MSD COBACTAN LA 7,5% 250 ml VET ONLY (S4)

PHARMACOLOGICAL ACTION

Pharmacodynamic properties

Cefquinome is a bactericidal antibiotic of the cephalosporin group which acts by inhibition of cell wall synthesis.

It is characterised by its broad therapeutic spectrum of activity and combines high cellular penetration and a very high stability against ß-lactamases.

In vitro activity has been demonstrated against common gram-positive and gram-negative bacteria including Escherichia coli, Citrobacter spp., Klebsiella spp., Pasteurella spp., Proteus spp., Salmonella spp., Serratia marcescens, Trueperella pyogenes, Mannheimia haemolytica, Histophilus somni, Corynebacterium spp., Staphylococcus aureus, coagulase negative staphylococci, Streptococcus dysgalactiae, Streptococcus agalactiae, Streptococcus uberis and Streptococcus bovis.

Pharmacokinetic properties

Cefquinome is rapidly absorbed from the subcutaneous site of injection.

Protein binding is low, less than 5 % in cattle.

Maximum serum concentrations (Cmax) of about 1 µg/mℓ are reached after 3 to 6 hours after subcutaneous administration of Cobactan® LA 7,5% at the recommended dosage of 2,5 mg/kg.

Plasma elimination half-life after intravenous administration of an aqueous cefquinome solution is 1½ to 3 hours in cattle.

Cefquinome administered parenteral, is mainly excreted by the kidneys. Metabolism occurs only to a small extent – 90 % of the urinary radioactivity excreted within 8 hours was unchanged cefquinome. There was no evidence for a principle change in kinetics after repeated administration.

In cattle, 90 % of the dose is recovered in urine and about 5 % from faeces.

INDICATIONS

Treatment of infections of the respiratory tract of cattle, associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni that is sensitive to cefquinome.

CONTRAINDICATIONS

Do not administer to animals with known hypersensitivity to cephalosporins and other ß-lactam antibiotics.

WARNINGS

Withdrawal period: Cattle (meat and offal): Must not be slaughtered for human consumption until 14 days after last treatment.

Milk: Do not use in lactating or pregnant animals producing milk for human consumption less than 2 months prior to calving.

SAFETY IN PREGNANCY AND LACTATION

Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE

For subcutaneous administration, one single injection of 2,5 mg cefquinome/kg body weight (equivalent to 1 mℓ of Cobactan® LA 7,5%/30 kg body weight). Treat the animals from the beginning of the disease and evaluate the response to the treatment for 48 hours following the injection. If clinical signs of respiratory disease remain, a second injection of 2,5 mg cefquinome/kg body weight is recommended at a 48-hour interval. To ensure the correct dosage and to avoid possible underdosing, body weight should be determined as accurately as possible.

It is recommended to divide the dose so that no more than 10 mℓ is injected at one site.

SIDE EFFECTS AND SPECIAL PRECAUTIONS

Subcutaneous injection of Cobactan® LA 7,5% induces an inflammatory tissue reaction at the injection site. The lesions caused by the injection may persist for at least 28 days after the last dose has been administered.

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

SPECIAL PRECAUTIONS FOR USE

Special precautions to be taken by the person administering Cobactan® LA 7,5% 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 cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

Do not handle Cobactan® LA 7,5% if you know you are sensitised to penicillins and cephalosporins, or if you have been advised not to work with such preparations.

Handle Cobactan® LA 7,5% with great care to avoid any exposure. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the health care professional this warning. Swelling of the face, lips or eyes or difficulty in breathing, are more serious symptoms and require urgent medical attention.

INTERACTIONS

No interactions have been identified.

KNOWN SIGNS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

In cattle, no undesirable effects have been observed at 3 times the recommended dose.