Index of drugs

Treatment of iron deficiency in adult patients with chronic kidney disease and dialysis (the diagnosis of iron deficiency should be made on the basis of appropriate laboratory tests, eg serum ferritin, iron in serum, transferrin saturation, unstained red blood cells).

1 ml of solution contains 50 mg of iron in the form of iron (III) isomaltoside.

A parenteral iron preparation, a colloid containing iron strongly bound in spheroidal iron-carbohydrate particles. The carbohydrate part of the complex is isomaltoside 1000, which consists of 3-5 Glucose units with an average molecular weight of about 1000 kDa. The compound forms a stable matrix-like structure in which about 10 iron (III) atoms belong to one molecule of isomaltoside pentamers. Isomaltoside 1000 does not contain any residues of reducing sugars that may be involved in complex oxidation-reduction reactions. The iron is available in non-ionic form, soluble in water, in an aqueous solution with a pH between 5.0 and 7.0. Signs of therapeutic effect are visible after a few days of administration of the preparation as an increase in the amount of reticulocytes. The serum ferritin reaches its maximum within 7 to 9 days after the intravenous dose and slowly returns to baseline levels after about 3 weeks. The product contains iron in a highly bound complex that allows controlled, slow release of iron that is bioavailable to iron-binding proteins, with low risk of free iron formation. After intravenous administration, isomaltoside 1000 is very quickly absorbed by cells of the reticuloendothelial system (RES), especially in the liver and spleen, from where the iron is slowly released. T_0,5 in plasma is about 1 day for total iron (bound and circulating). Circulating iron is removed from the plasma by cells of the reticuloendothelial system that break down the complex into iron and isomaltoside 1000 components. Iron is immediately bound to available protein subunits to form hemosiderin or ferritin, physiological forms of iron stores, or to a lesser extent to the transport molecule - transferrin. In this form, iron is subject to physiological control and complements hemoglobin and depleted iron stocks. Iron is not easily removed from the body, and its accumulation can be toxic. Due to the large particle size of the isomaltoside 1000 iron is not excreted through the kidneys. Small amounts of iron are removed in urine and faeces. Isomaltoside 1000 is metabolised or excreted.

Hypersensitivity to the active substance or any of the excipients. Anemia not caused by iron deficiency (eg haemolytic anemia). Iron overload or impaired iron utilization (eg hemochromatosis, hemosiderosis). Asthma, allergic eczema or other atopic sensitization. Incomplete cirrhosis and hepatitis. Rheumatoid arthritis with symptoms of active inflammation.

Parenteral administration of all iron complexes may result in an ACUTE, immediate and potentially life-threatening hypersensitivity reaction. The risk is increased in patients with known allergies. Therefore, there should be resuscitation medications on site and trained personnel who can recognize the anaphylactoid reaction and take appropriate action if it occurs. An increased risk of allergic reactions to iron complexes administered parenterally occurs especially in patients with impaired immune responses or inflammation (eg systemic lupus erythematosus, rheumatoid arthritis). Parenteral iron administration should be used with caution in acute or chronic infections. The preparation should not be used in patients with ongoing bacteraemia. In the case of too fast intravenous injection, episodes of hypotension may occur. The preparation is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.

The risks and benefits should be carefully evaluated before using the product during pregnancy.The preparation should not be used during pregnancy unless it is absolutely necessary. Anemia caused by iron deficiency in the first trimester of pregnancy can in many cases be treated with oral iron. If the expected benefit of using the product for the mother outweighs the potential risk to the fetus, treatment should be limited to the second and third trimesters. There is no information available on the excretion of milk in breast milk.

Uncommon: blurred vision, numbness, dysphonia, shortness of breath, nausea, vomiting, abdominal pain, constipation, redness, pruritus, rash, spasms, anaphylactoid reactions, feeling hot, fever, pain, inflammation within the injection site, local phlebitis. Rare: arrhythmia, tachycardia, loss of consciousness, epileptic seizure, dizziness, restlessness, tremor, tiredness, change of mental state, chest pain, diarrhea, angioneurotic edema, sweating, muscle pain, joint pain, low blood pressure, fatigue. Very rare: fetal bradycardia, palpitations, haemolysis, headache, paresthesia, transient deafness, hypertension, acute and severe anaphylactic reactions.

Adults. The preparation can be administered in a dose of up to 200 mg, with a maximum weekly dose of 1000 mg. If you need more than 200 mg, you should use other iron preparations for intravenous use. The iron dose must be determined individually based on the clinical response to treatment, including the assessment of hemoglobin, ferritin and transferrin saturation, treatment with erythropoiesis stimulating factor (ESA) and doses of ESA treatment. Target levels may vary depending on the patient and local guidelines. Maintenance therapy with intravenous iron can be used at low doses administered at regular intervals to maintain the stability of the iron test results at specific intervals to prevent iron deficiency or deterioration of iron parameters in studies below the specified values. Anaphylactoid reactions to parenteral iron usually appear after a few minutes and for observation it is necessary to observe. If signs of hypersensitivity or intolerance are detected at any time during the intravenous administration, the treatment should be discontinued immediately. Whenever parenteral iron is given, drugs and equipment for resuscitation should be available, and medical personnel trained in identifying and intervening in the event of anaphylactoid reactions should be present. The drug can be administered as a rapid intravenous injection (bolus) or as a direct injection into the arm of the venous dialyser. It can be administered undiluted or diluted with 10-20 ml of sterile 0.9% sodium chloride solution. The drug should not be administered concurrently with oral iron preparations.