Cephorum Film-Coated Tablets are used for the treatment of bacterial skin infections, and urinary tract infections caused by Klebsiella pneumoniae. They contain an antibiotic called Cephalexin, which is effective in fighting a broad spectrum of gram-positive and gram-negative bacteria in dogs.
Cephorum Tablets are presented as film-coated tablets for easy administration.
Contra-indications, warnings, etc
Do not use in cases of known hypersensitivity to the active substance, to other cephalosporins, to other substances of the β-lactam group or to any of the excipients.
Do not use in rabbits, gerbils, guinea pigs and hamsters.
Use of Cephorum® Tablets 250 mg should be based on susceptibility testing and take in to account official and local antimicrobial policies.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to cefalexin and may decrease the effectiveness of treatment with other cephalosporins, or with penicillins, due to potential cross-resistance.
In case of an allergic reaction, treatment should be withdrawn.
Cephorum® Tablets 250 mg should not be administered to animals which are known to be hypersensitive to cefalexin.
As with other antibiotics which are excreted mainly by the kidneys, accumulation may occur in the body when renal function is impaired. In cases of known renal insufficiency the dose should be reduced, antimicrobials known to be nephrotoxic should not be administered concurrently and the product should be used only according to a risk/benefit assessment by the responsible veterinarian.
In rare cases vomiting, diarrhoea and hypersensitivity can occur. In cases of hypersensitivity reactions the treatment should be stopped.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports)
The safety of the veterinary medicinal product has not been established in bitches during pregnancy and lactation. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
The bactericidal activity of cephalosporins is reduced by concomitant administration of bacteriostatic acting compounds (macrolides, sulphonamides and tetracyclines). Nephrotoxicity can be increased when 1st generation cephalosporins are combined with polypeptide antibiotics, aminoglycosides and some diuretics (furosemide). Concomitant use with such active substances should be avoided.
Symptoms of overdose include nausea, vomiting, epigastric distress, diarrhoea and haematuria. Treatment should be symptomatic.
Keep out of reach of children. For animal treatment only.
Cephalosporins may cause sensitisation (allergy) following injection, inhalation, ingestion, or skin contact. Sensitivity to penicillin may lead to cross-sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.
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 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 breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Summary of Products Characteristics is available on request from TVM UK Animal Health.