Instructions for use FERRUM LEK®

Ferrum lek

It is recommended to take the drug during or immediately after meals. Chewable tablets can be chewed or swallowed whole. The daily dose can be divided into several doses or taken at once.

Doses and duration of treatment depend on the degree of iron deficiency.

The syrup can be mixed with fruit or vegetable juices or added to baby food. The measuring spoon included in the package is used for precise dosing of syrup.

For iron deficiency anemia, the duration of treatment is about 3-5 months. After normalization of hemoglobin levels, you should continue taking the drug for several more weeks to replenish iron reserves in the body.

Children under 1 year of age are prescribed 2.5-5 ml (1/2-1 scoop) of syrup/day.

Children aged 1 to 12 years - 5-10 ml (1-2 scoops) of syrup/day.

Children over 12 years old, adults and mothers breastfeeding - 1-3 tablets. chewing or 10-30 ml (2-6 scoops) syrup/day.

Pregnant women are prescribed 2-3 tablets. chewing or 20-30 ml (4-6 scoops) of syrup until hemoglobin levels normalize. After this, you should continue to take 1 tablet. chewable or 10 ml (2 scoops) syrup/day, at least until the end of pregnancy to replenish iron reserves in the body.

For latent iron deficiency, the duration of treatment is about 1-2 months.

Children aged 1 to 12 years - 2.5-5 ml (1/2-1 scoop) of syrup/day.

Children over 12 years old, adults and mothers breastfeeding - 1 tablet. chewing or 5-10 ml (1-2 scoops) syrup/day.

Pregnant women are prescribed 1 tablet. chewable or 5-10 ml (1-2 scoops) syrup/day.

Daily doses of Ferrum Lek® for the prevention and treatment of iron deficiency in the body.

* - due to the fact that this group of patients requires low doses of iron, it is not recommended in these cases to prescribe the drug in the form of tablets or syrup.

Overdose

In cases of overdose of Ferrum Lek® for oral administration, no signs of intoxication or signs of excessive intake of iron into the body have been described to date, since iron from the active substance is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.

Instructions for use FERRUM LEK®

Chewable tablets

It is recommended to take the drug during or immediately after meals. The tablet can be chewed or swallowed whole. The daily dose can be taken at one time or divided into several doses.

The dose of the drug and duration of treatment depend on the degree of iron deficiency.

Iron-deficiency anemia

Treatment continues for 3-5 months until hemoglobin levels normalize. After this, the drug is prescribed for several more weeks to replenish iron reserves in the body.

Adults, nursing mothers, children and adolescents over 12 years of age

Prescribe, as a rule, 1-3 chewable tablets per day.

Pregnant women

Prescribe 2-3 chewable tablets per day until hemoglobin levels normalize. After this, 1 chewable tablet per day is prescribed, at least until the end of pregnancy, to replenish iron reserves in the body.

Children 0-12 years old

Ferrum Lek® is prescribed in syrup form.

Latent iron deficiency

Treatment continues for 1-2 months.

Adults, nursing mothers, children and adolescents over 12 years of age are prescribed

1 chewable tablet per day.

Children aged 1 to 12 years

Ferrum Lek® is prescribed in syrup form.

Due to the fact that children under 1 year of age

Iron supplements are prescribed in very low doses; Ferrum Lek® in the form of chewable tablets is not intended for this category of patients.

Latent iron deficiency and prevention of iron deficiency

Pregnant women

Prescribe 1 chewable tablet per day.

Table. Daily doses of Ferrum Lek® chewable tablets

* - for this indication, the drug is prescribed in very low doses, so chewable tablets are not used.

Solution for intramuscular administration

Ferrum Lek® can only be administered intramuscularly. The drug cannot be used for intravenous administration.

Before administering the first therapeutic dose of Ferrum Lek®, each patient should be given a test dose

, amounting to 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 can be administered within 15 minutes.

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

General iron deficiency = body weight (kg) × (calculated hemoglobin level (g/l) - actual hemoglobin level (g/l) × 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 = 0.0034×0.07×1000

(Iron content = 0.34%; total blood volume = 7% body weight; factor 1000 = conversion from g to mg).

Example:

Patient body weight: 70 kg

Real hemoglobin concentration: 80 g/l

Total iron deficiency = (150 – 80)×0.24 + 500 = 1700 mg iron

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 must be administered, based on the actual hemoglobin concentration and body weight

Body weight (kg)	Total number of Ferrum Lek® ampoules to be administered
Нb 60 g/l	Нb75 g/l	Нb 90 g/l	Нb 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 total number of Ferrum Lek® ampoules to be administered exceeds the maximum daily dose, they should be divided into several days.

