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 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 4.4).
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 Venofer 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 = 13 g/dl and storage iron = 15 mg/kg BW
•   35 kg BW and above: Target Hb = 15 g/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 amount of Venofer (ml) to be administered according to body weight, actual Hb level and target Hb level*:



BW               Total amount of Venofer (20mg iron per ml) to be administered:
Hb 6.0 g/dl   Hb 7.5 g/dl    Hb 9.0 g/dl   Hb 10.5 g/dl
30 kg           47.5 ml       42.5 ml       37.5 ml         32.5 ml
35 kg           62.5 ml       57.5 ml        50 ml           45 ml
40 kg           67.5 ml        60 ml         55 ml          47.5 ml
45 kg            75 ml         65 ml        57.5 ml          50 ml
50 kg            80 ml         70 ml         60 ml          52.5 ml
55 kg            85 ml         75 ml         65 ml           55 ml
60 kg            90 ml         80 ml        67.5 ml         57.5 ml
65 kg            95 ml        82.5 ml       72.5 ml          60 ml
70 kg           100 ml        87.5 ml        75 ml          62.5 ml
75 kg           105 ml        92.5 ml        80 ml           65 ml
80 kg          112.5 ml       97.5 ml       82.5 ml         67.5 ml
85 kg          117.5 ml      102.5 ml        85 ml           70 ml
90 kg          122.5 ml      107.5 ml        90 ml          72.5 ml

* 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
5-10 ml of of Venofer (100 – 200 mg iron) 1 to 3 times a week. For administration time and dilution ration see “Method of administration”


Paediatric population
The use of Venofer has not been adequately studied in children and, therefore, Venofer is not recommended for use in children.


Method of administration
Venofer 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
Venofer 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:
Venofer dose Venofer dose           Maximum dilution volume          Minimum Infusion Time (mg of iron)     (ml of Venofer)    of sterile 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 Venofer concentrations are not permissible.


Intravenous injection
Venofer may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute and not exceeding 10 ml Venofer (200 mg iron) per injection.


Injection into venous line of dialysis machine
Venofer may be administered during a haemodialysis session directly into the venous line of the dialysis machine under the same conditions as for intravenous injection.