4.1 Target species
Dogs
4.2 Indications for use, specifying the target species
Treatment of infections of the respiratory tract, gastro-intestinal tract, urogenital tract, the skin and localised infections in soft tissue caused by bacteria sensitive to cefalexin.
4.3 Contraindications
Do not use in cases of known hypersensitivity to the active substance, to other cephalosporins, to other substances of the -lactam group or to any of the excipients.
Do not use in rabbits, gerbils, guinea pigs and hamsters.
4.4 Special warnings for each target species
None
4.5 Special precautions for use
Special precautions for use in animals
Use of the product should be based on susceptibility testing and take into 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 penicillins, due to the potential for cross resistance.
In the case of an allergic reaction, treatment should be withdrawn.
As with other antibiotics which are excreted mainly by the kidneys, unnecessary 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross-reactions to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised or if you have been advised not to be in contact with such substances.
Handle this product with great care to avoid exposure, taking all recommended precautions. 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 breathing are more serious symptoms and require urgent medical attention.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
Vomiting has been observed occasionally in dogs when given products containing cefalexin.
4.7 Use during pregnancy, lactation or lay
The safety of the product has not been demonstrated in studies in pregnant or lactating dogs. Use only in accordance with a risk/benefit assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
See section 4.5i Special precautions for use in animals.
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.
