SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cefquinor DC, 150 mg Intramammary Ointment for Dry Cows[AT, BG, HR, CY, CZ, DE, EL, FR HU, IT, MT, PL, PT, RO, SI, SK].

Cefimam DC, 150 mg Intramammary Ointment for Dry Cows [EE, IE, LV, LT, UK].

Cefquinor secado, 150 mg Intramammary Ointment for Dry Cows [ES].

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 3 g pre-filled syringe contains:

Active substance:

Cefquinome: 150 mg

(as cefquinome sulfate)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Intramammary ointment

Homogenous off-white oily ointment

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (Dry cows)

4.2 Indications for use, specifying the target species

For the treatment of subclinical mastitis at drying off and the prevention of new bacterial infections of the udder during the dry period in the dairy cow caused by the following cefquinome sensitive organisms: Streptococcus uberis, Streptococcus dysgalactiae, Streptococcus agalactiae, Staphylococcus aureus, coagulase negative staphylococci.

4.3 Contraindications

Do not use in cows with clinical mastitis.

Do not use in case of hypersensitivity to cephalosporin antibiotics or other β-lactam antibiotics, or to any of the excipients.

See section 4.7.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If it is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. The product should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials or narrow spectrum β-lactam antimicrobials.

Use of the product deviating from instructions given in the SPC may increase the potential for resistance development.

Do not use the cleaning towel on teats with lesions.

In case of erroneous use during lactation, the milk should be discarded for 35 days.

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 sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.

Do not handle this product if you know you are sensitised to penicillins or cephalosporins, or if you have been advised not to work with such preparations.

Handle this product with great care to avoid exposure. Use impervious gloves when handling and administering the product. Wash exposed skin after use.

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 and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention. Persons developing a reaction after contact with the product should avoid handling the product (and other cephalosporin and penicillin containing products) in future.

The cleaning towels provided with the intramammary product contain isopropyl alcohol. Wash hands after using the towels and wear protective gloves if skin irritation due to isopropyl alcohol is known or suspected. Avoid contact with eyes because isopropyl alcohol can cause eye irritation.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

There is no evidence of reproductive toxicity (incl. teratogenicity) in cattle.

Laboratory studies in rats and rabbits have not shown any teratogenic, foetotoxic or maternotoxic effects.

Can be used during pregnancy.

Do not use during lactation.

4.8 Interaction with other medicinal products and other forms of interaction

No data available.

4.9 Amounts to be administered and administration route

Intramammary use

Single intramammary administration.

150 mg cefquinome, i.e. the content of one syringe should be instilled gently into the teat of each quarter, immediately after the last milking.

Before instillation, the udder should be milked out completely and the teat and its orifice should be thoroughly cleaned and disinfected with the cleaning towel provided. Care should be taken to avoid contamination of the injector nozzle.

Gently insert either about 5mm or the total length of the nozzle and instill the content of one syringe into each quarter. Disperse the product by gentle massage of the teat and udder.

The syringe must only be used once.

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

No symptoms expected or emergency procedures required

4.11 Withdrawal period(s)

Meat and offal: 2 days

Milk: 1 day after calving when dry period is more than 5 weeks

36 days after treatment when dry period is 5 weeks or less

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Other β-lactam antibacterials for intramammary use

ATCvet code: QJ51DE90

5.1 Pharmacodynamic properties

The antibacterial drug cefquinome is a broad spectrum cephalosporin of the fourth generation which acts by inhibition of cell wall synthesis. It is bactericidal and is characterised by its broad therapeutic spectrum of activity and a high stability against penicillinases and beta-lactamases.

In vitro activity has been demonstrated against common Gram positive and Gram negative bacteria including Staphylococcus aureus, coagulase negative Staphylococci, Streptococcus dysgalactiae, Streptococcus agalactiae, Streptococcus uberis, Streptococcus bovis, Escherichia coli, Citrobacterspp., Klebsiellaspp., Pasteurellaspp., Proteusspp., Salmonellaspp., Serratia marcescens, Arcanobacterium pyogenes, Corynebacteriumspp..

Following bacterial species: Staphylococcus aureus, coagulase negative Staphylococci, Streptococcus uberis, Streptococcus dysgalactiaeand Streptococcus agalactiaeisolated from a field study conducted between 2000 and 2002 in Germany, France, Belgium and the Netherlands proved to be susceptible to cefquinome with MIC values between ≤ 0.008 µg/ml and 2.0 µg/ml.

An overview of the MIC90 of each bacterial pathogen is presented in the table below:

Cefquinome as a fourth generation cephalosporin combines high cellular penetration and β-lactamase stability. In contrast to cephalosporins of previous generations, cefquinome is not hydrolysed by chromosomally–encoded cephalosporinases of the Amp-C type or by plasmid mediated cephalosporinases of some enterobacterial species. However, some extended spectrum beta-lactamases (ESBL) can hydrolyse cefquinome and cephalosporins of other generations. The potential for resistance development against cefquinome is rather low. High-level resistance to cefquinome would require the coincidence of two genetic modifications, i.e. hyperproduction of specific β-lactamases as well as decreased membrane permeability.

No cross-resistance has been described for the mechanism of alteration of penicillin binding protein encountered in Gram positive bacteria. Resistance due to changes in membrane permeability might result in cross-resistance.

5.2 Pharmacokinetic particulars

Resorption of cefquinome from the udder to the systemic circulation is insignificant. The cefquinome concentrations reach a peak in the dry udder secretions after 7 to 14 days and slowly decrease during the dry period.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Silica colloidal hydrophobic.

Liquid paraffin.

6.2 Incompatibilities

None known.

6.3 Shelf life

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

6.4. Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Pre-filled 4.5 ml syringe consisting of white opaque high density polyethylene (HDPE) barrels with white opaque low density polyethylene (LDPE) plungers and white opaque (HDPE) dual end cap.

Cartons of 20, 24 and 60 syringes or buckets of 120 syringes (in aluminium foil sachets containing 4 syringes) including 20, 24, 60 or 120 individually wrapped teat cleaning towels.

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 product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited,

Station Works,

Camlough Road,

Newry,

County Down,

Northern Ireland

BT35 6JP

Tel. + 44 (0)28 30264435

Fax. + 44(0)28 30265060

e-mail enquiries@norbrook.co.uk

8. MARKETING AUTHORISATION NUMBER

Vm 02000/4393

9. DATE OF FIRST AUTHORISATION

20 February 2015

10. DATE OF REVISION OF THE TEXT

February 2015

PROHIBITION OF SALE, SUPPLY AND/OR USE

To be supplied only on veterinary prescription.

Approved: 20/02/2015