Χώρα: Τανζανία
Γλώσσα: Αγγλικά
Πηγή: Tanzania Medicinces & Medical Devices Authority
Deflazacort
Faes Farma. S.A, SPAIN
Corticosteroids for systemic use/ plain
Deflazacort
22.75
Oral Suspension
Faes Farma, S.A, SPAIN
Physical description: Deflazacort suspension is a homogeneous suspension of a whitish color; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited (2404)
Registered/Compliant
2022-07-19
SUMMARY OF PRODUCT CHARACTERISTICS 1. PRODUCT NAME Defal 22,75 mg/mL oral drops suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of suspension contains 22,75 mg of deflazacort, or each drop of suspension contains 1 mg of deflazacort. Excipients with a known effect: each ml of suspension contains 100 mg of sorbitol, 2,4 mg of sodium and 10.45 mg of benzyl alcohol. See section 6.1 for full list of excipients. 3. PHARMACEUTICAL FORM Defal drops. Homogeneous suspension of a whitish colour 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS RHEUMATIC AND COLLAGEN DISORDERS: treatment of acute episodes and/or maintenance therapy in rheumatoid arthritis, psoriatic arthritis when conservative treatment has been ineffectual; polymyalgia rheumatica; acute rheumatic fever; systemic lupus erythematosus; severe dermatomyositis; periarteritis nodosa; cranial arteritis and Wegener's granulomatosis. DERMATOLOGICAL DISORDERS: Pemphigus, bullous pemphigoid, exfoliative dermatitis in general, severe erythema multiforme, erythema nodosum and severe psoriasis. ALLERGIES: Bronchial asthma resistant to conventional treatment. LUNG DISORDERS: pulmonary sarcoidosis, extrinsic allergic alveolitis (pneumonoconiosis due to inhalation of organic dust), desquamative interstitial pneumonia (idiopathic pulmonary fibrosis). OCULAR PATHOLOGIES: choroiditis, chorioretinitis, iritis and iridocyclitis. HAEMATOLOGICAL DISORDERS: idiopathic thrombocytopenia, haemolytic anaemia and palliative treatment of leukaemia and lymphomas. GASTROINTESTINAL AND HEPATIC PATHOLOGIES: ulcerative colitis, Crohn’s disease and active chronic hepatitis. RENAL DISORDERS: nephrotic syndrome. 4.2. DOSAGE AND METHOD OF ADMINISTRATION Dosage The initial dose in adults may vary within ranges 6 – 90 mg/day and in children within ranged 0.25 – 1.5 mg/kg, depending on the severity of the illness and on its course. Its initial dose should be maintained or varied so as to achieve a satisfactory clinical response. The maintenance dose should always be the small Διαβάστε το πλήρες έγγραφο