Betamox LA
Suspension for Injection
COMPOSITION
Active substance: Each ml contains: 150 mg (15% w/v) Amoxicillin (as Amoxicillin Trihydrate 17.21 %w/v),
Excipients: 0.08 mg (0.008% w/v) butylated hydroxytoluene
0.08 mg (0.008% w/v) butylated hydroxyanisole as antioxidants.
PHARMACEUTICAL FORM
Suspension for injection.
An off-white oily non-aqueous suspension.
TARGET SPECIES
Cattle, Sheep, Pigs, Dogs, Cats
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In vitro Amoxicillin is effective against a wide range of Gram-positive and Gramnegative bacteria which include:
Escherichia coli
Klebsiella pneumoniae
Proteus species
Salmonella species
Staphylococci and
Streptococci
Not effective against beta-lactamase producing organisms.
Suitable for the control of infections due to susceptible microorganisms in cattle,
sheep, pigs, dogs and cats where a single injection giving prolonged activity is
required. It may also protect from secondary bacterial invasion due to sensitive
organisms in cases where bacteria are not the initial cause of the disease.
Indications include infections of:
(a) Alimentary tract
(b) Respiratory tract
(c) Skin and soft tissue
(d) Urogenital tract and,
(e) In prevention of post-operative infection (treat before surgery).
CONTRAINDICATIONS
This product is not suitable for intravenous or intrathecal use
This product should not be administered to rabbits, hamsters, gerbils or guinea pigs.
Not for use in known cases of hypersensitivity to penicillins or cephalosporins.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings.
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
Care should be taken to avoid accidental self-injection. In the case of accidental selfinjection, 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 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.
Adverse reactions (frequency and seriousness)
In rare cases, hypersensitivity reactions such as urticaria anaphylaxis shock can
occur after use. In the case of allergic reactions, treatment should be discontinued
and a symptomatic treatment should be initiated. In very rare cases, local tissue
reactions such as swelling and pruritus may result from the use of amoxicillin.
The frequency of adverse reactions is defined using the following convention:
– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
– common (more than 1 but less than 10 animals in 100 animals treated)
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Use during pregnancy, lactation or lay
Can be safely administered during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
It is not generally recommended to use bactericidal and bacteriostatic antibiotics at the same time.
Amounts to be administered and administration route
To ensure the correct dosage, bodyweight should be determined as accurately as
possible to avoid underdosing or overdosing.
Cattle, sheep and pigs – By intramuscular injection only.
Dogs and cats – By subcutaneous or intramuscular injection.
The recommended dosage rate is 15 mg per kg bodyweight, repeatable if necessary
after 48 hours. Massage the injection site.
Shake the vial before use
Swab the septum before removing each dose. Use a dry sterile needle and syringe.
A separate injection site should be used for each administration.
| Animal | Weight (kg) | Dosage volume (ml) |
| Cattle | 450 kg | 45.0 ml |
| Sheep | 65 kg | 6.5 ml |
| Pigs | 150 kg | 15.0 ml |
| Dogs | 20 kg | 2.0 ml |
| Cats | 5 kg | 0.5 ml |
Dose volume is equivalent to 1 ml per 10 kg bodyweight. If dose volume exceeds 15
ml in cattle and 4 ml in sheep and pigs, it should be divided and injected into two or
more sites. As with other injectable preparations, normal aseptic precautions should
be observed as this product does not contain antimicrobial preservative.
An appropriately graduated syringe must be used to allow accurate administration of
the required dose volume. This is particularly important when injecting small
volumes.
If no distinct clinical response is seen after the second treatment, a check of the
diagnosis and eventually a change of treatment are required.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Penicillins have a wide safety margin.
Withdrawal period(s)
Cattle:
Meat and offal: 39 days
Milk: 108 hours (4.5 days)
Pigs:
Meat and offal: 42 days
Sheep:
Meat and offal: 29 days
Milk: Not authorised for use in sheep producing milk for human consumption.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antibacterial
ATC Vet Code: QJ01CA04
Pharmacodynamic properies
Amoxicillin predominately inhibits cell wall synthesis in susceptible bacteria. Amoxicillin 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.
PHARMACEUTICAL PARTICULARS
List of excipients
Butylated Hydroxyanisole
Butylated Hydroxytoluene
Aluminium Stearate
Propylene Glycol Dicaprylocaprate
Major incompatibilities
None known
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 12 months.
Shelf life after first opening the immediate packaging: 28 days
Special precautions for storage
Do not store above 25ºC.
Protect from light.
Following withdrawal of the first dose, use the product within 28 days. Discard unused material.
This product does not contain an antimicrobial preservative.
Nature and composition of immediate packaging
100 ml and 50 ml clear, colourless Type II or III multidose glass vials, closed with
nitrile rubber bungs and aluminium overseals.
50 ml, 100 ml, 250 ml and 500 ml clear polyethylene terephthalate vials sealed with
nitryl bungs and aluminium overseals.
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.
