SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Pathocef 250 mg Intramammary Suspension

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance mg/10ml

Cefoperazone 250

(as the Sodium salt) 258.9

Excipients

Tocopherol 4.6

For the full list of all other excipients see section 6.1

3. PHARMACEUTICAL FORM

Intramammary Suspension.

White to off-white oily suspension

4. CLINICAL PARTICULARS

4.1 Target species

Cattle.

4.2 Indications for use, specifying the target species

PATHOCEFIntramammary Suspension is indicated for the treatment of clinical mastitis in lactating cows.

Clinical mastitis caused by a wide range of organisms including the following pathogens have been shown to respond to treatment with cefoperazone.

- Streptococcus dysgalactiae
-Streptococcusuberis

- Streptococcus agalactiae

- Staphlococcus aureus(including penicillinase producing strains)
- Escherichia coli
- Arcanobacterium (Actinomyces) pyogenes
- Pseudomonas aeruginosa
- Micrococcus spp.
- Klebsiellaspp.

The single dose treatment with PATHOCEF Intramammary Suspension has been shown to provide a high response rate in mastitis caused by major pathogens.

4.3 Contraindications

The product is contraindicated in animals which are known to have exhibited allergic reactions to cephalosporins or to have severe disturbance of kidney function.

There is a rare possibility of cross reaction with other beta-lactam antibiotics.

It is not envisaged for this product to be administrated to species other than lactating cattle.

4.5 Special precautions for use

(i) Special precautions for use in animals

None

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

Penicillinsand 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 reaction 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, such as a skin rash, you should seek medical advice and show the doctor this warning or the package leaflet. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and may require urgent medical attention.Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

None.

By definition the product has been developed for use in lactating cows and has been shown to be safe in that regard.

In reproductive studies no adverse findings have been seen which might make the product unsafe in pregnant animals.

4.8 Interaction with other medicinal products and other forms of interaction

Cefoperazone is not compatible with aminoglycoside antibiotic such as streptomycin, neomycin and gentamycin. The simultaneous administration of possibly nephrotoxic drugs may prolong the elimination of cefoperazone.

4.9 Amounts to be administered and administration route

The contents of one 10 ml syringe should be injected into the infected quarter immediately after milking. Before injection the teat should be thoroughly cleaned and disinfected.

Overdosing is unlikely to be a problem as the contents of a full syringe have been administered.

Meat: 2 days

Milk: 72 hours

5. PHARMACOLOGICAL PROPERTIES

Cefoperazone is a third generation, semi-synthetic cephalosporin antibiotic with a broad spectrum of bactericidal activity covering both Gram-positive and Gram-negative organisms. It acts by inhibition of bacterial cell wall synthesis. As a third generation cephalosporin, cefoperazone shows greater ability to withstand degradation by beta-lactamase enzymes than do members of the first and second generations whose activity in the presence of beta-lactamases is therefore less reliable.

ATC Vet Code:QJ51DA32

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tocopherol

Glycerol monostearate

Sorbitan monostearate

Arachis oil

6.2 Incompatibilities

Cefoperazone is not physico-chemically compatible with drugs of the aminoglycoside group.

6.3 Shelf-life

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

6.4. Special precautions for storage

Do not store above 25°C.
For single use only.

10 ml white opaque low density polyethylene syringe fitted with a protective cap of red low density polyethylene. Cartons contain four syringes.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

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

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm42058/4094

9. DATE OF THE FIRST AUTHORISATION

Date:5 June 1985

10. DATE OF REVISION OF THE TEXT

Date:February 2014

12 February 2014