Betamox Palatable Drops Powder For Oral Suspension 50 Mg/Ml
Revised: 16th December 2008
1. Name of the veterinary medicinal product
Betamox Palatable Drops, Powder for Oral Suspension 50 mg/ml
Qualitative and quantitative composition
Each bottle contains:
Active Substance: mg
(as Amoxicillin Trihydrate)
When reconstituted with 12 ml water gives a 15 ml suspension containing amoxicillin at a concentration of 50 mg/ml.
Erythrosin E127 …………………………………..2.34
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Powder for oral suspension
A pale red powder
4. Clinical Particulars
4.1 Target species
4.2 Indications for use, specifying the target species
For the control of infections in dogs and cats, including infections of the alimentary tract, respiratory tract and urogenital tract, eye and ear infections, and skin and wound infections. In vitro, amoxycillin is effective against a wide range of Gram-positive and Gram-negative bacteria, including:
Pasteurellaspp (including P. multocida)
Staphylococci(penicillin sensitive stains)
Not to be used in animals known to be hypersensitive to penicillin.
Not to be used orally or parenterally in rabbits, guinea pigs, hamsters or gerbils.
Caution is advised when used in any 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
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
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 the use of Betamox Palatable Drops during pregnancy.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
Reconstitution: Add 12 ml water to the powder and shake vigorously. This will make 15 ml of the suspension, containing amoxycillin at a concentration of 50 mg/ml.
Administration and Dosage: Recommended dosage rate is 10 mg/kg bodyweight amoxycillin twice daily for up to 7 days. The drops are given orally using a graduated pipette provided. The dosage rate of 10 mg/kg is achieved by administering 1 ml of reconstituted product per 5 kg bodyweight.
Shake well before use
To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid under dosing.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Penicillins have a high margin of safety and clinical signs are unlikely even in accidental overdose.
No treatment specified.
5. pharmacological properties
Pharmacotherapeutic group: Antibacterial
ATC Vet Code: QJ01CA04
Amoxycillin is a broad-spectrum semi-synthetic penicillin. Amoxycillin predominately inhibits cell wall synthesis in susceptible bacteria. Amoxycillin has a mode of action which directly and irreversibly disrupts cell wall peptidoglycan. Amoxicillin is absorbed well after oral administration, giving high plasma and tissue levels. Excretion takes place in both bile and urine.
6. Pharmaceutical particulars
List of excipients
Trusil Strawberry Select Flavour H9922
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after dilution or reconstitution according to direction: 7 days
Special precautions for storage
Do not store above 25ºC.
Do not store reconstituted product above 25ºC.
Any reconstituted product remaining 7 days after preparation should be discarded
Nature and composition of immediate packaging
White polyethylene / polypropylene bottle with white, wadded polypropylene cap (screw-fit), with a graduated natural polyethylene pipette with white polypropylene screw-on cap and natural rubber bulb as a dosing device.
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 form 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)
DATE OF FIRST AUTHORISATION
10. DATE OF REVISION OF THE TEXT