If, 1-2 weeks after the start of Ferrum Lek® administration, the hematological parameters do not change, the diagnosis should be clarified.

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

Required number of Ferrum Lek® ampoules to compensate for post-hemorrhagic iron deficiency

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calculated using the following formula:

If the amount of blood lost is known: administration of 200 mg IM (2 ampoules of Ferrum Lek®) leads to an increase in hemoglobin level, 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 blood units lost×200 or required number of Ferrum Lek® ampoules = number of blood units lost×2

If a reduced hemoglobin level is known, then the following formula should be used, taking into account that the deposited iron does not need to be replaced:

iron to be replaced (mg) = body weight (kg)× (estimated hemoglobin level (g/L) - actual hemoglobin level (g/L)×0.24

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®.

Ferrum Lek® injection solution is prescribed in the following doses.

Children:

0.06 ml Ferrum Lek®/kg body weight/day (3 mg iron/kg/day).

Adults and elderly patients:

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

Maximum daily doses of Ferrum Lek®:

• children -
  0.14 ml Ferrum Lek/kg/day (7 mg iron/kg/day);
• adults -
  4 ml (2 ampoules) Ferrum Lek®.

Rules for administration and handling of the drug

If the ampoules are stored incorrectly, sediment may form. The use of such ampoules is unacceptable. If sediment appears in the ampoules or the shelf life has expired, they must be destroyed.

An opened ampoule should be used immediately.

It is important to administer IM injections carefully and appropriately to avoid pain and discoloration of the skin. IM injections of Ferrum Lek® are made into the upper outer quadrant of the gluteal muscle. The minimum needle length for adults is 50 mm, for overweight patients - from 80 to 100 mm, for children - 32 mm. Before injection, the skin should be disinfected and the subcutaneous tissue should be moved down 2 cm to reduce leakage of the drug after injection. After injection, the subcutaneous tissue is released and the injection site is held under pressure for 1 minute.

The contents of Ferrum Lek® ampoules should not be mixed with other drugs.

Ferrum lek 100 mg 50 pcs. chewable tablets

pharmachologic effect

Replenishes iron deficiency, antianemic.

Composition and release form Ferrum lek 100 mg 50 pcs. chewable tablets

Chewable tablets - 1 tablet:

• active substance: iron (III) hydroxide polymaltosate - 400 mg (in terms of iron - 100 mg);
• excipients: macrogol 6000; aspartame; chocolate flavoring; talc; dextrates.

Chewable tablets, 100 mg. 10 tablets each in a strip or blister; 3, 5 or 9 strips in a cardboard pack.

Description of the dosage form

Round flat tablets, dark brown interspersed with light brown, with a bevel.

Directions for use and doses

Inside, during or immediately after meals.

Ferrum Lek® chewable tablets can be chewed or swallowed whole.

The daily dose can be divided into several doses or taken at one time.

Pharmacodynamics

The molecular mass of the complex is so large - about 50 kDa - that its diffusion through the gastrointestinal mucosa is 40 times slower than the diffusion of ferrous iron. The complex is stable and does not release iron ions under physiological conditions. The iron of the multinuclear active zones of the complex is bound into a structure similar to the structure of the natural iron compound - ferritin. Due to this similarity, the iron of this complex is absorbed only through active absorption. Iron-binding proteins located on the surface of the intestinal epithelium absorb iron (III) from the complex through competitive ligand exchange. Absorbed iron is mainly deposited in the liver, where it binds to ferritin. Later in the bone marrow it is incorporated into hemoglobin.

Iron (III) complex polymaltose hydroxide does not have the pro-oxidant properties inherent in iron (II) salts.

Pharmacokinetics

Studies using the dual isotope method (55Fe and 59Fe) have shown that iron absorption, as measured by red blood cell hemoglobin levels, is inversely proportional to the dose administered (the higher the dose, the lower the absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). Iron is absorbed to the greatest extent in the duodenum and jejunum.

The remaining (unabsorbed) iron is excreted in the feces. Its excretion with exfoliating epithelial cells of the gastrointestinal tract and skin, as well as with sweat, bile and urine is approximately 1 mg of iron per day. Women experience additional iron loss during menstruation, which must be taken into account.

Indications for use Ferrum lek 100 mg 50 pcs. chewable tablets

• treatment of latent iron deficiency;
• treatment of iron deficiency anemia;
• prevention of iron deficiency during pregnancy.

Contraindications

• hypersensitivity to the components of the drug;
• excess iron in the body (hemochromatosis, hemosiderosis);
• violation of iron utilization mechanisms (lead anemia, sideroachrestic anemia, thalassemia);
• anemia not associated with iron deficiency (for example, hemolytic, megaloblastic, caused by a lack of cyanocobalamin).
• children's age up to 12 years.

