Χώρα: Κύπρος
Γλώσσα: Ελληνικά
Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
SACCHARATED IRON OXIDE
THE STAR MEDICINES IMPORTERS CO. LTD (0000003109) 10 LOUKIS AKRITAS STR, LEMESOS, 3601, 50151
B03AC
IRON TRIVALENT, PARENTERAL PREPARATIONS
100MG/5ML
SOLUTION FOR INJECTION
SACCHARATED IRON OXIDE (0008047674) 100MG
INTRAVENOUS USE
Εθνική Διαδικασία
SACCHARATED IRON OXIDE
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 5 AMPS X 5ML (930008701) 5 AMPOULE - Εγκεκριμένο - Με Ιατρική Συνταγή
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 ”Undesirable effects” for how to report adverse reactions. NAME OF THE MEDICINAL PRODUCT Venofer QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL ampoule contains 20 mg/mL iron as iron sucrose corresponding to 100 mg iron per ampoule. For the full list of excipients, see section “List of excipients”. PHARMACEUTICAL FORM Solution for injection or concentrate for solution for infusion. Venofer is a dark brown, non transparent, aqueous solution with a pH of 10.5 – 11.0 and an osmolarity of 1250 mOsmol/L. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Venofer is indicated for the treatment of iron deficiency in the following indications: where there is a clinical need for a rapid iron supply, in patients who cannot tolerate oral iron therapy or who are non-compliant, where oral iron preparations are ineffective (e.g., in active inflammatory bowel disease). Venofer should only be administered where the indication is confirmed by appropriate investigations. POSOLOGY AND METHOD OF ADMINISTRATION Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Venofer. Venofer 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 Venofer administration (see section “Special warnings and precautions for use”). Posology The cumulative dose of Venofer must be calculated for each patient individually and must not be exceeded. _Calculation of dosage_ The total cumulative dose of Venofer, equivalent to the total iron deficit (mg), is determined by the haemoglobin level (Hb) and body weight (BW). The dose of Venof Διαβάστε το πλήρες έγγραφο
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 ”Undesirable effects” for how to report adverse reactions. NAME OF THE MEDICINAL PRODUCT Venofer QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL ampoule contains 20 mg/mL iron as iron sucrose corresponding to 100 mg iron per ampoule. For the full list of excipients, see section “List of excipients”. PHARMACEUTICAL FORM Solution for injection or concentrate for solution for infusion. Venofer is a dark brown, non transparent, aqueous solution with a pH of 10.5 – 11.0 and an osmolarity of 1250 mOsmol/L. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Venofer is indicated for the treatment of iron deficiency in the following indications: where there is a clinical need for a rapid iron supply, in patients who cannot tolerate oral iron therapy or who are non-compliant, where oral iron preparations are ineffective (e.g., in active inflammatory bowel disease). Venofer should only be administered where the indication is confirmed by appropriate investigations. POSOLOGY AND METHOD OF ADMINISTRATION Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Venofer. Venofer 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 Venofer administration (see section “Special warnings and precautions for use”). Posology The cumulative dose of Venofer must be calculated for each patient individually and must not be exceeded. _Calculation of dosage_ The total cumulative dose of Venofer, equivalent to the total iron deficit (mg), is determined by the haemoglobin level (Hb) and body weight (BW). The dose of Venof Διαβάστε το πλήρες έγγραφο