Product Description

Target species

Dogs

Indications for use, specifying the target species

For the treatment of bacterial skin infections in dogs (including deep and superficial pyoderma) caused by organisms sensitive to cefalexin.

For the treatment of urinary tract infections in dogs (including nephritis and cystitis) caused by organisms sensitive to cefalexin.

Contraindications

Do not use in animals which are known to be hypersensitive to penicillins, cephalosporins or any of the excipients

Do not use in case of severe renal failure

Do not use in rabbits, guinea pigs, hamsters and gerbils.

Special warnings for each target species

None

Special precautions for use

Special precautions for use in animals

Whenever possible, the use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

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.

The product is not recommended for use in dogs less than 2.5 kg bodyweight.

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 beta-lactam antibiotics due to the potential for cross-resistance.

Safety of the excipient, ammonium glycyrrhizate, has not been established in dogs less than 1 year old.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Cephalosporins may cause sensitization (allergy) following injection, inhalation, ingestion or skin contact. Sensitivity to penicillins 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 sensitized 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. Swellings of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.

In the event of accidental ingestion, particularly by a child, seek medial attention and show the doctor the leaflet

Adverse reactions (frequency and seriousness)

Vomiting and diarrhoea have been observed in dogs. In rare cases hypersensitivity can occur.

Use during pregnancy, lactation or lay

Do not use in pregnant or lactating bitches.

Interactions with other medicinal products and other forms of interaction

In order to ensure efficacy, the 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

Amounts to be administered and administration route

For oral administration.

15 mg cefalexin per kg body weight twice daily (equivalent to 30 mg per kg body weight per day) for duration of:

-14 days in cases of urinary tract infection

-At least 15 days in cases of superficial infectious dermatitis

-At least 28 days in cases of deep infectious dermatitis

In severe or acute conditions the dose may be safely doubled to 30 mg/kg twice daily. To allow for accuracy of dosing, tablets can be halved or quartered.

Any increase in the dose or duration of treatment should be according to a risk/ benefit assessment by the prescribing veterinarian

To ensure a correct dosage bodyweight should be determined as accurately as possible to avoid under dosing.

Therios tablets are well accepted by dogs but may be crushed or added to a small quantity of food immediately prior to feeding if necessary

Overdose (symptoms, emergency procedures, antidotes), if necessary

Trials performed on animals with up to 5 times the recommended twice daily dosage of 15 mg/kg demonstrated that cefalexin was well tolerated.

Withdrawal period(s)

Not applicable

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