MICROCLOX EDC

600 mg/syringe, intramammary suspension for cows (dry period)

Indications

MICROCLOX EDC is recommended for use in cows at drying off, to treat existing intramammary infection, including subclinical mastitis and to provide prolonged protection against new infections during the dry period.

MICROCLOX EDC is active against Gram-positive organisms associated with mastitis. These include Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, penicillin-resistant and sensitive staphylococci and Arcanobacterium pyogenes. Cloxacillin has bactericidal action and is not inactivated by staphylococcal beta-lactamase. It is therefore, active against penicillin-resistant staphylococci which are an important cause of mastitis.

COMPOSITION

Each syringe of 4.5 ml (3.6 g) contains:

Cloxacillin  600 mg (equivalent to 765,4 mg cloxacillin benzathine)

 

CONTRAINDICATIONS

Do not use in the lactating cow. If a lactating cow is accidentally infused, milk should not be given for human consumption for at least 46 days, or less if no specific antibiotic residues are detected by specific tests. Do not use in animals with known hypersensitivity to cloxacillin or excipients.

 

ADVERSE REACTIONS

None known.

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

 

DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

For intramammary use only.

One syringe to be infused per quarter immediately after cleaning and disinfecting the teats following the last milking before drying off. 

 

ADVICE ON CORRECT ADMINISTRATION

Before administering the product, the nipple must be cleaned and disinfected. Care should be taken to avoid contamination of the injector nozzle. Insert nozzle into the teat and apply gentle and continuous pressure until the suspension is expressed. Keep the peak of the nipple and exert a gentle upward massage to facilitate the dispersion of the product into the udder quarter. After infusion it is advisable to dip each teat in a licensed teat dip.

During treatment, the clinical evolution should be evaluated by the veterinarian.

 

WITHDRAWAL PERIOD

Not intended for use in cows with dry periods of 42 days or less. 

Milk for human consumption may only be taken from 96 hours after calving. If calving occurs before 42 days after last treatment, milk for human consumption may only be taken from 42 days plus 96 hours after the last treatment. Cattle must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 28 days from the last treatment.

 

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

The expiry date refers to the last day of that month.

 

SHELF-LIFE

Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.

 

SPECIAL WARNINGS

Special precautions for use in animals

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. Official, national and regional antimicrobial policies will be considered when using the product.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to cloxacillin and may decrease the effectiveness of treatment with other beta-lactam antibiotics.

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 cephalosporins and vice versa. Allergic reaction to these substances may occasionally be serious. Do not handle this product if you know you are sensitized, 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 skin rash, you should seek medical advice. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and may require urgent medical attention. Wash hands after use.

Use during pregnancy, lactation or lay

Not for use in lactating cows.

Interaction with other medicinal products and other forms of interaction

None known.

Incompatibilities

None known.

Overdose (symptoms, emergency procedures, antidotes), if necessary

Not applicable.

 

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

Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment

 

PRESENTATION/PACKAGE

Low density polyethylene syringes containing 4.5 ml (3.6 g).


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