Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Prednisolone
LE VET B.V.
QH02AB06
Prednisolone
Horses
Corticosteroids for systemic use, plain, prednisolone, Systemic hormonal preparations, excl. sex hormones and insulin
Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control.
Revision: 9
Authorised
2014-03-12
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET EQUISOLON 100 MG ORAL POWDER FOR HORSES EQUISOLON 300 MG ORAL POWDER FOR HORSES EQUISOLON 600 MG ORAL POWDER FOR HORSES 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Le Vet B.V. Wilgenweg 7 3421 TV Oudewater THE NETHERLANDS Manufacturer responsible for batch release: LelyPharma B.V. Zuiveringweg 42 8243 PZ Lelystad THE NETHERLANDS 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Equisolon 100 mg oral powder for horses Equisolon 300 mg oral powder for horses Equisolon 600 mg oral powder for horses prednisolone 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) White to off-white powder containing 33.3 mg/g of prednisolone. ACTIVE SUBSTANCE: 100 mg prednisolone per 3 g sachet. 300 mg prednisolone per 9 g sachet. 600 mg prednisolone per 18 g sachet. 4. INDICATION(S) Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control. 5. CONTRAINDICATIONS Do not use in known cases of hypersensitivity to the active substance, to corticosteroids and to any other ingredient of the product. Do not use in viral infections in which the virus particles circulate in the bloodstream or in cases of systemic fungal infections. Do not use in animals suffering from gastrointestinal ulcers. Do not use in animals suffering from corneal ulcers. Do not use during pregnancy. 25 6. ADVERSE REACTIONS Very rarely, laminitis has been observed after use of the product. Therefore horses should be monitored frequently during the treatment period. Very rarely, neurological signs such as ataxia, recumbency, head tilting, restlessness or incoordination have been observed after use of the product. Whilst single high doses of corticosteroids are generally well tolerated, they may induce severe side- effects in long term use. Dosage in medium to long term use should therefore gener Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Equisolon 100 mg oral powder for horses Equisolon 300 mg oral powder for horses Equisolon 600 mg oral powder for horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 100 mg prednisolone per 3 g sachet. 300 mg prednisolone per 9 g sachet 600 mg prednisolone per 18 g sachet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral powder. White to off-white powder 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control. 4.3 CONTRAINDICATIONS Do not use in known cases of hypersensitivity to the active substance, to corticosteroids or to any of the excipients. Do not use in viral infections during the viraemic stage or in cases of systemic mycotic infections. Do not use in animals suffering from gastrointestinal ulcers. Do not use in animals suffering from corneal ulcers. Do not use during pregnancy. 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 environmental control. Each case should be assessed individually by the veterinarian and an appropriate treatment program determined. Treatment with prednisolone should only be initiated when satisfactory alleviation of clinical symptoms have not been obtained or are unlikely to be obtained by environmental control alone. Treatment with prednisolone may not sufficiently restore respiratory function in all cases, and in each individual case the use of medicinal products with more rapid onset of action may need to be considered. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Do not use in animals suffering from diabetes mellitus, renal insufficiency, cardiac insufficiency, hyperadrenocorticism, or os Lesen Sie das vollständige Dokument