FERROLOGIC 20 MG/ML SOLUTION FOR INJECTION/CONCENT
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
30-04-2024
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Virkt innihaldsefni:
IRON SUCROSE
Fáanlegur frá:
Fresenius Medical Care Nephrologica Deutschland GmbH
Skammtar:
20
Lyfjaform:
Solution for Injection
Leyfisdagur:
2008-04-18
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre of solution contains 20 mg iron as iron sucrose [iron(III)-hydroxide sucrose complex].
Each 5 ml ampoule contains 100 mg iron as iron sucrose [iron(III)-hydroxide sucrose complex].
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/concentrate for solution for infusion.
Ferrologic is a dark brown, non transparent, aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ferrologic is indicated for the parenteral treatment of iron deficiency in those cases where oral iron preparations are
inadequate.
This can apply to:
•
Patients who demonstrated intolerance to oral iron preparations,
•
Patients who demonstrated non-compliance with oral iron therapy,
•
Conditions where there is a clinical need to deliver iron rapidly to iron stores,
•
Patients who insufficiently absorb oral iron preparations (e.g. due to active inflammatory bowel disease).
The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. serum ferritin, serum iron,
transferrin saturation, haemoglobin, haematocrit, erythrocytic count and hypochromic red cells or red blood cells
indices: MCV, MCH, MCHC).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CALCULATION OF THE REQUIRED DOSAGE
_Adults and Elderly:_
The total cumulative dose of Ferrologic, equivalent to the total iron deficit (mg), is determined by the haemoglobin
level and body weight. The dose and dosage schedule for Ferrologic must be individually estimated for each patient
based on a calculation of the total iron deficit:
Total iron deficit [mg] = body weight [kg] x (target Hb - actu
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