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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>SIMIVET</b><b><sup>®</sup></b><b> retard</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>oily injection suspension</i> |
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</p> |
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</div> |
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<div 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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1 mL contains 150 mg of amoxicillin as amoxicillin trihydrate. |
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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>Action</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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Amoxicillin is a semi-synthetic penicillin of a broader spectrum in relation to the source benzylpenicillin. As other beta-lactam antibiotics, during bacterial growth it interferes with the synthesis of its cell wall, thus exerting its bactericidal effect. Antimicrobial spectrum of Simivet<b><sup>®</sup></b> covers many gram-positive and gram-negative bacteria: <i>Streptococcus</i> spp., <i>Staphylococcus</i> spp., <i>Erysipelothrix insidiosa</i>, <i>Actinomyces</i> spp., <i>Clostridium</i> spp., <i>Corynebacterium</i> spp., <i>E. coli</i>, <i>Salmonella</i> spp., <i>Actinobacillus</i> spp., <i>Bordetella bronchiseptica</i>, <i>Fusobacterium</i> spp., <i>Haemophilus</i> spp., <i>Moraxella</i> spp., <i>Pasteurella</i> spp., <i>Proteus mirabilis,</i> etc. |
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</p> |
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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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After i. m. or s. c. administration of Simivet<b><sup>®</sup></b> retard peak plasma concentrations of amoxicillin are achieved in 2-hours time. Injection suspension is formulated so that a single dose maintains its effective level over 48 hours. Simivet<b><sup>®</sup></b><sup> </sup>is well distributed in majority of tissues, with markedly high levels attained in parenchymal organs, urine and bile. Amoxicillin readily passes through the inflamed respiratory tract membranes to bronchial mucus, thus aiding the treatment of respiratory infections. It is not active upon bacterial beta-lactamase, while bacterial resistance to it is built gradually. Toxicity of amoxicillin is negligible. The doses in excess of the recommended ones are well tolerated. Oily base of the preparation ensures efficient tissue levels of amoxicillin and maintains them over at least 48 hours. |
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</p> |
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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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- General and local infections due to gram-negative and gram-positive organisms sensitive to amoxicillin; |
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</p> |
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</div> |
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- gastrointestinal infections; |
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</p> |
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</div> |
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- respiratory infections; |
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</p> |
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</div> |
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- genitourinary infections; |
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</p> |
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</div> |
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- skin and soft tissue infections; |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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- mastitis with concomitant treatment with intramammary antibiotics; |
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</p> |
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</div> |
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- atrophic rhinitis in swine and MMA syndrome in sows. |
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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>Contraindications</i></b> |
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</p> |
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</div> |
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Simivet<b><sup>®</sup></b><sup> </sup>retard should not be given by intravenous or intrathecal route. |
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</p> |
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</div> |
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</p> |
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</div> |
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Amoxicillin should not be administered to small monogastric herbivore, such as rabbits, guinea-pigs, hamsters, etc. |
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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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Hypersensitivity to penicillin antibiotics, which is extremely rare. |
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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 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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Simivet<b><sup>®</sup></b> retard is given by i. m. or s. c. injection. |