With caution: bronchial asthma; chronic polyarthritis; cardiovascular failure; low ability to bind iron and/or folic acid deficiency.

Application Ferrum lek 100 mg 50 pcs. Chewable tablets during pregnancy and breastfeeding

During controlled studies in pregnant women (II, III trimesters of pregnancy), no negative effects on the body of the mother and fetus were noted. No harmful effects on the fetus were detected when taking the drugs in the first trimester of pregnancy.

special instructions

For children under 12 years of age, due to the need to prescribe low doses of the drug, it is preferable to prescribe Ferrum Lek® in syrup form.

Neither chewable tablets nor Ferrum Lek® syrup cause staining of tooth enamel.

In cases of anemia caused by an infectious or malignant disease, iron accumulates in the reticuloendothelial system, from which it is mobilized and utilized only after the underlying disease has been cured.

When using the drug Ferrum Lek®, the stool may turn dark, which does not have any clinical significance. Taking iron supplements does not affect the results of the test for hidden bleeding (selective for hemoglobin).

Notice for diabetics: 1 chewable tablet or 1 ml of Ferrum Lek® syrup contains 0.04 XE.

Notice to patients with phenylketonuria: Ferrum Lek® contains aspartame (E951), a source of phenylalanine, in an amount equivalent to 1.5 mg per tablet.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. The drug does not affect the ability to concentrate.

Overdose

Symptoms: in case of an overdose of Ferrum Lek® syrup or chewable tablets, there were no signs of intoxication or excess iron in the body, because iron from the active substance is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.

Treatment: symptomatic; As an antidote, deferoxamine is administered intravenously slowly (15 mg/kg/hour), depending on the severity of the overdose, but not more than 80 mg/kg/day. Hemodialysis is ineffective.

Side effects Ferrum lek 100 mg 50 pcs. chewable tablets

The side effects reported were mostly mild and transient.

According to WHO, adverse reactions are classified according to their frequency as follows: very often (≥1/10), often (≥1/100,

From the gastrointestinal tract: very rarely - pain in the abdomen, nausea, constipation, diarrhea, dyspepsia, vomiting, change in the color of feces (due to the excretion of unabsorbed iron, has no clinical significance).

From the skin and subcutaneous tissue: very rarely - urticaria, rash, itching of the skin.

Drug interactions

No interactions with other drugs or food products have been identified.

Concomitant use of polymaltosate hydroxide with parenteral iron preparations and other oral iron (III) preparations is not recommended due to the pronounced inhibition of the absorption of orally administered iron.

Ferrum Lek for intramuscular administration

Release form, composition and packaging

The solution for intramuscular administration is brown, opaque, with virtually no visible particles.

1 ml. iron [III] hydroxide polyisomaltose 50 mg.

1 amp. iron [III] hydroxide polyisomaltose 100 mg.

Excipients: sodium hydroxide, hydrochloric acid (concentrated), water for injection.

Clinical and pharmacological group: Antianemic drug.

pharmachologic effect

Antianemic drug.

In the preparation, iron is in the form of a complex compound of iron (III) hydroxide with polyisomaltose. This macromolecular complex is stable and does not release iron in the form of free ions. The complex is similar in structure to the natural iron compound ferritin.

Iron (III) hydroxide polyisomaltose complex does not have the pro-oxidant properties that are inherent in iron (II) salts. Iron, which is part of the drug, quickly compensates for the lack of this element in the body (including in iron deficiency anemia), restores the level of hemoglobin (Hb).

When using the drug, there is a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, dry skin) and laboratory symptoms of iron deficiency.

Pharmacokinetics

Suction

After intramuscular administration of the drug, iron quickly enters the bloodstream: 15% of the dose - after 15 minutes, 44% of the dose - after 30 minutes.

Iron, in combination with transferrin, is transported to the cells of the body, where it is used for the synthesis of hemoglobin, myoglobin and some enzymes.

Removal

T1/2 - 3-4 The complex of iron (III) hydroxide with polyisomaltose is large enough and therefore is not excreted through the kidneys; the compound is stable and does not release iron ions under physiological conditions.

Indications

Treatment of all iron deficiency conditions requiring rapid replenishment:

• severe iron deficiency due to blood loss;
• impaired absorption of iron in the intestines;
• conditions for which treatment with oral iron preparations is ineffective or impracticable.

Dosage regimen

The drug in solution form can only be administered intramuscularly. IV administration of the drug is not allowed!

