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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> 20%</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>soluble powder</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="left"> |
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<p style="text-align: left;"> |
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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 g contains 200 mg of amoxicillin as amoxicillin trihydrate. |
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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>Action</i></b><i></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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Amoxicillin is a broad-spectrum semi-synthetic penicillin. It exerts bactericidal action on many gram-positive and gram-negative organisms, is stable in gastric acid and is well resorbed from the gastrointestinal tract, achieving rapidly high blood- and tissue levels. Its resorption and antimicrobial action are superior to that of ampicillin. Unlike with ampicillin, resorption of Simivet<b><sup>®</sup></b> is not diminished by food in gastrointestinal tract. |
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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>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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General and local infections due to gram-positive and gram-negative bacteria sensitive to amoxicillin: |
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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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- gastrointestinal infections; |
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</p> |
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</div> |
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<p style="text-align: justify;"> |
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- respiratory infections; |
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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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- genitourinary infections; |
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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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- skin and soft tissue infection; |
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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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- prophylaxis and treatment of chronic respiratory disease complex (CRD) in poultry. |
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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>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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- Commercial layers; |
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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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- 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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- hypersensitivity to penicillin antibiotics, which is extremely rare. |
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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</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> 20% soluble powder is given mixed with feed or dissolved in drinking water, milk or milk substitute. Always prepare a fresh solution. To ensure the intake of medicated drinking water, the animals should be restricted from other sources of liquid 2 hours prior to treatment and during it. |
