Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
PREDNISOLONE
PCO Manufacturing
5 Milligram
Tablets
2006-07-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Deltacortril Enteric Coated Tablets 5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 5mg prednisolone. Excipients: Lactose _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Gastro-resistant tablet. _Product imported from UK:_ Round, biconvex, coated, maroon-coloured tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ALLERGY AND ANAPHYLAXIS_: bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis. _ARTERITIS/COLLAGENOSIS_: giant cell arteritis/polymyalgia rheumatica, mixed connective tissue disease, polyarteritis nodosa, polymyositis. _BLOOD DISORDERS_: haemolytic anaemia (auto-immune), leukaemia (acute and chronic lymphocytic), lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura. _CARDIOVASCULAR DISORDERS_: post-myocardial infarction syndrome, rheumatic fever with severe carditis. _ENDOCRINE DISORDERS_: primary and secondary adrenal insufficiency, congenital adrenal hyperplasia. _GASTRO-INTESTINAL DISORDERS_: Crohn's disease, ulcerative colitis, persistent coeliac syndrome (coeliac disease unresponsive to gluten withdrawal), auto-immune chronic active hepatitis, multisystem disease affecting liver, biliary peritonitis. _HYPERCALCAEMIA_: sarcoidosis, vitamin D excess. _INFECTIONS (WITH APPROPRIATE CHEMOTHERAPY)_: helminthic infestations, Herxheimer reaction, infectious mononucleosis, miliary tuberculosis, mumps orchitis (adult), tuberculous meningitis, rickettsial disease. _MUSCULAR DISORDERS_: polymyositis, dermatomyositis. _NEUROLOGICAL DISORDERS_: infantile spasms, Shy-Drager syndrome, sub-acute demyelinating polyneuropathy. _OCULAR DISEASE_: scleritis, posterior uveitis, retinal vasculitis, pseudo-tumours of the orbit, giant cell arteritis, malignant IRISH MEDI Przeczytaj cały dokument