Presentation 

Amoxypen LA is an off-white, sterile, non-aqueous suspension for injection containing 150 mg amoxicillin (as Amoxicillin Trihydrate Ph.Eur.) per ml.

Uses 

Amoxicillin is a broad-spectrum, bactericidal antibiotic. Amoxypen LA is indicated for the treatment of infections caused by micro-organisms sensitive to amoxicillin in cattle, sheep, pigs, dogs and cats where prolonged antibiotic cover from a single injection is required. In vitro,   amoxicillin is active against a wide range of both Gram-positive and Gram-negative organisms including: Escherichia coli, Klebsiella pneumoniae, Proteus spp,  Salmonella spp. staphylococci and streptococci. Particular clinical indications include infections of the gastro-intestinal, respiratory and urogenital tracts,skin and soft tissue infections, secondary bacterial infections in viral or parasitic diseases and where post-operative antibiotic cover is required.

Dosage and administration 

Dosage: in general 15 mg/kg (equivalent to 1 ml per 10 kg bodyweight), repeated if necessary after 48 hours.  

A separate injection site should be used for each administration.

Suggested doses are:

Cattle    500 kg    -    50 ml

Sheep      50 kg    -     5 ml

Pigs         50 kg    -     5 ml

Dogs        10 kg   -     1 ml

Cats           5 kg   -     0.5 ml 

Administration:Cattle, sheep and pigs - by intramuscular injection only. Dogs and cats - intramuscular or subcutaneous injection. Normal aseptic precautions should be observed. After administration massage the injection site. Dose volumes in excess of 20ml should be injected at more than one 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.

Contra-indications, warnings, etc.

Do not administer via intravenous or intrathecal routes. 

Amoxypen LA should not be administered to animals sensitive to penicillin.

As with other penicillins, amoxicillin should not be used orally or parenterally   in rabbits, guinea pigs, hamsters, gerbils or in any other small herbivores.

Not effective against beta-lactamase producing organisms.

Allergies to amoxicillin 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 23 days from the last treatment.

Sheep and pigs may be slaughtered for human consumption only after 16 days from the last treatment.

Milk for human consumption must not be taken from a cow during treatment. 

Milk for human consumption may be taken only after 79 hours after the last treatment. 

Not for use in sheep producing milk for human consumption.

Operator warnings:

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 25^oC. Protect from light. Shake the vial before use. 

In common with other oil-based suspensions this product does not contain an antimicrobial preservative.   Swab the septum before removing each dose. Only dry, sterile needles and syringes should be used for administration. Following withdrawal of the first dose, use the product within 28 days.  

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Keep container in outer carton.

Legal category  

POM-V                To be supplied only on veterinary prescription.

Package quantities 

Multidose vials of 100 ml.

Further information 

Following parenteral administration, amoxicillin is widely distributed and high levels are seen particularly in kidney, urine, liver and bile.

Marketing authorisation number 

Vm 01708/4340

Marketing authorisation holder:

IntervetUK Ltd.               

Walton Manor

Walton

Milton Keynes

Buckinghamshire 

MK7 7AJ

Date of text preparation:

October 2006