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Date: Thursday, December 2, 2021 16:27

Description: Dechra
Release 5.69
Prednidale Tablets
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Other steroids
Active ingredient: Prednisolone
Product:Prednidale Tablets
Product index: Prednidale Tablets
Qualitative and quantitative composition
Prednidale 5 mg tablets for dogs and cats:
1 tablet contains: Active substance:
Prednisolone 5 mg
Prednidale 25 mg tablets for dogs:
1 tablet contains: Active substance:
Prednisolone 25 mg
Pharmaceutical form
Prednidale 5 mg tablets for dogs and cats:
Tablet. 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.
Prednidale 25 mg tablets for dogs:
Tablet. White, 11 mm circular tablets.
Clinical particulars
Target species
Prednidale 5 mg tablets for dogs and cats:
Dogs and cats.
Prednidale 25 mg tablets for dogs:
Dogs.
Indications for use
Prednidale 5 mg tablets for dogs and cats:
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.
Prednidale 25 mg tablets for dogs:
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.
Contraindications
Do not use in animals with renal insufficiency, diabetes mellitus or corneal ulceration.
Do not use in animals recieving 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 The dosage should be reduced and withdrawn gradually to avoid precipitation of adrenal insufficiency.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 your 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 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.
Amounts to be administered and administration route
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.
Prednidale 5 mg tablets for dogs and cats: The tablets are divisible.
Overdose
Signs of overdosage should be treated symptomatically.
Pharmacological particulars
Pharmacotherapeutic group: Corticosteroid for systemic use.
ATCvet code: QH02AB06
Pharmacodynamic properties
Prednisolone is a synthetic glucocorticoid with anti-inflammatory and immunosuppressant properties. It possesses only slight mineralocorticoid activity. Prednisolone is used to suppress the clinical manifestations of a wide range of disorders.
Pharmacokinetic properties
Prednisolone is readily absorbed from the gastro-intestinal tract. Peak plasma concentrations are reached one to two hours after administration, with a plasma half-life of between two and three hours. It is extensively bound to plasma proteins. It is excreted in the urine as free and conjugated metabolites and parent compound. It has a biological half-life of several hours, making it suitable for alternate-day therapy.
Pharmaceutical particulars
Shelf life
Prednidale 5 mg tablets for dogs and cats:
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Prednidale 25 mg tablets for dogs:
Shelf life of the veterinary medicinal product as packaged for sale: 48 months.
Special precautions for storage
Do not store above 25°C. Store in tightly closed original container. Store in a dry place.
Immediate packaging
Prednidale 5 mg tablets for dogs and cats:
Polypropylene tubs with a low density polyethylene cap (push-fit) with a tamper evident ring, containing 500 or 1000 tablets.
Prednidale 25 mg tablets for dogs:
Polypropylene containers with low density polyethylene push-fit tamper evident closures containing 100 tablets.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Dechra Limited, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, United Kingdom.
Marketing Authorisation Number
Vm 10434/4009: 5 mg
Vm 10434/4008: 25 mg
Significant changes
Date of the first authorisation or date of renewal
Prednidale 5 mg tablets for dogs and cats:
14 August 1998
Prednidale 25 mg tablets for dogs:
19 November 2007
Date of revision of the text
Prednidale 5 mg tablets for dogs and cats:
September 2016
Prednidale 25 mg tablets for dogs:
September 2016
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Prednidale 5 mg Tablets for Dogs and Cats:
GTIN:05055031410538
GTIN description:Prednidale 25 mg Tablets for Dogs:
GTIN:05055031418916