Summary of Product Characteristics.
Presentation:
Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs. Contains Acetylisovaleryltylosin 42.5 mg/g (as Acetylisovaleryltylosin tartrate) in a
magnesium trisilicate, wheat feed flour carrier.
Uses:
Treatment and prevention of Swine Enzootic Pneumonia caused by susceptible
strains of Mycoplasma hyopneumoniae. At the recommended dose, lung lesions
and weight loss are reduced but infection with Mycoplasma hyopneumoniae is
not eliminated.
Dosage and Administration:
In-feed use. The dosage is 2.125 mg acetylisovaleryltylosin per kg bodyweight
per day. This is normally achieved by incorporating Aivlosin at a level of 1
kg/tonne feed to provide 42.5 mg acetylisovaleryltylosin per kg feed, assuming
that the pig eats 5 % of its bodyweight in feed.
The medicated feed should be fed as the sole ration for 7 days. In older pigs, or
in pigs with reduced appetite, or on restricted feed intake, inclusion levels may
need to be increased to achieve target dosage. Acute cases and severely
diseased pigs with reduced food or water intake should be treated with a suitable
injectable product. Secondary infection by organisms such as Pasteurella
multocida and Actinobacillus pleuropneumoniae may complicate Enzootic
Pneumonia and require specific medication.
Mixing Instructions: A horizontal ribbon mixer should be used to incorporate the
product into feeding stuff. It is recommended that Aivlosin is first mixed with 10 kg
of the feeding stuff, followed by the rest of the feeding stuff and mixed well.
Medicated feed may then be pelleted. Pelleting conditions involve preconditioning
ingredients with steam for 5 minutes and pelleting at 70°C under
normal conditions.
Interaction with other medicinal products and other
forms of interaction: None Known
Contra-indications, warnings etc:
Contra-indications: None.
Undesirable Effects: None known.
If you notice any side effects, please inform your veterinary surgeon.
Withdrawal Period: Meat and offal: Two days.
For animal treatment only.
Special Warning(S): When mixing the veterinary medicinal product and handling
the medicated feed, direct contact with eyes, skin and mucous membranes
should be avoided. Personal protective equipment should be worn when mixing
the veterinary medicinal product or handling the medicated feed: overalls,
impervious gloves and either a disposable half-mask respirator conforming to
European Standard EN 149 or a non-disposable respirator conforming to
European Standard EN 140, with a filter to European Standard EN 143. Wash
contaminated skin.
In case of accidental ingestion seek medical advice immediately and show the
label to the physician. Because Aivlosin has been shown to cause
hypersensitivity reactions in laboratory animals people with known
hypersensitivity to acetylisovaleryltylosin tartrate should avoid any contact with
the product.
The safety of Aivlosin during pregnancy and lactation has not been established in
pigs. Use only in accordance with risk/benefit assessment by the responsible
veterinarian. Studies in laboratory animals have not produced any evidence of
teratogenicity. Maternal toxicity in rodents has been observed at doses of 400
mg acetylisovaleryltylosin per kg bodyweight and above. In mice, a slight
reduction in the foetal bodyweight was seen at doses causing maternal toxicity.
Special Precautions For The Disposal Of Unused Veterinary Medicinal Products
Or Waste Materials Derived From Such Veterinary Medicinal Products, If
Appropriate: Any unused veterinary medicinal product or waste materials
derived from such veterinary medicinal products should be disposed of in
accordance with local requirements.
Conditions Or Restrictions Regarding Supply And Use: Veterinary medicinal
product subject to prescription. Consideration should be given to official
guidance on the incorporation of medicated premixes in final feed.
Pharmaceutical precautions:
Keep out of the reach and sight of children.
Do not store above 25°C.
Keep the container tightly closed.
Store in the original container.
Do not use after the expiry date stated on the label.
Shelf life after incorporation into meal or pelleted feed: 1 month.
Legal Category : MFS
Package quantities: 20kg
Number in the Community Register of Medicinal Products: EU/2/04/044/001
Distributor (UK)
Schering-Plough Animal Health,
Breakspear Road South,
Harefield,
Uxbridge,
Middlesex UB9 6LS,
United Kingdom.
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert.
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