Target species
Pigs (weaned piglets)
Indications for use, specifying the target species
In weaned piglets: in herds where infection has been confirmed; treatment of infections caused by Streptococcus suis susceptible to amoxicillin.
Contraindications
Do not use in cases of hypersensitivity to penicillins, to other β-lactams or to the excipient.
Do not use orally to rabbits, guinea pigs, hamsters and horses since the amoxicillin, like all the aminopenicillins, has adverse impact on caecal microflora population. Do not use in the presence of ß-lactamase-producing bacteria.
Special warnings for each target species
Sick animals may have reduced feed intake and consequently, may require parenterally administered medication instead.
The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of amoxicillin has to be adjusted accordingly.
Special precautions for use
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin and may decrease the effectiveness of the treatment.
The prolonged or repeated use should be avoided by e.g. improving management practices, proper cleaning and disinfection. Particular attention should be paid to improvement of farming practices to avoid any stress condition.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Persons handling this product should avoid inhalation of any dust and contact with skin. Wear either a disposable half-mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard to EN140 with filter EN143 when mixing or handling this product.
Rubber gloves should be worn when mixing or handling this product. Hands and exposed skin should be washed thoroughly after use.
Do not smoke, eat or drink while handling the product.
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 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 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 with breathing, are more serious symptoms and require urgent medical attention.
Adverse reactions (frequency and seriousness)
In very rare cases, the following adverse reactions may occur:
- Hypersensitivity reactions, the severity varying from skin rash to anaphylactic shock.
- Gastrointestinal symptoms (vomiting, diarrhoea).
- Haematology disturbances and colitis.
Use during pregnancy, lactation or lay
Not applicable.
Interaction with other medicinal products and other forms of interaction
Do not use simultaneously with neomycin since it blocks the absorption of oral penicillins.
Do not use jointly with antibiotics that inhibit the bacterial protein synthesis since they can antagonise the bactericidal action of penicillins.
Amounts to be administered and administration route
For oral administration only after incorporation in feed. In-feed use at the final dose 15 mg amoxicillin/ kg b.w./ day, during 14 consecutive days.
In the case of an altered feed intake (clinical status, weight class, age, environment), adjust the incorporation rate in order to guarantee an intake of 15 mg amoxicillin/kg b.w./day.
According to the recommended dose, the number and animal's weight to be treated, the exact dose of medicinal product to be incorporated in the feed should be calculated using the following formula:
0.3 g of medicinal product X Average bodyweight of treated animals (kg)/day | |
____________________________________________________________ | = kg Vetrimoxin/ton of feed |
Daily feed intake (kg) | |
During the granulation, mixture should not reach a temperature above 60ºC.
Body weight should be evaluated accurately to avoid underdosing.
Feed intake depends on the clinical condition of the animal, thus the concentration in the feed should be adjusted to assure the correct dosage. Mix well to ensure homogeneous distribution.
The medicated feed should be the only source of feed during the 14 days of treatment, which represents the maximum period of treatment with the product.
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 2 kg per tonne for final feed.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In the event of severe allergic reactions stop the treatment and administer corticosteroids and adrenaline.
In other cases administer symptomatic treatment.
Withdrawal period(s)
Meat and offal: 3 days