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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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</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>GUMPESKAL</b><b><sup>®</sup></b><b>+IB</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>inactivated trivalent oily vaccine against Gumboro disease, Newcastle disease and avian infectious bronchitis</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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<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>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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The vaccine contains infectious bursal disease virus (Gumboro disease), Newcastle disease virus (NDV) and avian infectious bronchitis virus (AIBV) each inactivated with formaldehyde. NDV and AIBV are also dissociated with non-ionic detergent. All three immunogens are re-suspended, with the addition of an emulsifier, in mineral oil as a multiple emulsion water/oil/water type. |
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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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<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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The vaccine stimulates formation of specific antibodies for Gumboro disease, Newcastle disease and avian infectious bronchitis. |
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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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<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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Immunisation of breeding hens and commercial laying chicks against Gumboro disease, Newcastle disease and avian infectious bronchitis. |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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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>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 vaccine is administered to healthy chicks only. |
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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>Administration and dosage</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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Commercial laying chicks are vaccinated at the age of 16-20 weeks, i. e. not later than 2-4 weeks before point of lay. Before being vaccinated with GUMPESKAL<b><sup>®</sup></b>+IB, the chicks should be given live vaccine against Gumboro and Newcastle disease and avian infectious bronchitis. Time between these two vaccinations and administration of GUMPESKAL<b><sup>® </sup></b>+IB should not be shorter than 2 weeks. Optimum effect is achieved with an interval of 6 weeks. |
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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 dose per bird is 0.5 mL given by i. m. route in the breast muscle or s. c. into the skin fold at the upper neck side. |
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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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Before administration the vaccine should be heated to room temperature (15-20°C) and shaken prior to and during administration.<b></b> |
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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>Immunity</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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The vaccine establishes immunity in the breeding hens during the entire egg production period, i. e. “technological life” of the bird.<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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<b><i> </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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<b><i>Warnings and precautions</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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Before administration the vaccine should be heated to room temperature (18-20°C) and shaken prior to and during administration.<b></b> |
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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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The vaccine is administered to healthy chicks only.<b></b> |
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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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Do not administer by i. v. route. |
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</p> |
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</div> |
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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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Vaccination equipment should be sterile.<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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</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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Once opened use within 24 hours.<b></b> |
