Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Prednisolone
Ceva Santé Animale
QH02AB06
Prednisolone
5 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
prednisolone
Corticosteroid
Authorised
2016-11-11
Health Products Regulatory Authority 16 July 2021 CRN00C3H1 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Dermipred 5 mg tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE Prednisolone 5.0 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Oblong shaped beige to light brown tablet, with one score line on one side. The tablets can be divided into two equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the symptomatic treatment or as adjunct treatment of inflammatory and immune-mediated dermatitis in dogs. 4.3 CONTRAINDICATIONS Do not use in animals with: Viral, mycotic or parasitic infections that are not controlled with an appropriate treatment Diabetes mellitus Hyperadrenocorticism Osteoporosis Heart failure Severe renal insufficiency Corneal ulceration Gastro-intestinal ulceration Glaucoma Do not use concomitantly with attenuated live vaccines Do not use in known cases of hypersensitivity to the active substance, to other corticosteroids, or to any of the excipients. See also sections 4.7 and 4.8. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Glucocorticoids administration is to induce an improvement in clinical signs rather than a cure. The treatment should be combined with treatment of the underlying disease and/or environmental control. Health Products Regulatory Authority 16 July 2021 CRN00C3H1 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals In cases where a bacterial infection is present the product should be used in association with suitable antibacterial therapy. Pharmacologically-active dose levels may result adrenal insufficiency. This may become apparent particularly after withdrawal of corticosteroid treatment. This effect may be minimised by institution of alternate-day therapy if practical. The dosage should be reduced and w Prečítajte si celý dokument