Intramammary suspension for cattle (lactating cows).
STATEMENT OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS
One syringe (3g) contains
Active substance:
Amoxicillin 200 mg (as amoxicillin trihydrate);
Clavulanic acid 50 mg (as potassium clavulanate);
Prednisolone 10 mg.
TARGET SPECIES
Cattle (lactating cows).
INDICATIONS
For the treatment of clinical cases of mastitis, including those associated with infections by the following important pathogens:
Staphylococci (including beta-lactamase producing strains).
Streptococci (including S. agalactiae, S. Dysgalactiae and S. uberis).
Escherichia coli (including beta-lactamase producing strains).
CONTRAINDICATIONS
Do not use in animals known to be hypersensitive to beta-lactam antibiotics.
ADVERSE REACTIONS
None known.
DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION
The contents of one syringe should be infused into each affected quarter at the level of the teat canal and sphincter, immediately after the quarter has been completely milked, at 12-hour intervals for 3 consecutive milkings. During the treatment, the clinical evolution should be evaluated by the veterinarian. In cases of infections caused by Staphyloccocus aureus, a longer duration of treatment may be necessary. Therefore, the total duration of treatment can be left to the veterinarian’s decision, but should be long enough to ensure complete resolution of the bacterial condition.
WARNINGS / RECOMMENDATIONS FOR CORRECT ADMINISTRATION
Before the infusion is carried out, the teat should be cleaned and disinfected.
WITHDRAWAL PERIOD
Meat and offal: 7 days.
Milk: 84 hours.
In cows milked twice daily, milk intended for human consumption can be given for consumption at the 7th milking after the last treatment. In the case of any other milking routine, milk can be given for human consumption only after the same period after the last treatment (e.g. milking 3 times daily, milk can be given for human consumption at the 11th milking).
SPECIAL STORAGE PRECAUTIONS
Keep out of reach of children. Do not store above 250°C.
Store in a dry place.
SPECIAL WARNING(S)
The product should only be used for the treatment of clinical mastitis.
The use of the product should be based on epidemiological information regarding the susceptibility of the target bacteria and taking into account official and local antimicrobial policies.
Avoid use of the product in herds where beta-lactamase producing staphylococci have not been isolated. Inappropriate use of the product may increase the incidence of bacteria resistant to beta-lactam antibiotics and may decrease the effectiveness of treatment with beta-lactam antibiotics, due to the potential for cross-resistance.
SPECIAL PRECAUTIONS FOR PERSONNEL ADMINISTERING THE PRODUCT
Penicillins and cephalosporins may cause hypersensitivity (allergic) reactions following self-injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may be associated with cross-sensitivity to cephalosporins and vice versa. Occasionally, allergic reactions to these substances may be serious.
Do not handle this product if you know you are a sensitive person or have been advised not to handle such preparations.
Handle this product with great care to prevent exposure by taking all precautions.
If symptoms occur following exposure to this product, such as: skin itching, you should seek medical advice immediately and show the doctor this warning. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require immediate medical attention. Wash your hands after using this product.
USE DURING PREGNANCY, LACTATION
No special precautions are required.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS OR OTHER FORMS OF INTERACTION
None known.
INCOMPATIBILITIES
In the absence of compatibility studies, this medicinal product should not be mixed with other veterinary medicinal products.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY.
Any unused veterinary medicinal product or waste materials derived from the use of such a product should be disposed of in accordance with local requirements. Medicines should not be disposed of in wastewater or household waste.
PACKAGING/DESIGN
24 x White low density polyethylene syringes.


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