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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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Accidental self-administration may cause local reaction. |
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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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Packaging and vaccine leftovers must be heated. |
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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 every animal population there are some with poorer response to vaccination. In addition to proper storage and administration, success of vaccination depends on hereditary factors, age of the animal, present diseases, titer of maternal antibodies, feeding status, stress factors, concurrent administration of other drugs, 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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</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>Withdrawal</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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Meat and other edible tissues - 0 days. |
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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>Storage</i></b> |
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</p> |
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</div> |
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|
901 |
|
902 |
|
903 |
<div align="justify"> |
904 |
<p style="text-align: justify;"> |
905 |
|
906 |
Store in a dark place at 2-88C (refrigerator). Keep away from children. Avoid freezing. |
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="justify"> |
942 |
<p style="text-align: justify;"> |
943 |
|
944 |
<b><i>Shelf life</i></b><b></b> |
945 |
|
946 |
</p> |
947 |
</div> |
948 |
|
949 |
|
950 |
|
951 |
|
952 |
|
953 |
|
954 |
|
955 |
|
956 |
|
957 |
|
958 |
|
959 |
|
960 |
<div align="justify"> |
961 |
<p style="text-align: justify;"> |
962 |
|
963 |
Denoted on the packaging (18 months). |
964 |
|
965 |
</p> |
966 |
</div> |
967 |
|
968 |
|
969 |
|
970 |
|
971 |
|
972 |
|
973 |
|
974 |
|
975 |
|
976 |
|
977 |
|
978 |
|
979 |
<div align="justify"> |
980 |
<p style="text-align: justify;"> |
981 |
|
982 |
|
983 |
|
984 |
</p> |
985 |
</div> |
986 |
|
987 |
|
988 |
|
989 |
|
990 |
|
991 |
|
992 |
|
993 |
|
994 |
|
995 |
|
996 |
|
997 |
|
998 |
<div align="justify"> |
999 |
<p style="text-align: justify;"> |
1000 |
|
1001 |
<b><i>Legal category</i></b><b></b> |
1002 |
|
1003 |
</p> |
1004 |
</div> |
1005 |
|
1006 |
|
1007 |
|
1008 |
|
1009 |
|
1010 |
|
1011 |
|
1012 |
|
1013 |
|
1014 |
|
1015 |
|
1016 |
|
1017 |
<div align="justify"> |
1018 |
<p style="text-align: justify;"> |
1019 |
|
1020 |
On prescription only. |
1021 |
|
1022 |
</p> |
1023 |
</div> |
1024 |
|
1025 |
|
1026 |
|
1027 |
|
1028 |
|
1029 |
|
1030 |
|
1031 |
|
1032 |
|
1033 |
|
1034 |
|
1035 |
|
1036 |
<div align="justify"> |
1037 |
<p style="text-align: justify;"> |
1038 |
|
1039 |
|
1040 |
|
1041 |
</p> |
1042 |
</div> |
1043 |
|
1044 |
|
1045 |
|
1046 |
|
1047 |
|
1048 |
|
1049 |
|
1050 |
|
1051 |
|
1052 |
|
1053 |
|
1054 |
|
1055 |
<div align="justify"> |
1056 |
<p style="text-align: justify;"> |
1057 |
|
1058 |
<b><i>Supply</i></b><b></b> |
1059 |
|
1060 |
</p> |
1061 |
</div> |
1062 |
|
1063 |
|
1064 |
|
1065 |
|
1066 |
|
1067 |
|
1068 |
|
1069 |
|
1070 |
|
1071 |
|
1072 |
|
1073 |
|
1074 |
<div align="justify"> |
1075 |
<p style="text-align: justify;"> |
1076 |
|
1077 |
Bottles of 500 mL (1000 doses). |
1078 |
|
1079 |
</p> |
1080 |
</div> |
1081 |
|
1082 |
|
1083 |
|
1084 |
|
1085 |
|
1086 |
|
1087 |
|
1088 |
|
1089 |
|
1090 |
|
1091 |
|
1092 |
|
1093 |
<div align="justify"> |
1094 |
<p style="text-align: justify;"> |
1095 |
|
1096 |
|
1097 |
|
1098 |
</p> |
1099 |
</div> |
1100 |
|
1101 |
|
1102 |
|
1103 |
|
1104 |
|
1105 |
|
1106 |
|
1107 |
|
1108 |
|
1109 |
|
1110 |
|
1111 |
|
1112 |
<div align="justify"> |
1113 |
<p style="text-align: justify;"> |
1114 |
|
1115 |
<b><i>Manufacturer</i></b><b></b> |
1116 |
|
1117 |
</p> |
1118 |
</div> |
1119 |
|
1120 |
|
1121 |
|
1122 |
|
1123 |
|
1124 |
|
1125 |
|
1126 |
|
1127 |
|
1128 |
|
1129 |
|
1130 |
|
1131 |
<div align="justify"> |
1132 |
<p style="text-align: justify;"> |
1133 |
|
1134 |
VETERINA Animal Health Ltd., Croatia |
1135 |
|
1136 |
</p> |
1137 |
</div> |
1138 |
|
1139 |
|
1140 |
|
1141 |
|
1142 |
|
1143 |
|
1144 |
|
1145 |
|
1146 |
|
1147 |
|
1148 |
|
1149 |
|
1150 |
<div align="justify"> |
1151 |
<p style="text-align: justify;"> |
1152 |
|
1153 |
|
1154 |
|
1155 |
</p> |
1156 |
</div> |
1157 |
|
1158 |
|
1159 |
|
1160 |
|
1161 |
|
1162 |
|
1163 |
|
1164 |
|
1165 |
|
1166 |
|
1167 |
|
1168 |
|
1169 |
<div align="left"> |
1170 |
<p style="text-align: left;"> |
1171 |
|
1172 |
|
1173 |
|
1174 |
</p> |
1175 |
</div> |
1176 |
|
1177 |
|
1178 |
|
1179 |
|
1180 |
|
1181 |
|
1182 |
|
1183 |
<!--Section Ends--> |
1184 |
|
1185 |
|
1186 |
|
1187 |
|
1188 |
|
1189 |
|
1190 |
|
1191 |
|