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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>RABIKAL</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>inactivated adsorbate vaccine against rabies in dogs, cats, cattle, horse, swine and sheep</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> |
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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 inactivated rabies virus, Flury LEP strain (low egg passage), grown in the cell culture of hamster kidneys (BHK21). The virus is inactivated with aziridine and adsorbed on aluminium hydroxide. |
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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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</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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In healthy vaccinated animals the vaccine induces formation of specific antibodies for rabies. |
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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>Indications</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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Active immunisation of healthy dogs, cats, cattle, horses, swine and sheep against rabies. |
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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>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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Weak and sick animals, those suspected of being rabid or already infected should not be vaccinated. |
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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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<p style="text-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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<div align="justify"> |
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<p style="text-align: justify;"> |
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Shake well before injecting into the syringe. A light-yellow precipitate turns into homogeneous suspension. |
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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 vaccine is administered by s. c. route. |
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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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The dose for all animals is 1 mL. |
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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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All animals may be vaccinated already at the age of 7 weeks. |
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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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If puppies and cats below 12 weeks of age are vaccinated, re-vaccination should be done when they are 12-13 weeks old. |
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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>Immunity</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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Immunity develops 7-10 days post vaccination and is maintained for at least 12 months. |
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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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Warnings and precautions<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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Once opened use within 7 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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</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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Prolonged exposure to increased temperatures may affect potency of the vaccine |
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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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Vaccinate under sterile conditions. |
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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 case of allergic reactions, particularly of anaphylactic condition, instantaneously administer adrenaline (1/3 dose i. v. and the rest i.m.). If necessary introduce soluble glucocorticoid (e. g. dexamethasone sodium phosphate by i. v. route and i. m. antihistaminic). |
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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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If the animals were given immunosuppressants (e. g. glucocorticoids) they should not be vaccinated within 4 weeks of their administration. |
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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. Immune reaction is affected by hereditary factors, subclinical diseases, health condition, stress, concurrent administration of other medicines, storage and administration of the vaccine. |
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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>Storage</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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Store in a dark place at 2-8°C (refrigerator). Keep away from children. Avoid freezing. |
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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, other edible tissues and milk - 0 days. |
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</p> |
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</div> |
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916 |
|
917 |
|
918 |
|
919 |
|
920 |
|
921 |
|
922 |
<div align="justify"> |
923 |
<p style="text-align: justify;"> |
924 |
|
925 |
<b><i></i></b> |
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 |
Shelf life |
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 (36 months in the original pack). |
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 |
<b></b> |
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 |
<b></b> |
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> |
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 |
Box with 10 bottles of 1 dose. |
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 |
Box with 5 pierced bottles of 5 doses. |
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 |
Box with 5 pierced bottles of 10 doses. |
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 |
|
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 |
<b><i>Manufacturer</i></b><b></b> |
1154 |
|
1155 |
</p> |
1156 |
</div> |
1157 |
|
1158 |
|
1159 |
|
1160 |
|
1161 |
|
1162 |
|
1163 |
|
1164 |
|
1165 |
|
1166 |
|
1167 |
|
1168 |
|
1169 |
<div align="justify"> |
1170 |
<p style="text-align: justify;"> |
1171 |
|
1172 |
VETERINA Animal Health Ltd., Croatia |
1173 |
|
1174 |
</p> |
1175 |
</div> |
1176 |
|
1177 |
|
1178 |
|
1179 |
|
1180 |
|
1181 |
|
1182 |
|
1183 |
|
1184 |
|
1185 |
|
1186 |
|
1187 |
|
1188 |
<div align="justify"> |
1189 |
<p style="text-align: justify;"> |
1190 |
|
1191 |
|
1192 |
|
1193 |
</p> |
1194 |
</div> |
1195 |
|
1196 |
|
1197 |
|
1198 |
|
1199 |
|
1200 |
|
1201 |
|
1202 |
|
1203 |
|
1204 |
|
1205 |
|
1206 |
|
1207 |
<div align="left"> |
1208 |
<p style="text-align: left;"> |
1209 |
|
1210 |
|
1211 |
|
1212 |
</p> |
1213 |
</div> |
1214 |
|
1215 |
|
1216 |
|
1217 |
|
1218 |
|
1219 |
|
1220 |
|
1221 |
<!--Section Ends--> |
1222 |
|
1223 |
|
1224 |
|
1225 |
|
1226 |
|
1227 |
|
1228 |
|
1229 |
|