Venofer

Venofer®

Composition

Active substance: Iron in the form of saccharated ferric oxide

One ampoule of 5 mL contains 100 mg iron (Iron sucrose).

Indications:

Iron deficiency in patients in whom oral iron therapy is insufficiently effective or not feasible, such as:

In case of intolerance of oral iron preparations.
In inflammatory gastrointestinal diseases (e.g. ulcerative colitis) which may be aggravated by oral iron therapy.
In therapy-refractory iron deficiency states with suspected unreliable intake of oral iron preparations.

Dosage/Administration::

Venofer must only be administered slowly intravenously.

Venofer must NOT be administered subcutaneously or intramuscularly.

The total cumulative dose of Venofer, corresponding to the total iron deficit (mg), is determined by the haemoglobin value (Hb) and the body weight (BW).

Adults: 5-10 mL Venofer (100-200 mg iron) one to three times weekly

Venofer must only be administered intravenously by drip infusion, slow injection or directly into the venous part of the dialysis machine.
Venofer must only be diluted in sterile 0.9% m/V sodium chloride solution (NaCl solution).

common undesirable effects:

Pain, extravasation, irritation, reaction, discolouration, haematoma, itching at the injection/infusion site.

Pregnancy or Breast-feeding:

There are insufficient data from the use of iron sucrose in pregnant women in the first trimester. Data from the use of Venofer in pregnant women in the second and third trimesters revealed no safety concerns for the mother or the newborn.
Limited data are available on the excretion of iron in human milk in humans after intravenous administration of iron sucrose, Therefore, a risk-benefit assessment must be carried out.

Contraindications:

Known hypersensitivity to the active substance or to any of the excipients according to the composition.
Anaemia not due to iron deficiency (e.g. haemolytic anaemia, megaloblastic anaemia due to vitamin B12 deficiency, disorders of erythropoiesis, bone marrow hypoplasia, lead anaemia).
Indications of iron overload (haemochromatosis, hemosiderosis) or hereditary iron utilisation disorders (sideroblastic anaemia, thalassaemia, porphyria cutanea tarda).
1st pregnancy trimester.

For more information, consult your doctor or your pharmacist.

Indications:

Dosage/Administration::

common undesirable effects:

Pregnancy or Breast-feeding:

Contraindications:

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