Posology : מינונים

4.2   Posology and method of administration

Unless otherwise ordered, depending on the degree of iron deficiency, adults are given one ampoule daily of 5 ml by infusion after dilution with physiological saline solution or by slow intravenous injection.
Not more than one ampoule should be given, even in exceptional cases such as marked iron deficiency after repeated autologous blood donation.
For preference, the product can be given as an intravenous infusion over 20 to 30 minutes, diluted with 100 to 250 ml of physiological saline solution.
I.V. injections must always be given very slowly with the patient supine.

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Ferrlecit.
Ferrlecit 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 Ferrlecit injection (see section 4.4).

Patients with impaired hepatic or renal function
Ferrlecit is contraindicated in patients with severe inflammatory diseases of the liver or kidneys (see section 4.3).

Paediatric population

Due to lack of clinical data on safety and efficacy, Ferrlecit solution for injection or concentrate for solution for infusion is contraindicated in children younger than the age of 6 years.

From six years 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]1) x Hb deficit [g/dl]2) x factor 3.5 1) to be based on the normal weight in the case of overweight patients.
2) 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.