Introduction

Pfizer

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Clamoxyl L.A. Injection is an off-white oily suspension containing 150 mg/ml amoxicillin as Amoxicillin trihydrate PhEur.

The formulation is designed to provide effective antibiotic activity over a period of 48 hours.

Uses

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	Gram-Positive
Actinobacillus lignieresi	Actinomyces bovis
Actinobacillus equuli	Bacillus anthracis
Bordetella bronchiseptica	Clostridium spp.
Escherichia coli	Corynebacterium spp.
Fusobacterium spp.	Erysipelothrix rhusiopathiae
Haemophilus spp.	streptococci and staphylococci (penicillin sensitive strains)
Moraxella spp.
Pasteurella spp.
Proteus mirabilis
Salmonella spp.

Clamoxyl L.A. Injection is suitable for the control of infections caused by susceptible organisms in cattle, sheep, pigs, 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 L.A. Injection are:

1.Alimentary tract infections, including enteritis.

2.Respiratory tract infections, including pneumonia in growing cattle.

3.Urogenital tract infections, including cystitis and metritis.

4.Skin and soft tissue infections, including wounds, abscesses, foot infections, joint and navel ill.

5.Prevention of post-operative infections by injection prior to surgery.

Clamoxyl L.A. Injection may also be used as an adjunct to the intramammary therapy of bovine mastitis.

Dosage and administration

The recommended dosage rate is 15 mg/kg (7 mg/lb) bodyweight. If necessary, the dose may be repeated after 48 hours.

The following is intended as a guide
Animal	Specimen weight (kg)	Dose (volume)
Cattle	450	45.0 ml
Store Cattle	200	20.0 ml
Calf	50	5.0 ml
Sheep	65	6.5 ml
Lamb	10	1.0 ml
Pig	150	15.0 ml
Porker	70	7.0 ml
Piglet	7	0.7 ml
Dog – large	35	3.5 ml
– medium	20	2.0 ml
– small	10	1.0 ml
Cat	5	0.5 ml

The recommended dose is equivalent to 1.0 ml per 10 kg (22 lb) bodyweight.

Shake the vial well before use to suspend the active material. Inject by the subcutaneous or 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 20 ml it should be divided and injected into two separate sites. The suspension is not suitable for intravenous or intrathecal administration.

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.

Contra-indications, warnings, etc

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.

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

Milk from treated cattle or sheep must not be taken for human consumption until 96 hours after the last treatment. Not for use in sheep producing milk for human consumption.

Animals must not be slaughtered for human consumption until 21 days after the last treatment.

For animal treatment only.

Operator warnings

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 reactions 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.

Wash hands after use.

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.

Pharmaceutical precautions

Store below 25°C.

Keep out of the reach of children.

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

Shake well before use.

Legal category

POM-V

Packaging Quantities

Clamoxyl L.A. Injection is available in packs containing 6×100 ml and 4×250 ml vials.

Further information

The following features of Clamoxyl L.A. Injection warrant special mention:

1.After absorption, amoxicillin is widely distributed throughout body tissues, with especially high levels in the kidneys, urine, liver and bile.

2.In respiratory infections, amoxicillin crosses inflamed pulmonary membranes into mucus. As the disease responds and associated inflammation recedes, amoxicillin levels are maintained in the mucus thus preventing recrudescence of the original infection.

3.Amoxicillin shares with other penicillins the virtual absence of toxicity problems even at very high dose levels.

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