Prednidale Tablets (Prednisolone)

Prednidale 5 mg Tablets

Presentation

Each tablet contains: Active substance:

Prednisolone 5 mg

Excipients: Lactose monohydrate, maize starch, pre-gelatinised maize starch, stearic acid, purified talc, magnesium stearate.

White, circular, flat faced tablets with a breakline and PL5 imprinted on one face and CP or DP on the reverse. No data has been provided to demonstrate reproducible halving of the tablets.

Uses

For the treatment of inflammatory and allergic diseases, including some autoimmune diseases and some neoplastic conditions in cats and dogs. Inflammatory, allergic and autoimmune processes may be involved in cutaneous, alimentary, respiratory, musculoskeletal and haematological manifestations of disease.

Dosage and administration

For oral administration.

Dogs and cats: 0.1-2.0 mg per kg body weight per day.

A single administration may be sufficient for certain conditions such as anaphylaxis, but for more general treatment, treatment for one to three weeks at the above dosage levels may be required. Dosage levels should be monitored carefully to ensure that the lowest effective dose is used. To minimise the risk of adrenal insufficiency, alternate day treatment may be implemented, using dose levels that adequately control the symptoms. Dogs should be dosed in the morning and cats should be dosed at night to coincide with the endogenous cortisol peak.

Higher dose levels may be used in animals with tumours responsive to corticosteroid therapy. In these cases, the dosage level is related to the surface area of the animal, and dose levels of between 20 mg per m2 and 60 mg per m2 have been found to be useful. The potential risks associated with these high dose levels should be assessed before commencing treatment.

The tablets are divisible.

Contraindications, warnings, etc

Do not use in animals with renal insufficiency, diabetes mellitus or corneal ulceration.

Do not use in animals receiving vaccines containing live organisms.

Do not use in pregnant animals.

Special warnings for each target species: There are no special warnings required for either target species.

Special precautions for use in animals: 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.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Gloves should be worn to administer the product and you should wash hands immediately after administration of the product.

Adverse reactions: Administration of single high doses are generally tolerated well, but medium to long term use may provoke reactions.

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.

Use during pregnancy and lactation: 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.

Insignificant amounts of prednisolone are generally eliminated in the milk of lactating animals, and therefore such use is not contraindicated.

Interactions: There are no known interactions of significance in veterinary medicine.

Overdose: Signs of overdosage should be treated symptomatically.

Incompatibilities: There are no known incompatibilities.

Pharmaceutical precautions

Do not store above 25°C. Store in a dry place. Store in tightly closed original container.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Disposal: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging quantities

Polypropylene tubs with a low density polyethylene cap (push-fit) with a tamper evident ring, containing 500 or 1000 tablets.

Further information

For animal treatment only. To be supplied only on veterinary prescription. Keep out of the reach and sight of children.

Date of last review: May 2012

Marketing authorisation holder (if different from distributor)

Dechra Limited, Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW.

Marketing authorisation number

Vm 10434/4009.

GTIN (Global Trade Item No)

Prednidale 5 mg Tablets

05055031410538

Prednidale 25 mg Tablets for Dogs

Presentation

Each tablet contains: Active substance:

Prednisolone 25 mg

Excipients: Lactose monohydrate, maize starch, pre-gelatinised maize starch, stearic acid, purified talc, magnesium stearate.

White, 11 mm circular tablets.

Uses

For the treatment of inflammatory and allergic diseases, including some autoimmune diseases and some neoplastic conditions, in dogs. Inflammatory, allergic and autoimmune processes may be involved in cutaneous, alimentary, respiratory, musculoskeletal and haematological manifestations of disease.

Dosage and administration

For oral administration in dogs. 0.1-2.0 mg per kg body weight per day.

A single administration may be sufficient for some conditions such as anaphylaxis, but for more general treatment, administration for one to three weeks at the above dosage levels may be required. Dosage levels should be monitored carefully to ensure that the lowest effective dose is used. To minimise the risk of adrenal insufficiency, alternate day treatment may be implemented, using dose levels that adequately control the symptoms. Dogs should be dosed in the morning to coincide with the endogenous cortisol peak.

Higher dose levels may be used in animals with tumours responsive to corticosteroid therapy. In these cases, the dosage level is related to the surface area of the animal, and dose levels of between 20 mg per m2 and 60 mg per m2 have been found to be useful. The potential risks associated with these high dose levels should be assessed before commencing treatment.

Contraindications, warnings, etc

Do not use in animals with renal insufficiency, diabetes mellitus or corneal ulceration.

Do not use in animals receiving vaccines containing live organisms.

Do not use in pregnant animals.

Special precautions for use in animals: 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.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Gloves should be worn to administer the product and you should wash hands immediately after administration of the product.

In the event of accidental ingestion, particularly by a child, seek medical advice and show the doctor the label or the package leaflet.

Adverse reactions: Administration of single high doses are generally tolerated well, but medium to long term use may provoke reactions.

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.

Use during pregnancy and lactation: 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.

Insignificant amounts of prednisolone are generally eliminated in the milk of lactating animals, and therefore such use is not contraindicated.

Interactions: There are no known interactions of significance in veterinary medicine.

Overdose: Signs of overdosage should be treated symptomatically.

Incompatibilities: None known.

Pharmaceutical precautions

Do not store above 25°C. Store in tightly closed original container. Store in a dry place.

Shelf life of the veterinary medicinal product as packaged for sale: 48 months.

Disposal: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging quantities

Polypropylene containers with low density polyethylene push-fit tamper evident closures containing 100 tablets.

Further information

For animal treatment only. To be supplied only on veterinary prescription. Keep out of the reach and sight of children.

Date of last review: February 2013

Marketing authorisation holder (if different from distributor)

Dechra Limited, Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW.

Marketing authorisation number

Vm 10434/4008.

GTIN (Global Trade Item No)

Prednidale 25 mg Tablets for Dogs

05055031418916