Before administering the first therapeutic dose, the patient should be given a test dose of 1/4-1/2 ampoule (25-50 mg of iron) for adults and 1/2 the daily dose for children. If there are no adverse reactions within 15 minutes after administration, the remainder of the initial daily dose is administered.

Doses of the drug Ferrum Lek are selected individually in accordance with the general iron deficiency, calculated using the following formula:

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

For body weight up to 35 kg: calculated Hb level = 130 g/l, deposited iron = 15 mg/kg body weight.

With a body weight of more than 35 kg: calculated Hb level = 150 g/l, deposited iron = 500 mg.

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

With a known amount of lost blood, intramuscular administration of 200 mg of iron (2 ampoules) leads to an increase in hemoglobin equivalent to 1 blood unit (400 ml with a hemoglobin content of 150 g/l).

Amount of iron to be replaced (mg) = number of blood units lost x 200 or number of ampoules required = number of blood units lost x 2

When the hemoglobin level is known, the above formula is used, taking into account the fact that the deposited iron does not need to be replenished.

Amount of iron to be replaced (mg) = body weight (kg) x (estimated Hb level (g/l) - detected Hb level (g/l)) x 0.24

Usual doses of Ferrum Lek

Adults and elderly patients are prescribed 100-200 mg (1-2 ampoules) depending on the hemoglobin level; children - 3 mg/kg/(0.06 ml/kg body weight/day).

The maximum daily dose for adults is 200 mg (2 ampoules); for children - 7 mg/kg/(0.14 ml/kg body weight/day).

Rules for administering the drug

The drug is administered every other day deep intramuscularly alternately into the right and left buttocks.

In order to reduce fighting sensations and avoid skin staining, the following rules should be followed:

• the drug should be injected into the upper outer quadrant of the buttock using a needle 5-6 cm long;
• before injection, after disinfection of the skin, the subcutaneous tissues should be moved down 2 cm to prevent subsequent leakage of the drug;
• after administration of the drug, the subcutaneous tissues should be released, and the injection site should be pressed and held in this position for 1 minute.

Before using the solution for intramuscular injection, ampoules should be carefully inspected. Only ampoules containing a homogeneous solution without sediment should be used. The solution for intramuscular injection should be used immediately after opening the ampoule.

Side effect

From the digestive system: nausea, vomiting.

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

Local reactions: if the drug is administered incorrectly, it is possible to stain the skin, develop pain and an inflammatory reaction at the injection site.

Other: arterial hypotension, arthralgia, enlarged lymph nodes, increased temperature; extremely rarely - allergic or anaphylactic reactions.

Contraindications

• excess iron content in the body (hemosiderosis, hemochromatosis);
• violations of the mechanisms of inclusion of iron in hemoglobin (anemia caused by lead poisoning, sideroachrestic anemia, thalassemia);
• anemia not associated with iron deficiency;
• Osler-Rendu-Weber syndrome;
• infectious kidney diseases in the acute stage;
• uncontrolled hyperparathyroidism;
• decompensated cirrhosis of the liver;
• infectious hepatitis;
• I trimester of pregnancy;
• hypersensitivity to the components of the drug.

The drug should be used with caution in case of bronchial asthma, chronic polyarthritis, cardiovascular failure, low ability to bind iron and/or folic acid deficiency, in pediatric patients under 4 months.

Pregnancy and lactation

Parenteral administration of the drug is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy and during breastfeeding, the drug is prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Use for liver dysfunction

The use of the drug is contraindicated in cases of decompensated liver cirrhosis and infectious hepatitis.

Use for renal impairment

The use of the drug is contraindicated for infectious kidney diseases in the acute stage.

special instructions

The drug should be used only in a hospital setting.

When prescribing Ferrum Lek, laboratory tests are required: a general clinical blood test and determination of serum ferritin levels; it is necessary to exclude impaired iron absorption.

Treatment with oral forms of iron-containing drugs should begin no earlier than 5 days after the last injection of Ferrum Lek. Ferrum Lek is intended for intramuscular administration only. It is necessary to insert deeply into the gluteal muscle (a needle 5-6 cm long), as well as shifting the tissue when inserting the needle and squeezing the tissue after removing the needle; injected in turn into the right and left gluteal muscles.

The opened ampoule should be used immediately.

The contents of the ampoules should not be mixed with other drugs.

The use of ampoules in which sediment has formed as a result of improper storage of the drug is unacceptable.

Overdose

Symptoms: An overdose of iron supplements can lead to acute iron overload and hemosiderosis.

Treatment: symptomatic therapy. As an antidote, deferoxamine is administered intravenously slowly (15 mg/kg/hour), depending on the severity of the overdose, but not more than 80 mg/kg. Hemodialysis is ineffective.