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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>PLIVACILLIN</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>dry injections </i>- powder for injection suspension/solution |
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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>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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Each bottle 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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100,000, 200,000 or 1,000,000 iu of benzylpenicillin potassium and |
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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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300,000, 600,000 or 3,000,000 iu of benzylpenicillin procaine |
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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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Plivacillin<b><sup>®</sup></b> is a mixture of readily soluble crystalline benzylpenicillin potassium, which acts immediately after administration, and of sparingly soluble benzylpenicillin procaine, which has a prolonged action due to its slow resorption. The preparation is used for the treatment and prophylaxis of the infections caused by gram-positive organisms: streptococci, enterococci, pneumococci, Corynebacteria, actinomycetes, leptospira, anthrax and swine erysipelas bacteria, etc. |
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</p> |
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</div> |
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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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<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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Some major indications: |
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</p> |
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</div> |
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<ul> |
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<li> |
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<p style="text-align: justify;"> |
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streptococcal, stastaphylococcal and enterococcal infections; |
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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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specific infections: swine erysipelas, leptospirosis, tetanus, actinomycosis, etc.; |
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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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secondary bacterial infections associated with and following viral diseases (distemper, panleukopenia, parvovirosis, viral bronchopneumonia, equine influenza, etc.); |
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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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puerperal infections, metritis, mastitis (accompanied by local treatment), MMA syndrome in sows; |
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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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phlegmonas, pyodermia, abscesses, infected wounds, panaritium, acute suppurative arthritis, umbilical infections, etc. |
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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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<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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Plivacillin<b><sup>®</sup></b> should not be administered by i. v. 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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<div align="justify"> |
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<p style="text-align: justify;"> |
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Established hypersensitivity to beta-lactam antibiotics or the ingredients of Plivacillin<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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</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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Penicillins should not be given to rabbits, guinea-pigs, hamsters and other small monogastric herbivore. |
