Appertex 2.5 Mg Tablets
Revised: August 2008
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Appertex 2.5mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Clazuril 2.5mg per tablet
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White circular bioconvex tablet inscribed Janssen and Appertex on opposing faces.
4. CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
Therapeutic and routine treatment of
coccidiosis in homing pigeons caused by:
4.4 Special warnings for each target species
4.5 Special precautions for use
Special precautions for use in animals
The product is not soluble in water and cannot be administered in the drinking water. Do not use simultaneously with L-Spartakon as the latter drug may cause vomiting.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after administration of the tablets to birds and after clearing the waste from treated birds.
4.6 Adverse reactions (frequency and seriousness)
4.7 Use during pregnancy, lactation or lay
Can be used safely during
reproduction and holds no danger for young pigeons still in the
4.8 Interaction with other medicinal products and other forms of interaction
Should not be administered simultaneously with other drugs.
4.9 Amounts to be administered and administration route
For oral administration only; 5
mg/kg body mass, equivalent to 1 tablet perpigeon
Method of administration
The tablet is placed directly into the mouth. All pigeons in a loft should be treated simultaneously to prevent untreated birds acting as a source of re-infection for treated birds.
Breeding pigeons should be treated before mating and again three weeks later.
Good management and hygiene in the lofts is essential for the prevention of re-infection.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
At overdosing of up to 128 times the recommended therapeutic dose the only symptoms seen were vomiting and loose faeces. These symptoms were mild and transitory in nature. No specific treatment was necessary. Deaths were never seen.
4.11 Withdrawal period(s)
Appertex must not be used in pigeons intended for human consumption.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Agents against protozoal diseases
ATCvet code: QP51 AJ02
Clazuril is an anticoccidial belonging to the group of the benzene-acetonitriles.
5.1. Pharmacodynamic properties
Clazuril has its anticoccidial effect by means of a cidal effect on the endogenous stages of the Eimeria species in pigeons.
5.2 Pharmacokinetic particulars
Clazuril is rapidly absorbed with maximum plasma concentrations found 5 – 8 hours after dosing. The half-life of clazuril in pigeons is about 3 days.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Silica colloidal anhydrous
6.3 Shelf life
Shelf life of veterinary medicinal product as packaged for sale: 3 years.
6.4 Special precautions for storage
Do not store above 25ºC.
Store in a dry place.
6.5 Nature and composition of immediate packaging
30 tablets in polyvinylchloride blister pack with an aluminium foil closure in an outer carton.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Excreta from treated birds should not be spread onto land used for growing crops.
7. MARKETING AUTHORISATION HOLDER
Unit 2, Cavendish Road
Bury St Edmunds
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17 September 1992
10 DATE OF REVISION OF THE TEXT