Summary of product characteristics

Cobactan MC Intramammary Suspension 75 mg Milking Cow

Per 8g syringe:

Active substance:

Cefquinome 75.0mg

(as cefquinome sulphate)

For full list of excipients, see section 6.1

Intramammary Suspension

White to slightly yellow, oily viscous homogeneous intramammarysuspension

Lactating cows

For the treatment of clinical mastitis in the lactating dairy cow caused by bacteria susceptible to cefquinome.

Not to be administered to animals which are known to be hypersensitive to cephalosporin antibiotics.

There may be cross sensitivity to penicillins.

None

None

When infusing heifers 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.

Wash hands after use.

None known

The product is intended for use during lactation. No restrictions apply for use during pregnancy.

There is a cross sensitivity between the various cephalosporins.

The contents 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, 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.

Further Information:

Combined Therapy

For the treatment of E.colimastitis, experimental challenge studies have shown that the use of this product in combination with Cobactan 25 mg/ml suspension for injection leads to an improvement in efficacy, particularly in terms of bacterial cure rate.

For combined therapy the following treatment regime should be followed:

No symptoms expected or emergency procedures required.

Meat and offal: 4 days

Milk: 5 days (120 hours)

When using Cobactan MC and Cobactan 25 mg/ml in combination, the withdrawal periods are as follows: Meat and offal: 5 days; Milk: 5 days (120 hours).

ATCvet Code:QJ51DA92

Pharmacotherapeutic group:antibacterials for intramammary use, Other β-lactam antibacterials for intramammary use, Cephalosporins and related substances.

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 penicillinases and beta-lactamases.

In vitro, Cefquinome has antibiotic activity against common Gram negative and Gram positive bacteria includingSalmonellaspp, Haemophilusspp, Pasteurellaspp,Klebsiella spp, Corynebacterium pyogenes, Escherichia coli, A.pleuropneumoniae, Proteus mirabilis, Staphylococcus aureus, Streptococcus dysgalactiae and Streptococcus uberis.

The product has been developed to treat clinical mastitis caused by sensitive strains of Staphylococcus aureus, Streptococcus uberis, Streptococcus dysgalactiae, Escherichia coli and other enterobacteria.

The base disperses readily in milk and allows rapid distribution of Cefquinome.

Cefquinome as a fourth generation cephalosporin combines high cellular penetration and ß-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 ß-lactamases as well as decreased membrane permeability.

White soft paraffin

Liquid paraffin

None known

Shelf life of the veterinary medicinal product as packaged for sale: 30 months

Do not store above 25°C

The syringe must only be used once. Part used syringes should be discarded.

White opaque polyethylene syringe containing 75mg cefquinome in packs of 3, 15, 20, 24 and 30 syringes.

Not all presentations may be marketed.

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

Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

Vm:01708/4444

Date:29 May 1997

Date:June 2014

03 June 2014