Cobactan 2.5 % 100 ml

Presentation:

Suspension for injection.Each ml contains:Cefquinome (as sulfate) 25 mg

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 P. multocida, Haemophilus parasuis, Actinobacillus pleuropneumoniae, Streptococcus suis and other cefquinome-sensitive organisms.
•  Mastitis-Metritis-Agalactia Syndrome (MMA) with involvement of E. coli, Staphylococcus ssp., Streptococcus spp. and other cefquinome-sensitive organisms.

 Piglets

•  Reduction of mortality in cases of meningitis caused by S. 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 :

See dosage table.

Dosage Table: COBACTAN 2.5%

 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 the muscular tissue of the mid-neck region. 
To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing. 
Shake the vial well before using. 
The veterinary medicinal 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. 

Contra-indications:

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. Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans. 
Use of the veterinary medicinal product may result in localized tissue reaction. Tissue lesions should resolve 15 days after the last administration of the veterinary medicinal product. 
Hypersensitivity reactions to cephalosporins occur rarely. 
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. 
Use only according to the benefit/risk assessment of the responsible veterinary surgeon. 
It is known that a cross-sensitivity to cephalosporin exists for bacteria sensitive to the cephalosporin group. 
Due to undesirable pharmacodynamic interaction, do not apply cefquinome simultaneously with pharmaceuticals acting bacteriostatically. 
Overdoses of 20 mg/kg/day in cattle and 10 mg/kg/day in pigs have been well tolerated. 
Cobactan 2.5% selects for resistant strains such as bacteria carrying extended spectrum betalactamases (ESBL) which may constitute a risk to human health if these strains disseminate to humans e.g. via food. For this reason, Cobactan 2.5% should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly (refers to very acute cases when treatment must be initiated without bacteriological diagnosis), to first line treatment. Official, national and regional antimicrobial policies should be taken into account when the product is used. Increased use, including use of the product deviating from the instructions given in the SPC, may increase the prevalence of such resistance. Whenever possible, Cobactan 2.5% should only be used based on susceptibility testing. 
Cobactan 2.5% is intended for treatment of individual animals. Do not use for disease prevention or as a part of herd health programmes. Treatment of groups of animals should be strictly restricted to ongoing disease outbreaks according to the approved conditions of use.

Operator warnings:
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 veterinary medicinal 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 or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. 
4. 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. 

Withdrawal periods:

For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions:

Do not store above 25°C. Protect from light. 
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category:

POM-V

Packaging Quantities:

50 ml and 100 ml multidose bottles. 
Not all pack sizes may be marketed.