style="text-align: justify;"> |
1286 |
|
1287 |
Once prepared use within 3 months. |
1288 |
|
1289 |
</p> |
1290 |
</div> |
1291 |
|
1292 |
|
1293 |
|
1294 |
|
1295 |
|
1296 |
|
1297 |
|
1298 |
|
1299 |
|
1300 |
|
1301 |
|
1302 |
|
1303 |
<div align="justify"> |
1304 |
<p style="text-align: justify;"> |
1305 |
|
1306 |
|
1307 |
|
1308 |
</p> |
1309 |
</div> |
1310 |
|
1311 |
|
1312 |
|
1313 |
|
1314 |
|
1315 |
|
1316 |
|
1317 |
|
1318 |
|
1319 |
|
1320 |
|
1321 |
|
1322 |
<div align="justify"> |
1323 |
<p style="text-align: justify;"> |
1324 |
|
1325 |
<b><i>Legal category</i></b><b></b> |
1326 |
|
1327 |
</p> |
1328 |
</div> |
1329 |
|
1330 |
|
1331 |
|
1332 |
|
1333 |
|
1334 |
|
1335 |
|
1336 |
|
1337 |
|
1338 |
|
1339 |
|
1340 |
|
1341 |
<div align="justify"> |
1342 |
<p style="text-align: justify;"> |
1343 |
|
1344 |
On prescription or veterinarian's written request to prepare. |
1345 |
|
1346 |
</p> |
1347 |
</div> |
1348 |
|
1349 |
|
1350 |
|
1351 |
|
1352 |
|
1353 |
|
1354 |
|
1355 |
|
1356 |
|
1357 |
|
1358 |
|
1359 |
|
1360 |
<div align="justify"> |
1361 |
<p style="text-align: justify;"> |
1362 |
|
1363 |
|
1364 |
|
1365 |
</p> |
1366 |
</div> |
1367 |
|
1368 |
|
1369 |
|
1370 |
|
1371 |
|
1372 |
|
1373 |
|
1374 |
|
1375 |
|
1376 |
|
1377 |
|
1378 |
|
1379 |
<div align="justify"> |
1380 |
<p style="text-align: justify;"> |
1381 |
|
1382 |
<b><i>Supply</i></b> |
1383 |
|
1384 |
</p> |
1385 |
</div> |
1386 |
|
1387 |
|
1388 |
|
1389 |
|
1390 |
|
1391 |
|
1392 |
|
1393 |
|
1394 |
|
1395 |
|
1396 |
|
1397 |
|
1398 |
<div align="justify"> |
1399 |
<p style="text-align: justify;"> |
1400 |
|
1401 |
Bags with 200 g, 1 kg, 5 kg and 25 kg. |
1402 |
|
1403 |
</p> |
1404 |
</div> |
1405 |
|
1406 |
|
1407 |
|
1408 |
|
1409 |
|
1410 |
|
1411 |
|
1412 |
|
1413 |
|
1414 |
|
1415 |
|
1416 |
|
1417 |
<div align="justify"> |
1418 |
<p style="text-align: justify;"> |
1419 |
|
1420 |
|
1421 |
|
1422 |
</p> |
1423 |
</div> |
1424 |
|
1425 |
|
1426 |
|
1427 |
|
1428 |
|
1429 |
|
1430 |
|
1431 |
|
1432 |
|
1433 |
|
1434 |
|
1435 |
|
1436 |
<div align="justify"> |
1437 |
<p style="text-align: justify;"> |
1438 |
|
1439 |
<b><i>Manufacturer</i></b><b></b> |
1440 |
|
1441 |
</p> |
1442 |
</div> |
1443 |
|
1444 |
|
1445 |
|
1446 |
|
1447 |
|
1448 |
|
1449 |
|
1450 |
|
1451 |
|
1452 |
|
1453 |
|
1454 |
|
1455 |
<div align="justify"> |
1456 |
<p style="text-align: justify;"> |
1457 |
|
1458 |
VETERINA Animal Health Ltd., Croatia |
1459 |
|
1460 |
</p> |
1461 |
</div> |
1462 |
|
1463 |
|
1464 |
|
1465 |
|
1466 |
|
1467 |
|
1468 |
|
1469 |
|
1470 |
|
1471 |
|
1472 |
|
1473 |
|
1474 |
<div align="justify"> |
1475 |
<p style="text-align: justify;"> |
1476 |
|
1477 |
|
1478 |
|
1479 |
</p> |
1480 |
</div> |
1481 |
|
1482 |
|
1483 |
|
1484 |
|
1485 |
|
1486 |
|
1487 |
|
1488 |
|
1489 |
|
1490 |
|
1491 |
|
1492 |
|
1493 |
<div align="left"> |
1494 |
<p style="text-align: left;"> |
1495 |
|
1496 |
|
1497 |
|
1498 |
</p> |
1499 |
</div> |
1500 |
|
1501 |
|
1502 |
|
1503 |
|
1504 |
|
1505 |
|
1506 |
|
1507 |
<!--Section Ends--> |
1508 |
|
1509 |
|
1510 |
|
1511 |
|
1512 |
|
1513 |
|
1514 |
|
1515 |
|