Index of drugs

Treatment of iron deficiency in the case of the need to quickly replenish systemic iron stores, poor tolerability of oral iron preparations or lack of response to these preparations or active inflammation of the intestines, in which oral iron preparations are ineffective.

1 ampoule (5 ml) contains 100 mg of Fe (III) in the form of a ferric hydroxide complex with sucrose (sugars).

Iron is the basis of hemoglobin and myoglobin and many of the ferroporphyrin enzymes associated with intracellular respiration. Part of the iron is directly used by cells of the erythroblastic system to produce hemoglobin, the remainder accumulates in the form of ferritin, mainly in the liver and spleen and other organs. The serum iron carrier protein is transferrin. The iron stored in the body remains in a dynamic balance with the one found in the serum. Spare iron can also be used in combination with hemosiderin. Parenteral administered iron is rapidly removed from the plasma to tissue stores. After 24 h, approximately 75% of the administered dose of sugars is excreted and plasma iron levels return to pre-injection values. T_0,5 is about 6 hours.

Hypersensitivity to the active substance or any of the excipients. Known hypersensitivity to other parenteral iron preparations. Anemia caused by other causes than iron deficiency. Excessive iron resources in the body or disturbances in its consumption. And trimester of pregnancy.

Intravenous iron-containing medications can cause severe hypersensitivity reactions that can lead to death. These reactions may occur even if the previously administered doses were well tolerated (also in the absence of a reaction after the trial dose). The risk of hypersensitivity is greater in people diagnosed with allergies (including allergies to drugs) or with immunological or inflammatory diseases (such as systemic lupus erythematosus, rheumatoid arthritis), as well as in patients with severe asthma, eczema or other atopic allergy in interview. In these patients, intravenous iron-containing medicines should only be used in cases where the benefits clearly outweigh the possible risks. Intravenous iron-containing medicines should only be administered under the direct supervision of medical personnel trained in the evaluation and treatment of anaphylactic reactions. The patient should be monitored for adverse effects for at least 30 minutes after each administration. If hypersensitivity reactions or signs of intolerance occur during treatment, treatment should be discontinued immediately. Cardiopulmonary resuscitation equipment and medicines to treat acute anaphylactic or anaphylactoid reactions, including an adrenaline 1: 1000 solution for injection, must be available. If necessary, additional treatment with antihistamines and / or corticosteroids should also be used. Use with caution in patients with low iron binding capacity and / or folic acid deficiency (increased risk of allergic reactions), liver problems, as well as in patients with acute or chronic infections with excessive ferritin in the blood (increased risk of adverse course of infection). The product should not be administered intramuscularly or outside the vein (tissue necrosis and brown skin discoloration) or too fast (risk of hypotension). Do not combine in one solution with other drugs.

Use in the first trimester of pregnancy is contraindicated. Iron deficiency in the first three months of pregnancy can in many cases be treated with oral iron preparations. Treatment with intravenous iron should be restricted to the second or third trimester if the benefits clearly outweigh the possible risks to the mother and to the fetus. Anaphylactoid or anaphylactoid reactions following intravenous administration of iron-containing medicines may affect both the mother and the fetus (eg fetal distress, distress, death).Unmetabolized iron sugars are unlikely to be excreted in human milk; therefore, the drug should not pose a risk to the breast-fed child.

Transient dysfunction often occurs (especially metallic taste). Uncommon: pain and dizziness, hypotonia, collapse, tachycardia, palpitations, bronchospasm, shortness of breath, nausea, vomiting, abdominal pain, diarrhea, pruritus, urticaria, skin rash, rash, erythema, muscle spasms, myalgia, fever, chills and hot flushes, pain and tightness in the chest, superficial phlebitis, burning and swelling at the injection site. Rarely: paresthesia, anaphylactoid reactions (sometimes with joint pain), peripheral edema, fatigue, weakness, malaise, isolated cases of consciousness disorders, feelings of emptiness in the head, confusion, vascular edema and swelling of the joints.

Intravenously (after appropriate dilution of the ampoule content with 0.9% NaCl solution) in a drip infusion at a rate of 100 mg in at least 15 minutes (in the case of a maximum tolerated single dose of 7 mg / kg - in at least 3.5 hours) or in a slow injection (without dilution, at a rate of 1 ml / min, a maximum of 2 ampoules) or during hemodialysis directly into the venous part of the dialysis apparatus (administration as in intravenous injection). The dose of the drug is determined individually depending on the existing iron deficiency, using the appropriate formula.Test dose. There is no relevant data clearly demonstrating the protective effect of the test dose application. The administration of the test dose may provide false confidence, as allergic reactions may also occur in patients who do not respond after the trial dose. For this reason, a trial dose is no longer recommended and recommendations for minimizing the risk of hypersensitivity reactions have been introduced instead: particular care must be taken when administering any intravenous iron dose, even if the previously administered doses are well tolerated; in a place fully equipped with resuscitation equipment; when observing the patient for at least 30 minutes after each administration of the drug.Healing dose. Usually, the treatment dose is in adults 1-2 ampoules, ie 100-200 mg of iron (maximum 0.35 ml / kg, ie 7 mg / kg, but not more than 500 mg) 1-3 times in week, depending on the Hb concentration; in children, a maximum of 0.15 ml / kg (ie 3 mg / kg) 1-3 times a week, depending on the Hb concentration. The maximum dose given in infusion is 7 mg / kg. once a week, and injections of 200 mg iron (10 ml).