Betamox 150 Mg/Ml Suspension For Injection
Revised October 2014
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Betamox 150 mg/ml Suspension for Injection
2. Qualitative and quantitative composition
Each ml contains
Amoxicillin 150 mg
(as Amoxicillin Trihydrate 172.1 mg)
Butylated Hydroxyanisole 0.08 mg
Butylated Hydroxytoluene 0.08 mg
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Suspension for injection.
An off-white oily suspension.
4. Clinical Particulars
4.1 Target species
4.2 Indications for use, specifying the target species
For the treatment of infections caused by a wide range of Gram-positive and Gram-negative pathogenic bacteria including:
Actinobacillus equuli Actinomyces bovis
Actinobacillus lignieresi Bacillus anthracis
Erysipelothrix rhusiopathiae Bordetella bronchiseptica
Escherichia coli Clostridium species
Haemophilus species Corynebacterium species
Proteus mirabilis Moraxellaspecies
Not effective against beta-lactamase producing organisms.
Intravenous or intrathecal use.
Use in rabbits, hamsters, gerbils and guinea pigs.
Use in known cases of hypersensitivity to amoxycillin.
4.4 Special Warnings for each target species
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
Care should be taken to avoid accidental self-injection. In the case of accidental self-injection, seek medical advice immediately. 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.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations
Handle this product with great care to avoid exposure taking all recommended precautions.
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 breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
Occasional local tissue reactions may result from use of this product.
4.7 Use during pregnancy, lactation or lay
Betamox Injection can be safely administered during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
Cattle, sheep and pigs : By intramuscular injection only.
Dogs and cats : By subcutaneous or intramuscular injection.
The recommended dosage rate is 7 mg/kg bodyweight once a day for up to five days. Massage the injection site.
A separate injection site should be used for each administration.
Dose volume (ml)
(Guide-dose volume is equivalent to about 0.25 ml per 5 kg daily).
Normal aseptic precautions should be observed. Shake vial before use. This product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Use a dry, sterile needle and syringe.
If dose volume exceeds 20 ml in cattle or 10 ml in pigs, it should be divided and injected into two sites.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Penicillin’s have a wide safety margin
Milk for human consumption must not be taken from a cow during treatment. Milk for human consumption may only be taken after 24 hours from the last treatment.
Not for use in sheep producing milk for human consumption.
Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 18 days from the last treatment. Sheep may be slaughtered for human consumption only after 10 days from the last treatment. Pigs may be slaughtered for human consumption only after 16 days from the last treatment.
5. pharmacological properties
Pharmacotherapeutic group: Antibiotic
ATC Vet Code: QJ 01 CA 04
5.1 Pharmacodynamic properties
Amoxycillin predominately inhibits cell wall synthesis in susceptible bacteria. Amoxycillin has a unique mode of action which directly and irreversibly disrupts existing cell wall peptidoglycan rather than newly forming peptidoglycan of the divisory septal wall as with other members of the penicillin family.
6. Pharmaceutical particulars
6.1 List of excipients
Propylene Glycol Dicaprylocaprate
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 28 days
6.4 Special precautions for storage
Following withdrawal of the first dose, use the product within 28 days. Discard unused material.
Do not store above 25ºC.
6.5 Nature and composition of immediate packaging
Betamox Injection is supplied in 50 ml and 100 ml clear, colourless Type III or Type II glass vials, closed with nitrile rubber bungs and aluminium overseals, and 50 ml and 100 ml clear plastic vials closed with nitrile rubber bungs and aluminium overseals.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterianry medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
7. MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
Date: 30 June 1986
10. DATE OF REVISION OF THE TEXT
Date: October 2014
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