VENOFER 100MG/5ML SOLUTION FOR INJECTION

Country: Cyprus

Language: Greek

Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Active ingredient:

SACCHARATED IRON OXIDE

Available from:

THE STAR MEDICINES IMPORTERS CO. LTD (0000003109) 10 LOUKIS AKRITAS STR, LEMESOS, 3601, 50151

ATC code:

B03AC

INN (International Name):

IRON TRIVALENT, PARENTERAL PREPARATIONS

Dosage:

100MG/5ML

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SACCHARATED IRON OXIDE (0008047674) 100MG

Administration route:

INTRAVENOUS USE

Prescription type:

Εθνική Διαδικασία

Therapeutic area:

SACCHARATED IRON OXIDE

Product summary:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 5 AMPS X 5ML (930008701) 5 AMPOULE - Εγκεκριμένο - Με Ιατρική Συνταγή

Patient Information leaflet

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

Summary of Product characteristics

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