Ferrum Lek - instructions for use, dose, side effects, contraindications

Active substanceIron [III] hydroxide dextranIron [III] hydroxide dextran

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Ferrum Lek®

solution w / m

Lek dd Slovenia

Dosage form: & nbsp

Solution for intramuscular injection.

Composition:

1 ampoule (2 ml) contains:

- active substance: Iron (III) as a complex of iron (III) hydroxide with dextran - 100 mg;

- auxiliary substance: water for injections.

Note. To adjust the pH of the solution, sodium hydroxide is used in the form of a 6 M solution or a hydrochloric acid concentrated.

Description:

Brown opaque solution with practically no visible particles.

Pharmacotherapeutic group:Anti-anemic agent. The iron preparation.

ATX: & nbsp

B.03.A.C Preparations of iron for parenteral use

B.03.A.C.06 Iron [III] hydroxide dextran

Pharmacodynamics:

The preparation contains trivalent iron as a complex of ferric hydroxide iron with dextran. Iron, which is part of the drug, quickly replenishes the lack of this element in the body (in particular, with iron deficiency anemia), restores the hemoglobin content. When treating 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 injection of iron quickly enters the bloodstream: 15% of the dose - after 15 minutes, 44% - after 30 minutes. The biological half-life is 3-4 days.

Iron in a complex with transferrin is transferred to the cells of the body, where it is used for the synthesis of hemoglobin, myoglobin and some enzymes. The iron (III) hydroxide complex with dextran is sufficiently large and therefore not excreted through the kidneys.

Indications:

Treatment of all forms of iron deficiency conditions, in which a rapid replacement of the iron reserve is necessary, including the following:

- severe iron deficiency due to blood loss;

- violation of iron absorption in the intestine;

- the conditions under which treatment with iron for oral administration is ineffective or unworkable.

Contraindications:

- hypersensitivity to the components of the drug;

- excess iron in the body (hemochromatosis, hemosiderosis);

- Anemia not associated with iron deficiency (eg, hemolytic anemia);

- violation of the mechanisms of "utilization" of iron (lead anemia, sideroahrestic anemia,thalassemia);

- First trimester of pregnancy;

- Osler-Randu-Weber Syndrome;

- Infectious diseases of the kidneys in the acute stage;

infectious hepatitis.

Carefully:

- bronchial asthma, allergic eczema or other atopic allergy;

- chronic polyarthritis;

- cardiovascular insufficiency;

- low ability to bind iron and / or deficiency of folic acid;

- Children's age up to 4 months.

Pregnancy and lactation:The drug is contraindicated in the first trimester of pregnancy. In the second and third trimesters and during the period of breastfeeding, the use of the drug is possible only if the intended benefit to the mother exceeds the potential harm to the fetus or baby.

Dosing and Administration:

The preparation Ferrum Lek® solution is intended only for intramuscular injection.

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

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

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

The dose of the drug Ferrum Lek® must be selected individually according to the total iron deficiency, which is calculated by the following formula:

Total iron deficiency (mg) = body weight (kg) x (calculated hemoglobin level (g / l) - real 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: calculated 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% of body weight, factor 1000 = conversion from g / l in mg / l).

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

The total number of ampoules of the preparation of Ferrum Lek®, which must be entered Total iron deficiency (mg) / 100 mg.

Table: Calculation of the total number of ampoules of the preparation of Ferrum Lek®, which must be introduced, 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 administration of the drug should be fractional (within a few days).

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

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

The necessary amount of the drug to compensate posthemorrhagic iron deficiency is calculated by the following formula:

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

Iron, which should be compensated (mg) = number of blood units lost x 200 or Necessary number of ampoules of the drug Ferrum Lek® = number of blood units lost x 2.

If the final level of hemoglobin is known: use the following formula, given that the deposited iron does not have to be reimbursed.

Iron, which should be compensated (mg) = body weight (kg) x (calculated hemoglobin level (g / l) - real 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 compensated with 150 mg of iron, which is 1 1/2 ampoules of the preparation Ferrum Lek®.

Standard doses

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

Adults: 1 - 2 ampoules of the preparation Ferrum Lek® (100-200 mg of 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 the preparation of Ferrum Lek®) per day.

