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Ferrum Lek injection solution 50mg/ml 2ml amp 5 pcs

Ferrum Lek® solution is intended for intramuscular administration only. The drug should be administered only in a hospital setting, by specially trained personnel who can recognize the signs of incipient anaphylactic shock, in conditions of availability of resuscitation facilities and the possibility of carrying out a complex of anti-shock measures. The patient should be observed for at least 30 minutes after each injection. Before administering the first therapeutic dose of the drug, each patient should be given a test dose of 1/4-1/2 ampoule of Ferrum Lek® (25 - 50 mg of iron) for an adult and half the daily dose for a child. If there are no adverse reactions, the remainder of the daily dose should be administered within 15 minutes. The dose of Ferrum Lek® must be selected individually in accordance with the general iron deficiency, which is calculated using the following formula:

Total iron deficiency [mg] = body weight (kg) x (calculated hemoglobin level (g/l) - actual hemoglobin level (g/l)) x 0.24* + deposited iron (mg).

Body weight up to 35 kg: calculated hemoglobin level = 130 g/l and deposited iron = 15 mg/kg body weight.

Body weight over 35 kg: estimated hemoglobin level = 150 g/l and deposited iron = 500 mg. *Factor 0.24 = 0.0034 x 0.07 x 1000: (Iron content = 0.34%; total blood volume = 7% body weight; factor 1000 = conversion from g/L to mg/L).

Example:

Patient body weight: 70 kg

Real hemoglobin concentration: 80 g/l

Total iron deficiency = 70 x (150 - 80) x 0.24 + 500 = 1676 -1700 mg of iron.

Total number of ampoules of Ferrum Lek® that must be administered = Total iron deficiency (mg)/100 mg

If the required dose of Ferrum Lek® exceeds the maximum daily dose, the drug should be administered in fractional doses (over several days).

If 1-2 weeks after the start of treatment the hematological parameters do not change, an additional examination should be carried out to clarify the diagnosis.

Calculation of the total dose for iron replacement due to blood loss

The required amount of the drug to compensate for post-hemorrhagic iron deficiency is calculated using the following formula:

If the amount of blood lost is known: administration of 200 mg intramuscularly (2 ampoules of Ferrum Lek®) leads to an increase in hemoglobin concentration, which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l).

Iron to be replaced (mg) = number of units of blood lost x 200 or Number of ampoules of Ferrum Lek® required = number of units of blood lost x 2. If the final hemoglobin level is known: use the following formula, taking into account that deposited iron does not need to be replaced .

Iron to be replaced (mg) = body weight (kg) x (estimated hemoglobin level (g/L) - actual hemoglobin level (g/L)) x 0.24.

Example:

A patient with a body weight of 60 kg and a hemoglobin deficiency of 10 g/l should be replaced with 150 mg of iron, which is 1 1/2 ampoules of Ferrum Lek®.

Standard doses

Children: 0.06 ml/kg body weight/day (3 mg iron/kg/day).

Adults: 1 - 2 ampoules of Ferrum Lek® (100 - 200 mg iron), depending on the hemoglobin content.

Maximum daily doses

Children: 0.14 ml/kg body weight per day (7 mg iron/kg/day).

Adults: 4 ml (2 ampoules of Ferrum Lek®) per day.

Contraindications to the use of the drug Ferrum lek

Hypersensitivity to the drug , anemia not caused by iron deficiency, including hemolytic; hypersensitivity to any of the components of the drug; excess iron in the body (hemochromatosis, hemosiderosis); disorders of hemoglobin synthesis (anemia caused by lead poisoning, sideroblastic anemia), thalassemia; severe hemostasis disorders (hemophilia); oral administration is not advisable when there is a decrease in the concentration of iron in the blood serum and anemia caused by a chronic inflammatory process or neoplasm.

Interactions of the drug Ferrum lek

Do not mix the solution for intramuscular administration with other medications; Like other iron preparations for parenteral use, Ferrum Lek is not prescribed simultaneously with iron preparations for oral administration. The interval between parenteral use of the drug and the start of use of oral dosage forms of iron should be at least 5 days. Since iron is included in the drug in the form of a complex of iron (III) hydroxide with polymaltose, when taken in the form of chewable tablets or syrup, it does not form insoluble chelate compounds with components of food products (phytin, oxalates, tannin) or medicines (tetracyclines, antacids ).

Ferrum Lek®

Ferrum Lek® solution is intended for intramuscular administration only.

