SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Pathozone 250 mg Intramammary Suspension for Cattle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

mg/10ml

Active substance: Cefoperazone 250

(as the sodium salt) 258.9

Excipients: all-rac-α-Tocopherol (E307) 4.6

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Intramammary Suspension.

White to off-white oily suspension

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (lactating dairy cows).

4.2 Indications for use, specifying the target species

The product 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

- Streptococcus uberis

- Streptococcus agalactiae

- Staphylococcus aureus (including penicillinase producing strains)

- Escherichia coli

- Trueperella pyogenes

- Pseudomonas aeruginosa

- Micrococcus spp.

- Klebsiella spp.

4.3 Contraindications

Do not use in case of hypersensitivity to cephalosporins or to any of the excipients or in case of severe disturbance of kidney function.

4.4 Special warnings for each target species

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

4.5 Special precautions for use

Special precautions for use in animals

Use of the product should be based on susceptibility testing and should take into account official and local antimicrobial policies.

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

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 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.

4.7 Use during pregnancy, lactation or lay

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 gentamicin. The simultaneous administration of possibly nephrotoxic drugs may prolong the elimination of cefoperazone.

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

4.9 Amounts to be administered and administration route

For intramammary use. Single administration. 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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

4.11 Withdrawal period(s)

Meat and offal: 2 days

Milk: 72 hours

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterial for intramammary use, cephalosporins and related substances

ATCvet code: QJ51DA32

5.1 Pharmacodynamic 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.

5.2 Pharmacokinetic particulars

Systemic drug absorption of cefaperazone has been found to be negligible in healthy animals, whereas it tends to be higher in infected animals, probably due to the damage to epithelial cell junctions caused by subclinical infections.

The detected urine concentrations indicate that cefoperazone is absorbed from the udder and is at least partly excreted by the kidneys. In tissue residue studies, no residues were detected in samples of muscle, liver, kidney, fat, heart or supramammary lymph node.

The highest concentrations of cefoperazone in milk are detected at the first milking (12 hours) after administration. From five days after administration, cefoperazone is not detectable in the milk. Milk yield does not influence the percentage of cefoperazone excreted in the milk.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

all-rac-α-Tocopherol (E307)

Glycerol monostearate

Sorbitan stearate

Arachis oil, Refined

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.

6.5 Nature and composition of immediate packaging

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

Not all pack sizes may be marketed.

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

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

5^thFloor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm 42058/4095

9. DATE OF FIRST AUTHORISATION

14 December 2012

10. DATE OF REVISION OF THE TEXT

May 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.