Šalis: Armėnija
kalba: anglų
Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
iron (III)-hydroxide sucrose complex
Help S.A. Pedini
առկա չէ (B03AC)
iron (III)-hydroxide sucrose complex
20mg/ml
solution for i/v injection or concentrate for solution for infusion
(5) ampoules 5ml
Prescription
Registered
2021-04-21
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 _▼_ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. _ _ 1. NAME OF THE MEDICINAL PRODUCT SOLUFERR 20 mg/ ml, solution for injection or concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION Each 5 ml ampoule contains 100 mg iron as iron sucrose (iron (III)-hydroxide sucrose complex; 20 mg iron per ml) 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection or concentrate for solution for infusion. SOLUFERR is a dark brown, non transparent, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SOLUFERR is indicated for the treatment of iron deficiency in the following indications: • where there is a clinical need to deliver iron rapidly to iron stores, • in patients who cannot tolerate oral iron therapy or who are non-compliant, • in active inflammatory bowel disease where oral iron preparations are ineffective. The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Hb, serum ferritin, serum iron, etc.). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of SOLUFERR. SOLUFERR should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each SOLUFERR injection (see section 4.4). ADMINISTRATION: SOLUFERR must only be administered by the intravenous route. This may be by a slow intravenous injection or by an intravenous drip infusion. SOLUFERR must not be used for Perskaitykite visą dokumentą