SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME of the veterinary medicinal product

Ceffect LC, 75 mg, intramammary ointment for lactating cows (BE, BG, CZ, HU, IE, IT, LU, NL, PL, PT, RO, SI, SK, UK)

Cefaxxess LC, 75 mg, intramammary ointment for lactating cows (AT, DE, FR)

Ceffect Lactación 75 mg, pomada intramamaria (ES)

2. QUALITATIVE and QUANTITATIVE COMPOSITION:

Each prefilled syringe of 8 g contains:

Active substance:

Cefquinome (as sulfate) 75 mg

Excipients:

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Intramammary ointment.

White to slightly yellowish ointment.

4.1. Target species

Cattle (lactating cows).

4.2. Indications for use, specifying the target species

For the treatment of clinical mastitis in the lactating dairy cow caused by the following cefquinome-sensitive organisms: Streptococcus uberis, Streptococcus dysgalactiae, Staphylococcus aureusandEscherichia coli.

4.3 Contraindications

Do not administer to animals which are known to be hypersensitive to cephalosporin antibiotics, and other ß-lactam antibiotics or to any of the excipients.

Do not use the cleaning towel if lesions are present on the teat.

4.4 Special warnings for each animal 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 and take into account official and local antimicrobial policies.

Inappropriate use of the product may increase the prevalence of bacteria resistant to cefquinome and may decrease the effectiveness of treatment with other beta lactam antibiotics, due to the potential for cross resistance.

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.

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.

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 the product.

4.7 Use during pregnancy and lactation

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 cephalosporin exists for bacteria sensitive to the cephalosporin group.

4.9 Amounts to be administered and administration route

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.

Milk out the affected quarter(s). After thoroughly cleaning and disinfecting the teat and teat orifice with the cleaning towel provided remove the cap from the nozzle without touching the nozzle with the fingers.

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 syringe must only be used once.Partly used syringes should be discarded.

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

No symptoms expected or emergency procedures required.

4.11 Withdrawal periods

Meat and offal: 4 days

Milk: 5 days (120 hours).

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for intramammary use, fourth

generationcephalosporins.

ATCvet code: QJ51DE90

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, Streptococcus agalactiae andStreptococcus uberis.

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

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 or 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.

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

The paper cleaning towels contain 70% isopropanol.

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 32 months.

Shelf life after first opening the immediate packaging:use immediately.

6.4. Special precautions for storage

Do not store above 30°C.

6.5 Nature and composition of immediate packaging

White, low-density polyethylene intramammary syringes with a dual push-fit nozzle cap containing 8 grams of ointment.

Carton with 3, 15, 20 or 24 syringes and 3, 15, 20, respectively 24 cleaning towels individually packed in a laminate sachet with copolymer inner layer.

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

Emdoka bvba

John Lijsenstraat, 16

B-2321 Hoogstraten

Belgium

8. MARKETING AUTHORISATION NUMBER

Vm 34534/4006

9. DATE OF FIRST AUTHORISATION

08 May 2014

10. DATE OF REVISION OF THE TEXT

May 2014

Approved: 08/05/2014