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Therios 300 mg Palatable Tablets for Dogs

Information leaflet

             Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!
                                                            Revised 29/03/2010 – AN 02535/2008
1.    NAME OF THE VETERINARY MEDICINAL PRODUCT

UK, AT, IE, PL, CZ,         Therios 300 mg palatable tablets for dogs
BE, HU, GK, LUX, NL,
PT
IT, ES, FI                  Therios 300 mg flavoured tablets for dogs
DE                          Therios 300 mg aromatisierte Tabletten für Hunde

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:
Each tablet contains:
Cefalexin (as cefalexin monohydrate).........................................300 mg

For a full list of excipients, see section 6.1.

3.    PHARMACEUTICAL FORM

Tablet
Round scored beige palatable tablet
The tablet can be divided into equal halves and quarters

4.      CLINICAL PARTICULARS

4.1     Target species

Dogs.

4.2     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.

4.3     Contraindications

Do not use in animals which are known to be hypersensitive to penicillins.
Do not use in case of severe renal failure
Do not use in rabbits, guinea pigs, hamsters and gerbils.

4.4   Special warnings for each target species

None.

4.5     Special precautions for use

i) Special precautions for use in animals

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.
Wherever possible, the use of the product should be based on susceptibility testing and take
into account official and local antimicrobial policies
           Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!
                                                          Revised 29/03/2010 – AN 02535/2008


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

ii) 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.

1. Do not handle this product if you know you are sensitized 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. 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

4.6   Adverse reactions (frequency and seriousness)

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

4.7    Use during pregnancy, lactation or lay

Do not use in pregnant or lactating bitches.

4.8   Interaction 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

4.9    Amounts to be administered and administration route
For oral administration.

15 mg cefalexin per kg bodyweight twice daily (equivalent to 30 mg per kg bodyweight 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.

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

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
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