Cefaseptin Tablets for Dogs.
For the treatment of bacterial skin infections (including deep and superficial pyoderma) caused by organisms, including Staphylococcus spp., susceptible to cefalexin.
For the treatment of urinary-tract infections (including nephritis and cystitis) caused by organisms, including Escherichia coli, susceptible to cefalexin.
Dosage and administration
For oral administration.
15 mg of cefalexin per kg of bodyweight twice daily (equivalent to 30 mg per kg of bodyweight per day) for a duration of:
- 14 days in case of urinary-tract infection
- at least 15 days in case of superficial bacterial infection of the skin.
- at least 28 days in case of deep bacterial infection of the skin.
To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
The product may be crushed or added to food if necessary.
In severe or acute conditions, except in cases of known renal insufficiency (see special precautions for use in animals), the dose may be doubled.
Contra-indications, warnings, etc
Do not use in cases of known hypersensitivity to the active substance, to other cephalosporins, to other substances of the ß-lactam group or to any of the excipients.
Do not use in the case of resistance to cephalosporins or penicillins.
Do not use in rabbits, guinea pigs, hamsters and gerbils.
Special precautions for use in animals
The need for systemic antibiotics compared with non-antibiotic alternatives for the treatment of superficial pyoderma should be carefully considered by the responsible veterinarian.
As with other antibiotics which are excreted mainly by the kidneys, systemic 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.
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.
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 and penicillins, due to the potential for cross-resistance.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Adverse reactions (frequency and seriousness)
In very rare cases, nausea, vomiting and/or diarrhoea have been observed in some dogs after administration. In rare cases 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).
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established in bitches during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
In order to ensure efficacy, the veterinary medicinal product should not be used in combination with bacteriostatic antibiotics. Concurrent use of first generation cephalosporins with aminoglycoside antibiotics or some diuretics such as furosemide can enhance nephrotoxicity risks.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Trials performed on animals with up to 5 times the recommended twice daily dosage of 15 mg cefalexin/kg demonstrated that the product was well tolerated. Adverse reactions that may occur at the recommended dose are expected in the case of overdose. In the event of overdose, treatment should be symptomatic.
Store in the orginal packaging.
Return any part used tablet to the opened blister-pack.
Shelf life of the verterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 75 mg: 16 hours, 300 mg & 750 mg: 48 hours.
Legal category: POM-V
PVC/aluminium/OPA blister, with an aluminium foil for sealing: cardboard box of 10 blisters of 10 tablets (75 mg & 300 mg), cardboard box of 25 blisters of 10 tablets (75 mg & 300 mg), cardboard box of 12 blisters of 6 tablets (750 mg) and cardboard box of 25 blisters of 6 tablets (750 mg). Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
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