Side effects:

From the immune system

Anaphylactoid reactions, including dyspnea, urticaria, rash, itching, nausea and shivering, severe severe anaphylactoid reactions (shortness of breath, vascular collapse) with fatal outcome. It is also possible to develop delayed reactions (arthralgia, myalgia, fever).

From the nervous system

Loss of consciousness, convulsions, dizziness, headache, paresthesia, perversion of taste.

From the side of the cardiovascular system

Arrhythmia, tachycardia, palpitations, marked decrease / increase in blood pressure.

From the respiratory system

Bronchospasm, shortness of breath.

From the digestive system

Dyspeptic phenomena (including nausea, vomiting), abdominal pain, diarrhea.

From the skin and subcutaneous tissue

Itching, hives, rash, swelling of the Quincke, increased sweating.

From the musculoskeletal and connective tissue

Convulsions, myalgia, pain in the joints.

From the genitourinary system

Chromaturia (change of color of urine).

General disorders and disorders at the site of administration

Chills, "tides" of blood to the face, chest pain, swollen lymph nodes, fever, increased fatigue. In the place of intramuscular injection (usually due to a violation of the technique of drug administration) - staining the skin, bleeding, the formation of sterile abscesses, tissue necrosis or their atrophy, pain.

Overdose:

Overdose can lead to acute overload with iron and hemosiderosis. Treatment is symptomatic; as an antidote is administered intravenously slowly (15 mg / kg / h) deferoxamine depending on the severity of the overdose, but not more than 80 mg / kg per day.Hemodialysis is ineffective.

Interaction:

Do not use concomitantly with oral iron-containing drugs.

Simultaneous administration of ACE inhibitors can cause an increase in the systemic effects of parenteral iron preparations.

Special instructions:

Use only in a hospital. When using the preparation of Ferrum Lek®, it is mandatory to conduct laboratory tests: general clinical analysis of blood and serum ferritin; it is necessary to exclude the violation of iron absorption.

The preparation of Ferrum Lek® is intended only for intramuscular injection.

Technique of introduction: mandatory introduction deep in the gluteus muscle (needle length of 5-6 cm), as well as shearing of tissues when the needle is inserted and the tissues are squeezed after the needle is removed; injected in turn into the right and left gluteal muscles. The opened ampoule should be used immediately.

Parenterally administered iron preparations can cause hypersensitivity reactions, including anaphylactoid reactions, which can be potentially life-threatening, and appropriate means should be available for cardiopulmonary resuscitation.

The risk of developing anaphylactoid reactions is increased in patients with an allergy in history (including drug history), in patients with severe history of bronchial asthma, eczema or other allergic manifestations, as well as in patients with immune-inflammatory diseases (eg, systemic lupus erythematosus, rheumatoid arthritis).

In patients with impaired liver function, parenteral iron should be administered only after a thorough assessment of the benefit / risk ratio. Parenteral administration of iron should be avoided in patients with impaired liver function, where iron overload can be a pathogenetic factor in the development of adverse events (in particular, late cutaneous porphyria). A careful control of the concentration of iron is recommended.

The contents of ampoules of the Ferrum Lek® preparation should not be mixed with other drugs. Treatment with oral forms of iron-containing preparations should be started no earlier than 5 days after the last injection of the drug Ferrum Lek®. If the product is stored incorrectly, precipitation may occur, the use of such ampoules is unacceptable.

Form release / dosage:Solution for intramuscular injection.

Packaging:

2 ml of the drug in a glass ampoule (hydrolytic class I) with a break point in red. On the top of the ampoule is a ring of red color.

For 5 or 10 ampoules are placed in an open blister made of PVC or a PVC blister covered with a thermo-lacquered film. For 1 or 2 blisters for 5 ampoules or 1 or 5 blisters for 10 ampoules are placed in a cardboard pack together with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

5 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014059 / 01

Date of registration:11.12.2007

The owner of the registration certificate: Lek dd Lek dd Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp03.10.2014

Illustrated instructions

Instructions

Ferrum Lek® (Ferrum Lek®)