Likferr 100 ampoules 20 mg/ml 5 ml №5

Solution for intravenous administration

Composition

1 ml contains iron (III) sucrose hydroxide complex (in terms of iron (III) 20 mg;
Excipients: sodium hydroxide; water for injections.

Packing

5 ampoules of 5 ml.

Mechanism of action

Likferr100 - a preparation of iron, regulates metabolic processes. It is a colloidal solution, which consists of spheroidal iron-carbohydrate nanoparticles. In the core (center) of each particle is iron [III] hydroxide. The core is surrounded by a shell of sucrose, which stabilizes iron [III] hydroxide, slowly releases bioactive iron and stores the particles in a colloidal solution. As a result, a complex is formed, the molecular weight of which is approximately 43 kDa, as a result of which its excretion by the kidneys in unchanged form is impossible. Iron [III] in this complex is associated with structures similar to natural ferritin. The active substance of the iron preparation [III] hydroxide sucrose complex when released into the body dissociates into the reticuloendothelial system into iron and sucrose. Due to the lower stability of iron saharat compared with transferrin, there is a competitive exchange of iron in favor of transferrin.As a result, about 31 mg of iron is transferred in 24 hours. Polycyclic iron hydroxide [III] is partially preserved in the form of ferritin after complexation with the protein ligand apoferritin of the liver mitochondria. The hemoglobin index rises faster and more reliably than after therapy with drugs containing iron [II]. The introduction of 100 mg of iron [III] leads to an increase in hemoglobin by 2-3%; during pregnancy - by 2%. The toxicity of the drug is very low. The therapeutic index is 30 (200/7).

Indications and usage

• iron deficiency states (including iron deficiency and acute post-hemorrhagic anemia), if necessary, rapid replenishment of iron;
• with intolerance to iron preparations for oral administration;
• diseases of the gastrointestinal tract, in which it is impossible to take iron orally

Contraindications

• hypersensitivity to the drug Likferr100;
• anemia not related to iron deficiency;
• the presence of signs of iron overload (hemosiderosis, hemochromatosis) or violation of the process of its utilization;
• I trimester of pregnancy.
• Carefully:
• bronchial asthma;
• eczema;
• polyvalent allergy, allergic reactions to other parenteral iron preparations (due to the high risk of developing allergic reactions - see the section "Special Instructions");
• liver failure;
• acute infectious diseases;
• low serum iron-binding capacity and / or folic acid deficiency;
• diabetes mellitus (seesection "Special instructions");
• children's age (up to 18 years) (due to the lack of data on safety and efficacy).

Pregnancy and Breastfeeding

The drug is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, they are used only if the intended benefit to the mother outweighs the potential risk to the fetus. During lactation, the safety of the drug has not been established. It is recommended to stop breastfeeding (if necessary, use the drug) or to cancel the drug.

Dosage and administration

In / in (slowly jet or drip), as well as in the venous area of ​​the dialysis system. The drug is not intended for i / m administration. It is unacceptable simultaneous introduction of a full (cumulative) therapeutic dose of the drug. Before the introduction of the first therapeutic dose, you must assign a test dose. If intolerance occurs during the observation period, the administration of the drug should be immediately discontinued. Before opening the ampoule, you need to inspect it for possible sediment and damage. You can use only brown solution without sediment.

Drip Introduction.Likferr100 is preferable to be administered during the drip infusion in order to reduce the risk of a pronounced decrease in blood pressure and the risk of solution getting into the near-venous space. Immediately before the infusion, Likferr100 should be diluted with a 0:20% solution of sodium chloride in the ratio of 1:20 - for example, 1 ml (20 mg of iron) in 20 ml of 0.9% sodium chloride solution.The resulting solution is injected at the following rate: 100 mg of iron - no less than 15 minutes; 200 mg - for 30 minutes; 300 mg - for 1.5 hours; 400 mg - for 2.5 hours; 500 mg - for 3.5 hours. The introduction of the maximum tolerated single dose of 7 mg of iron / kg should be made for at least 3.5 hours, regardless of the total dose of the drug. Before the first drip of a therapeutic dose of Likferr100, a test dose must be injected: 1 ml of Likferr100 (20 mg of iron) to adults and children weighing more than 14 kg and half the daily dose (1.5 mg of iron / kg) to children of body weight less than 14 kg for 15 min. In the absence of adverse events, the remaining part of the solution should be injected at the recommended rate.

Inkjet injection.Likferr100 can also be administered as an undiluted solution slowly slowly at a rate of 1 ml of Likferr100 (20 mg of iron) per minute - for example, 5 ml of Likferr 100 (100 mg of iron) is injected within 5 minutes. The maximum amount of the drug should not exceed 10 ml of Likferr100 (200 mg of iron) per injection. After the injection, it is recommended that the patient fix the arm in an extended position for a while. Before the first jet injection of a therapeutic dose of Likferr100, a test dose should be injected: 1 ml of Likferr100 (20 mg of iron) to adults and children weighing more than 14 kg and half the daily dose (1.5 mg of iron / kg) to children who have a body weight less than 14 kg, for 1–2 minutes In the absence of adverse events over the next 15 minutes of observation, the remaining part of the solution should be injected with the recommendedby speed. After injection, the patient is recommended to fix the arm in an extended position.

