Betamox 40 Mg Palatable Tablets
Revised: 31 July 2008
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Betamox 40mg Palatable Tablets
2. Qualitative and quantitative composition
Each tablet contains :
Amoxicillin 40 mg
(as Amoxicillin Trihydrate) 45.92 mg
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Off-white circular tablets scored on one face
4. Clinical Particulars
4.1 Target species
4.2 Indications for use, specifying the target species
For use in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts and in the eye, ear, skin and wound infections caused by susceptible organisms. In vitro, amoxicillin is effective against a range of Gram-positive and Gram-negative bacteria, including:
Pasteurella sppincluding Pasteurella multocida
Staphylococci (penicillin sensitive strains)
Do not use in known cases of hypersensitivity to amoxicillin.
Not for administration to rabbits, guinea pigs, hamsters or gerbils.
Caution is advised when used in other small herbivores.
4.4 Special Warnings for each target species
No special warnings.
4.5 Special precautions for use
Special precautions for use in 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 cephalosporins 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.
3. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Wash hands after use
4.6 Adverse reactions (frequency and seriousness)
No known undesirable effects.
4.7 Use during pregnancy, lactation or lay
No known contraindication exists for use of during pregnancy.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
The recommended dose rate is 10 mg amoxicillin per kg bodyweight (one tablet per 4kg bodyweight) twice daily for 7 days.
Tablets are given orally by hand or crushed in food.
Any remaining medicated feed should be disposed of at the end of the day.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Penicillins have a remarkably good safety record and overdose is highly unlikely.
5. pharmacological properties
Pharmacotherapeutic group: Antibiotic
ATC Vet Code: QJ01CA04
5.1 Pharmacodynamic properties
Amoxicillin is a broad-spectrum semi-synthetic penicillin. Amoxicillin predominately inhibits cell wall synthesis in susceptible bacteria. Amoxicillin has a mode of action which directly and irreversibly disrupts cell wall peptidoglycan. Amoxicillin is well absorbed following oral administration.
6. Pharmaceutical particulars
6.1 List of excipients
Sodium Starch Glycollate
Yeast Dried (spray dried)
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Special precautions for storage
Do not store above 25ºC. Store in a dry place.
Nature and composition of immediate packaging
Betamox 40mg Palatable Tablets are supplied in white opaque high density polypropylene tubs with white opaque tamper evident, push-fit low density polyethylene caps of the following sizes:
100 x Betamox 40 mg Tablets
500 x Betamox 40 mg Tablets
Not all pack sizes may be marketed
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.
7. MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
Co. Down, BT35 6JP
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION
10. DATE OF REVISION OF THE TEXT