MICROCLOX EDC

COMPOSITION

A syringe of 4.5 mL (3.6 g) contains

active substance

Cloxacillin benzathine 765.4 mg equivalent to 600 mg cloxacillin              

TARGET SPECIES

Cattle (cows in dry period)

INDICATIONS

Indications for use, specifying target species

MICROCLOX EDC is recommended in milk cows during dry periods, for the treatment of existing intramammary infections, including subclinical mastitis, and to provide prolonged protection against potential infections throughout their dry periods. MICROCLOX EDC is effective against Gram-positive germs that cause mastitis: streptococci (S. agalactiae, S. dysgalaciae, S. uberis), penicillin-resistant staphylococci and Arcanobacterium pyogenes. Cloxacillin is bactericidal and is not inhibited by staphylococcal beta-lactamase. It is also active against penicillin-resistant staphylococci that are the main cause of mastitis.

CONTRAINDICATIONS

Do not use in lactating cows. 

However, if the product has been accidentally administered, the milk will not be used for human consumption for a period of at least 46 days or less if no specific antibiotic residues are detected by specific tests. Do not use in animals with hypersensitivity to cloxacillin or to any of the excipients.

ADVERSE REACTIONS

None known.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 

Treatment consists of a single syringe in each quarter of the udder, immediately after the last milking, before the dry period. During treatment, the situation should be frequently re-evaluated by the veterinarian.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

Before the administration, the nipple must be cleaned and disinfected.

Be careful not to infect the tip of the syringe.

Insert the tip of the intramammary syringe into the nipple and empty the contents by pressing the syringe plunger. After administration, nipple is introduced into special solutions for nipple protection.

WITHDRAWAL PERIOD(S)

Do not administer to cows that have a 42-day or less dry period.

Milk for human consumption can only be used 96 hours after calving. If calving occurs within 42 days after treatment, milk may be given for human consumption after the 42 days plus 96 hours from calving. Animals intended for human consumption will not be slaughtered during treatment. Cattle will be slaughtered for human consumption 28 days after the last treatment. 

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on testing the susceptibility of bacteria isolated from animals. If this is not possible, therapy should be based on local epidemiological information on target bacteria’s susceptibility.

National and regional official antimicrobial policies shall be observed when using the product.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Penicillins and cephalosporins may produce hypersensitivity (allergy) reactions after self-injection, inhalation, ingestion or skin contact. Penicillin hypersensitivity may be associated with cross-sensitivity to cephalosporins and vice versa. Occasionally, the allergic reactions to these substances can be serious.

Those with known sensitivity or those who have been warned by the physician not to handle such preparations shall not handle this product.

Handle this product with great care to prevent exposure and take all precautions.

If symptoms occur following exposure to this product, such as rash, you should immediately see a doctor and present 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 AND LACTATION 

Do not use in lactating cows.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

None known.

INCOMPATIBILITIES

None known.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 

PRESENTATION/PACKAGE

White low-density polyethylene syringes.