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  • Ferrlecit
    / Sanofi


    Active Ingredient
    Iron (as sodium ferric gluconate complex) 62.5 mg / 5 ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    5 X 5 ml

    partial basket chart 28921 6429

    Dosage

    Unless otherwise ordered, depending on the level of iron deficiency, adults are given one ampoule daily of 5 ml by slow intravenous injection or by infusion after dilution with 0.9% sodium chloride. Not more than one ampoule should be given, even in exceptional cases such as marked iron deficiency after repeated autologous donation.I.V. injections must always be given very slowly with the patient supine. For preference, the product can also be given as an intravenous infusion over 20 to 30 minutes diluted with 100 to 250 ml of 0.9% sodium chloride.From six years of age and upwards until achievement of a body weight of 40 kg, children with iron deficiency and erythropoietin therapy under haemodialysis receive a dose of 0.12 ml Ferrlecit/kg body weight, equivalent to 1.5 mg iron (III) ion/kg body weight at each dialysis. Children and adolescents with a body weight of more than 40 kg receive a single dose of 5 ml Ferrlecit, equivalent to 62.5 mg iron (III) ion at each dialysis.
    The duration of treatment depends on the degree of iron deficiency, that can be approximately calculated according to the following equation:Required amount of iron [mg] = body weight) [kg] x Hb deficit [g/dl]) x factor 3.5) to be based on the normal weight in the case of overweight patients.) target Hb corresponding to normal for age and gender.Reliable values for serum ferritin and transferrin saturation will not be obtained for at least one week after the last Ferrlecit dose. Total and reticulocyte haemoglobin begin to increase within one to two weeks of starting treatment.


    Indications

    Severe iron deficiency when oral administration impossible, gastrointestinal malabsorption, dialysis patients getting erythropoietin.


    Contra-Indications

    Ferrlecit should not be used in
    – Hypersensitivity to the active substance, to Ferrlecit or any of its excipients.
    – Known serious hypersensitivity to other parenteral iron products.
    – Iron overload (haemochromatosis, chronic haemolysis) or iron utilisation disorders (sideroblastic anaemia, lead anaemia, thalassaemia).
    – Severe inflammatory diseases of the liver or kidneys.
    – Due to the content of benzyl alcohol, Ferrlecit must not be given to premature babies or neonates.
    – Because of its sucrose content, this medicinal product must not be used in patients suffering from hereditary fructose intolerance.


    Special Precautions

    Ferrlecit should only be used with special caution in:- patients with known allergic diathesis e.g. in asthmatics- chronic inflammatory diseases (Crohn’s disease, progressive rheumatoid arthritis)In order to avoid haemosiderosis, it is essential to calculate the amount of iron required before the i.v. administration of iron.Accidental paravenous or intramuscular injection is painful due to the content of benzyl alcohol and must therefore be avoided. In addition, accidental paravenous administration can lead to reddish-brown discolouration of the skin.Benzyl alcohol can cause toxic and anaphylactic reactions in infants and children below 3 years of age.The administration of medications containing benzyl alcohol to newborns or premature neonates has been associated with a fatal “Gasping Syndrome” (symptoms include a striking onset of gasping syndrome, hypotension, bradycardia, and cardio-vascular collapse). As benzyl alcohol may cross the placenta, solution for injection should be used with caution in pregnancy.In conjunction with oral iron preparations, pregnancy, lactation.


    Side Effects

    See prescribing information for full details.


    Drug interactions

    The incidence and severity of possible anaphylactic/anaphylactoid reactions with Ferrlecit therapy can be increased if Ferrlecit is used in patients under treatment with ACE-inhibitors.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data on the use of the sodium ferric gluconatesucrose complex in pregnancy. Animal studies have shown reproductive toxicity . The potential risk for human is unknown.Use during pregnancy should only be contemplated if the expectedbenefits for the mother outweigh all possible risks for the foetus Due to the rarely occurring circulatory reactions that an injection ofiron can cause, there is the potential risk with pregnant women that nutritional disorders occur in the foetus due to inadequateblood supply to the placenta. Therefore particular attention should bepaid to correct use.
    Breast-feeding: It is not known whether excretion of iron into breast milk is increasedafter parenteral administration of iron. Ferrlecit should therefore be used during lactation only after carefully weighing the benefits and risks.


    Overdose

    Signs of an overdose with Ferrlecit may be circulatory collapse, shock, pallor, dyspnoea, restlessness as well as confusion and coma. Fever and convulsions have also been reported.
    If serum iron levels exceed 3 mg/l and the iron binding capacity of transferrin is exceeded, i.v. infusion of 1 to 2 g deferoxamine (maximum 16 mg/kg/hour) is recommended. The infusion should be repeated on the next day if necessary and serum iron levels should be checked.


    Manufacturer
    Sanofi-Aventis, S.P.A, Italy
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