SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cefquinor LC, 75 mg Intramammary Ointment for Lactating Cows [UK, AT, BE, BG, CY, CZ, DE, EL, FR, HU, HR, IT, LU, MT, NL, PL, PT, RO, SI, SK]

Cefimam LC, 75 mg Intramammary Ointment for Lactating Cows [IE, EE, LV, LT]

Cefimam LC [DK]

Cefimam vet, 75 mg Intramammary Ointment for Lactating Cows [NO]

Cefquinor, 75 mg Intramammary Ointment for Lactating Cows [FI]

Cefquinor Vet, 75 mg Intramammary Ointment for Lactating Cows [SE]

Cefquinor Lactación, 75 mg Intramammary Ointment for Lactating Cows [ES]

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each pre-filled syringe of 8 g contains:

Active substance<s>:

Cefquinome 75 mg

(as Cefquinome Sulfate)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Intramammary ointment.

A homogenous off-white oily ointment.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (Lactating cow)

4.2 Indications for use, specifying the target species

For the treatment of clinical mastitis in the lactating cow caused by bacteria susceptible to cefquinome, namely Staphylococcus aureus, Streptococcus uberis, Streptococcus dysgalactiae, Escherichia coli.

4.3 Contraindications

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

4.4 Special warnings for each target species

None

4.5 Special precautions for use

Special precautions for use in animals

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 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.

Official, national and regional antimicrobial policies should be taken into account when the

product is used.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to cefquinome and may decrease the effectiveness of treatment with cephalosporins, due to the potential for crossresistance.

Do not use the cleaning towel on teats with lesions.

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

When infusing the product, protective gloves should always be worn in order to avoid skin contact.

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.

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

2. Handle this product with great care to avoid exposure, taking all recommended precautions.

3. If you develop symptoms following exposure, such as 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.

Wash hands after using the cleaning towels and wear protective gloves if skin irritation due to Isopropyl alcohol is known or suspected.

4.6 Adverse reactions (frequency and seriousness)

In very rare cases anaphylactic reactions have been noted in animals after administration of cefquinome containing intramammary products.

4.7 Use during pregnancy, lactation or lay

The product is intended for use during lactation.

There is no available information indicating reproductive toxicity (inc. teratogenicity) in cattle. In reproductive toxicity studies in laboratory animals cefquinome did not reveal any effect on reproduction or teratogenic potential.

4.8 Interaction with other medicinal products and other forms of interaction

It is known that a cross sensitivity to cephalosporins exists for bacteria sensitive to the cephalosporin group.

4.9 Amounts to be administered and administration route

For intramammary administration. The syringe must only be used once.

Partly used syringes should be discarded.

Milk out the affected quarter(s). After thoroughly cleaning and disinfecting the teat and teat orifice, gently infuse the contents of one syringe into each affected quarter. Disperse the product by gentle massage of the teat and udder of the affected animal.

The content of one syringe should be infused gently into the teat of the infected quarter every 12 hours after each of three successive milkings.

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

No symptoms expected or emergency procedures required.

4.11 Withdrawal period(s)

Meat and offal: 4 days

Milk: 5 days (120 hours)

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for intramammary use, fourth-generation cephalosporins

ATCvet code: QJ51DE90

5.1 Pharmacodynamic properties

Cefquinome is an antibacterial drug of the cephalosporin group which acts by inhibition of cell wall synthesis. It is characterised by its broad therapeutic spectrum of activity and a high stability against beta-lactamases.

In vitro, Cefquinome has antibiotic activity against common Gram negative and Gram positive bacteria including Escherichia coli, Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.

As a fourth generation cephalosporin, cefquinome combines high cellular penetration and a high beta-lactamases stability. In contrast to cephalosporins of previous generations, cefquinome is not hydrolysed by chromosomally-encoded cephalosporinases of the Amp-C type of by plasmid mediated cephalosporinases of some enterobacterial species. Resistance mechanism in Gram negative organisms due to extended spectrum beta-lactamases (ESBL) and in Gram-positive organisms due to alteration of penicillin binding proteins (PBPs) may lead to cross-resistance with other beta-lactams.

The highest MIC₉₀value was found for Staphylococcus aureus. This pathogen has a MIC₉₀in the range of 1 µg/ml.

5.2 Pharmacokinetic particulars

After intramammary administration, a mean concentration of 19 µg/ml in milk is observed 12 hours post last infusion.

At the second milking following the last infusion the mean concentration is still approximately 2.5 µg/ml and then falls to 0.75 µg/ml at the third milking post last infusion.

Resorption of cefquinome from the udder is insignificant.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White soft paraffin

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

Do not store above 30°C.

6.5 Nature and composition of immediate packaging

Pre-filled 8 g Intramammary syringe consisting of white opaque low density polyethylene (LDPE) barrel with white opaque LDPE plunger and white opaque LDPE end-cap.

Cartons of 12, 24 and 36 syringes including 12, 24 or 36 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 products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down

BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER

Vm 02000/4388

9. DATE OF FIRST AUTHORISATION

09 September 2014

10. DATE OF REVISION OF THE TEXT

September 2014

Approved: 09/09/2014