Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Kloxerate DC (Dry Cow) is an off-white, stable intramammary suspension prepared under sterile conditions. Each single dose 4.5 g syringe contains 500 mg cloxacillin as the benzathine salt in a long acting base with 3% aluminium monostearate.

Benzathine cloxacillin is a semi-synthetic penicillin derived from 6-aminopenicillanic acid.

Uses

Kloxerate DC (Dry Cow) is formulated for use in the dairy cow at the point of drying off, that is immediately after the last milking of the lactation in order to treat existing mastitis and to provide protection against further infections during the dry period.

Kloxerate DC is indicated for use against those Gram-positive bacteria associated with mastitis and susceptible to cloxacillin therapy, such as most Streptococcus agalactiae, Streptococcus dysgalactiae and other streptococci, penicillin resistant and penicillin sensitive staphylococci and Arcanobacterium pyogenes species.

As cloxacillin is not destroyed by staphylococcal penicillinase, Kloxerate DC is indicated against penicillin resistant staphylococci which are an important cause of bovine mastitis. Kloxerate DC contains benzathine cloxacillin in a long acting aluminium monostearate base and maintains effective antibacterial levels in the dry cow udder for approximately four weeks.

Kloxerate DC is bactericidal in action and is non-irritant in the udder tissue.

Dosage and administration

For intramammary use. After the final milking of a lactation, clean and disinfect the teats and introduce the contents of one syringe into each quarter via the teat canal.

Advice on correct administration:

Before infusion, the teat should be thoroughly cleaned and disinfected and care should be taken to avoid contamination of the injection nozzle. Following infusion, it is advisable to use a teat dip or spray.

The product can be safely administered during pregnancy.

Contra-indications, warnings, etc

Do not use in cows with a drying off period of four weeks or less.

Not intended for use within 28 days of calving.

Milk for human consumption may only be taken from 60 hours after calving. Should a cow calve earlier than 28 days after the last treatment, milk for human consumption may only be taken from 28 days plus 60 hours after the last treatment. Should a cow calve earlier than 28 days after treatment consult your veterinary surgeon. In cows suffering from hypocalcaemia it may be necessary to withhold milk for a longer period than that stated above. In such cases, milk should be withheld until the levels of antibiotics are below the maximum accepted residue levels, i.e. 0.03 mcg/ml for cloxacillin.

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 28 days from the last treatment.

The product must not be used in the treatment of lactating cows. Should this occur milk should be discarded for 28 days, following which time milk should be tested until antibiotic can no longer be detected.

Operator warnings

When infusing heifers, protective gloves should always be worn in order to avoid skin contact with the product.

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.

(1) Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

(2) Handle this product with great care to avoid exposure, taking all recommended precautions.

(3) 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.

Pharmaceutical precautions

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

The syringe may only be used once. Part used syringes must be discarded.

Legal category

POM-V

Packaging Quantities

Cartons of 24 syringes and buckets of 144 single dose syringes. Each 4.5 g syringe contains 500 mg of cloxacillin as the benzathine salt.

Further information

For Animal Treatment Only.

Users are reminded that it is a contractual requirement of the Milk Marketing Boards in the United Kingdom that milk is withheld for up to 5 days after calving. If you are in any doubt as to what the requirement is you should contact your Milk Marketing Board for advice.

Disposal:

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Marketing authorisation number

Vm 01596/4087.