Referis Dosage/Direction for Use

Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Iron Sucrose.
Iron Sucrose should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilitates can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Iron Sucrose injection.
Posology: The cumulative dose of Iron Sucrose must be calculated for each patient individually and must not be exceeded.
Calculation of Dosage: The total cumulative dose of Iron Sucrose, equivalent to the total Iron deficit (mg), is determined by the haemoglobin level (Hb) and body weight (BW).
The dose of Iron Sucrose must be individually calculated for each patient according to the total iron deficit calculated with the following Ganzoni formula, for example. (See equation.)

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Total amount of Iron Sucrose (mL) to be administered according to body weight, actual Hb level and target Hb level* (see Table 1).

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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 iron sucrose (100-200 mg Iron) 1 to 3 times a week. For administration time and dilution ratio see "Method of Administration" as follows.
Paediatric population: The use of Iron Sucrose has not been adequately studied in children and therefore, Iron Sucrose is not recommended for use in children.
Method of administration: Iron Sucrose must only be administrated 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: Iron Sucrose 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 be administered as follows: See Table 2.

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For stability reasons dilutions to lower Iron Sucrose concentrations are not permissible.
Intravenous injection: Iron Sucrose may be administered by slow intravenous injection at a rate of 1 mL undiluted solution per minute and not exceeding 10 mL Iron Sucrose (200 mg Iron) per injection.
Injection into venous line of dialysis machine: Iron Sucrose may be administered during a haemodialysis session directly into the venous line of the dialysis machine under the same conditions as for intravenous injection.
Note: Do not mix Iron Sucrose Injection (Referis) with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever the solution and container permit.