SUMMARY OF PRODUCT CHARACTERISTICS

Clamoxyl Long Acting 150 mg/ml Suspension for Injection

Active ingredients: mg/ml

Amoxicillin 150

(As Amoxicillin trihydrate)

For a full list of excipients please see section 6.1

Suspension for injection.

White to off-white oily suspension.

Sheep, dogs and cats

Clamoxyl is a broad-spectrum semi-synthetic penicillin which is bactericidal in vitro against a wide range of Gram-positive and Gram-negative bacteria including the following:

Gram-negative:

Actinobacillus lignieresi; Bordetella bronchiseptica, Escherichia coli (non beta-lactamase producing strains), Corynebacterium spp.; Fusobacterium spp.; Haemophilus spp.; Moraxella spp.; Pasteurella spp.; Proteus mirabilis (non beta-lactamase producing strains); Salmonella spp.

Gram-positive:

Bacillus anthracis; Clostridium spp.; Erysipelothrix rhusiopathiae; Streptococci; Staphylococci (non beta-lactamase producing strains).

Clamoxyl Long Acting Suspension for Injection is suitable for the control of infections caused by susceptible organisms in sheep, dogs and cats where prolonged activity from a single injection is required. It may also be used to control secondary bacterial invasion in conditions where bacteria are not a primary cause of disease.

Particular indications for Clamoxyl Long Acting Suspension for Injection are:

In common with all other penicillins, amoxicillin should not be used orally or parenterally in rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use in any other very small herbivores. Clamoxyl Long Acting Suspension for Injection is not suitable for intravenous injection.

Although preruminants such as lambs may be treated orally or parenterally, animals possessing a functional rumen should only be treated parenterally.

Do not use in animals with known sensitivity to the active substance.

Shake vial before use. The product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Since amoxicillin hydrolyses rapidly in the presence of water, it is important that a dry sterile needle and syringe is used when withdrawing the suspension to avoid contaminating the remaining suspension with drops of water.

Do not broach more than 40 times.

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information.

Care should be taken to avoid accidental self-injection.

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reaction to these substances may occasionally be serious.

Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

Handle this product with great care to avoid exposure taking all recommended precautions.

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.

Use of the product may occasionally result in local tissue reaction.

Clamoxyl Long Acting Suspension for Injection is indicated for use in pregnancy and lactation.

None known

Clamoxyl Long Acting Suspension for Injection is intended for use via the intramuscular or subcutaneous routes in cats and dogs and via the intramuscular route only in sheep.

Dosage rate: the recommended dosage rate is 15 mg/kg which is equivalent to 1.0 ml/10 kg bodyweight. The dose may be repeated after 48 hours.

Use a new anatomical site for repeated injections.

To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid overdosing.

Dosing guide:

The following table gives examples of doses for the different species.

Shake the vial well before use. Inject by the intramuscular route, then massage the injection site. (For ease of administration in dogs and cats, needles no finer than 20 gauge should be used). If the volume to be given is greater than 5 ml (sheep) it should be divided and injected into two separate sites. The suspension is not suitable for intravenous or intrathecal administration.

Amoxicillin is of a very low order of acute toxicity and is well tolerated by the parenteral route. Occasional injection site reactions may occur with the recommended dose, but no other adverse side-effects are to be expected from accidental overdosing.

Meat: 45 days

Not to be used in sheep producing milk for human consumption.

ATCVet Code: QJ01CA04

Amoxicillin is a broad spectrum semi-synthetic penicillin that is bactericidal against a wide range of Gram-positive and Gram-negative pathogens.

The following features of Clamoxyl Long Acting Suspension for Injection warrant special mention:

Aluminium distearate

Fractioned coconut oil

None known

Shelf-life of the medicinal product as packaged for sale: 3 years.

Shelf-life after first opening the immediate packaging: 28 days.

Do not store above 25°C.

Following withdrawal of the first dose, use the product within 28 days.

Discard unused material.

Carton containing either 6 x 100 ml or 4 x 250 ml clear colourless type III glass vials with rubber nitrile bungs with aluminium overseals.

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm:42058/4013

Date:28 January 1998

Date:June 2014

26 June 2014