Product Description

Prednidale 5 mg Tablets are indicated for dogs and cats suffering from conditions where corticosteroid therapy is required to suppress inflammatory, allergic or autoimmune processes.

For Dogs and Cats:

Treatment of inflammatory and allergic diseases, including some autoimmune diseases and some neoplastic conditions

Inflammatory, allergic and autoimmune processes may be involved in cutaneous, alimentary, respiratory, musculo-skeletal and haematological manifestations of disease

A single administration may be sufficient for certain conditions such as anaphylaxis. For more general treatment, administration for one to three weeks at the recommended dosage levels may be required. Higher dose levels, calculated on the basis of body surface area, may be used in animals with tumours responsive to corticosteroid therapy.

Which Animals Can Use Prednidale 5 mg Tablets?

Prednidale 5 mg Tablets are licensed for use in dogs and cats. The tablets are divisible, enabling accurate dosing across a range of bodyweights in both species. This product must not be used in animals with renal insufficiency, diabetes mellitus or corneal ulceration, in pregnant animals, or in animals receiving vaccines containing live organisms. Always use only under the direction of your vet.

Available Strengths & Sizes

Please order the specific pack size as directed on your veterinary prescription.

Directions for Use

This is a prescription medication and must be used exactly as directed by your veterinary surgeon. Administer orally. Dogs should be dosed in the morning and cats should be dosed at night, to coincide with the endogenous cortisol peak in each species. Dosage levels should be monitored carefully to ensure that the lowest effective dose is used at all times. Treatment should not be withdrawn suddenly — the dosage should be reduced gradually to avoid precipitation of adrenal insufficiency.

To minimise the risk of adrenal insufficiency, alternate-day therapy may be implemented at dose levels that adequately control symptoms. The potential risks associated with high dose levels for neoplastic conditions should be assessed by the veterinarian before commencing treatment.

Wear gloves when administering the product and wash hands immediately afterwards.

Contraindications

Source: SPC Section 4.3

Do not use in animals with renal insufficiency

Do not use in animals with diabetes mellitus

Do not use in animals with corneal ulceration

Do not use in animals receiving vaccines containing live organisms

Do not use in pregnant animals

Storage & Handling

Do not store above 25°C. Store in a tightly closed original container in a dry place. Keep out of sight and reach of children. Shelf life as packaged for sale: 2 years.

Withdrawal period: Not applicable (not indicated for use in food-producing animals).

Important Warnings

Source: SPC Sections 4.5 & 4.6

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; dosage should be reduced and withdrawn gradually; alternate-day therapy should be considered if practical to minimise this risk

Dosage in medium to long-term use should be kept to the minimum necessary to control symptoms; whilst single high doses are generally well tolerated, medium to long-term use may provoke reactions

Corticosteroid therapy may lead to increased time in wound healing and to a reduction in the ability of the body to resist infection; appropriate anti-infective therapy may be required

Pregnancy and lactation: Corticosteroids are not recommended for use in pregnant animals — administration during early pregnancy may cause foetal abnormalities in laboratory animals; administration during later stages of pregnancy may cause abortion or early parturition; insignificant amounts of prednisolone are generally eliminated in the milk of lactating animals and use during lactation is not contraindicated

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

Human safety: Gloves should be worn when administering this product; wash hands immediately after administration; in the event of accidental ingestion, particularly by a child, seek medical advice immediately and show the doctor the label or package leaflet

POM-V Prescription Notice

This product is a Prescription Only Medicine — Veterinary (POM-V). It may only be supplied by a veterinary surgeon or, when prescribed by a veterinary surgeon, by a pharmacist or SQP. A valid veterinary prescription is required before this product can be dispensed.

MA Number: Vm 50406/5030