Posology : מינונים

4.2 Posology and method of administration
Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of FERROVIN.
FERROVIN 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 FERROVIN administration (see section 4.4).

Posology
The cumulative dose of FERROVIN must be calculated for each patient individually and must not be exceeded.
Calculation of Dosage:
The total cumulative dose of FERROVIN, equivalent to the total iron deficit (mg), is determined by the haemoglobin level (Hb) and body weight (BW). The dose of FERROVIN must be individually calculated for each patient according to the total iron deficit calculated with the following Ganzoni formula, for example:


Total iron deficit [mg] = BW [kg] X (target Hb- actual Hb) [g/dl] X 2.4* + storage iron [mg]
•   Below 35 kg BW: Target Hb= 13g/dl and storage iron= 15mg/kg BW
•   35 kg BW and above: Target Hb= 15g/dl and storage iron= 500 mg *Factor 2.4 = 0.0034 (iron content of Hb=0.34%) x 0.07 (blood volume=7% of BW) x 1000 (conversion of [g] to [mg]) x 10


Total FERROVIN to be administered (in ml)= Total iron deficit [mg]
20 mg iron/ml

Total amount of FERROVIN (ml) to be administered according to body weight, actual Hb level and target Hb level*:


Body weight      Total amount of FERROVIN (20mg iron per ml) to be administered: 
[kg]               Hb 6.0 g/dl          Hb 7.5 g/dl       Hb 9.0 g/dl   Hb 10.5 g/dl 
30            47.5ml               42.5ml             37.5ml       32.5ml 35            62.5ml               57.5ml              50ml         45ml 40            67.5ml                60ml               55ml        47.5ml
45              75ml                65ml              57.5ml        50ml
50              80ml                70ml               60ml        52.5ml 55              85ml                75ml               65ml         55ml 60              90ml                80ml              67.5ml       57.5ml 65              95ml               82.5ml             72.5ml        60ml 70             100ml               87.5ml              75ml        62.5ml 75             105ml               92.5ml              80ml         65ml 80            112.5ml              97.5ml             82.5ml       67.5ml 85            117.5ml             102.5ml              85ml         70ml 90            122.5ml             107.5ml              90ml        72.5ml Below 35 kg BW:                          Target HB=13 g/dl
35 kg BW and above:                      Target Hb=15 g/dl
To convert Hb (mM) to Hb (g/dl), multiply the former by 1.6.


If the total necessary dose exceeds the maximum allowed single dose, then the administration must be divided.


Posology:
Adults:
5-10ml of FERROVIN (100-200 mg iron) one to three times a week. For administration time and dilution ration see "Method of administration".
Paediatric population:
The use of iron sucrose has not been adequately studied in children and, therefore, FERROVIN is not recommended for use in children.


Method of Administration:
FERROVIN must only be administered by the intravenous route. This may be by a slow intravenous injection, by an intravenous drip infusion or directly into the venous line of the dialysis machine.


Intravenous drip infusion:
FERROVIN must only be diluted in sterile 0.9% m/V sodium chloride (NaCl) solution.
Dilution must take place immediately prior to infusion and the solution should be administered as follows:
FERROVIN dose            FERROVIN dose      Maximum dilution       Minimum Infusion (mg of iron)             (ml of FERROVIN)   volume of sterile      Time 0.9% m/V NaCl solution
50 mg                    2.5 ml             50 ml                  8 minutes 100 mg                   5 ml               100 ml                 15 minutes 200 mg                   10 ml              200 ml                 30 minutes
For stability reasons, dilutions to lower FERROVIN concentrations are not permissible.
Intravenous injection:
FERROVIN may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute and not exceeding 10 ml FERROVIN (200 mg iron) per injection.
Injection into venous line of dialysis machine:
FERROVIN may be administered during a haemodialysis session directly into the venous line of the dialysis machine under the same conditions as for intravenous injection.