Target species
Cattle and pigs
Indications for use, specifying the target species
In cattle:
Treatment of respiratory infections caused by Mannheimia haemolytica and Pasteurella multocida susceptible to amoxicillin.
In pigs:
Treatment of respiratory infections caused by Pasteurella multocida susceptible to amoxicillin.
Contraindications
Do not use in cases of known hypersensitivity to penicillins, cephalosporins or to any of the excipients.
Do not use in cases of severe renal dysfunction with anuria and oliguria.
Do not use in case of infection with beta-lactamase-producing bacteria.
Do not use in rabbits, hares, hamsters, guinea pigs or other small herbivores.
Do not administer to Equidae, because amoxicillin – like all aminopenicillins – may adversely affect the bacterial flora of the caecum.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
The choice of using amoxicillin should be based on bacterial susceptibility testing and take into account official, national and regional antimicrobial policies.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to amoxicillin and may decrease the effectiveness of treatment with amoxicillin due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillin and cephalosporin may cause an allergic reaction following accidental injection, inhalation or absorption via the skin, which may be life threatening. Hypersensitivity to penicillin may lead to cross sensitivity to cephalosporins and vice versa. Avoid direct contact of the veterinary medicinal product with the skin or the mucosae.
Handle the product with great care to avoid exposure.
Wear gloves and wash hands after use of the veterinary medicinal product.
In case of contact with the skin or eyes, wash immediately with water.
Do not smoke, eat or drink during use of the product.
If you develop symptoms following exposure, such as a skin rash, seek medical advice immediately and show the package leaflet or the label to the physician. Swelling of the face, lips and eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Adverse reactions (frequency and seriousness)
Allergic reactions, varying in severity from a light skin reaction such as urticaria to anaphylactic shock.
In rare cases local irritation may occur due to the injection of amoxicillin. The frequency of this adverse reaction may be decreased by reducing the volume of injection per injection site (see Amounts to administer and administration route). The irritation is always of low intensity and recedes spontaneously and quickly.
In the case of allergic reactions, treatment should be discontinued and a symptomatic treatment should be initiated.
Use during pregnancy, lactation or lay
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects of amoxicillin. However, the tolerance of the medicinal product in cattle and pigs during pregnancy and lactation has not been investigated. In these cases, use only in accordance with the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Do not use with antibiotics which inhibit bacterial protein synthesis, as these can antagonise the bactericidal action of penicillins.
Amounts to be administered and administration route
Intramuscular use.
Shake well before use.
15 mg amoxicillin per kg bodyweight; corresponding to 1 ml of the veterinary medicinal product per 10 kg.
Administration should be repeated after 48 hours.
To ensure a correct dosage and to avoid underdosing, body weight should be determined as accurately as possible.
In cattle, do not administer more than 20 ml of the veterinary medicinal product per injection site.
In pigs, do not administer more than 6 ml of the veterinary medicinal product per injection site.
A separate injection site should be used for each administration.
As with other injectable preparations normal aseptic precautions should be observed.
If no distinct clinical response is seen after the second treatment, a check of the diagnosis and eventually a change of treatment are required.
Do not broach the vial more than 10 times: if necessary, use automatic syringes.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Amoxicillin has a wide safety margin.
Withdrawal period(s)
Cattle:
Meat and offal: 18 days
Milk: 3 days
Pigs:
Meat and offal: 16 days