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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>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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<i>Calves, lambs, kids, piglets and 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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Average dose of amoxicillin for majority of animals is 6-10 mg/kg of b. w., i. e. 1 g of Simivet<b><sup>®</sup></b> 20% soluble powder per 20-33 kg of b. w. every 12 hours. One levelled teaspoonful of powder contains 4 g of the preparation, which is sufficient for the animal weighing 80-130 kg (e. g. calf). |
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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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When preparing medicated feed (e. g. for swine) mix 200-320 g of powder with 100 kg of feed, which makes 400-640 ppm of amoxicillin trihydrate. |
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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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<i>Poultry</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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Simivet<b><sup>®</sup></b> 20% soluble powder is given with drinking water in the dose of 100 g per 70-140 L of water, which makes 300 mg, i. e. 150 mg of amoxicillin per 1 L of water. The doses are relevant to the required water volume: |
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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="100.00%" border="1" cols="2" rows="4"> |
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<tr> |
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<td bgcolor="White" width="50.00%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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<b>150 mg of amoxicillin/L of water</b> |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="50.00%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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300 mg of amoxicillin/L of water |
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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="50.00%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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|
723 |
1 g of Simivet<b><sup>®</sup></b>powder/1.4 L of water |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="50.00%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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1 g of Simivet<b><sup>®</sup></b>powder/0.7 L of water |
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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="50.00%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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10 g of Simivet<b><sup>®</sup></b>powder/14 L of water |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="50.00%" 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 g of Simivet<b><sup>®</sup></b>powder/7 L of water |
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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="50.00%" 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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100 g of Simivet<b><sup>®</sup></b>powder/140 L of water |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="50.00%" rowspan="1" colspan="1"> |
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<div align="justify"> |
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<p style="text-align: justify;"> |
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100 g of Simivet<b><sup>®</sup></b>powder/70 L of water |
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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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866 |
|
867 |
|
868 |
|
869 |
|
870 |
|
871 |
|
872 |
|
873 |
|
874 |
<div align="justify"> |
875 |
<p style="text-align: justify;"> |
876 |
|
877 |
Relevant to severity of the infection, the treatment lasts for 3-5 days, i. e. at least 1 additional day upon remission of clinical symptoms. Gram-negative infections and severe diseases, particularly acute infections, are treated with higher doses without any risk of side effects. |
