Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Kloxerate Gold DC is an off-white stable intramammary suspension prepared under sterile conditions. Each single dose 5.4 g syringe contains:

Cloxacillin (as Benzathine Salt)	600 mg
Ampicillin (as the Trihydrate) in a long acting base	300 mg

Ampicillin and Cloxacillin are semi‑synthetic penicillins derived from 6-amino-penicillanic acid.

Uses

Kloxerate Gold DC is formulated for use in the dairy cow at the point of drying off, immediately after the last milking of the lactation, in order to treat existing mastitis caused by organisms sensitive to cloxacillin and ampicillin and to provide protection against further infections during the dry period.

Kloxerate Gold DC is indicated for use against both Gram-positive and Gram-negative organisms which are associated with mastitis and susceptible to cloxacillin and ampicillin therapy, including Streptococcus agalactiae and other Streptococcus species, penicillin resistant and sensitive Staphylococci, Arcanobacterium species, Escherichia coli and other susceptible Gram-negative bacteria.

Cloxacillin benzathine and ampicillin trihydrate are presented in a long-acting base which is non-irritant to udder tissue and maintains effective antibacterial levels in the dry cow udder for up to 10 weeks.

Dosage and administration

Drying Off Therapy: For intramammary use. 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 is as follows:

The animal(s) should be properly restrained. Each teat should be cleaned and disinfected and then the teat orifice located and the nozzle of the syringe placed against it but NOT inserted. When the syringe plunger is steadily depressed the antibiotic will pass easily through the teat into the udder.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not use in cows which have a short drying 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 the 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 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.

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.

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 20 and 100 syringes, each syringe containing 600 mg cloxacillin as the benzathine salt and 300 mg ampicillin as the trihydrate.

Further information

Disposal:

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

Marketing authorisation number

Vm 01596/4171.