Presentation 

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

Uses 

Amoxicillin is a broad-spectrum, bactericidal antibiotic. Amoxypen Injection is indicated for the treatment of infections caused by micro-organisms sensitive to   amoxicillin in cattle, sheep, pigs, dogs and cats. In vitro,   amoxicillin 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. Proteus mirabilis, Pasteurella spp. staphylococci and streptococci.

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 - 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.

Contra-indications, warnings, etc.

Do not administer via intravenous or intrathecal routes. 

Amoxypen Injection 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 or gerbils. Caution is advised when used in any other very 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 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 a cow 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 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. Swab the septum before removing each dose. 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. 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 01708/4339

Marketing Authorisation holder:                 

IntervetUK Ltd.                                      

Walton                                                             

Milton Keynes                                                  

Buckinghamshire MK7 7AJ                               

Distributed in Northern Ireland by:

Intervet Ireland Ltd

Magna Drive

Magna Business Park

Citywest Road

DUBLIN 24

Date of   text preparation: 

November 2006