878 |
|
879 |
</p> |
880 |
</div> |
881 |
|
882 |
|
883 |
|
884 |
|
885 |
|
886 |
|
887 |
|
888 |
|
889 |
|
890 |
|
891 |
|
892 |
|
893 |
<div align="justify"> |
894 |
<p style="text-align: justify;"> |
895 |
|
896 |
|
897 |
|
898 |
</p> |
899 |
</div> |
900 |
|
901 |
|
902 |
|
903 |
|
904 |
|
905 |
|
906 |
|
907 |
|
908 |
|
909 |
|
910 |
|
911 |
|
912 |
<div align="justify"> |
913 |
<p style="text-align: justify;"> |
914 |
|
915 |
<b><i>Warnings, precautions and interactions</i></b> |
916 |
|
917 |
</p> |
918 |
</div> |
919 |
|
920 |
|
921 |
|
922 |
|
923 |
|
924 |
|
925 |
|
926 |
|
927 |
|
928 |
|
929 |
|
930 |
|
931 |
<div align="justify"> |
932 |
<p style="text-align: justify;"> |
933 |
|
934 |
In the ruminants with functionally developed forestomach, systemic infections are not treated with oral amoxicillin. |
935 |
|
936 |
</p> |
937 |
</div> |
938 |
|
939 |
|
940 |
|
941 |
|
942 |
|
943 |
|
944 |
|
945 |
|
946 |
|
947 |
|
948 |
|
949 |
|
950 |
<div align="justify"> |
951 |
<p style="text-align: justify;"> |
952 |
|
953 |
|
954 |
|
955 |
</p> |
956 |
</div> |
957 |
|
958 |
|
959 |
|
960 |
|
961 |
|
962 |
|
963 |
|
964 |
|
965 |
|
966 |
|
967 |
|
968 |
|
969 |
<div align="justify"> |
970 |
<p style="text-align: justify;"> |
971 |
|
972 |
Sick animals taking scarce water and feed should be treated by parenteral route. |
973 |
|
974 |
</p> |
975 |
</div> |
976 |
|
977 |
|
978 |
|
979 |
|
980 |
|
981 |
|
982 |
|
983 |
|
984 |
|
985 |
|
986 |
|
987 |
|
988 |
<div align="justify"> |
989 |
<p style="text-align: justify;"> |
990 |
|
991 |
|
992 |
|
993 |
</p> |
994 |
</div> |
995 |
|
996 |
|
997 |
|
998 |
|
999 |
|
1000 |
|
1001 |
|
1002 |
|
1003 |
|
1004 |
|
1005 |
|
1006 |
|
1007 |
<div align="justify"> |
1008 |
<p style="text-align: justify;"> |
1009 |
|
1010 |
If after three days of treatment there is no apparent improvement, causative organism is probably amoxicillin-resistant, which requires institution of another antimicrobial. |
1011 |
|
1012 |
</p> |
1013 |
</div> |
1014 |
|
1015 |
|
1016 |
|
1017 |
|
1018 |
|
1019 |
|
1020 |
|
1021 |
|
1022 |
|
1023 |
|
1024 |
|
1025 |
|
1026 |
<div align="justify"> |
1027 |
<p style="text-align: justify;"> |
1028 |
|
1029 |
|
1030 |
|
1031 |
</p> |
1032 |
</div> |
1033 |
|
1034 |
|
1035 |
|
1036 |
|
1037 |
|
1038 |
|
1039 |
|
1040 |
|
1041 |
|
1042 |
|
1043 |
|
1044 |
|
1045 |
<div align="justify"> |
1046 |
<p style="text-align: justify;"> |
1047 |
|
1048 |
<b><i>Withdrawal</i></b> |
1049 |
|
1050 |
</p> |
1051 |
</div> |
1052 |
|
1053 |
|
1054 |
|
1055 |
|
1056 |
|
1057 |
|
1058 |
|
1059 |
|
1060 |
|
1061 |
|
1062 |
|
1063 |
|
1064 |
<div align="justify"> |
1065 |
<p style="text-align: justify;"> |
1066 |
|
1067 |
Meat, organs and other edible tissues |
1068 |
|
1069 |
</p> |
1070 |
</div> |
1071 |
|
1072 |
|
1073 |
|
1074 |
|
1075 |
|
1076 |
|
1077 |
|
1078 |
|
1079 |
|
1080 |
|
1081 |
|
1082 |
|
1083 |
<div align="justify"> |
1084 |
<p style="text-align: justify;"> |
1085 |
|
1086 |
Calves, swine, lambs, kids 7 days |
1087 |
|
1088 |
</p> |
1089 |
</div> |
1090 |
|
1091 |
|
1092 |
|
1093 |
|
1094 |
|
1095 |
|
1096 |
|
1097 |
|
1098 |
|
1099 |
|
1100 |
|
1101 |
|
1102 |
<div align="justify"> |
1103 |
<p style="text-align: justify;"> |
1104 |
|
1105 |
Broilers 1 day |
1106 |
|
1107 |
</p> |
1108 |
</div> |
1109 |
|
1110 |
|
1111 |
|
1112 |
|
1113 |
|
1114 |
|
1115 |
|
1116 |
|
1117 |
|
1118 |
|
1119 |
|
1120 |
|
1121 |
<div align="justify"> |
1122 |
<p style="text-align: justify;"> |
1123 |
|
1124 |
|
1125 |
|
1126 |
</p> |
1127 |
</div> |
1128 |
|
1129 |
|
1130 |
|
1131 |
|
1132 |
|
1133 |
|
1134 |
|
1135 |
|
1136 |
|
1137 |
|
1138 |
|
1139 |
|
1140 |
<div align="justify"> |
1141 |
<p style="text-align: justify;"> |
1142 |
|
1143 |
<b><i>Storage</i></b> |
1144 |
|
1145 |
</p> |
1146 |
</div> |
1147 |
|
1148 |
|
1149 |
|
1150 |
|
1151 |
|
1152 |
|
1153 |
|
1154 |
|
1155 |
|
1156 |
|
