SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Noroclox DC Xtra 600mg Intramammary Suspension

2. Qualitative and quantitative composition

Active Substance:

Cloxacillin 600 mg

(as benzathine salt)

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Intramammary suspension

An oily off white suspension

4. Clinical Particulars

4.1 Target species

Dairy cows and heifers

4.2 Indications for use, specifying the target species

The product is formulated for use in cows 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.

The product is a useful aid in reducing the incidence of summer mastitis in dry cows at risk.

Cloxacillin is active against Gram-positive organisms which are associated with mastitis. These include Streptococcus agalactiaeand other Streptococcusspecies, penicillin resistant and sensitive Staphylococci and Arcanobacterium pyogenes.

The product is formulated with a long-acting base and maintains effective antibacterial levels in the majority of quarters in dry cows for at least 7 weeks and is non-irritant to udder tissue.

4.3 Contraindications

Do not use on animals with known hypersensitivity to the active substance.

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 lactating cows. Should this occur, milk should be discarded for 24 days, following which time milk should be tested until the levels of antibiotic are below the maximum acceptable residue limit i.e., 0.03 mcg/ml for cloxacillin.

4.4 Special Warnings for each target species

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. 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.

4.5 Special precautions for use

i. Special precautions for use in animals

None known

ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals

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.

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.

4.6 Adverse reactions (frequency and seriousness)

No known undesirable effects.

4.7 Use during pregnancy, lactation or lay

The product is safe for use during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

For intramammary infusion in dairy cows and heifers

Dry Off Therapy: After the final milking of a lactation, milk out the udder completely, thoroughly clean and disinfect the teats and introduce the contents of one syringe into each quarter via the teat canal. Care should be taken to avoid contamination of the injector nozzle.

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

Not applicable.

Do not use in cows with dry periods of less than 49 days. Not intended for use within 49 days of calving. Milk for human consumption should only be taken from 96 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 96 hours after last treatment. Should a cow calve earlier than 49 days after the treatment consult your veterinary surgeon.

Do not use Noroclox DC Xtra in the treatment of lactating cows. Should this occur, milk should be discarded for 24 days, following which time milk should be tested until the levels of antibiotic are below the maximum acceptable residue level i.e., 0.03 g/ml for cloxacillin

In cows suffering from hypocalcaemia it may be necessary to withhold milk for a longer period than stated above. In such cases milk should be withheld until levels of antibiotic are below the maximum acceptable residue level i.e., 0.03 g/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.

Do not use in lactating cows.

Do not use on cows which have a short dry period. Not intended for use within 49 days of calving.

5. pharmacological properties

Pharmacotherapeutic group:Antibacterials for intramammary use, Betalactam antibacterials, penicillins, for intramammary use, Betalactamase resistant penicillins

ATCvet Code:QJ51CF02

Pharmacodynamic properties:

Cloxacillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins.

Cloxacillin is relatively resistant to staphylococcal beta-lactamases but of lower activity than penicillin G against susceptible Gram-positive bacteria and inactive against Gram-negative bacteria.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis only of growing cells.

6. Pharmaceutical particulars

6.1 List of excipients

Aluminium Distearate

Liquid Paraffin

6.2 Incompatibilities

None known

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Do not store above 25ºC.

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

5.4g white intramammary syringes with low density polyethylene barrel and white or orange plunger with white or orange low density polyethylene caps

Available in cartons of 24 and 120 unit-dose syringes

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down,

BT35 6JP,

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm02000/4126

9. DATE OF FIRST AUTHORISATION

10^thMarch 1995

10. DATE OF REVISION OF THE TEXT

July 2010