Ferrum Lek 50 mg/ml 2 ml ampoule 50 pcs

Ferrum Lek – antianemic drug

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Pharmacodynamic

Tablets. Syrup. The molecular weight of the complex is so high – about 50 kDa – that its diffusion through the gastrointestinal mucosa to 40 times slower than the diffusion of the divalent iron. The complex is stable under physiological conditions and does not release iron ions. Polynuclear iron cores of complex bound in a structure similar to a natural compound of iron – ferritin. Because of this similarity, this iron complex is absorbed only by the active suction. Iron binding proteins located on the surface of the intestinal epithelium, absorb iron (III) from the complex by a competitive ligand exchange. Absorbed iron is deposited mainly in the liver, where it binds to the ferritin. Later in the bone marrow, it is included in the hemoglobin.

The complex iron (III) hydroxide polymaltose has no prooxidant properties inherent iron salts (II).

The solution for intramuscular injection. The preparation contains iron as ferric iron complex of ferric hydroxide with a dextran. Iron, which is part of the drug quickly compensates for the deficiency of this element in the body (especially in iron deficiency anemia), restores hemoglobin. In drug treatment, there is a gradual reduction in both clinical symptoms (weakness, fatigue, dizziness, tachycardia, pain and dryness of the skin) and laboratory parameters of iron deficiency.

pharmacokinetics

Tablets. Syrup. Studies using the method of double isotope ( ⁵⁵ Fe and ⁵⁹ Fe) have shown that iron absorption, as measured by the level of hemoglobin in red blood cells is inversely proportional to the dose (the higher the dose, the lower absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of absorbed iron (higher iron deficiency, the better absorption). In most iron is absorbed in the duodenum and jejunum.

The remaining (unabsorbed) iron excreted in the faeces. Its excretion exfoliating GIT epithelial cells and skin, as well as sweat, bile and urine of approximately 1 mg of iron per day. In women during menstruation there is an additional loss of iron that must be taken into account.

The solution for intramuscular injection. After intramuscular injection of iron quickly enters the bloodstream 15% of the dose – 15 min, 44% – 30 minutes. Biology T _1/2 is 3-4 days. Iron in complex with transferrin transferred to the cells of the body, where it is used for the synthesis of hemoglobin, myoglobin and certain enzymes. iron hydroxide (III) complexes with dextran is big enough and therefore not eliminated via the kidneys.

Active substance:
Ferric III hydroxide polymaltosate

Manufacturer

Sandoz, Switzerland

Prescribing

Pregnant II and III trimester prescribed by a doctor for adults prescribed by a doctor, nursing mothers

Composition

Active substance: iron (III) hydroxide poliizomaltozat;

Excipients: sodium hydroxide, hydrochloric acid (concentrated) Water, d / and

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Indications

To prevent iron deficiency from bleeding, anemia

• severe iron deficiency due to blood loss;
• impaired iron absorption in the intestine;
• states in which iron preparations for oral treatment ineffective or impractical.

Contraindications

• I trimester of pregnancy;
• syndrome Rendu-Osler-Weber;
• infectious diseases of the kidneys in the acute stage;
• uncontrolled hyperparathyroidism;
• decompensated cirrhosis;
• infectious hepatitis.


• hypersensitivity to the drug;
• the excess iron in the body (hemochromatosis, hemosiderosis);
• disturbance of iron utilization mechanisms (lead anemia, sideroahrestical anemia, thalassemia);
• anemia, non-iron deficient (e.g. haemolytic, megaloblastic caused drawback cyanocobalamin).

Precautions: diabetes mellitus (syrup); bronchial asthma; chronic polyarthritis; heart failure; Low ability to bind iron and / or folate deficiency; children’s age (up to 4 months – for a solution for intramuscular injection)

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Side effects

From the digestive system: nausea, vomiting

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From the CNS: headache, dizziness

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Local reactions: the art of irregular injection possible – staining of skin, the appearance of pain and inflammation at the injection site

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Other: hypotension, arthralgia, lymph node enlargement, fever, malaise; rarely – allergic or anaphylactic reactions

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How to accept, acceptance rate and dosage

The drug is in solution form can be administered only in / m. Not allowed in / with the introduction of the drug!

