Target species
Dogs.
Indications for use for each target species
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, musculo-skeletal and haematological manifestations of disease.
Contraindications
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
None.
Special precautions for use
Special precautions for safe use in the target species:
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 The dosage should be reduced and withdrawn gradually to avoid precipitation of adrenal insufficiency.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
Personal protective equipment consisting of gloves should be worn when handling the product. Wash hands immediately after administration.
In the case of accidental ingestion, particularly by a child, seek medical advice and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dog
Rare (1 to 10 animals / 10 000 animals treated): | Polyuriaa Polydipsiaa Eosinopenia, neutrophilia, lymphopenia |
Very rare (<1 animal / 10 000 animals treated, including isolated reports): | Adrenal gland disorderb Cortisol suppressionc, hyperalbuminaemia, elevated serum alkaline phosphatase (SAP), elevated liver enzymes, decreased aspartate transaminase, decreased lactate dehydrogenase, hypokalaemiad, low thyroxine (T4) Weight gain, polyphagiaa, delayed healing (wound), weakend resistance to, or exacerbation of existing infectionse, depression Cutaneous calcinosis, skin thinning Gastrointestinal ulcerationf, pancreatitis Diabetes Mellitus Excitation |
Undetermined frequency (cannot be estimated from the available data) | Elevated triglycerideg, low tri-iodothyronine (T3), elevated parathyroid (PTH) concentration Inhibition of longitudinal growth of bones Sodium and water retentiond |
a May be caused by systemically administered corticosteroids, particularly during the early stages of therapy.
b Following cessation of treatment, signs of adrenal insufficiency can arise, and this may render the animal unable to deal adequately with stressful situations.
c Significant dose related suppression noticed during therapy is a result of effective doses suppressing the hypothalamic-pituitary-adrenal-axis.
d After long term use.
e The immunosuppressant actions may weaken resistance to, or exacerbate existing infections.
f May be exacerbated by steroids in animals given non-steroidal anti-inflammatory drugs.
g The significant increase can be a part of possible iatrogenic hyperadrenocorticism (Cushing’s disease) involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, increase in body weight, muscle weakness, wastage and osteoporosis may result.
Anti-inflammatory corticosteroids, such as prednisolone, are known to exert a wide range of side effects. Whilst single high doses are generally well tolerated, they may induce severe side-effects in long term use. Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control symptoms.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The use is not recommended during pregnancy.
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.
Interaction with other medicinal products and other forms of interaction
None known.
Administration routes and dosage
Oral use.
Dose: 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, 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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Signs of overdosage should be treated symptomatically.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable