Presentation

Suspension for injection.

Each ml contains:

Active substance(s):      Cefquinome 25 mg (equivalent to 29.64 mg/ml

                            cefquinome sulphate)

Excipient(s):                  Ethyl oleate 856.36 mg

                            Nitrogen for saturation (as layer gas)

Uses

For the treatment of bacterial infections in cattle and pigs caused by the Gram positive and Gram negative microorganisms sensitive to cefquinome:

Cattle:

·        Respiratory disease caused by Pasteurella multocida and Mannheimia haemolytica.

·        Digital dermatitis, infectious bulbar necrosis and acute interdigital necrobacillosis (foul in the foot).

·        Acute E. coli mastitis with signs of systemic involvement.

                 Calves:

·        E. coli septicaemia in calves

                  Pigs:

·        For the treatment of bacterial infections of the lungs and respiratory tract caused by Pasteurella multocida, Haemophilus parasuis, Actinobacillus pleuropneumoniae, Streptococcus suis and other cefquinome-sensitive organisms.

·        Mastitis-Metritis-Agalactia syndrome (MMA) with involvement of E. coli, Staphylococcus spp., Streptococcus spp. and other cefquinome-sensitive organisms.

Piglets:

·        Reduction of mortality in cases of meningitis caused by Streptococcus suis.

For the treatment of:

·        Arthritis caused by Streptococcus spp., E. coli and other cefquinome-sensitive organisms.

·        Epidermitis (mild or moderate lesions) caused by Staphylococcus hyicus.

Dosage and administration

All treatments to be given by intramuscular injection. Studies have indicated the advisability of giving second and subsequent injections at a different injection site. The preferred injection site is in muscular tissue of the mid-neck region.

To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

Contra-indications, warnings, etc.

Do not use Cobactan 2.5% in animals which are known to be hypersensitive to ß-lactam

antibiotics.

Do not administer to animals less than 1.25 kg body weight.

Use of the product may result in localised tissue reaction. Tissue lesions are repaired 15 days

after the last administration of the product.

Hypersensitivity to cephalosporins is rare.

Shake the vial well before using.

The product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Use a dry sterile needle and syringe. An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes, for example when treating piglets.  The cap may be safely punctured  up to 25 times. The 50 ml vial should be used for treating small piglets.  When treating groups of animals, use a draw-off needle.

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

To prevent the claimed infections in piglets, attention should be paid to hygiene and ventilation, and overcrowding should be avoided. When the first piglets are affected, careful examination of the other animals of the same pen is recommended to enable an early treatment.

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

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

Overdoses of 20 mg/kg/day in cattle and 10 mg/kg/day in pigs have been well tolerated.

Operator warnings:

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

1. Do not handle this product if you know you are sensitized, 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 a skin rash, you should seek medical    advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention. 

Wash hands after use.

Withdrawal periods:

FOR ANIMAL TREATMENT ONLY. KEEP OUT OF REACH AND SIGHT OF CHILDREN.

Pharmaceutical precautions

Do not store above 25°C. Keep vial in outer carton. After first broaching the container, use within 28 days. Discard unused material.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V          To be supplied only on veterinary medicinal prescription.

Package quantities

50ml and 100ml multidose bottles.

Further information

Overdoses of 20 mg/kg/day in cattle and 10 mg/kg/day in pigs have been well tolerated.

Marketing Authorisation number

Vm 01708/4452

Marketing Authorisation holder

Intervet UK Ltd.

Walton Manor, Walton,

Milton Keynes

Bucks. MK7 7AJ

Date of text preparation:

May 2008.