Ferrum lek, solution 50 mg/ml 2 ml ampoules 5 pcs.

Composition

1 ampoule with a solution for intramuscular administration contains:

Active ingredient:

iron (III) in the form of a complex of iron (III) hydroxide with dextran 100 mg;

Auxiliary substances:

water for injection.

Pharmacological action

Ferrum Lek is an antianemic drug.

Pharmacodynamics

The preparation contains ferric iron in the form of a complex of ferric hydroxide with dextran. Iron, which is part of the drug, quickly makes up for the lack of this element in the body (in particular, in iron-deficient anemia), restores the content of hemoglobin. When treated with the drug, there is a gradual decrease in both clinical symptoms (weakness, fatigue, dizziness, tachycardia, soreness and dryness of the skin) and laboratory indicators of iron deficiency.

Pharmacokinetics

After intramuscular administration of the drug, iron quickly enters the bloodstream: 15% of the dose — after 15 minutes,44% – after 30 minutes. The biological T_1/2 is 3-4 days. Iron in combination with transferrin is transferred to the cells of the body, where it is used for the synthesis of hemoglobin, myoglobin and some enzymes. The complex of iron (III) hydroxide with dextran is quite large and therefore is not excreted through the kidneys.

Indications

Treatment of all forms of iron deficiency conditions that require rapid replenishment of iron reserves, including the following::

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

Use during pregnancy and lactation

The drug is contraindicated in the first trimester of pregnancy. In the second and third trimesters and during breastfeeding, the drug can only be used if the intended benefit to the mother exceeds the potential harm to the fetus or baby.

Contraindications

• hypersensitivity to the components of the drug;
• excess iron in the body (hemochromatosis, hemosiderosis);
• violation of the mechanisms of iron utilization (lead anemia, sideroachrestic anemia, thalassemia);
• anemia not associated with iron deficiency (for example, hemolytic, megaloblastic, caused by a lack of cyanocobalamin).
• First trimester of pregnancy;
• Osler-Randu-Weber syndrome;
• acute infectious kidney diseases;
• uncontrolled hyperparathyroidism;
• decompensated cirrhosis of the liver;
• infectious hepatitis.

With caution: children’s age (up to 4 months).

Side effects

• Hypotension,
• joint pain,
• enlarged lymph nodes,
• fever,
• headache,
• dizziness,
• malaise,
• dyspepsia (nausea, vomiting);
• extremely rare — allergic or anaphylactic reactions.

Improper injection techniques can lead to skin discoloration, soreness, and inflammation at the injection site.

Interaction

Do not use concomitantly with oral iron-containing medications.

Concomitant administration of ACE inhibitors may increase the systemic effects of parenteral iron preparations.

How to take, course of administration and dosage

Intramuscularly (only).

Before the first therapeutic dose of the drug is administered, each patient should be given a test dose of 1/4-1/2 ampoules of Ferrum Lek (25-50 mg of iron) for an adult and half the daily dose for a child. In the absence of adverse reactions, the remainder of the daily dose can be administered within 15 minutes.

Ferrum Lek doses should be selected individually, in accordance with the total iron deficiency, which is calculated using the following formula::

Total iron deficiency = body weight (kg) × (estimated hemoglobin level (g/l) − real hemoglobin level (g/l) × 0.24) + deposited iron (mg)

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

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% of body weight; factor 1000 = conversion from g to mg).

Example

Patient’s body weight: 70 kg

Actual hemoglobin concentration: 80 g / l

General iron deficiency= (150 − 80) × 0,24 + 500 = 1700 mg of iron

Total amount of Ferrum Lek ampoules to be administered = Total Iron Deficiency (mg) / 100 mg

Calculation of the total number of Ferrum Lek ampoules to be administered based on the actual hemoglobin concentration and body weight

If the required dose of Ferrum Lek exceeds the maximum daily dose, the drug should be administered in fractions (for several days).

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

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 the level of hemoglobin, 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 the final hemoglobin level is known, 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) − real 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 reimbursed 150 mg of iron, which is 1.5 ampoules of Ferrum Lek.

Standard doses

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

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

Maximum daily doses

Children: 0.14 ml / kg / day (7 mg of iron/kg / day).

Adults: 4 ml (2 ampoules) per day.

Overdose

Symptoms from the drug: iron overdose can lead to acute iron overload and hemosiderosis. Treatment: symptomatic therapy. As an antidote, deferoxamine is administered intravenously slowly (15 mg/kg/h), depending on the severity of overdose, but not more than 80 mg/kg/day. Hemodialysis is ineffective.

Special instructions

Use only in a hospital setting.

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

Ferrum Lek is intended for intramuscular administration only.

Be sure to insert deep into the gluteal muscle (needle 5-6 cm long), as well as shifting the tissues when inserting the needle and squeezing the tissues after removing the needle; enter in turn into the right and left gluteal muscles.

The opened ampoule should be used immediately.

The contents of Ferrum Lecne ampoules should be mixed with other medications.

Treatment with oral forms of iron-containing drugs should be started no earlier than 5 days after the last Ferrum Lek injection.

If the drug is stored improperly, precipitation may occur, and the use of such ampoules is unacceptable.

Form of production

Solution for intramuscular administration

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Do not freeze it.

Shelf life

5 years

Active ingredient

Iron III hydroxide dextran

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

Children as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Pregnant women in the second and third trimester as prescribed by a doctor, For adults as prescribed by a doctor

Indications

Anemia, Bleeding, Iron Deficiency Prevention

Weight

Weight: 33 gr.