Prednidale

1 x 250 pc
Tablet
PA

Active substance

  • Prednisolone : 5 mg
  • Species

    Dogs and cats.

    Indications

    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.

    Dose to be administered and administration route

    For oral administration.


    Dogs and cats: 0.1 - 2.0 mg per kg bodyweight 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.

    Adverse reactions

    Administration of single high doses are generally tolerated well, but medium to longterm 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.

    Dispensing

    POM-V - Prescription Only Medicine – Veterinarian

    SUMMARY OF PRODUCT CHARACTERISTICS

    1. NAME OF VETERINARY MEDICINAL PRODUCT

    Prednidale 5 mg Tablets

    2. QUALITATIVE AND QUANTITATIVE COMPOSITION

    Active ingredient

    Prednisolone 5 mg/tablet

    For a full list of excipients, see section 6.1.

    3. PHARMACEUTICAL FORM

    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.

    4. CLINICAL PARTICULARS

    4.1 Target species

    Dogs and cats.

    4.2 Indications for use, specifying the target species

    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.

    4.3 Contra-indications

    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.

    4.4 Special warnings for each target species

    There are no special warnings required for either target species.

    4.5 Special precautions for use

    i. 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.

    ii. 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.

    iii. Other precautions

    No special precautions required.

    4.6 Adverse reactions (frequency and seriousness)

    Administration of single high doses are generally tolerated well, but medium to longterm 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.

    4.7 Use during pregnancy, lactation or lay

    Corticosteroids are not recommended for use in pregnant animals. Studies in laboratory animals have shown that administration in 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 contra-indicated.

    4.8 Interaction with other medicinal products and other forms of interaction

    There are no known interactions of significance in veterinary medicine.

    4.9 Amounts to be administered and administration route

    For oral administration.

    Dogs and cats: 0.1 - 2.0 mg per kg bodyweight 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.

    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

    Signs of overdosage should be treated symptomatically.

    4.11 Withdrawal periods

    Not applicable. Prednidale 5 is not indicated for use in food-producing animals.

    5. PHARMACOLOGICAL PARTICULARS

    Pharmacotherapeutic group: Corticosteroid for systemic use ATC Vet Code: QH02AB06

    5.1 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.

    5.2 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.

    6. PHARMACEUTICAL PARTICULARS

    6.1 List of excipients

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

    6.2 Incompatibilities

    There are no known incompatibilities.

    6.3 Shelf life

    2 years.

    6.4 Special precautions for storage

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

    6.5 Nature and contents of immediate packaging

    White polypropylene container with a white polyethylene tamper evident lid, containing 250 tablets.

    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

    Any unused product or waste material should be disposed of in accordance with national requirements.

    7. MARKETING AUTHORISATION HOLDER

    Dechra Limited

    Snaygill Industrial Estate

    Keighley Road

    Skipton

    North Yorkshire

    BD23 2RW

    United Kingdom

    8. MARKETING AUTHORISATION NUMBER

    Vm 10434/4009

    9. DATE OF FIRST AUTHORISATION

    14 August 1998

    image10. DATE OF REVISION OF THE TEXT

    August 2023

    Approved: 11 August 2023

    Cat icon
    Dog icon
    Product identification - 10434/4009
    Art. Nr. 10434/4009
    EAN 5701170448429
    PACKAGES
    Prednidale
    Dechra Veterinary Products
    1 x 250 pc
    10434/4009

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