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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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<div align="justify"> |
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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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<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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- 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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<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> |
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</div> |
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<div 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> |
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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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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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| 778 |
|
| 779 |
|
| 780 |
|
| 781 |
|
| 782 |
<td bgcolor="White" width="50.00%" rowspan="1" colspan="1"> |
| 783 |
|
| 784 |
<div align="justify"> |
| 785 |
<p style="text-align: justify;"> |
| 786 |
|
| 787 |
10 g of Simivet<b><sup>®</sup></b>powder/7 L of water |
| 788 |
|
| 789 |
</p> |
| 790 |
</div> |
| 791 |
|
| 792 |
|
| 793 |
|
| 794 |
|
| 795 |
</td> |
| 796 |
|
| 797 |
|
| 798 |
|
| 799 |
|
| 800 |
|
| 801 |
|
| 802 |
|
| 803 |
</tr> |
| 804 |
|
| 805 |
|
| 806 |
|
| 807 |
<tr> |
| 808 |
<td bgcolor="White" width="50.00%" rowspan="1" colspan="1"> |
| 809 |
|
| 810 |
<div align="justify"> |
| 811 |
<p style="text-align: justify;"> |
| 812 |
|
| 813 |
100 g of Simivet<b><sup>®</sup></b>powder/140 L of water |
| 814 |
|
| 815 |
</p> |
| 816 |
</div> |
| 817 |
|
| 818 |
|
| 819 |
|
| 820 |
|
| 821 |
</td> |
| 822 |
|
| 823 |
|
| 824 |
|
| 825 |
|
| 826 |
|
| 827 |
<td bgcolor="White" width="50.00%" rowspan="1" colspan="1"> |
| 828 |
|
| 829 |
<div align="justify"> |
| 830 |
<p style="text-align: justify;"> |
| 831 |
|
| 832 |
100 g of Simivet<b><sup>®</sup></b>powder/70 L of water |
| 833 |
|
| 834 |
</p> |
| 835 |
</div> |
| 836 |
|
| 837 |
|
| 838 |
|
| 839 |
|
| 840 |
</td> |
| 841 |
|
| 842 |
|
| 843 |
|
| 844 |
|
| 845 |
|
| 846 |
|
| 847 |
|
| 848 |
</tr> |
| 849 |
|
| 850 |
</table> |
| 851 |
|
| 852 |
|
| 853 |
|
| 854 |
|
| 855 |
<div align="justify"> |
| 856 |
<p style="text-align: justify;"> |
| 857 |
|
| 858 |
|
| 859 |
|
| 860 |
</p> |
| 861 |
</div> |
| 862 |
|
| 863 |
|
| 864 |
|
| 865 |
|
| 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 |
|
Parent Directory
| 
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