CLAMOX LC

suspension for intramammary administration in cattle (lactating cows)

Indications

For use in clinical cases of mastitis in lactating cows including cases associated with infections with the following pathogens:

Staphylococci (including β-lactamase producing strains).

Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis).

Escherichia coli (including β-lactamase producing strains).

COMPOSITION

Each syringe of 3 g contains:

Amoxicillin           200 mg  (as  amoxicillin trihydrate)

Clavulanic acid       50 mg (as potassium clavulanate)

Prednisolone       10 mg

CONTRAINDICATIONS

Do not use in animals which are known to be hypersensitive to β-lactam antibiotics.

 

ADVERSE REACTIONS

None known.

If you notice any serious effects, even those not already listed in this leaflet or if you think the medicine has not had an effect, please inform your veterinarian.

 

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

The content of one syringe should be infused into each affected quarter via the teat canal, immediately after milking, at 12 hours intervals for three consecutive milkings.

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

In cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required. Therefore, overall treatment length must be at the veterinary surgeon’s discretion but should be long enough to ensure complete resolution of the intramammary infection.

 

ADVICE ON CORRECT ADMINISTRATION

Before the infusion is made, the teat end should be cleaned and disinfected.

 

WITHDRAWAL PERIODS

Meat and offal: 7 days.

Milk: 84 hours.

During the treatment, milk from lactating cows will not be given to human consumption.

With cows milked twice daily, milk for human consumption may only be taken the 7th milking after the last treatment. Where any other milking routine is followed, milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk may be taken for human consumption at the 11th milking).

Animals will not be slaughtered during treatment.

 

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 25oC.

Store in a dry place.

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

To be stored in the original package.

 

SHELF-LIFE

Shelf-life of the veterinary medicinal product as packaged for sale: 18 months.

 

SPECIAL WARNINGS

Special warnings for each target species

Do not use in cases associated with Pseudomonas.

Special precautions for use in animals

Swab teat end with an appropriate disinfectant before treatment.

The product should be used for treatment of clinical mastitis only.

Use of the product should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria and take into account official and local antimicrobial policies.

Avoid use of the product in herds where no β-lactamase producing Staphylococci strains have been isolated. Inappropriate use of the product may increase the prevalence of bacteria resistant to β-lactam antibiotics and may decrease the effectiveness of treatment with β-lactam antibiotics, due to the potential for cross-resistance.

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 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.

Wash hands after use.

The use during pregnancy, lactation

No special precautions are required.

Interactions with other medicinal products and other forms of interaction

None known

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

Adverse effects should not be expected in the event of accidental overdose.

 

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 syringe with 3g of  suspension for intramammary administration.


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