Baytril Flavour Tablets 150 Mg
Revised: August 2012
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Flavour Tablets 150 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
mg per tablet
Relevant Constituents of the Excipients
Artificial Beef Flavour Irradiated
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Light brown to brown, slightly marbled, round, curved, scored tablets for oral administration to dogs.
4. CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
The product is for use in dogs in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Not for use in dogs less than 1 year of age or in exceptionally large breeds of dog with a longer growth period under 18 months of age, as articular cartilage may be affected during the period of rapid growth.
Baytril Flavour Tablets 150mg should not be used for prophylaxis.
4.4 Special warnings for each target species
Please see point 4.3.
4.5 Special precautions for use
i. Special precautions for use in animals
Do not exceed the recommended dose.
ii. Special precautions to be taken by the person administering the medicinal product to animals
iii. Other precautions
4.6 Adverse reactions (frequency and seriousness)
In dogs enrofloxacin may affect articular cartilage during the period of rapid growth.
4.7 Use during pregnancy, lactation or lay
The product may be used safely in pregnant and lactating animals.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amount(s) to be administered and administration route
The dosage rate of enrofloxacin is 5 mg/kg given orally once daily or as a divided dose twice daily for 3 to 10 days with or without food. Treatment may be initiated with Baytril 5% Injection or Baytril 2.5% Injection and maintained with Baytril Flavour Tablets.
The daily dose is achieved as follows:-
Large dogs: 1 tablet Baytril Flavour Tablets 150 mg per 30 kg bodyweight.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Do not exceed the recommended dose. In accidental overdose vomiting, diarrhoea and CNS/behavioural changes may occur. There is no antidote and treatment should be symptomatic.
4.11 Withdrawal period(s)
5. PHARMACOLOGICAL PROPERTIES
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics.
ATC Vet Code:QJ01MA90
Enrofloxacin is bactericidal in action with activity against Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials – they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double standard helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
The pharmacokinetics of enrofloxacin in dogs and cats are such that oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 times higher than that found in the serum, have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Silica colloidal anhydrous
Artificial beef flavour Irradiated
Shelf-life of the product as packaged for sale:
6.4 Special precautions for storage
Do not store above 25ºC. Store in a dry place.
6.5 Nature and composition of immediate packaging
Aluminium foil blister or plastic coated aluminium blister.
Silver or white coloured.
Strips of 10 light brown to brown tablets supplied in dispensing cartons containing 100 tablets.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused product or waste material should be disposed of in accordance with national requirements.
7. MARKETING AUTHORISATION HOLDER
Animal Health Division,
Berkshire RG14 1JA
Animal Health Division,
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/ LAST RENEWAL OF THE AUTHORISATION
Date: 20 May 1992
Date: 20 May 2007
01 October 1988
30 October 2008
10. DATE OF REVISION OF THE TEXT
Date: August 2012
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