Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
PREDNISOLONE
Ceva Santé Animale
QH02AB06
PREDNISOLONE
5 Milligram
Tablets
POM
Canine
Prednisolone
Corticosteroid
Authorised
2016-11-11
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 Corticoid 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 ________________________________________________________________________________________________________________________ _Date Printed 11/11/2016_ _CRN 7021354_ _page number: 1_ 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 Lees het volledige document