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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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Shake well before use. |
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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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Average dose for all animals is 1 mL/10 kg of b. w. (15 mg of amoxicillin/kg of b. w./day). Application is repeated every 24 hours till remission of the symptoms. |
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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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Doses above 20 mL should be administered at two sites. |
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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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After administering to cats and dogs gently massage the site of application. |
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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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<b><i>Warnings and precautions</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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Like other penicillin preparations, Simivet<b><sup>®</sup></b> retard is unstable in water. Use dry and sterile needles and syringes for withdrawal of the vaccine from the bottle and for its administration. |
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</p> |
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</div> |
| 777 |
|
| 778 |
|
| 779 |
|
| 780 |
|
| 781 |
|
| 782 |
|
| 783 |
|
| 784 |
|
| 785 |
|
| 786 |
|
| 787 |
|
| 788 |
|
| 789 |
<div align="justify"> |
| 790 |
<p style="text-align: justify;"> |
| 791 |
|
| 792 |
|
| 793 |
|
| 794 |
</p> |
| 795 |
</div> |
| 796 |
|
| 797 |
|
| 798 |
|
| 799 |
|
| 800 |
|
| 801 |
|
| 802 |
|
| 803 |
|
| 804 |
|
| 805 |
|
| 806 |
|
| 807 |
|
| 808 |
<div align="justify"> |
| 809 |
<p style="text-align: justify;"> |
| 810 |
|
| 811 |
Transient swelling may develop at the site of injection, which disappears a few days from administration. |
| 812 |
|
| 813 |
</p> |
| 814 |
</div> |
| 815 |
|
| 816 |
|
| 817 |
|
| 818 |
|
| 819 |
|
| 820 |
|
| 821 |
|
| 822 |
|
| 823 |
|
| 824 |
|
| 825 |
|
| 826 |
|
| 827 |
<div align="justify"> |
| 828 |
<p style="text-align: justify;"> |
| 829 |
|
| 830 |
|
| 831 |
|
| 832 |
</p> |
| 833 |
</div> |
| 834 |
|
| 835 |
|
| 836 |
|
| 837 |
|
| 838 |
|
| 839 |
|
| 840 |
|
| 841 |
|
| 842 |
|
| 843 |
|
| 844 |
|
| 845 |
|
| 846 |
<div align="justify"> |
| 847 |
<p style="text-align: justify;"> |
| 848 |
|
| 849 |
<b><i>Withdrawal</i></b> |
| 850 |
|
| 851 |
</p> |
| 852 |
</div> |
| 853 |
|
| 854 |
|
| 855 |
|
| 856 |
|
| 857 |
|
| 858 |
|
| 859 |
|
| 860 |
|
| 861 |
|
| 862 |
|
| 863 |
|
| 864 |
|
| 865 |
<div align="justify"> |
| 866 |
<p style="text-align: justify;"> |
| 867 |
|
| 868 |
Meat and other edible tissues - cattle, sheep and swine 14 days |
| 869 |
|
| 870 |
</p> |
| 871 |
</div> |
| 872 |
|
| 873 |
|
| 874 |
|
| 875 |
|
| 876 |
|
| 877 |
|
| 878 |
|
| 879 |
|
| 880 |
|
| 881 |
|
| 882 |
|
| 883 |
|
| 884 |
<div align="justify"> |
| 885 |
<p style="text-align: justify;"> |
| 886 |
|
| 887 |
Cow milk 3 days |
| 888 |
|
| 889 |
</p> |
| 890 |
</div> |
| 891 |
|
| 892 |
|
| 893 |
|
| 894 |
|
| 895 |
|
| 896 |
|
| 897 |
|
| 898 |
|
| 899 |
|
| 900 |
|
| 901 |
|
| 902 |
|
| 903 |
<div align="justify"> |
| 904 |
<p style="text-align: justify;"> |
| 905 |
|
| 906 |
Sheep milk 6 days |
| 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>Storage</i></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 |
Store in a dark place at room temperature (up to 25°C). Keep away from children. Avoid freezing. |
| 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>Shelf life</i></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 |
Denoted on the packaging (3 years in the original pack). |
| 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 |
Once opened use within 4 weeks.<b><i></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 |
|
| 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 |
Legal category |
| 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 |
On prescription only. |
| 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>Supply</i></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 |
Pierced bottle of 100 mL and 6x100 mL |
| 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="justify"> |
| 1208 |
<p style="text-align: justify;"> |
| 1209 |
|
| 1210 |
<b><i>Manufacturer</i></b> |
| 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 |
VETERINA Animal Health Ltd., Croatia |
| 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></b> |
| 1249 |
|
| 1250 |
</p> |
| 1251 |
</div> |
| 1252 |
|
| 1253 |
|
| 1254 |
|
| 1255 |
|
| 1256 |
|
| 1257 |
|
| 1258 |
|
| 1259 |
|
| 1260 |
|
| 1261 |
|
| 1262 |
|
| 1263 |
|
| 1264 |
<div align="left"> |
| 1265 |
<p style="text-align: left;"> |
| 1266 |
|
| 1267 |
|
| 1268 |
|
| 1269 |
</p> |
| 1270 |
</div> |
| 1271 |
|
| 1272 |
|
| 1273 |
|
| 1274 |
|
| 1275 |
|
| 1276 |
|
| 1277 |
|
| 1278 |
<!--Section Ends--> |
| 1279 |
|
| 1280 |
|
| 1281 |
|
| 1282 |
|
| 1283 |
|
| 1284 |
|
| 1285 |
|
| 1286 |
|
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| 
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