Fersinoli IM 2ml 5 ampoules

Form

khsnari

Dosage mg

100მგ/2

Pack

5

Fersinol IM 2ml 5 ampoules Dosage form: Solution for injection. Description: Brown solution. Composition 1 ampoule of the preparation contains: Active substance: 100 mg of iron in the form of iron (III) hydroxide polymaltose complex. Excipients: Sodium hydroxide or hydrochloric acid, water for injection. ATC code of the preparation: B03AC See blog: Fersinol - a preparation for the treatment and prevention of iron deficiency anemia Pharmacotherapeutic group Stimulators of hemopoiesis. Iron (trivalent) preparations for parenteral use. Pharmacological properties Pharmacodynamics Antianemic preparation. Iron transport in plasma is carried out by the γ-globulin transferrin, which is synthesized in the liver. Trivalent iron participates in heme formation, leading to an increase in hemoglobin levels. During the administration of the preparation, a gradual regression of clinical (weakness, increased fatigue, tachycardia, dryness of the skin) and laboratory symptoms of iron deficiency occurs. The iron in the preparation is part of hemoglobin, stimulates erythropoiesis in iron deficiency. The iron in the preparation is in the form of a complex hydroxide polymaltose complex. This complex consists of a central lattice formed by trivalent iron cores, surrounded by a large number of polymaltose molecules. This complex does not have pro-oxidant properties, which leads to a reduction in the oxidation of low-density lipoproteins and very low-density lipoproteins. Pharmacokinetics After intramuscular administration, it enters the bloodstream through the lymphatic system. Cmax is reached after 24 hours. In the reticuloendothelial system, the complex is divided into iron hydroxide and polymaltose (metabolized by oxidation). In the bloodstream, iron binds to transferrin, is deposited in tissues in the form of ferritin, is incorporated into hemoglobin in the bone marrow, and is used in the process of erythropoiesis. Less than 1% of the total dose of the preparation is excreted by the kidneys. Indications for use Fersinol is used in iron deficiency conditions, such as: _ Severe posthemorrhagic anemia; _ Iron deficiency anemia of various origins in adults and children when oral iron preparations are ineffective or cannot be taken (including in patients with gastrointestinal diseases and malabsorption syndrome). Fersinol is administered only in iron deficiency conditions confirmed by appropriate laboratory studies. Contraindications: - Hypersensitivity; - Anemias not associated with iron deficiency (hemolytic, megaloblastic, caused by vitamin B12 deficiency, erythropoiesis disorders, bone marrow hypoplasia); _ Iron overload in the body (hemochromatosis, hemosiderosis); _ Impaired iron utilization (sideroachrestic anemia, thalassemia, lead anemia, late cutaneous porphyria); _ Rendu-Osler-Weber syndrome; _ Chronic polyarthritis; _ Bronchial asthma; _ Infectious diseases of the kidneys in the acute stage; _ Uncontrolled hyperparathyroidism; _ Decompensated liver cirrhosis; _ Children under 4 months of age; _ Pregnancy (I trimester); _ Infectious hepatitis (as the preparation accumulates in the reticuloendothelial system). With caution: Liver and/or kidney failure, cardiovascular and allergic diseases. Side effects In rare cases, arthralgia, enlarged lymph nodes, fever, headache, malaise, dyspepsia (nausea, vomiting), very rarely - allergic reactions. Local reactions (if administered incorrectly): skin discoloration, pain, inflammation. Method of administration and dosage Administered deeply intramuscularly. Injection technique is crucial. Incorrect administration of the preparation can lead to pain and skin discoloration at the injection site. The ventrogluteal injection method described below is recommended instead of the generally accepted method (in the upper outer quadrant of the gluteal muscle): _ The needle length should be at least 5-6 cm. The lumen of the needle should not be too wide. For children, as well as for adults with low body weight, needles should be shorter and thinner. _ The injection zone is determined as follows: on the line of the vertebral column, corresponding to the hip joint, point A is fixed. If the patient is lying on their right side, the middle finger of the left hand is fixed at point A. The index finger is spread from the middle finger so that it lies below the iliac crest line at point B. The triangle formed by the proximal phalanges, the middle and index fingers, is the injection site. _ Before puncturing the needle, the skin is retracted by about 2 cm to ensure that the injection site is well closed after needle removal. This prevents the injected solution from entering the subcutaneous tissue and causing skin discoloration. _ The needle is placed vertically to the skin surface, at a larger angle to the hip joint point than to the thigh joint point. _ After injection, the needle should be slowly withdrawn, and pressure on the skin at the injection site should be maintained for about 5 minutes. _ The patient should move after the injection. Daily dose for adults - 1 ampoule (100 mg). Lower doses are recommended for children according to age and weight. The duration of iron therapy during parenteral administration is determined by the attending physician, taking into account the hemoglobin level. Maximum daily dose: Children weighing up to 5 kg 0.5 ml (1/4 ampoule, 25 mg elemental iron) Children weighing 5-10 kg 1.0 ml (1/2 ampoule, 50 mg elemental iron) Adults 4.0 ml (2 ampoules, 200 mg elemental iron) Overdose No data on overdose. Overdose can cause acute iron overload, which manifests with symptoms of hemosiderosis. Chronic iron overload leads to the development of hemochromatosis. This can occur if iron deficiency anemia is misdiagnosed in cases of treatment-resistant anemia. Hemochromatosis should be treated similarly to thalassemia (intravenous administration of deferoxamine). With the administration of very high doses of Fersinol, the complex cannot be removed from the body with hemodialysis due to its high molecular weight. In case of overdose, treatment is symptomatic; the specific antidote for iron is deferoxamine, a chelating agent. Periodic monitoring of serum ferritin levels is recommended to detect progressive iron accumulation in a timely manner. Interaction with other medicinal products Angiotensin-converting enzyme inhibitors enhance systemic effects. Concomitant administration with oral iron-containing preparations is not recommended (iron absorption from the gastrointestinal tract is reduced), therefore, treatment with oral iron-containing preparations should be started 1 week after the last injection. Special instructions and warnings Parenteral iron preparations can cause allergic and anaphylactic reactions. Before use, it is advisable to perform a sensitivity test (test dose: 0.5 ml intramuscularly). In case of an allergic reaction, epinephrine and glucocorticoids may be used. It is prescribed with particular caution in patients prone to allergic reactions. Only intact ampoules can be used. If sediment appears, the solution is unsuitable for use. After opening the ampoule, the solution should be administered immediately. In anemia arising against the background of malignant tumors or infectious diseases, iron is deposited in the reticuloendothelial system, from where it can be mobilized and consumed only after the underlying disease is cured. Effect on the ability to drive and operate other mechanisms The use of this preparation does not affect the ability to drive and operate other mechanisms. Use during pregnancy and lactation Contraindicated in the I trimester of pregnancy; use is possible in the II and III trimesters. Pregnancy, Category C: Experimental reproduction studies, as well as controlled studies in pregnant women, have not been conducted. The preparation can be used only when the therapeutic effect outweighs the potential risk to the fetus. A small amount of unchanged iron from the polymaltose complex may penetrate into breast milk, but it is unlikely that adverse effects will develop in breastfed infants. Dosage form 2 ml solution for injection in ampoules. 5 ampoules are placed in a contour cell package in a cardboard box with an insert leaflet. Storage conditions Store at a temperature not exceeding 25ºС in a place inaccessible to children. Shelf life 4 years from the date of manufacture. Do not use after the expiry date. Dispensing conditions from pharmacies Group II, Form #3 by prescription.