Stabox 50 mg/g premix for medicated feeding stuff for pigs

Composition

Each g contains:

Active substance:

Amoxicillin………………………50mg

(as Amoxicillin trihydrate)

Excipients:

Qualitative composition of excipients and other constituents

Polyvidone K 90

Rofelys (maize based)

Beige to brown powder with some white to yellow grains.

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Pharmacological properties

4.1 ATCvet code: QJ01CA04

4.2 Pharmacodynamics

The veterinary medicinal product contains 5% coated amoxicillin for oral administration to piglets as a medicated-feed supplement.

The formulation of this veterinary medicinal product 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 microorganisms, penicillinase staphylococci, Corynebacteria (Actinomyces, Eubacteria) Clostridia, Bacillus anthracis for the Gram-positive germs and Campylobacter, Pasteurella, Escherichia coli, Salmonella, Brachyspira hyodysenteriae, Bordetella, Actinobacillus pleuropneumoniae for the Gram-negative germs.

4.3 Pharmacokinetics

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.

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Target species

Pigs (weaned piglets)

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Indications

For the treatment and metaphylaxis of diseases caused by Streptococcus suis in weaned piglets.

The presence of the disease in the group must be established before the product is used.

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Dosage

In-feed use.

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 of bodyweight daily for 14 consecutive days.

This dose may be achieved by the addition of:

1) 400 ppm or 8 kg of the veterinary medicinal product per tonne of feed in starter feed

2) 300 ppm or 6 kg of the veterinary medicinal product per tonne 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.

The intake of medicated feed depends on the clinical condition of the animal. In order to obtain the correct dosage, the concentration of the veterinary medicinal product has to be adjusted accordingly.

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Contraindications

Do not use in cases of hypersensitivity to the active substance.

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Adverse reactions

Pigs (weaned piglets):

Undetermined frequency Hypersensitivity reaction1 (e.g. allergic reaction1) (cannot be estimated from the available data):

1 May occasionally be serious.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the immediate packaging for respective contact details.

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Warnings

Special precautions for safe use in the target species:

The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of feed/water, animals should be treated parenterally. Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing.

Use of the product should be in accordance with official, national and regional antimicrobial policies.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

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. Allergic reactions 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 penicillin-containing products.

Handle this product with great care to avoid exposure, taking recommended precautions.

If you develop symptoms following exposure such as skin rash, seek medical advice immediately and show the package leaflet or the label to the physician.

Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and may require urgent medical attention.

When incorporating into feed, adequate measures must be taken not to create dust or to inhale any dust. Personal protective equipment consisting of a disposable half-mask respirator conforming to European Standard EN149 FFP1 (or non-disposable respirator to European Standard EN140 with a filter to EN143), coveralls, impervious gloves and safety glasses should be worn when handling the veterinary medicinal product.

Avoid skin contact.

Hands and exposed skin should be washed thoroughly after use.

Do not smoke or eat during use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Do not use for prophylaxis.

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Use during pregnancy, lactation or lay

Not applicable.

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Interactions

The bactericidal effect of amoxicillin is neutralised by simultaneous use of bacteriostatic acting pharmaceuticals.

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Overdose

Penicillins have a wide margin of safety.

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Special warnings

None.

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Withdrawal period

Meat and offal: 4 days

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Incompatibilities

None known.

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Immediate packaging

Pack sizes: 1 kg can, 6 kg, 5 kg, 8 kg, 10 kg, 20 kg, 25 kg and 50 kg bags

1 kg cans are made of white high density polyethylene stopped by a yellow high density polyethylene screw-fit lid.

6 kg, 8 kg, 10 kg, 20 kg and 50 kg bags are made of 4 layers: low density polyethylene film /paper/ paper/ external film made of paper, polyethylene and aluminium complex.

5 and 25 kg bags are made of 4 layers: low density polyethylene film / paper / film made of paper, polyethylene and aluminium complex/ external paper film.

Not all pack sizes may be marketed.

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Storage

Store below 30°C

Store in the original container.

Store in a dry place.

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Shelf life

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

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

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 05653/4044

8 DATE OF FIRST AUTHORISATION

02 November 1995

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

October 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 17 December 2025

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Registration holder

VIRBAC

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