Ferrum Lek solution for injection 50mg / ml, 2ml No. 5

For oral administration:

• treatment of iron deficiency anemia of various origins and latent iron deficiency in infants and young children;

• increased need for iron (pregnancy, lactation, donation, period of intensive growth, vegetarianism, old age).

For parenteral administration:

• treatment of iron deficiency anemia with ineffectiveness or inability to take oral iron-containing drugs (including in patients with gastrointestinal diseases, with malabsorption syndrome).

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

For intramuscular injection.

The dose is set individually, depending on the indications, the patient's age and the clinical situation.

For 1 ml:

Active ingredient: iron [III] hydroxide polyisomaltosate - 50 mg

Excipients: sodium hydroxide, hydrochloric acid (concentrated), water d / i.

• Excess iron in the body (hemochromatosis, hemosiderosis);

• anemia not associated with iron deficiency (hemolytic anemia or megaloblastic anemia caused by a lack of cyanocobalamin, aplastic anemia);

• violation of the mechanisms of iron utilization (lead anemia, sideroachrestic anemia, thalassemia, tardive porphyria of the skin);

• hypersensitivity to the active substance.

For intramuscular injection only (optional):

• Randu-Weber-Osler disease;

• chronic polyarthritis;

• acute infectious kidney disease;

• uncontrolled hyperparathyroidism;

• decompensated liver cirrhosis;

• infectious hepatitis;

• children under 4 months of age;

• I trimester of pregnancy.

Clinical and pharmacological group: Antianemic drug

Pharmaco-therapeutic group: Hematopoiesis stimulant-iron drug

pharmachologic effect

A remedy for the treatment of anemia. The multinuclear centers of Fe3 + hydroxide are surrounded on the outside by many non-covalently bound polymaltose molecules, forming a complex with a total molecular weight of 50 thousand Daltons, which is so large that its diffusion through the intestinal mucosa membranes is approximately 40 times less than that of Fe2 + hexahydrate.

This macromolecular complex is stable, does not release iron in the form of free ions, and is structurally similar to the natural compound of iron and ferritin. Due to this similarity, Fe3 + ions from the intestine enter the blood only through active absorption, which explains the impossibility of overdose (and intoxication), in contrast to simple iron salts, the absorption of which occurs along a concentration gradient.

The absorbed iron is deposited in a form associated with ferritin, mainly in the liver. Later, in the bone marrow, it is incorporated into hemoglobin. Iron, which is part of the Fe3 + hydroxide of the polymaltose complex, does not possess prooxidant properties (which are inherent in simple Fe2 + salts), which leads to a decrease in the oxidation of LDL and VLDL.

Quickly replenishes iron deficiency in the body, stimulates erythropoiesis, restores hemoglobin.

Pharmacokinetics

The degree of absorption after oral administration depends on the degree of iron deficiency (the greater the deficiency, the higher the absorption) and on the size of the dose of the drug (the higher the dose, the worse the absorption). Absorbed mainly in the duodenum and small intestine. The unabsorbed part is excreted in the feces.

After intramuscular injection, it enters the bloodstream through the lymphatic system. The time to reach Cmax is 24 hours. In the RES, the complex is split into iron (III) hydroxide and polymaltose (metabolized by oxidation). In the bloodstream, iron binds to transferrin, in tissues it is deposited as part of ferritin, in the bone marrow it is included in hemoglobin and is used in the process of erythropoiesis.

Indications

For oral administration:

• treatment of iron deficiency anemia of various origins and latent iron deficiency in infants and young children;

• increased need for iron (pregnancy, lactation, donation, period of intensive growth, vegetarianism, old age).

For parenteral administration:

• treatment of iron deficiency anemia with ineffectiveness or inability to take oral iron-containing drugs (including in patients with gastrointestinal diseases, with malabsorption syndrome).

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

For oral administration and intramuscular administration.

The dose is set individually, depending on the indications, the patient's age and the clinical situation.

Side effect

Ingestion : dyspepsia (feeling of fullness and pressure in the epigastric region, nausea, constipation or diarrhea), dark color of feces (due to the excretion of non-absorbed iron and has no clinical significance).

With i / m administration : in rare cases - arthralgia, swollen lymph nodes, fever, headache, malaise, dyspepsia (nausea, vomiting); extremely rare - allergic reactions. Local reactions (with the wrong injection technique): skin staining, soreness, inflammation.

Contraindications for use

• Excess iron in the body (hemochromatosis, hemosiderosis);

• anemia not associated with iron deficiency (hemolytic anemia or megaloblastic anemia caused by a lack of cyanocobalamin, aplastic anemia);

• violation of the mechanisms of iron utilization (lead anemia, sideroachrestic anemia, thalassemia, tardive porphyria of the skin);

• hypersensitivity to the active substance.

For intramuscular injection only (optional):

• Randu-Weber-Osler disease;

• chronic polyarthritis;

• acute infectious kidney disease;

• uncontrolled hyperparathyroidism;

• decompensated liver cirrhosis;

• infectious hepatitis;

• children under 4 months of age;

• I trimester of pregnancy.

Application during pregnancy and lactation

No negative effect on the fetus has been established when using oral forms during pregnancy (including in the first trimester).

IM administration is contraindicated in the first trimester of pregnancy.

In small amounts, unchanged iron from the polymaltose complex can be excreted in breast milk, but undesirable effects are unlikely to occur in breastfed babies.

Application in children

It is contraindicated for use in children under 4 months of age.

special instructions

Iron supplementation must be continued after the normalization of hemoglobin.

Does not stain tooth enamel.

Iron preparations for parenteral use can cause allergic and anaphylactic reactions. In the case of moderate allergic reactions, antihistamines should be prescribed; with the development of a severe anaphylactic reaction, immediate administration of adrenaline is necessary. Cardiopulmonary resuscitation facilities should be available. Care should be taken when administering jelly preparations to patients with allergies, as well as hepatic and renal insufficiency. Side effects that occur in patients with cardiovascular diseases can aggravate the course of the underlying disease. Patients with bronchial asthma or those with low serum iron-binding capacity and / or folic acid deficiency are at high risk of developing allergic or anaphylactic reactions.

In children, parenteral iron supplements can adversely affect the course of the infectious process.

Drug interactions

Oral forms : no interactions with other drugs were found.

Solution for injection: ACE inhibitors enhance systemic effects. Should not be used concurrently