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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>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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Immediately prior to administration resuspend the contents of the bottle in as small amount of water for injection as possible (400,000 iu/2 mL; 800,000 iu/4-5 mL; 4,000,000 iu/10 mL). Before injecting the obtained solution-suspension into the syringe and prior to its administration, shake it several times. In general, the injections are not painful because smaller portion of the preparation is dissolved and major is re-suspended. |
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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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<table width="87.71%" border="1" cols="2" rows="3"> |
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<tr> |
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<td bgcolor="White" width="20.59%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Species |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="79.41%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Dose |
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</p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="20.59%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Dogs, cats |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="79.41%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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20 000 iu/kg b. w. (e. g. 400 000 iu /20 kg b. w.) |
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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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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="20.59%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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Horses, cattle, |
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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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swine, sheep |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="79.41%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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|
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10 000 - 15 000 iu/kg b. w. (e. g. 800 000 iu /55-80 kg b. w.; |
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|
733 |
</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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4 000 000 iu/270-400 kg). |
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</p> |
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</div> |
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</td> |
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</tr> |
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</table> |
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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;"> |
794 |
|
795 |
Large animals are given Plivacillin<b><sup>®</sup></b> by deep i.m. injection, dogs and cats by s.c. or i.m. route. In the treatment of local infections Plivacillin<b><sup>®</sup></b> is injected into the surrounding tissue or directly into the process. Before injecting check if the needle is erroneously in the blood vessel. |
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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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829 |
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<div align="justify"> |
831 |
<p style="text-align: justify;"> |
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833 |
Plivacillin<b><sup>®</sup></b> is given once daily plus at least two more days after remission of fever and clinical signs. In severe infections the dose may be increased. |
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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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866 |
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867 |
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<div align="justify"> |
869 |
<p style="text-align: justify;"> |
870 |
|
871 |
To broaden antimicrobial spectrum, Plivacillin<b><sup>®</sup></b> may be given concomitantly with dihydrostreptomycin (e. g. Hystrecin<b><sup>®</sup></b> (PLIVA). |
