Introduction
Company name: Animalcare Limited
Address: Common Road
Dunnington
York YO19 5RU
Telephone: 01904 487687
Fax: 01904 487611
Email: animalcare@animalcare.co.uk
Amoxycare Injection
Introduction
Company name: Animalcare Limited
Address: Common Road
Dunnington
York YO19 5RU
Telephone: 01904 487687
Fax: 01904 487611
Email: animalcare@animalcare.co.uk
Presentation
Amoxycare Injection is an off-white sterile suspension containing 150 mg/ml Amoxycillin as Amoxycillin Trihydrate.
Chemically, amoxycillin is 6[D](-α -) amino p-hydroxyphenylacetamido] penicillanic acid. Also contains: Butylated Hydroxyanisole 0.08mg/ml and Butylated Hydroxytoluene 0.08 mg/ml, as antioxidants.
Uses
Amoxycare Injection is a broad spectrum semisynthetic penicillin, bactericidal in action. In vitro it is effective against a wide range of Gram-positive and Gram-negative pathogenic bacteria which include: Actinobacillus equuili, Actinobacillus lignieresi, Actinomyces bovis, Bacillus anthracis, Bordetella bronchiseptica, Clostridium species, Corynebacterium species, Erysipelothrix rhusiopathiae, Escherichia coli, Fusiformis species, Haemophilus species, Moraxella species, Pasteurella species, Proteus mirabilis, Salmonella species, Staphylococci and Streptococci in cattle, sheep, pigs, dogs and cats.
Dosage and administration
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.
ANIMAL | WEIGHT kg | DOSE VOLUME ml |
Cattle | 450 kg | 20.0 ml |
Sheep | 65 kg | 3.0 ml |
Pigs | 150 kg | 7.0 ml |
Dogs | 20 kg | 1.0 ml |
Cats | 5 kg | 0.25 ml |
(Guide-dose volume is equivalent to 0.25 ml per 5 kg daily).
If dose volume exceeds 20 ml in cattle or 10 ml in sheep and pigs it should be divided and injected in two sites.
Normal aseptic precautions should be observed.
An appropriately graduated syringe should be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.
Contra-indications, warnings, etc
This product is not suitable for administration via intravenous or intrathecal routes.
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.
Occasional local tissue reaction may result from use of this product.
Not effective against beta-lactamase producing organisms.
As with other penicillins Amoxycillin should not be used in rabbits, hamsters, gerbils and guinea pigs.
Operator warning - Penicillin/Cephalosporin sensitivity
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross reaction 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 breathing are more serious symptoms and require urgent medical attention.
Pharmaceutical precautions
Keep out of the reach of children. Do not store above 25°C. Shake bottle before use.
Following withdrawal of the first dose, use the product within 28 days. Discard unused material. This product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Use a dry, sterile needle and syringe.
When the container is broached for the first time, using the in-use shelf-life which is specified on this data sheet, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written on the space provided on the label.
Disposal
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Legal category
POM-V
Packaging Quantities
Multidose vials of 100 ml.
Further information
High levels of amoxycillin are found in kidney, urine, liver and bile after absorption due to its wide distribution.
In common with other penicillins an absence of toxicity is apparent even at high dose levels.
Animals with functional rumens should only be treated parenterally.
Marketing authorisation number
2000/4140.