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Amoxycillin is a broad-spectrum, bactericidal antibiotic. Amoxypen Injection is indicated for the treatment of infections caused by micro-organisms sensitive to amoxycillin in cattle, sheep, pigs, dogs and cats. In vitro, amoxycillin is active against a wide range of both Gram-positive and Gram-negative organisms including: Actinobacillus equuli, Actinobacillus lignieresi, Actinomyces bovis, Bacillus anthracis, Bordetella bronchiseptica, Clostridium spp., Corynebacterium spp., Erysipelothrix rhusiopathiae, Escherichia coli, Fusiformis spp., Haemophilus spp., Moraxella spp., Pasteurella spp., Proteus mirabilis, Salmonella spp., Staphylococci and Streptococci.
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Presentation
Amoxypen is an off-white, sterile, non-aqueous suspension for injection containing 150 mg amoxycillin (as Amoxycillin Trihydrate) per ml.
Uses
Amoxycillin is a broad-spectrum, bactericidal antibiotic. Amoxypen Injection is indicated for the treatment of infections caused by micro-organisms sensitive to amoxycillin in cattle, sheep, pigs, dogs and cats. In vitro, amoxycillin is active against a wide range of both Gram-positive and Gram-negative organisms including: Actinobacillus equuli, Actinobacillus lignieresi, Actinomyces bovis, Bacillus anthracis, Bordetella bronchiseptica, Clostridium spp., Corynebacterium spp., Erysipelothrix rhusiopathiae, Escherichia coli, Fusiformis spp., Haemophilus spp., Moraxella spp., Mannheimia spp., Pasteurella spp., Proteus mirabilis, Salmonella spp., Staphylococci and Streptococci.
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Dosage and administration
Dosage
in general 7 mg/kg bodyweight (equivalent to 0.5 ml per 10 kg), once daily for up to five days. Suggested doses are:
Cattle
500 kg 25.0 ml (max 20 ml at one site)
Sheep
50 kg 2.5 ml
Pigs
50 kg 2.5 ml
Dogs
10 kg 0.5 ml
Cats
5 kg 0.25 ml
Administration
Cattle, Sheep and Pigs – by intramuscular injection only.
Dogs and Cats – by intramuscular or subcutaneous injection.
Normal aseptic precautions should be observed. After administration massage the injection site.
An appropriately graduated syringe must be used to ensure accurate administration of the required dose volume. This is particularly important when injecting small volumes.
A separate injection site should be used for each administration.
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Contra-indications, warnings, etc
Do not administer via the intravenous or intrathecal routes.
Amoxypen Injection should not be administered to animals sensitive to penicillin.
As with other penicillins, amoxycillin should not be used orally or parenterally in rabbits, guinea pigs, hamsters or gerbils. Caution is advised when used in any other very small herbivores.
Not effective against beta-lactamase producing organisms.
Allergies to amoxycillin can occur rarely.
Occasional local tissue reactions may occur following the use of this product.
Withdrawal periods
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.
Milk for human consumption must not be taken from cows during treatment. Milk for human consumption may be taken only after 24 hours from the last treatment.
Not for use in sheep producing milk for human consumption.
Operator warning
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may cause 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.
For animal treatment only. Keep out of reach and sight of children.
Pharmaceutical precautions
Do not store above 25oC. Protect from light.
Shake the vial before use. Swab the septum before removing each dose. Keep container in outer carton.
In common with other oil-based suspensions this product does not contain an antimicrobial preservative. Only dry, sterile needles and syringes should be used for administration.
Following withdrawal of the first dose, use the product within 28 days. Discard unused material safely.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
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Legal category
POM-V
Packaging Quantities
Multidose vials of 100 ml.
Further information
Following parenteral administration, amoxycillin is widely distributed and high levels are seen particularly in kidney, urine, liver and bile.
Marketing authorisation number
Vm 01708/4339.
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