872 |
|
873 |
</p> |
874 |
</div> |
875 |
|
876 |
|
877 |
|
878 |
|
879 |
|
880 |
|
881 |
|
882 |
|
883 |
|
884 |
|
885 |
|
886 |
|
887 |
<div align="justify"> |
888 |
<p style="text-align: justify;"> |
889 |
|
890 |
|
891 |
|
892 |
</p> |
893 |
</div> |
894 |
|
895 |
|
896 |
|
897 |
|
898 |
|
899 |
|
900 |
|
901 |
|
902 |
|
903 |
|
904 |
|
905 |
|
906 |
<div align="justify"> |
907 |
<p style="text-align: justify;"> |
908 |
|
909 |
<b><i>Warnings and precautions</i></b> |
910 |
|
911 |
</p> |
912 |
</div> |
913 |
|
914 |
|
915 |
|
916 |
|
917 |
|
918 |
|
919 |
|
920 |
|
921 |
|
922 |
|
923 |
|
924 |
|
925 |
<div align="justify"> |
926 |
<p style="text-align: justify;"> |
927 |
|
928 |
Once resuspended, i. e. dissolved, use immediately. |
929 |
|
930 |
</p> |
931 |
</div> |
932 |
|
933 |
|
934 |
|
935 |
|
936 |
|
937 |
|
938 |
|
939 |
|
940 |
|
941 |
|
942 |
|
943 |
|
944 |
<div align="justify"> |
945 |
<p style="text-align: justify;"> |
946 |
|
947 |
|
948 |
|
949 |
</p> |
950 |
</div> |
951 |
|
952 |
|
953 |
|
954 |
|
955 |
|
956 |
|
957 |
|
958 |
|
959 |
|
960 |
|
961 |
|
962 |
|
963 |
<div align="justify"> |
964 |
<p style="text-align: justify;"> |
965 |
|
966 |
Plivacillin<b><sup>®</sup></b> should not be injected on two consecutive days at the same site. |
967 |
|
968 |
</p> |
969 |
</div> |
970 |
|
971 |
|
972 |
|
973 |
|
974 |
|
975 |
|
976 |
|
977 |
|
978 |
|
979 |
|
980 |
|
981 |
|
982 |
<div align="justify"> |
983 |
<p style="text-align: justify;"> |
984 |
|
985 |
|
986 |
|
987 |
</p> |
988 |
</div> |
989 |
|
990 |
|
991 |
|
992 |
|
993 |
|
994 |
|
995 |
|
996 |
|
997 |
|
998 |
|
999 |
|
1000 |
|
1001 |
<div align="justify"> |
1002 |
<p style="text-align: justify;"> |
1003 |
|
1004 |
Preparations containing procaine penicillin may very seldom cause fever and induce abortion in the swine infected by erysipelas (<i>Erysipelothrix insidiosa</i>). |
1005 |
|
1006 |
</p> |
1007 |
</div> |
1008 |
|
1009 |
|
1010 |
|
1011 |
|
1012 |
|
1013 |
|
1014 |
|
1015 |
|
1016 |
|
1017 |
|
1018 |
|
1019 |
|
1020 |
<div align="justify"> |
1021 |
<p style="text-align: justify;"> |
1022 |
|
1023 |
|
1024 |
|
1025 |
</p> |
1026 |
</div> |
1027 |
|
1028 |
|
1029 |
|
1030 |
|
1031 |
|
1032 |
|
1033 |
|
1034 |
|
1035 |
|
1036 |
|
1037 |
|
1038 |
|
1039 |
<div align="justify"> |
1040 |
<p style="text-align: justify;"> |
1041 |
|
1042 |
In case of allergic reactions, which are rare in animals, discontinue Plivacillin<b><sup>®</sup></b> and institute adrenaline, glucocorticoids and antihistaminics. |
1043 |
|
1044 |
</p> |
1045 |
</div> |
1046 |
|
1047 |
|
1048 |
|
1049 |
|
1050 |
|
1051 |
|
1052 |
|
1053 |
|
1054 |
|
1055 |
|
1056 |
|
1057 |
|
1058 |
<div align="justify"> |
1059 |
<p style="text-align: justify;"> |
1060 |
|
1061 |
|
1062 |
|
1063 |
</p> |
1064 |
</div> |
1065 |
|
1066 |
|
1067 |
|
1068 |
|
1069 |
|
1070 |
|
1071 |
|
1072 |
|
1073 |
|
1074 |
|
1075 |
|
1076 |
|
1077 |
<div align="justify"> |
1078 |
<p style="text-align: justify;"> |
1079 |
|
1080 |
<b><i>Withdrawal</i></b><b></b> |
1081 |
|
1082 |
</p> |
1083 |
</div> |
1084 |
|
1085 |
|
1086 |
|
1087 |
|
1088 |
|
1089 |
|
1090 |
|
1091 |
|
1092 |
|
1093 |
|
1094 |
|
1095 |
|
1096 |
<div align="justify"> |
1097 |
<p style="text-align: justify;"> |
1098 |
|
1099 |
Meat and other edible tissues of cattle, swine, sheep, goats 10 days. |
1100 |
|
1101 |
</p> |
1102 |
</div> |
1103 |
|
1104 |
|
1105 |
|
1106 |
|
1107 |
|
1108 |
|
1109 |
|
1110 |
|
1111 |
|
1112 |
|
1113 |
|
1114 |
|
1115 |
<div align="justify"> |
1116 |
<p style="text-align: justify;"> |
1117 |
|
1118 |
Cows' milk 3 days |
1119 |
|
1120 |
</p> |
1121 |
</div> |
1122 |
|
1123 |
|
1124 |
|
1125 |
|
1126 |
|
1127 |
|
1128 |
|
1129 |
|
1130 |
|
1131 |
|
1132 |
|
1133 |
|
1134 |
<div align="justify"> |
1135 |
<p style="text-align: justify;"> |
1136 |
|
1137 |
|
1138 |
|
1139 |
</p> |
1140 |
</div> |
1141 |
|
1142 |
|
1143 |
|
1144 |
|
1145 |
|
1146 |
|
1147 |
|
1148 |
|
1149 |
|
1150 |
|
1151 |
|
1152 |
|
1153 |
<div align="justify"> |
1154 |
<p style="text-align: justify;"> |
1155 |
|
1156 |
<b><i>Storage</i></b><b></b> |
1157 |
|
1158 |
</p> |
1159 |
</div> |
1160 |
|
1161 |
|
1162 |
|
1163 |
|
1164 |
|
1165 |
|
1166 |
|
1167 |
|
1168 |
|
1169 |
|
1170 |
|
1171 |
|
1172 |
<div align="justify"> |
1173 |
<p style="text-align: justify;"> |
1174 |
|
1175 |
Store in a dark place at controlled room temperature (15-25°C). Keep away from children. |
