A feed premix containing 5% amoxycillin for incorporation into pig feed.

The amoxycillin in Stabox has been coated by a special process which improves stability during the manufacture and storage of pig feed (meal and pellets).

For the control of diseases caused by Streptococcus suis in weaned piglets.

For incorporation into dry feed at the registered mill. A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or premixtures containing such products must be responsible for mixing when incorporation is less than 2kg per tonne for final feed.

15 mg of amoxicillin per kg or bodyweight daily for 14 consecutive days.

This dose may be achieved by the addition of:

1) 400 ppm or 8 kg of Stabox per ton of feed in starter feed

2) 300 ppm or 6 kg of Stabox per ton of feed in feed intended for piglets older than 6 weeks.

To ensure thorough dispersion, the product should first be mixed with a suitable quantity of feed before incorporation in the final mix. The product can be incorporated into pelleted feed, preconditioned at a temperature not greater than 80°C, humidity of around 18 per cent and pressure of about 10 bars.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing. The intake of medicated feed depends on the clinical condition of the animal. In order to obtain the correct dosage, the concentration of Stabox has to be adjusted accordingly.

None known.

No special warnings

Whenever possible, Stabox should only be used based on susceptibility testing. Official, national and regional antimicrobial policies should be taken into account when the product is used.

Adequate measures must be taken not to create dust when incorporation of the product into feed is occurring. Whilst handling the product wear coveralls, protective goggles and chemically resistant impermeable gloves all times. Avoid inhalation of dust. Wear either a disposable half-mask respirator conforming to European Standard EN149 or non-disposable respirator to European Standard EN140 with a filter to EN143.

Do not smoke or eat during use. Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephaloporins and vice versa.

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 skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

WASH HANDS AFTER USE.

None known

Not applicable

None known

Penicillins have a wide margin of safety.

Meat : 4 days

Keep out of the reach of children.

Povidone K90, Rofelys

Incompatibilities: None known.

Shelf life of the veterinary medicinal product as packaged for sale : 2 years

Shelf life after incorporation into meal or pelleted feed : 6 months.

Special precautions for storage

Store in tightly-closed original container. Store in a dry place. Do not store above 30°C

Avoid extremes of temperature. Once incorporate into pelleted feed, use the product within 6 months.

25 kg bags.

PHARMACOLOGICAL PROPERTIES

ATC Vet Code: J01CA04

Pharmacotherapeutic group: Antiinfectives for systemic use

Pharmacodynamic properties: Stabox contains 5% coated amoxicillin for oral administration to piglets as a medicated-feed supplement. The formulation of Stabox is based on a new concept of coating the active ingredient. This method stabilises the amoxicillin and makes it less sensitive to temperature variations during storage, pelleting and storage of pelleted feed. Amoxicillin is a bactericidal antibiotic of the beta-lactam family which acts by blocking the biosynthesis of the cell wall. As a bactericidal antibiotic, amoxicillin inhibits the development of the peptidoglycan network structure of the bacterial cell wall. It is thought to act on transpeptidation which is the last step in the synthesis of the final bacterial membrane structure. Amoxicillin exerts very low M.I.C. values against Streptococcus suis type 2 (MIC 90 < 0.02 µg/ml) and is very active against other Streptococcus micro-organisms, Corynebacteria (Actinomyces, Eubacteria) Clostridia, Bacillus anthracis for the gram-positive bacteria and Pasteurella, Escherichia coli, Salmonella, Bordetella for the gram-negative bacteria.

Pharmacokinetic properties: When administered orally to 7-week-old piglets at the recommended dosage of 15 mg/kg bodyweight/day for 14 days, therapeutic plasma levels were maintained throughout the treatment. Amoxicillin is mainly excreted in the urine under its natural form and as penicilloic acid.