Introduction to the dialysis system.Likferr100 can be administered directly into the venous site of the dialysis system, strictly following the rules described for intravenous injection.

Adverse reactions

From the side of the central nervous system: dizziness, headache, loss of consciousness, paresthesia.

Cardiovascular: palpitations, tachycardia, lowering blood pressure, collaptoid states, feeling of heat, flushing, peripheral edema.

Respiratory: bronchospasm, shortness of breath.

Gastrointestinal: transient taste disturbances (especially metallic taste in the mouth), "diffuse" abdominal pain, pain in the epigastric region, diarrhea, taste perversion, nausea, vomiting.

From the skin: erythema, pruritus, rash, pigmentation disorders, increased sweating.

Musculoskeletal system: arthralgia, back pain, swelling of the joints, myalgia, pain in the limbs.

Allergic reactions: anaphylactoid reactions, swelling of the face, laryngeal edema.

Other: asthenia, chest pain, backache, feeling of heaviness in the chest, weakness, malaise, pallor, fever, chills.

Local reactions: pain and swelling at the injection site (especially with extravasal ingestion of the drug), phlebitis, burning sensation, hematoma.

If any of these side effects worsen or develop any other side effects, you should inform your doctor.

Special notes

It is necessary to strictly observe the rate of administration of the drug Likferr100 (with the rapid introduction of the drug may decrease blood pressure). Higher incidence of undesirable side reactions (especially - reduction of blood pressure), including and severe, is associated with an increase in dose. Thus, the time of administration of the drug, given in the section "Dosage and Administration", must be strictly observed, even if the patient does not receive the drug in the maximum tolerated single dose. During the period of administration of the drug Likferr100 it is necessary to control the hemodynamic parameters. Likferr100 should be administered only to those patients in whom the diagnosis of anemia is confirmed by relevant laboratory data (for example, the results of serum ferritin or hemoglobin and hematocrit, red blood cell counts and their parameters - the average red blood cell volume or the average red blood cell hemoglobin count). Intravenous iron preparations can cause allergic or anaphylactoid reactions that can be potentially life-threatening. Patients with bronchial asthma, eczema, atopic diseases, polyvalent allergies, allergic reactions to other iron preparations, as well as patients who have low serum iron binding capacity / or folic acid deficiency, have an increased risk of allergic or anaphylactoid reactions (see the “Contraindications” section, subsection "With caution").Studies conducted in patients with hypersensitivity reactions to iron dextran showed no complications during the treatment with the drug. It is necessary to avoid penetration of the drug into the space near getting Likferra100 outside the vessel leads to tissue necrosis and brown staining of the skin. If this complication develops, it is recommended (if the needle is still in the vessel) to introduce a small amount of 0.9% sodium chloride solution. To accelerate the excretion of iron and prevent its further penetration into the surrounding tissues, it is recommended to apply heparin-containing preparations to the injection site (gel or ointment is applied with light movements, without rubbing). The introduction of the drug in the presence of sediment is unacceptable. 1 ml of Likferr100 contains from 260 to 340 mg of sucrose. These data must be considered in patients with diabetes. When administered by drip, depending on the indications, the maximum tolerated single dose can reach 500 mg of iron, which corresponds to the introduction of 8.5 g of sucrose. When recalculating the amount of carbohydrates in XE (1 XE = 12 g of carbohydrates), it corresponds to 0.7 XE. During therapy with erythropoiesis stimulants, iron metabolism is controlled using indicators such as serum ferritin concentration and transferrin saturation with iron. Determining the number of hypochromic erythrocytes and the concentration of hemoglobin in reticulocytes helps to decide on the need for intravenous administration of iron when there is hyperferritinemia and low NTZh.The risk of iron overload is compensated by blood loss during dialysis procedures (1–3 g of iron is lost per year). Serum ferritin concentration should be monitored regularly. Serum ferritin concentration above 500 µg / l (at a normal C-reactive protein ratio), which persists for a long time, may indicate iatrogenic iron overload. In such cases, iron supplements should be discontinued (erythropoiesis stimulant therapy should continue). Due to the fact that iron stimulates the growth of most microorganisms, iron preparations should be canceled with the development of acute bacterial infections. Also, intravenous iron therapy should be carried out with caution in patients with permanent dialysis catheters.

The simultaneous administration of the drug Likferr100 with iron dosage forms for oral administration is unacceptable, since decreases iron absorption from the gastrointestinal tract. Treatment with oral iron preparations can begin no earlier than 5 days after the last injection. Likferr100 can be mixed in one syringe with only 0.9% sodium chloride solution. No other solutions for the on / in the introduction and therapeutic drugs are not allowed, because there is a risk of precipitation and / or other pharmaceutical interactions. Compatibility with containers of other materials than glass, PE and PVC, has not been studied.If the patient is taking other drugs, it is necessary to consult a doctor.

Symptoms: decrease in blood pressure (signs of collapse appear within 30 minutes), hemosiderosis symptoms.
Treatment: symptomatic, if necessary, iron-binding drugs (chelators), for example deferoxamine.

At a temperature not higher than 25 ° C (do not freeze).