Introduction

Company name: Dechra Veterinary Products

Address: (A business unit of Dechra Pharmaceuticals PLC)

Cartmel Drive

Harlescott

Shrewsbury SY1 3TB

Telephone: 01743 441632

Fax: 01743 462111

Email: info@dechra-uk.com

Website: www.dechra-uk.com

Presentation

White, circular, flat faced tablets.

Each tablet contains 5 mg Prednisolone.

Uses

Prednidale 5 is indicated in the treatment of inflammatory and allergic conditions in cats and dogs.

Dosage and administration

Dose: 0.1-2.0 mg Prednisolone per kg bodyweight per day. The tablets are divisible. The lowest effective dose must be used.

These tablets are not appropriate when dosing cats and small dogs at the lower recommended dosage rates and another tablet size may be required.

Treatment should not be withdrawn suddenly. A gradual reduction of dosage is recommended.

Dogs should be dosed in the morning and cats should be dosed at night to coincide with the endogenous cortisol peak.

A single administration may be sufficient for some conditions such as anaphylaxis. Other conditions may require treatment for between two and three weeks. Use the lowest effective dose. Alternate-day therapy should be implemented to control symptoms if possible, to minimise the risks of adrenal insufficiency.

For animals with tumours responsive to corticosteroid therapy, use dose levels based on the surface area of the animal. In some cases, dose levels of 20 mg per m2, reducing to 5 mg per m2, have been found useful.

For oral administration only.

Contra-indications, warnings, etc

Do not use in pregnant animals, those suffering from diabetes mellitus, in animals with renal insufficiency or those with corneal ulceration.

Do not use in animals being vaccinated with products containing live organisms. Treatment may render concurrent vaccination inoperative.

Appropriate therapy should be instituted in animals with concurrent bacterial infections. Use of corticosteroids may exacerbate viral infections.

Prolonged use at high dose levels may result in undesirable effects. Do not withdraw corticosteroid therapy suddenly.

Acute overdosage should be treated symptomatically. Serum electrolytes should be monitored. Consideration should be given to the use of antimicrobials due to the potential suppression of the immune system.

Corticosteroids, including Prednisolone, have a wide range of effects. Polydipsia, polyuria and polyphagia may develop, particularly during the early stages of therapy. In the longer term, iatrogenic Cushing’s disease may develop.

Gastrointestinal ulceration has been reported in animals treated with corticosteroids. Steroids may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes.

Corticosteroid therapy may lead to increased time in the healing of wounds and to a reduction in the ability of the body to resist infection. Appropriate anti-infective therapy may be required.

Pharmacologically active dose levels may lead to atrophy of the adrenal cortex, resulting in adrenal insufficiency. This may become apparent particularly after withdrawal of corticosteroid treatment. Adrenal insufficiency may be minimised by institution of alternate-day therapy, if practical. The dosage should be reduced and withdrawn gradually to avoid precipitation of adrenal insufficiency.

Corticosteroids are not recommended for use in pregnant animals. Studies in laboratory animals have shown that administration during early pregnancy may cause foetal abnormalities. Administration during the later stages of pregnancy may cause abortion or early parturition.

Gastrointestinal ulceration may be exacerbated by corticosteroids in animals given non-steroidal anti-inflammatory drugs (NSAIDs).

Regular veterinary re-evaluation of animals on prolonged courses of Prednisolone is recommended.

Operator warnings: Gloves should be worn to administer the product and you should wash hands immediately after administration of the product.

General precautions: For animal treatment only.

Pharmaceutical precautions

Do not store above 25°C. Store in a dry place. Store in tightly closed original container. Keep out of the reach of children.

Disposal: Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Plastic pots containing 1000 tablets.

Further information

To be supplied only on veterinary prescription.

UK authorised veterinary medicinal product.

Marketing authorisation number

Vm 10434/4009.