Amoxycare 200 Mg Tablets
Revised: 10th December 2008
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Amoxycare 200mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains Amoxicillin (as Amoxicillin Trihydrate) 200 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 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 spp including Pasteurella multocida
Staphylococci (penicillin sensitive strains)
Amoxycare 200mg Tablets should not be given to penicillin sensitive animals. As with other penicillins, amoxicillin should not be used orally or parenterally in rabbits, guinea pigs, hamsters or gerbils. Caution is advised when used in other very 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
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillin’s 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 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 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)
4.7 Use during pregnancy, lactation or lay
No known contraindication exists for the use of Amoxycare 200mg Tablets 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 dosage rate is 10 mg amoxicillin/kg bodyweight (one tablet per 20 kg bodyweight) twice daily for 7 days. Tablets are given orally, by hand or crushed in food. To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
Any remaining medicated feed should be disposed of at the end of the day.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Penicillins have a wide safety margin and adverse effects are unlikely even in accidental overdose.
5. pharmacological properties
Pharmacotherapeutic group: Antibiotic
ATC Vet Code: QJ01CA04
Amoxicillin is a broad-spectrum semi-synthetic penicillin. Amoxicillin predominantly inhibits cell wall synthesis in susceptible bacteria. Amoxicillin has a mode of action, which directly and irreversibly disrupts cell wall peptidoglycan.
6. Pharmaceutical particulars
6.1 List of excipients
Sodium Starch Glycollate
Yeast Extract (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
Amoxycare 200mg Tablets are supplied in white, polypropylene tubs with white, low-density polyethylene closures of the following sizes:
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
29th December 1997
10. DATE OF REVISION OF THE TEXT