Tsefalen 50mg/ml Powder for Oral Suspension for Dogs up to 20 kg and Cats

Cross-resistance has been shown between antimicrobials in the beta-lactam group.
Use of the cefalexin should be carefully considered when susceptibility testing has
shown resistance to beta lactam group because its effectiveness may be reduced.

Special precautions for safe use in the target species:
Use of the product should be based on identification and susceptibility testing of the
target pathogen(s). If this is not possible, therapy should be based on
epidemiological information and knowledge of susceptibility of the target pathogens
at farm level, or at local/regional level.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG
category) should be used for first line treatment where susceptibility testing suggests
the likely efficacy of this approach.
Narrow spectrum antibiotic therapy with a lower risk of antimicrobial resistance
selection should be used for first line treatment where susceptibility testing suggests
the likely efficacy of this approach.
Deviating from the instructions given in the SPC when using the product may
increase the prevalence of bacteria resistant to cefalexin and may also decrease the
effectiveness of other beta-lactam antimicrobial treatments, due to the potential for
cross-resistance. Therefore, deviation from the instructions must only be undertaken
according to a risk/benefit assessment by the responsible veterinarian.
Do not administer in cases of known resistance to cephalosporins and penicillin.
As with other antibiotics which are excreted mainly by the kidneys, systemic
accumulation may occur when renal function is impaired. In case of known renal
insufficiency the dose should be reduced and substances known to be nephrotoxic
should not be administered concurrently.
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 veterinary medicinal
product if you know you are sensitised or if you have been advised not to be in
contact with such substances.
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Handle this veterinary medicinal product with great care to avoid exposure, taking all
recommended precautions and take care to avoid prolonged skin contact. When
preparing the reconstituted product, ensure lid is correctly closed before shaking to
mix product. Take care when loading the syringe to avoid spillage.
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.
Accidental ingestion may result in gastrointestinal disturbances. In order to reduce
the risk of accidental ingestion by children, close the bottle immediately after use. Do
not leave a syringe containing suspension unattended and ensure syringe is out of
sight and reach of children at all times. In order to prevent children from getting
access to the used syringe, store the bottle and syringe in the outer carton.
When stored in the refrigerator, the oral suspension should be kept in a safe place
out of sight and reach of children.
In case of accidental ingestion, particularly by children, seek medical advice
immediately and show the package leaflet or the label to physician.
Do not smoke, eat or drink while handling the medication.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.