1157 |
|
1158 |
|
1159 |
<div align="justify"> |
1160 |
<p style="text-align: justify;"> |
1161 |
|
1162 |
Store in a dry place at room temperature (up to 25°C). Keep away from children. |
1163 |
|
1164 |
</p> |
1165 |
</div> |
1166 |
|
1167 |
|
1168 |
|
1169 |
|
1170 |
|
1171 |
|
1172 |
|
1173 |
|
1174 |
|
1175 |
|
1176 |
|
1177 |
|
1178 |
<div align="justify"> |
1179 |
<p style="text-align: justify;"> |
1180 |
|
1181 |
|
1182 |
|
1183 |
</p> |
1184 |
</div> |
1185 |
|
1186 |
|
1187 |
|
1188 |
|
1189 |
|
1190 |
|
1191 |
|
1192 |
|
1193 |
|
1194 |
|
1195 |
|
1196 |
|
1197 |
<div align="justify"> |
1198 |
<p style="text-align: justify;"> |
1199 |
|
1200 |
<b><i>Shelf life</i></b> |
1201 |
|
1202 |
</p> |
1203 |
</div> |
1204 |
|
1205 |
|
1206 |
|
1207 |
|
1208 |
|
1209 |
|
1210 |
|
1211 |
|
1212 |
|
1213 |
|
1214 |
|
1215 |
|
1216 |
<div align="justify"> |
1217 |
<p style="text-align: justify;"> |
1218 |
|
1219 |
Denoted on the packaging (3 years in the original pack).<b><i></i></b> |
1220 |
|
1221 |
</p> |
1222 |
</div> |
1223 |
|
1224 |
|
1225 |
|
1226 |
|
1227 |
|
1228 |
|
1229 |
|
1230 |
|
1231 |
|
1232 |
|
1233 |
|
1234 |
|
1235 |
<div align="justify"> |
1236 |
<p style="text-align: justify;"> |
1237 |
|
1238 |
|
1239 |
|
1240 |
</p> |
1241 |
</div> |
1242 |
|
1243 |
|
1244 |
|
1245 |
|
1246 |
|
1247 |
|
1248 |
|
1249 |
|
1250 |
|
1251 |
|
1252 |
|
1253 |
|
1254 |
<div align="justify"> |
1255 |
<p style="text-align: justify;"> |
1256 |
|
1257 |
Legal category |
1258 |
|
1259 |
</p> |
1260 |
</div> |
1261 |
|
1262 |
|
1263 |
|
1264 |
|
1265 |
|
1266 |
|
1267 |
|
1268 |
|
1269 |
|
1270 |
|
1271 |
|
1272 |
|
1273 |
<div align="justify"> |
1274 |
<p style="text-align: justify;"> |
1275 |
|
1276 |
On prescription only. |
1277 |
|
1278 |
</p> |
1279 |
</div> |
1280 |
|
1281 |
|
1282 |
|
1283 |
|
1284 |
|
1285 |
|
1286 |
|
1287 |
|
1288 |
|
1289 |
|
1290 |
|
1291 |
|
1292 |
<div align="justify"> |
1293 |
<p style="text-align: justify;"> |
1294 |
|
1295 |
|
1296 |
|
1297 |
</p> |
1298 |
</div> |
1299 |
|
1300 |
|
1301 |
|
1302 |
|
1303 |
|
1304 |
|
1305 |
|
1306 |
|
1307 |
|
1308 |
|
1309 |
|
1310 |
|
1311 |
<div align="justify"> |
1312 |
<p style="text-align: justify;"> |
1313 |
|
1314 |
<b><i>Supply</i></b> |
1315 |
|
1316 |
</p> |
1317 |
</div> |
1318 |
|
1319 |
|
1320 |
|
1321 |
|
1322 |
|
1323 |
|
1324 |
|
1325 |
|
1326 |
|
1327 |
|
1328 |
|
1329 |
|
1330 |
<div align="justify"> |
1331 |
<p style="text-align: justify;"> |
1332 |
|
1333 |
Bags with 100 g and 1000 g. |
1334 |
|
1335 |
</p> |
1336 |
</div> |
1337 |
|
1338 |
|
1339 |
|
1340 |
|
1341 |
|
1342 |
|
1343 |
|
1344 |
|
1345 |
|
1346 |
|
1347 |
|
1348 |
|
1349 |
<div align="justify"> |
1350 |
<p style="text-align: justify;"> |
1351 |
|
1352 |
|
1353 |
|
1354 |
</p> |
1355 |
</div> |
1356 |
|
1357 |
|
1358 |
|
1359 |
|
1360 |
|
1361 |
|
1362 |
|
1363 |
|
1364 |
|
1365 |
|
1366 |
|
1367 |
|
1368 |
<div align="justify"> |
1369 |
<p style="text-align: justify;"> |
1370 |
|
1371 |
<b><i>Manufacturer</i></b> |
1372 |
|
1373 |
</p> |
1374 |
</div> |
1375 |
|
1376 |
|
1377 |
|
1378 |
|
1379 |
|
1380 |
|
1381 |
|
1382 |
|
1383 |
|
1384 |
|
1385 |
|
1386 |
|
1387 |
<div align="justify"> |
1388 |
<p style="text-align: justify;"> |
1389 |
|
1390 |
VETERINA Animal Health Ltd., Croatia |
1391 |
|
1392 |
</p> |
1393 |
</div> |
1394 |
|
1395 |
|
1396 |
|
1397 |
|
1398 |
|
1399 |
|
1400 |
|
1401 |
|
1402 |
|
1403 |
|
1404 |
|
1405 |
|
1406 |
<div align="justify"> |
1407 |
<p style="text-align: justify;"> |
1408 |
|
1409 |
|
1410 |
|
1411 |
</p> |
1412 |
</div> |
1413 |
|
1414 |
|
1415 |
|
1416 |
|
1417 |
|
1418 |
|
1419 |
|
1420 |
|
1421 |
|
1422 |
|
1423 |
|
1424 |
|
1425 |
<div align="left"> |
1426 |
<p style="text-align: left;"> |
1427 |
|
1428 |
|
1429 |
|
1430 |
</p> |
1431 |
</div> |
1432 |
|
1433 |
|
1434 |
|
1435 |
|
1436 |
|
1437 |
|
1438 |
|
1439 |
<!--Section Ends--> |
1440 |
|
1441 |
|
1442 |
|
1443 |
|
1444 |
|
1445 |
|
1446 |
|
1447 |
|