Before administration of the first therapeutic dose for each patient should introduce a test dose is 1 / 4-1 / 2 ampoules (25-50 mg iron) for adults and half the daily dose for children. In the absence of adverse reactions for 15 minutes after the administration, the residue is administered starting daily dosage.

Doses Ferrum Lek ^® is selected individually in accordance with the general lack of iron, calculated by the following formula:

Total iron deficiency (mg) = body weight (kg) × (calculated level of Hb (g / l) – detected Hb (g / l)) × 0.24 + iron deposited (mg)

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When a body weight of 35 kg: calculated level of Hb = 130 g / L, deposited iron = 15 mg / kg body weight

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When a body weight of 35 kg: calculated level of Hb = 150 g / L, deposited iron = 500 mg

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The factor 0.24 = 0.0034 × 0.07 × 1000 (iron content in the Hb = 0.34%, total blood volume = 7% of body weight, factor 1000 – transfer of the g in mg)

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The calculation of the total number of vials of the drug based on the detected level of hemoglobin and body weight

If the total number of ampoules to be administered exceeds the maximum daily dose, the total number of vials should be divided into the required number of days. If after 1-2 weeks after initiation of treatment of hematologic parameters did not improve, it should again clarify the diagnosis.

The calculation of the total dosage to compensate for iron due to blood loss

In a known amount of blood lost / m administration of 200 mg of iron (2 vials) leads to an increase in hemoglobin equivalent to 1 unit of blood (400 ml containing 150 g Hb / l).

The amount of iron that is necessary to compensate (mg) = number of lost blood units x 200 or ampoules required number = number of lost blood units x 2

In a known finite level of hemoglobin using the above formula, taking into account that the deposited iron is required to fill.

The amount of iron that is necessary to compensate (mg) = body weight (kg) × (calculated level of Hb (g / L) – the detected level of Hb (g / l)) x 0.24

The usual dose Ferrum Lek ^®

adults and elderly patients administered 100-200 mg (1-2 ampoules) depending on the hemoglobin level; children – 3 mg / kg / day (0.06 ml / kg body weight / day)

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The maximum daily dose for adults – 200 mg (2 capsules); for children – 7 mg / kg / day (0.14 ml / kg body weight / day)

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The rules of administration

The drug is injected deep into the / m alternately in the right and left buttocks.

In order to reduce pain and prevent staining of the skin, should observe the following rules:

– drug should be administered in the upper outer quadrant of the buttocks, using the needle length of 5-6 cm;

– before injection, after disinfecting the skin subcutaneous tissue to be shifted down by 2 cm in order to prevent subsequent leakage of the drug;

– after drug administration should release the subcutaneous tissue and the injection press and hold in this position for 1 minute

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vials should be examined carefully before applying the solution for i / m injection. Only use vials containing homogeneous solution without precipitate. Solution w / o Injection should be used immediately after opening of the ampoule.

Storage conditions

The drug should be stored in reach of children at a temperature not higher than 25 ° C. Do not freeze.

Active substance

Ferric III hydroxide polymaltosate

Interaction

Ferrum Lek ^® for / m injections should not be used simultaneously with iron preparations for oral administration.

The simultaneous use of the drug Ferrum Lek ^® with ACE inhibitors may cause enhanced systemic effects of parenteral iron preparations.

Special conditions

The drug should be used only in a hospital.

When you assign Ferrum Lek ^® be sure to laboratory analysis: total blood count and determination of serum ferritin; necessary to avoid damaging the absorption of iron.

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

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

Pregnancy and lactation

Parenteral administration of the drug is contraindicated in the I trimester of pregnancy. In II and III trimester of pregnancy and the breastfeeding period, the drug is prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Overdose

Symptoms: overdose iron supplementation can lead to acute overload of iron and hemosiderosis

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Treatment: symptomatic therapy. As an antidote is administered in / slow (15 mg / kg / hr) deferoxamine depending on the degree of severity of overdose, but not more than 80 mg / kg / day. Hemodialysis is not effective.