FEROSACŪ
Intravenous

Composition And Actions | Indications | Dosage And Administration | Side Effects | Precautions | Contraindications | Presentations

COMPOSITION AND ACTIONS
Standardized aqueous alkaline solution of Iron (III) Hydroxide Saccharate Complex (Iron Saccharate).
One ampoule of 5 ml contains 100 mg trivalent iron.

ACTIONS:
The polynuclear Ferric-Hydroxide is partly stored as ferritin (depot iron) after complex-formation with the protein ligand apoferritin of the mitochondria of the liver.
Iron is transported in the blood plasma bound to a B-globulin, transferrin. This protein reacts with two atoms of iron per protein molecule, with the formation of a pink-coloured complex.
The major function of transferrin is to act as the carrier of iron through the body (transportation to the sites of hemoglobin and myoglobin-synthesis as well as to the cells, producing iron containing enzymes). In doing this, it plays a vital and central role in iron metabolism.
Transferrin also has a second important function, that of participating in the body's defence mechanism against infection. The hemoglobin level increases quicker and with more certainty than after oral therapy with ferrous salts, although the kinetics of the iron incorporation is independent on the way of iron administration.

INDICATIONS
All cases of iron deficiency in which rapid and reliable substitution of iron is required, more particularly for the following:
- severe iron deficiency, e.g. after haemorrhages,
- disturbances in iron absorption in the gastro-intestinal tract,
- marked incompatibility of oral iron preparations,
- iron deficiency resistant to treatment, when the patient cannot be relied on to take the tablets, and contact between doctor and patient at irregular intervals.

DOSAGE AND ADMINISTRATION
1st day : 2.5 ml = 50 mg Fe (III)
2nd day : 5.0 ml = 100 mg Fe (III)
3rd day : 10.0 ml = 200 mg Fe (III)
To be followed with 10 ml two times a week depending on hemoglobin level.

In the average, administration of 100mg Fe (III) (=1 ampoule of 5 ml) results in an increase of the hemoglobin level of 2-3% and 2% during pregnancy respectively.
In order to avoid overdosage the maximum dose may be determined with the following method or according to the following table.
The dosage required may be calculated on the basis of a normal hemoglobin value of 15g/100ml at a blood volume estimated at 7% of the body weight, a hemoglobin iron content of 0.34% and the need for an iron depot of 500mg.

Total Dosage in mg Fe (see also table below):
The total dosage of iron has been calculated from the following formula:
Total iron deficiency in mg =
     Hb-iron deficiency + depot iron Hb-iron deficiency (in mg) = body weight (kg) x (normal Hb - actual Hb in g/I) x 0.24*
This calculation is based on :
     - a normal Hb 150 g/I for body weights higher than 35 kg and 130 g/I up to 34 kg body weight respectively.
     - the iron-content of hemoglobin (0.34%).
     - the blood volume (approx. 7% of the body weight) and the requirements of depot iron
(approx. 15 mg per kg up to a weight of about 34 kg. total of 500 mg above 34 kg).

*Factor 0.24 = 0.0034 x 0.07 x 1000
  Example:
  Patient weighing 70 kg normal
  Hb : 150 g/I   actual
  Hb : 80 g/I
       Hb-Fe deficit: 70 x (150 - 80) x 0.24 = 1176 mg
       Fe Need for depot iron 500 mg Fe
       Total dosage 1676 mg Fe
Therefore this patient requires 1700 mg iron or 17 ampoules during treatment.

Daily maximum doses:
Children up to 5 kg 1.25 ml (1/4 ampoule)
Children between 5-10 kg 2.50 ml (1/2 ampoule)
Adults 10.0 ml ( 2 ampoules)

SIDE EFFECTS
In rare cases anaphylactoid reactions have been observed.
The counter - measures to be taken are the same as with any anaphylaxis

PRECAUTIONS
Store below 20° C.
Do not freeze.
Only homogenous solution to be used.
Do not mix Ferosac i.v. with any other medicament.

CONTRAINDICATIONS
All cases of iron overload or disturbances in utilization of iron.

PRESENTATIONS

This is a medicament consumption contrary to instructions is dangerous for you instructions of the pharmacist who sold the medicament.