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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>AY-VAK</b><b><sup>®</sup></b><b> Bartha</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>lyophilised vaccine against Aujeszky's disease for swine</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 attenuated live virus of Aujeszky's disease, Bartha strain K/61 (gI<sup>-</sup>) grown in the cell culture of chicks' fibroblasts. |
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</p> |
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</div> |
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<div align="justify"> |
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</div> |
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<p style="text-align: justify;"> |
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<b><i>Action</i></b> |
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</p> |
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</div> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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The vaccine induces formation of specific antibodies for Aujeszky's disease virus. |
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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>Indications</i></b> |
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</p> |
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<p style="text-align: justify;"> |
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Immunisation of all production breeds of healthy swine against Aujeszky's disease. |
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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>Contraindications</i></b> |
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</p> |
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</div> |
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Sick and markedly cachectic animals should not be vaccinated. |
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</p> |
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</div> |
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</p> |
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</div> |
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<b><i>Administration, dosage and vaccination programme</i></b> |
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</p> |
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</div> |
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Immediately prior to vaccination resuspended the vaccine in as many mL of diluent as there are doses in the bottle, and shaken well. |
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</p> |
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</div> |
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</p> |
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</div> |
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The vaccine is administered by i. m. route. |
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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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Irrespective of the age, breed and body weight of swine the dose is 1 mL. |
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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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Piglets are vaccinated after fourth week of life. |
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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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Piglets to non-vaccinated sows may be vaccinated as early as the age of 14 days. In both cases revaccination of sows should be done 3-4 weeks from the first vaccination. |
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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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Sows and gilts are vaccinated once yearly, i. e. 14 days prior to farrowing, but not later than on weaning. |
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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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Boars are vaccinated once yearly. |
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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>Immunity</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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Immunity is developed 14 days after vaccination and is maintained over at least 12 months from booster vaccination. |
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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>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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Once reconstituted use within 3 hours. |
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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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Use sterile and dry needles and syringes. Do not sterilise with chemicals. Do not use the vaccination needle to withdraw the vaccine from the bottle. |
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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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In case of allergic reactions, particularly of anaphylactic condition, instantaneously administer intravenous soluble glucocorticoid (e. g. dexamethasone sodium phosphate) and intramuscular adrenaline and 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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The animals given immunosuppressants (e. g. glucocorticoids) 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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Packaging and vaccine leftovers must be disposed in a safe way. |
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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 response 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>Withdrawal</i></b> |
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</p> |
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</div> |
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917 |
|
918 |
|
919 |
|
920 |
|
921 |
|
922 |
<div align="justify"> |
923 |
<p style="text-align: justify;"> |
924 |
|
925 |
Meat and edible tissues of the vaccinated swine - 0 days. |
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></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 |
<b><i>Storage</i></b> |
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 |
Store in a dark place at the temperature 2-8°C (refrigerator). Keep away from children. |
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 |
|
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 |
<b><i>Shelf life</i></b> |
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 |
Denoted on the packaging (12 months in the original pack). |
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></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 |
<b><i>Legal category</i></b><b></b> |
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 |
On prescription only. |
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></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 |
<b><i>Supply</i></b> |
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 |
Box with 10 x 10 doses |
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 |
Box with 10 x 50 doses |
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 |
Box with 10 x 100 doses |
1192 |
|
1193 |
</p> |
1194 |
</div> |
1195 |
|
1196 |
|
1197 |
|
1198 |
|
1199 |
|
1200 |
|
1201 |
|
1202 |
|
1203 |
|
1204 |
|
1205 |
|
1206 |
|
1207 |
<div align="justify"> |
1208 |
<p style="text-align: justify;"> |
1209 |
|
1210 |
Box with 10 x 250 doses |
1211 |
|
1212 |
</p> |
1213 |
</div> |
1214 |
|
1215 |
|
1216 |
|
1217 |
|
1218 |
|
1219 |
|
1220 |
|
1221 |
|
1222 |
|
1223 |
|
1224 |
|
1225 |
|
1226 |
<div align="justify"> |
1227 |
<p style="text-align: justify;"> |
1228 |
|
1229 |
|
1230 |
|
1231 |
</p> |
1232 |
</div> |
1233 |
|
1234 |
|
1235 |
|
1236 |
|
1237 |
|
1238 |
|
1239 |
|
1240 |
|
1241 |
|
1242 |
|
1243 |
|
1244 |
|
1245 |
<div align="justify"> |
1246 |
<p style="text-align: justify;"> |
1247 |
|
1248 |
<b><i>Manufacturer</i></b> |
1249 |
|
1250 |
</p> |
1251 |
</div> |
1252 |
|
1253 |
|
1254 |
|
1255 |
|
1256 |
|
1257 |
|
1258 |
|
1259 |
|
1260 |
|
1261 |
|
1262 |
|
1263 |
|
1264 |
<div align="justify"> |
1265 |
<p style="text-align: justify;"> |
1266 |
|
1267 |
VETERINA Animal Health Ltd., Croatia |
1268 |
|
1269 |
</p> |
1270 |
</div> |
1271 |
|
1272 |
|
1273 |
|
1274 |
|
1275 |
|
1276 |
|
1277 |
|
1278 |
|
1279 |
|
1280 |
|
1281 |
|
1282 |
|
1283 |
<div align="justify"> |
1284 |
<p style="text-align: justify;"> |
1285 |
|
1286 |
|
1287 |
|
1288 |
</p> |
1289 |
</div> |
1290 |
|
1291 |
|
1292 |
|
1293 |
|
1294 |
|
1295 |
|
1296 |
|
1297 |
|
1298 |
|
1299 |
|
1300 |
|
1301 |
|
1302 |
<div align="left"> |
1303 |
<p style="text-align: left;"> |
1304 |
|
1305 |
|
1306 |
|
1307 |
</p> |
1308 |
</div> |
1309 |
|
1310 |
|
1311 |
|
1312 |
|
1313 |
|
1314 |
|
1315 |
|
1316 |
<!--Section Ends--> |
1317 |
|
1318 |
|
1319 |
|
1320 |
|
1321 |
|
1322 |
|
1323 |
|
1324 |
|