Company name: MSD Animal Health

Address: Walton Manor

Walton

Milton Keynes

MK7 7AJ

Telephone: 01908 685685 (Customer Support Centre)

Fax: 01908 685555

Email: vet-support.uk@merck.com

Website: www.msd-animal-health.co.uk

Presentation

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

Antioxidant preservatives per ml: Butylated hydroxytoluene 0.08 mg and Butylated hydroxyanisole 0.08 mg .

Uses

The product is suitable for the control of infections, due to susceptible micro-organisms, in cattle, pigs, sheep, dogs and cats where a single injection giving prolonged antibiotic cover is required. It may also protect from secondary bacterial invasion in cases where bacteria are not the initial cause of the disease.

Indications include infections of:

Alimentary tract, Respiratory tract, Skin and soft tissue

Urogenital tract and in prevention of post-operative infection (treat before surgery).

In vitro amoxicillin is effective against a wide range of Gram-positive and Gram-negative bacteria which include:

Escherichia coli, Klebsiella pneumonia, Proteus spp., Salmonella spp. staphylococci and streptococci.

Dosage and administration

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 – by intramuscular or subcutaneous injection. Normal aseptic precautions should be observed. After administration massage the injection site. Dose volumes in excess of 20 ml 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 the 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 reaction 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 warning

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin 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°C. Protect from light.

Shake the vial before use. Keep container in outer carton.

In common with other oil-based suspensions this product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Only dry 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.