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

Uses

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 Ready-To-Use Injection is indicated for the treatment of infections in dogs, cats, sheep, pigs and cattle, caused by amoxicillin sensitive organisms.

Dosage and administration

The recommended dosage rate is 7 mg/kg (3 mg/lb) body weight once daily for up to 5 days by subcutaneous (dogs, cats), or intramuscular (dogs, cats, sheep, pigs, cattle) injection.

The following is intended as a guide

Animal	Specimen weight (kg)	Dose (volume)
Cattle	600	28.0
Store Cattle	200	9.0
Calf	50	2.5
Sheep	60	3.0
Lamb	10	0.5
Pig	150	7.5
Porker	70	3.5
Piglet	7	0.35
Dog – large	35	1.5
– medium	20	1.0
– small	10	0.5
Cat	5	0.25

As a guide this is equivalent to 0.25 ml per 5 kg (11 lb) daily.

Shake the vial well to suspend the active ingredient before use. Swab the rubber septum and remove the required volume aseptically. Inject by the subcutaneous route (dogs and cats) or intramuscular route (all indicated species) then massage the injection site. 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

For animal treatment only.

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 result in local tissue reaction.

Animals must not be slaughtered for human consumption during treatment.

Sheep may be slaughtered for human consumption only after 35 days from the last treatment.

Pigs may be slaughtered for human consumption only after 14 days after the last treatment.

Cattle may be slaughtered for human consumption only after 21 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 from cows only after 48 hours from the last treatment

Where any other milking routine is followed, consult your veterinary surgeon.

Milk for human consumption must not be taken from treated sheep.

Clamoxyl Ready-to-Use Injection is not effective against beta-lactamase producing organisms.

Operator warning

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.

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 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 reach of children.

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. To avoid excessive perforation damage to the rubber seal, it is recommended that the 250ml vial be used for large animal treatment only.

Legal category

POM-V

Packaging Quantities

Packs of 6×100 ml and 4×250 ml vials.

Further information

The following features of Clamoxyl Ready-To-Use Injection warrant special mention:

1.After absorption, amoxicillin is widely distributed throughout body tissues with especially high levels in the kidney, 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 pre-ruminants such as calves and lambs may be treated orally or parenterally, animals possessing a functional rumen should only be treated parenterally.