Introduction

Company name: J. M. Loveridge p.l.c.

Address: Southbrook Road

Southampton SO15 1BH

Telephone: (023) 8022 8411

Fax: (023) 8063 9836

Email: admin@jmloveridge.com

Website: www.jmloveridge.com

Presentation

White sugar coated tablets containing: Phenylbutazone PhEur 200 mg.

Indications

Indicated in dogs of 20 kg and over for the treatment of osteoarthritis, acute musculo-skeletal trauma including spondylitis, bursitis and inflammation of ligaments, rheumatoid and other arthritic diseases.

Dosage and administration

20 mg/kg daily for 7 days preferably in divided doses every 8 or 12 hours, followed by 10 mg/kg daily for 7 days preferably in divided doses every 8–12 hours.

Phenylbutazone 200 mg should not be administered to dogs weighing less than 20 kg bodyweight.

The tablets should be administered whole, with or immediately after food. In older dogs suffering chronic musculo-skeletal disease the course of treatment at the lower dose may be extended but the patient must be regularly monitored for any possible adverse effects.

In the case of trauma, if symptoms persist after the initial two week course of treatment, the diagnosis should be reassessed.

Contra-indications, warnings, etc

If any of this product is accidentally swallowed, go at once to the Accident and Emergency (Casualty) department of a hospital and show the container to the doctor or nurse on duty.

Pet owners should return any unused tablets to their Veterinary Surgery for disposal.

Only to be dispensed by veterinarians, in secure child resistant containers.

Disposal:

Dispose of any unused product or containers in accordance with guidance from your local waste regulation authority, eg the local regional office of the Environment Agency or SEPA.

End user should be advised that any remaining after the course of treatment should be returned to the veterinary surgery.

Phenylbutazone 200 mg should not be administered to dogs weighing less than 20 kg bodyweight.

Do not exceed the stated dose or the duration of treatment.

Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease, where there is evidence of a blood dyscrasia or hypersensitivity to the product.

Do not administer other NSAIDs concurrently or within 24 hours of each other.

Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.

NSAID's can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infections, appropriate antimicrobial therapy should be instigated.

Not to be used in cats.

Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management.

Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a potential risk of increased renal toxicity.

Concurrent administration of potential nephrotoxic drugs should be avoided.

In suspected cases of renal or hepatic dysfunction an EDTA and clotted blood sample should be taken in order that relevant haematological and biochemical assays can be carried out prior to commencement of treatment.

Treatment should be discontinued in animals developing gastrointestinal symptoms or vascular disorders.

It is preferable that NSAID's which inhibit prostaglandin synthesis are not administered to animals undergoing anaesthesia until fully recovered.

Pharmaceutical precautions

Keep out of the reach of children.

Store in a dry place below 25°C.

Legal category

POM-V

Packaging Quantities

Containers of 500 and 1000 Tablets.

Further information

For dogs weighing less than 20 kg and more than 5 kg, the use of Phenylbutazone 100 mg is indicated.

Marketing authorisation number

Vm 00531/4041.