The drug should be administered only in a hospital setting, by specially trained personnel who can recognize the signs of incipient anaphylactic shock, in conditions of availability of resuscitation facilities and the possibility of carrying out a complex of anti-shock measures.

The patient should be observed for at least 30 minutes after each injection.

Before administering the first therapeutic dose of the drug, each patient should be given a test dose of 1/4-1/2 ampoule of Ferrum Lek® (25 - 50 mg of iron) for an adult and half the daily dose for a child. If there are no adverse reactions, the remainder of the daily dose should be administered within 15 minutes.

The dose of Ferrum Lek® must be selected individually in accordance with the general iron deficiency, which is calculated using the following formula:

Total iron deficiency (mg) = body weight (kg) x (calculated hemoglobin level (g/l) - actual hemoglobin level (g/l) x 0.24* + deposited iron (mg).

Body weight up to 35 kg: calculated hemoglobin level = 130 g/l and deposited iron = 15 mg/kg body weight.

Body weight over 35 kg: estimated hemoglobin level = 150 g/l and deposited iron = 500 mg.

*Factor 0.24 = 0.0034 x 0.07 x 1000: (Iron content = 0.34%; total blood volume = 7% body weight; factor 1000 = conversion from g/L to mg/L).

Example: Patient's body weight: 70 kg. Real hemoglobin concentration: 80 g/l. Total iron deficiency = 70 x (150 - 80) x 0.24 + 500 = 1676 ̴1700 mg of iron.

The total number of Ferrum Lek® ampoules that must be administered = Total iron deficiency (mg)/100 mg.

Table: Calculation of the total number of Ferrum Lek® ampoules that need to be administered, based on the actual hemoglobin concentration and body weight.

Body weight (kg)	Total number of Ferrum Lek® ampoules for administration
Body weight (kg)	Hb 60 g/l	Hb 75 g/l	Hb 90 g/l	Hb 105 g/l
5	1.5	1.5	1.5	1.0
10	3.0	3.0	2.5	2.0
15	5.0	4.5	3.5	3.0
20	6.5	5.5	5.0	4.0
25	8.0	7.0	6.0	5.5
30	9.5	8.5	7.5	6.5
35	12.5	11.5	10.0	9.0
40	13.5	12.0	11.0	9.5
45	15.0	13.0	11.5	10.0
50	16.0	14.0	12.0	10.5
55	17.0	15.0	13.0	11.0
60	18.0	16.0	13.5	11.5
65	19.0	16.5	14.5	12.0
70	20.0	17.5	15.0	12.5
75	21.0	18.5	16.0	13.0
80	22.5	19.5	16.5	13.5
85	23.5	20.5	17.0	14.0
90	24.5	21.5	18.0	14.5

If the required dose of Ferrum Lek® exceeds the maximum daily dose, the drug should be administered in fractional doses (over several days).

If 1-2 weeks after the start of treatment the hematological parameters do not change, an additional examination should be carried out to clarify the diagnosis.

Calculation of the total dose for iron replacement due to blood loss

The required amount of the drug to compensate for post-hemorrhagic iron deficiency is calculated using the following formula:

If the amount of blood lost is known

: administration of 200 mg intramuscularly (2 ampoules of Ferrum Lek®) leads to an increase in hemoglobin concentration, which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l).

Iron to be replaced (mg) = number of lost units of blood x 200 or Required number of ampoules of Ferrum Lek® = number of lost units of blood x 2.

If the final hemoglobin level is known

: Use the following formula, taking into account that deposited iron does not need to be reimbursed.

Iron to be replaced (mg) = body weight (kg) x (estimated hemoglobin level (g/L) - actual hemoglobin level (g/L) x 0.24.

Example: A patient with a body weight of 60 kg and a hemoglobin deficiency of 10 g/l should be replaced with 150 mg of iron, which is 1 1/2 ampoules of Ferrum Lek®.

Standard doses

For children

: 0.06 ml/kg body weight/day (3 mg iron/kg/day).

For adults:

1 - 2 ampoules of Ferrum Lek® (100 - 200 mg iron), depending on the hemoglobin content.

Maximum daily doses

For children:

0.14 ml/kg body weight per day (7 mg iron/kg/day).

Adults: 4

ml (2 ampoules of Ferrum Lek®) per day.

