Vialfer 20 mg/ml 5 ml, 5 pcs.

A remedy for the treatment of iron deficiency conditions. The multinuclear centers of iron (III) hydroxide are surrounded on the outside by many non-covalently bound sucrose molecules. As a result, a complex is formed with a molecular weight of approximately 43 kD, so that it cannot be excreted unchanged by the kidneys. This complex is stable and does not release iron ions under physiological conditions. Iron in this complex is bound to structures similar to natural ferritin.

Pharmacokinetics

After a single IV injection at a dose containing 100 mg of iron, C_max of iron, averaging 538 μmol, is reached 10 min after injection. The V_d central chamber corresponds almost entirely to the serum volume, about 3 L. V_d in equilibrium is approximately 8 L (indicating a low distribution of iron in the body fluids).

Owing to the low stability of iron sugars compared to transferrin, there is a competitive exchange of iron in favor of transferrin. As a result, about 31 mg of iron (III) is transferred in 24 h. T_1/2 is about 6 h. In the first 4 h, the kidneys excrete less than 5% of iron from total clearance. After 24 h, serum iron levels return to the original (pre-injection) value, and approximately 75% of sucrose leaves the vascular stream.

Indications

How to take, the dosage

Inject only v/v (slow drip or stream) or into the venous area of the dialysis system. It is not intended for intravenous administration. A full therapeutic dose should not be administered at one time.

A test dose should be administered before the first therapeutic dose is administered. If intolerance occurs during the observation period, administration should be stopped immediately.

The dose is calculated individually according to the total iron deficiency in the body using a special formula.

Interaction

Special Instructions

With caution use in patients with bronchial asthma, in eczema, polyvalent allergies, allergic reactions to other parenteral iron preparations; in patients with low serum iron-binding capacity and/or folic acid deficiency; patients with hepatic insufficiency, with acute or chronic infectious diseases, with increased serum ferritin content due to the fact that iron in parenteral administration can have adverse effects in the presence of bacterial or viral infection.

The treatment is used only if the diagnosis of anemia is confirmed by corresponding laboratory data (for example, by the results of the determination of serum ferritin or hemoglobin levels and hematocrit, the number of red blood cells and their parameters – the average red blood cell volume, the average content of hemoglobin in a red blood cell).

Intravenous iron preparations can cause allergic or anaphylactoid reactions, which can be potentially life-threatening.

The higher incidence of unwanted adverse reactions (especially decreased BP), which can also be severe, is associated with an increased dose.

Contraindications

Side effects

Nervous system disorders: very rarely – dizziness, headache, loss of consciousness, paresthesias.

Cardiovascular system: very rare – palpitations, tachycardia, decreased BP, collaptoid states, fever, “rushes” of blood to the face.

Respiratory system disorders: very rarely – bronchospasm, shortness of breath.

Gastrointestinal system: very rare – diffuse abdominal pain, epigastric pain, diarrhea, perversion of taste, nausea, vomiting.

Skin disorders: very rarely – erythema, itching, rash, pigmentation disorders, increased sweating.

Muscular system disorders: very rarely – arthralgia, back pain, joint swelling, myalgia, pain in the extremities.

Allergic reactions: very rare – anaphylactoid reactions, facial edema, laryngeal edema.

General reactions: very rare – asthenia, chest pain, feeling of heaviness in the chest, weakness, peripheral edema, feeling of malaise, pallor, fever, chills.

Local reactions: very rare – pain and swelling at the injection site.