NOAH Compendium

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Date: Monday, January 20, 2020 3:59

Release 4.293
Cefaseptin 75 mg tablets for dogs and cats, Cefaseptin 300 & 750 mg tablets for dogs
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Cefalexin
Product:Cefaseptin 75 mg tablets for dogs and cats, Cefaseptin 300 & 750 mg tablets for dogs
Product index: Cefaseptin 75 mg tablets for dogs and cats, Cefaseptin 300 & 750 mg tablets for dogs
Beige oblong tablet. 75 mg tablets can be divided into equal halves.
300 mg and 750 mg tablets can be divided into equal halves and quarters.
∙ For the treatment of cutaneous and subcutaneous infections (wounds and abscesses) caused by Staphylococcus spp., Streptococcus spp., Escherichia coli, Pasteurella spp., susceptible to cefalexin.
∙ 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).
Urinary-tract infection: 14 days
Superficial bacterial infection of the skin: At least 15 days
Deep bacterial infection of the skin: At least 28 days
Cutaneous and subcutaneous infections (wounds and abscesses): 5 days
Dogs and cats:
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 the dose may be doubled (see special precautions).
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 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 or kittens of less than 1 kg of bodyweight and kittens less than 10 weeks of age.
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.
The tablets are flavoured [presence of porcine liver powder]. In order to avoid accidental ingestion, store tablets out of reach of the animals.
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 penicillins may lead to cross-reactions 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. Wash hands after use.
3. 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 in breathing are more-serious symptoms and require urgent medical attention.
Adverse reactions (frequency and seriousness)
In very rare cases, nausea, vomiting and/or diarrhoea have been observed in some dogs after administration.
Mild and transient vomiting and/or diarrhoea have been commonly observed in cats in clinical studies.
Most of these adverse reactions were observed on a single occasion. They were reversible without symptomatic treatment and without discontinuation of cefalexin treatment.
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 treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established in bitches or queens during pregnancy and lactation.
Laboratory studies have not produced any evidence of teratogenic effects in mice (up to 400 mg cefalexin/kg bw/day) and rats (up to 1200 mg cefalexin/kg bw/day). In mice, maternal effects and foetotoxicity were observed from the lowest dose tested (100 mg cefalexin/kg bw/day). In rats, there is evidence of foetotoxicity at 500 mg cefalexin/kg bw/day and maternal effects from the lowest dose tested (300 mg cefalexin/kg bw/day).
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 (macrolides, sulfonamides, tetracyclines). Concurrent use of first generation cephalosporins with aminoglycoside antibiotics or some diuretics such as furosemide can enhance nephrotoxicity risks.
Concomitant use with such active substances should be avoided
Overdose (symptoms, emergency procedures, antidotes), if necessary
Studies on animals with up to 5 times the recommended twice daily dosage of 15 mg cefalexin/kg have been performed. Adverse reactions that may occur at the recommended dose (nausea, vomiting and/or diarrhoea) are expected in the case of overdose. In the event of overdose, treatment should be symptomatic.
Pharmaceutical precautions
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: 3 years.
Shelf life after first opening the immediate packaging: 75 mg: 16 hours, 300 mg & 750 mg: 48 hours.
Legal category
Legal category: POM-V
Packaging quantities
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.
Further information
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Cefaseptin 75 mg tablets for dogs and cats Vm 08007/4141
Cefaseptin 300 mg tablets for dogs Vm 08007/4142
Cefaseptin 750 mg tablets for dogs Vm 08007/4143
Significant changes
GTIN description:Cefaseptin 75 mg 100 tablets
GTIN description:Cefaseptin 75 mg 250 tablets
GTIN description:Cefaseptin 300 mg 100tablets
GTIN description:Cefaseptin 300 mg 250 tablets
GTIN description:Cefaseptin 750 mg 72 tablets
GTIN description:Cefaseptin 750 mg 150 tablets