Target Species
Cattle and pigs
Indications for use
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 ssp., E. coli and other cefquinome-sensitive organisms.
•Epidermitis (mild or moderate lesions) caused by Staphylococcus hyicus.
Contraindications
Do not use 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.
Special warnings for each target species
None.
Special precautions for use
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 50ml vial should be used for treating small piglets. When treating groups of animals, use a draw-off needle.
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.
Cobactan 25 mg/ml 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 25 mg/ml 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 25 mg/ml should only be used based on susceptibility testing.
Cobactan 25 mg/ml 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 limited to ongoing disease outbreaks according to the approved conditions of use.
Operator warnings
Care should be taken to avoid accidental self-injection
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.
1Do not handle this product if you know you are sensitized, or if you have been advised not to work with such preparation.
2Handle this product with great care to avoid exposure, taking all recommended precautions.
3If 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.
Adverse Reactions
Use of the product may result in localized tissue reaction. Tissue lesions are repaired 15 days after the last administration of the product.
Hypersensitivity reactions to cephalosporins occur rarely.
Hypersensitivity type reactions in cattle have been reported as individual isolated cases.
Use during pregnancy or lactation
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.
Interactions
It is known that a cross sensitivity to cephalosporin exists for bacteria sensitive to the cephalosporin group.
Amounts to be administered and administration route
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 localization for the injection site is preferably the neck resp. cervical region.
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Combined Therapy
Cobactan 25 mg/ml and Cobactan MC can be used concurrently.
For the treatment of E.coli mastitis, experimental challenge studies have shown that the use of Cobactan 25 mg/ml in combination with Cobactan MC lead to an improvement in efficacy, particularly in terms of bacterial cure rate.
For combined therapy the following treatment regime should be followed:
Overdose
Overdoses of 20 mg/kg/day in cattle and 10 mg/kg/day in pigs and piglets have been well tolerated.
Withdrawal periods
Pigs
Meat and offal: 3 days
Cattle
Meat and offal: 5 days
Milk: 24 hours
When using Cobactan 25 mg/ml and Cobactan MC Intramammary Suspension in combination for the treatment of E.coli mastitis in cattle, the withdrawal periods are 5 days for meat and offal and 120 hours for milk.