Indications for use of the drug Ferrum lek

Orally prescribed for the prevention and treatment of iron deficiency conditions of various etiologies, including the prevention of iron deficiency in children, women of childbearing age (especially during pregnancy and breastfeeding), adults (especially vegetarians) and the elderly; treatment of iron deficiency anemia. Ferrum Lek for parenteral administration is indicated for the treatment of iron deficiency conditions that require rapid and reliable compensation of iron deficiency: severe posthemorrhagic anemia, impaired iron absorption, as well as when treatment of iron deficiency anemia with oral iron preparations is ineffective. Ferrum Lek is used in patients with clear indications for the drug, with mandatory determination of the level of ferritin in the blood plasma and the number of red blood cells in the peripheral blood. If iron malabsorption is suspected, an iron absorption test should be performed.

Pharmacological properties of the drug Ferrum lek

Iron supplement. Contains iron Fe3+ in the form of a complex compound of iron (III) hydroxide with polymaltose (HPA). The iron in the polynuclear "core" is associated with a structure similar to serum ferritin. This macromolecular complex is stable and under physiological conditions does not release iron in the form of free ions. Therefore, when taken orally, iron, which is part of the GPC, enters the blood from the intestine only through active absorption. There is a correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). It is this property of the drug that explains the impossibility of poisoning with the drug even in the case of an overdose, unlike simple iron salts, the absorption of which occurs along a concentration gradient. Maximum absorption of iron after oral administration occurs in the duodenum and jejunum, and its absorption is not reduced by interaction with certain food components or with drugs containing a phenolic group (for example, tetracycline). Iron administered in the form of HPA is slowly absorbed and enters the blood serum, from where it quickly passes into iron-depositing tissues. Absorbed iron is stored bound to ferritin, mainly in the liver. Later in the bone marrow it is included in hemoglobin. In hemoglobin, iron is in divalent form, but it is Fe3+ (trivalent iron) that stimulates the formation of globin, which ultimately helps to increase hemoglobin levels. Since iron in the dosage form for oral administration is contained in non-ionized form, the drug does not have such side effects as irritation of the mucous membrane of the digestive tract, staining of tooth enamel, and the appearance of a metallic taste in the mouth. Chewable tablets and syrup are characterized by a high degree of safety and are well tolerated by patients. Comparative studies of the bioavailability of Ferrum Lek oral dosage forms using the radioisotope method, as well as comparative clinical trials, have proven that the absorption and bioavailability of iron in the form of iron (III) hydroxide complex with polyisomaltose is equivalent to the absorption and bioavailability of iron (II) salts.

Special instructions for the use of the drug Ferrum Lek

1 tablet contains 0.04 XE, 1 ml of syrup - 0.04 XE. Each Ferrum Lek tablet contains 1.5 mg of aspartame (a precursor to phenylalanine), and may therefore have an adverse effect on patients with phenylketonuria. In controlled trials, the use of the drug in the second and third trimester of pregnancy did not have a negative effect on the fetus. Iron is released into breast milk in the form of a complex with lactoferrin, only a small amount of iron from the complex of iron (III) hydroxide with polymaltose passes into breast milk in ionized form, so the occurrence of side effects in an infant when the mother takes Ferrum Lek is unlikely. Parenteral administration of iron preparations can cause the development of allergic reactions. For an allergic reaction of moderate severity, the administration of antihistamines is recommended. If an anaphylactic reaction develops, immediate administration of epinephrine is indicated. The risk of developing anaphylaxis is quite high in patients with asthma, Crohn's disease, polyarthritis, reduced iron binding capacity and/or folic acid deficiency.

Ferrum lek overdose, symptoms and treatment

With parenteral administration, hemosiderosis may develop. Incorrect diagnosis of anemia as iron deficiency can lead to iron overdose. In case of an overdose of tablets or syrup, symptoms of acute poisoning can develop in extremely rare cases, since iron from HPA is absorbed not through passive diffusion, but through active transport, and the degree of absorption of iron from HPA directly depends on the severity of iron deficiency. Treatment is symptomatic; a specific iron antidote is the chelating agent deferoxamine.

Side effects of Ferrum Lek

Usually well tolerated, side effects are mostly transient and mild. Gastrointestinal disorders such as a feeling of heaviness and fullness in the stomach, distension in the epigastric region, nausea, constipation or diarrhea are very rarely observed. Dark coloration of stool caused by iron supplementation is not clinically significant. With intramuscular administration, arterial hypotension, arthralgia, swollen lymph nodes, fever, headache, dizziness, and infiltrate at the injection site rarely occur; very rarely - anaphylactic and anaphylactoid reactions.