Clamoxyl Ready-To-Use 150 mg/ml suspension for injection is a sterile off-white suspension containing 150 mg/ml amoxicillin as Amoxicillin trihydrate.

Amoxicillin 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: Actinomyces spp; Bacillus spp; Bordetella bronchiseptica; Clostridium spp; Corynebacterium spp; Escherichia coli; Fusobacterium spp; Haemophilus spp; Leptospira spp; Moraxella spp; Pasteurella spp; Proteus spp; Salmonella spp; streptococci; staphylococci (penicillin-sensitive strains).

Clamoxyl RTU is indicated for the treatment of infections in dogs, cats, sheep, pigs and cattle, caused by amoxicillin sensitive organisms.

The recommended dosage rate is 7 mg/kg bodyweight once daily for up to 5 days by subcutaneous (dogs, cats), or intramuscular (dogs, cats, sheep, pigs, cattle) injection.

If the volume to be given is greater than 15 ml (cattle) and 5 ml (sheep and pigs), the dose should be divided and the remaining should be injected in another site.

As a guide this is equivalent to 0.25 ml per 5 kg daily.

Shake the vial well to suspend the active ingredient before use. Swab the rubber septum and remove the required volume aseptically.

Massage the injection site after administration. Use a new anatomical site for repeated injections. To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid overdosing.

In common with other penicillin preparations hydrolysis takes place rapidly in the presence of water. It is important, therefore, that a dry syringe is used when extracting suspension for injection to avoid contaminating the remaining contents of the vial with drops of water.

Not to be used in rabbits, guinea pigs, hamsters or gerbils.

The suspension is not suitable for intravenous or intrathecal administration.

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

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

Penicillins and cephalosporins may cause hypersensitivity (allergy, allergic skin reactions) after use. Allergic reactions may occasionally be serious (anaphylaxis).

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.

Clamoxyl RTU is not effective against beta-lactamase producing organisms.

Complete cross-resistance has been shown between amoxicillin and other penicillins, in particular amino-penicillins.

Use of the product/amoxicillin should be carefully considered when antimicrobial susceptibility testing has shown resistance to penicillins because its effectiveness may be reduced.

Meat: Cattle: 54 days.

Sheep: 47 days.

Pigs: 47 days.

Milk: Cattle: 60 hours from the last treatment.

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

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.

Do not store above 25°C.

Shake the bottle well before use.

This product does not contain an antimicrobial preservative. Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

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

To avoid excessive perforation damage to the rubber seal, it is recommended that the 250ml vial be used for large animal treatment only. Do not broach more than 40 times.

Keep out of the sight and reach of children.

For animal treatment only.

Packs of 6 x 100 ml and 4 x 250 ml vials. Not all pack sizes may be marketed.

The following features of Clamoxyl RTU Injection warrant special mention:

Although pre-ruminants such as calves and lambs may be treated orally or parenterally, animals possessing a functional rumen should only be treated parenterally.

It is not generally recommended to use bactericidal and bacteriostatic antibiotics at the same time.

Beta-lactam antibiotics are known to interact with antibiotics with bacteriostatic action such as chloramphenicol, macrolides, sulfonamides and tetracyclines. There is also synergic action of penicillins with aminoglycosides.

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.