Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Kloxerate Plus Dry Cow is an off-white, stable intramammary suspension prepared under sterile conditions. Each single dose 4.5 g syringe contains:

Cloxacillin (as benzathine salt)	500 mg
Ampicillin (as the trihydrate)	250 mg

in a long acting base with 3% aluminium monostearate.

Ampicillin and cloxacillin are semi-synthetic penicillins derived from 6-aminopenicillanic acid.

Uses

To be used under the guidance of a veterinary surgeon.

Kloxerate Plus Dry Cow is formulated for use in the dairy cow (including heifers) 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 Plus Dry Cow is indicated for use against those Gram positive and Gram negative bacteria associated with mastitis and susceptible to cloxacillin and ampicillin therapy. It is usually active against: Streptoccus agalactiae and other streptococcal species; penicillin-resistant and penicillin-sensitive staphylococci; Arcanobacterium species; E-coli and other susceptible Gram-negative bacteria.

Benzathine cloxacillin and ampicillin trihydrate in a long-acting aluminium monostearate base maintain effective antibacterial levels in the dry cow udder for approximately four weeks and are non-irritant to udder tissues.

Dosage and administration

Drying off therapy

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

Advice on correct administration

When infusing heifers it is important that the syringe nozzle is not introduced into the teat. The recommended procedure for dosing is as follows: The teats are cleaned and disinfected. The teat orifice is located and the nozzle of the syringe placed against it but not inserted. When the syringe plunger is depressed the antibiotic passes easily through the teat into the udder.

Contra-indications, warnings, etc

Withdrawal periods

Do not use in cows with a short dry period. Not intended for use within 49 days of calving.

Milk for human consumption may only be taken from 156 hours after calving. Should a cow calve earlier than 49 days after the last treatment, milk for human consumption may only be taken from 49 days plus 156 hours after the last treatment. Should a cow calve earlier than 49 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 levels of antibiotics are below the maximum accepted residue levels, i.e. 0.03 mcg/ml for cloxacillin and 0.004 mcg/ml for ampicillin.

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 treated until antibiotic can no longer be detected.

Operator warnings

Protective gloves should always be worn when infusing heifers, 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 reach and sight of children. For animal treatment only.

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 syringes. Each syringe containing 500 mg cloxacillin as cloxacillin benzathine BP(Vet) and 250 mg of ampicillin as ampicillin trihydrate Ph.Eur.

Further information

Disposal:

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

Marketing authorisation number

Vm 01596/4086.