Contraindications
Do not use in animals known to be hypersensitive to penicillins and cephalosporins.
Do not use in rabbits, guinea pigs, hamsters and gerbils.
Special precautions for use
Special precautions for safe use in the target species:
As with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is impaired. In case of known renal insufficiency, the dose should be reduced and antimicrobials known to be nephrotoxic should not be administered concurrently. This product should not be used to treat puppies of less than 1 kg of bodyweight or kittens under 9 weeks of age.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the cefalexin and may decrease the effectiveness of treatment with other cephalosporins and penicillins, due to the potential for cross resistance.
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
As the tablets are palatable for animals there is a danger of excessive ingestion. The tablets must therefore be stored out of the reach of animals.
Local treatment of cutaneous and subcutaneous infections in cats should be considered as a complement of the antibiotic treatment.
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 sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.
1Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations.
2Handle this product with great care to avoid exposure, taking all recommended precautions. Wash hands after use.
3If 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.
Adverse events
Cats:
Common (1 to 10 animals / 100 animals treated): | Vomiting1,2,3 Diarrhoea1,2,3 |
Rare (1 to 10 animals / 10,000 animals treated): | Hypersalivation Increased drinking Hypersensitivity reaction4 (e.g Allergic skin reaction, Hives, Allergic oedema, Abnormal breathing, Circulatory disorder) |
1Mild and transient
2In most cases, these effects only lasted a day. They were reversible without administering symptomatic treatment and without interrupting treatment with the veterinary medicinal product.
3If vomiting and/or diarrhea occurs repeatedly, treatment should be discontinued and the advice of the treating veterinarian sought.
4In animals sensitive to penicillins/cephalosporins.
Dogs:
Uncommon (1 to 10 animals / 1,000 animals treated): | Lethargy |
Rare (1 to 10 animals / 10,000 animals treated): | Hypersensitivity reaction1 (e.g Allergic skin reaction, Hives, Allergic oedema, Abnormal breathing, Circulatory disorder,) |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Vomiting2 , Diarrhoea2 |
1In animals sensitive to penicillins/cephalosporins. Allergic cross-reactivity with other βlactam may occur.
2If vomiting and/or diarrhea occurs repeatedly, treatment should be discontinued and the advice of the treating veterinarian sought.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The product can be used in pregnant and lactating animals.
Interaction with other medicinal products and other forms of interaction
The association of first-generation cephalosporins with aminoglycoside antibiotics and some diuretics such as furosemide can enhance nephrotoxicity risks.
The bactericidal activity of cephalosporins is reduced by concomitant administration of bacteriostatic acting compounds (tetracyclines, chloramphenicol, macrolides and rifampicin).
Overdose (symptoms, emergency procedures, antidotes), if necessary
Trials performed on animals with up to 5 times the recommended dose of 15 mg/kg demonstrated that the product is well tolerated.
Withdrawal periods
Not applicable.