1176 |
|
1177 |
</p> |
1178 |
</div> |
1179 |
|
1180 |
|
1181 |
|
1182 |
|
1183 |
|
1184 |
|
1185 |
|
1186 |
|
1187 |
|
1188 |
|
1189 |
|
1190 |
|
1191 |
<div align="justify"> |
1192 |
<p style="text-align: justify;"> |
1193 |
|
1194 |
|
1195 |
|
1196 |
</p> |
1197 |
</div> |
1198 |
|
1199 |
|
1200 |
|
1201 |
|
1202 |
|
1203 |
|
1204 |
|
1205 |
|
1206 |
|
1207 |
|
1208 |
|
1209 |
|
1210 |
<div align="justify"> |
1211 |
<p style="text-align: justify;"> |
1212 |
|
1213 |
<b><i>Shelf life</i></b> |
1214 |
|
1215 |
</p> |
1216 |
</div> |
1217 |
|
1218 |
|
1219 |
|
1220 |
|
1221 |
|
1222 |
|
1223 |
|
1224 |
|
1225 |
|
1226 |
|
1227 |
|
1228 |
|
1229 |
<div align="justify"> |
1230 |
<p style="text-align: justify;"> |
1231 |
|
1232 |
Denoted on the packaging (4 years in the original pack). |
1233 |
|
1234 |
</p> |
1235 |
</div> |
1236 |
|
1237 |
|
1238 |
|
1239 |
|
1240 |
|
1241 |
|
1242 |
|
1243 |
|
1244 |
|
1245 |
|
1246 |
|
1247 |
|
1248 |
<div align="justify"> |
1249 |
<p style="text-align: justify;"> |
1250 |
|
1251 |
|
1252 |
|
1253 |
</p> |
1254 |
</div> |
1255 |
|
1256 |
|
1257 |
|
1258 |
|
1259 |
|
1260 |
|
1261 |
|
1262 |
|
1263 |
|
1264 |
|
1265 |
|
1266 |
|
1267 |
<div align="justify"> |
1268 |
<p style="text-align: justify;"> |
1269 |
|
1270 |
<b><i>Legal category</i></b><b></b> |
1271 |
|
1272 |
</p> |
1273 |
</div> |
1274 |
|
1275 |
|
1276 |
|
1277 |
|
1278 |
|
1279 |
|
1280 |
|
1281 |
|
1282 |
|
1283 |
|
1284 |
|
1285 |
|
1286 |
<div align="justify"> |
1287 |
<p style="text-align: justify;"> |
1288 |
|
1289 |
On prescription only. |
1290 |
|
1291 |
</p> |
1292 |
</div> |
1293 |
|
1294 |
|
1295 |
|
1296 |
|
1297 |
|
1298 |
|
1299 |
|
1300 |
|
1301 |
|
1302 |
|
1303 |
|
1304 |
|
1305 |
<div align="justify"> |
1306 |
<p style="text-align: justify;"> |
1307 |
|
1308 |
|
1309 |
|
1310 |
</p> |
1311 |
</div> |
1312 |
|
1313 |
|
1314 |
|
1315 |
|
1316 |
|
1317 |
|
1318 |
|
1319 |
|
1320 |
|
1321 |
|
1322 |
|
1323 |
|
1324 |
<div align="justify"> |
1325 |
<p style="text-align: justify;"> |
1326 |
|
1327 |
Supply<b></b> |
1328 |
|
1329 |
</p> |
1330 |
</div> |
1331 |
|
1332 |
|
1333 |
|
1334 |
|
1335 |
|
1336 |
|
1337 |
|
1338 |
|
1339 |
|
1340 |
|
1341 |
|
1342 |
|
1343 |
<div align="justify"> |
1344 |
<p style="text-align: justify;"> |
1345 |
|
1346 |
50 liobottles with 400,000 iu (100,000 iu + 300,000 iu) |
1347 |
|
1348 |
</p> |
1349 |
</div> |
1350 |
|
1351 |
|
1352 |
|
1353 |
|
1354 |
|
1355 |
|
1356 |
|
1357 |
|
1358 |
|
1359 |
|
1360 |
|
1361 |
|
1362 |
<div align="justify"> |
1363 |
<p style="text-align: justify;"> |
1364 |
|
1365 |
50 liobottles with 800,000 iu (200,000 iu + 600,000 iu) |
1366 |
|
1367 |
</p> |
1368 |
</div> |
1369 |
|
1370 |
|
1371 |
|
1372 |
|
1373 |
|
1374 |
|
1375 |
|
1376 |
|
1377 |
|
1378 |
|
1379 |
|
1380 |
|
1381 |
<div align="justify"> |
1382 |
<p style="text-align: justify;"> |
1383 |
|
1384 |
1 liobottle with 4,000,000 iu (1,000,000 iu + 3,000,000 iu). |
1385 |
|
1386 |
</p> |
1387 |
</div> |
1388 |
|
1389 |
|
1390 |
|
1391 |
|
1392 |
|
1393 |
|
1394 |
|
1395 |
|
1396 |
|
1397 |
|
1398 |
|
1399 |
|
1400 |
<div align="justify"> |
1401 |
<p style="text-align: justify;"> |
1402 |
|
1403 |
|
1404 |
|
1405 |
</p> |
1406 |
</div> |
1407 |
|
1408 |
|
1409 |
|
1410 |
|
1411 |
|
1412 |
|
1413 |
|
1414 |
|
1415 |
|
1416 |
|
1417 |
|
1418 |
|
1419 |
<div align="justify"> |
1420 |
<p style="text-align: justify;"> |
1421 |
|
1422 |
<b><i>Manufacturer</i></b><b></b> |
1423 |
|
1424 |
</p> |
1425 |
</div> |
1426 |
|
1427 |
|
1428 |
|
1429 |
|
1430 |
|
1431 |
|
1432 |
|
1433 |
|
1434 |
|
1435 |
|
1436 |
|
1437 |
|
1438 |
<div align="justify"> |
1439 |
<p style="text-align: justify;"> |
1440 |
|
1441 |
VETERINA Animal Health Ltd., Croatia |
1442 |
|
1443 |
</p> |
1444 |
</div> |
1445 |
|
1446 |
|
1447 |
|
1448 |
|
1449 |
|
1450 |
|
1451 |
|
1452 |
|
1453 |
|
1454 |
|
1455 |
|
1456 |
|
1457 |
<div align="justify"> |
1458 |
<p style="text-align: justify;"> |
1459 |
|
1460 |
|
1461 |
|
1462 |
</p> |
1463 |
</div> |
1464 |
|
1465 |
|
1466 |
|
1467 |
|
1468 |
|
1469 |
|
1470 |
|
1471 |
|
1472 |
|
1473 |
|
1474 |
|
1475 |
|
1476 |
<div align="left"> |
1477 |
<p style="text-align: left;"> |
1478 |
|
1479 |
|
1480 |
|
1481 |
</p> |
1482 |
</div> |
1483 |
|
1484 |
|
1485 |
|
1486 |
|
1487 |
|
1488 |
|
1489 |
|
1490 |
<!--Section Ends--> |
1491 |
|
1492 |
|
1493 |
|
1494 |
|
1495 |
|
1496 |
|
1497 |
|
1498 |
|