Vetremox Fish 100% W/W Powder For Top-Dressing Use
Revised: 24 August 2010
AN: 00737/2010
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SUMMARY OF PRODUCT CHARACTERISTICS |
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1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
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Vetremox Fish 100% w/w Powder for top-dressing use |
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2. |
QUALITATIVE AND QUANTITATIVE COMPOSITION |
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Amoxicillin trihydrate |
100% w/w |
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For full list of excipients, see section 6.1 |
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3. |
PHARMACEUTICAL FORM |
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Powder for top-dressing use A fine white to cream crystalline powder |
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4. |
CLINICAL PARTICULARS |
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4.1 |
Target species |
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Atlantic salmon |
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4.2 |
Indications for use, specifying the target species |
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Furunculosis in Atlantic salmon, caused by Aeromonas salmonicida |
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4.3 |
Contraindications |
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In common with all other penicillins, Amoxycillin should not be used orally or parenterally in rabbits, guinea pigs, hamsters, gerbils or other very small herbivores. |
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4.4 |
Special warnings for each target species |
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None. |
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4.5 |
Special precautions for use |
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i. |
Special precautions for use in animals |
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None. |
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ii. |
Special precautions for the person administering the veterinary medicinal product to animals |
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Avoid skin contact. Whilst handling the product wear coveralls, protective goggles and chemically resistant impermeable gloves at all times. Avoid inhalation of dust. Wear either a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143. Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reaction to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure taking all recommended precautions. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention. Wash hands after use. |
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4.6 |
Adverse reactions (frequency and seriousness) |
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Product knowledge suggests resistance to antimicrobials in aquatic situations appears readily. It is recommended that resistance patterns in relevant pathogenic bacteria should be monitored. |
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4.7 |
Use during pregnancy, lactation or lay |
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Not applicable. |
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4.8 |
Interaction with other medicinal products and other forms of interaction |
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Not to be administered with other antibacterials. |
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4.9 |
Amount(s) to be administered and administration route |
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Dose Regime The product is administered at the rate of 80mg/kg bodyweight per day. A ten day course is recommended. Method of Administration The product is for administration only through feed by mixing with manufactured feed prior to feeding. Feeding rates will vary according to water temperature and it may therefore more convenient to medicate on a basis of a fixed rate: e.g. 1% of bodyweight with the extra daily feed requirement being met by unmedicated food. The following inclusion rates will provide the recommended dose.
As an aid to the adhesion of the product, edible oil or tepid gelatine solution is added to the feed while mixing until the feeds slightly dampened. The medicated feed should then be allowed to dry before feeding to the fish. |
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4.10 |
Overdose (symptoms, emergency procedures, antidotes), if necessary |
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None. |
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4.11 |
Withdrawal period(s) |
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Atlantic salmon may be slaughtered for human consumption only after 500 degree days from the last treatment. |
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5. |
PHARMACOLOGICAL PROPERTIES |
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Pharmacotherapeutic group: |
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Antibacterials for systemic use (amoxicillin) |
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ATC Vet Code: QJ01CA04 |
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5.1 |
Pharmacodynamic properties |
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A broad-spectrum semi-synthetic penicillin which has bactericidal activity against Gram-negative and Gram-positive bacteria. |
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5.2 |
Pharmacokinetic properties |
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Amoxicillin is acid stable, well absorbed following oral administration in the presence of feed and is excreted via the kidneys. |
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6. |
PHARMACEUTICAL PARTICULARS |
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6.1 |
List of excipients |
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None. |
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6.2 |
Incompatibilities |
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None known. |
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6.3 |
Shelf life |
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Shelf life of the veterinary medicinal product as packaged for sale: 18 months |
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6.4 |
Special precautions for storage |
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Do not store above 25°C. Store in a dry place. Store in tightly closed original container Medicated feed: use at once after preparation: Do not store. |
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6.5 |
Nature and composition of immediate packaging |
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400g, 1kg, 2kg, 3.2kg, 4kg, 5kg and 10kg White polypropylene tubs with white polypropylene lids and low density polyethylene liner.. Not all pack sizes may be marketed. |
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6.6 |
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate |
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Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. |
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7 |
MARKETING AUTHORISATION HOLDER |
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Pharmaq Limited Unit 15 Sandleheath Industrial Estate Fordingbridge Hants SP6 1PA |
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8. |
MARKETING AUTHORISATION NUMBER(S) |
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Vm 11003/4005 |
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9. |
DATE OF FIRST AUTHORISATION |
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12th April 1999 |
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10. |
DATE OF REVISION OF THE TEXT |
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August 2010 |
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