Expiration date: 02/2026
Description pharmaceutical form:
The solution for intramuscular introduction: brown opaque solution practically free of any visible particles.
Pharmacokinetics:
After the/m introduction of the product's iron is quickly released into the bloodstream: 15% rate — after 15 minutes, 44% after 30 min. of Biological T1/2 is 3-4 days. Iron in complex with transferrin is transferred to the body cells where it is used for the synthesis of hemoglobin, myoglobin and some enzymes. The complex of iron (III) hydroxide with dextran is large enough and therefore not excreted through the kidneys.
Description pharmacological action:
The product contains iron (III) complex of iron (III) hydroxide with dextran. Iron, part of the drug quickly makes up for the lack of this element in the body (in particular with iron deficiency anemias), restores hemoglobin. In drug treatment there is a gradual decrease in clinical symptoms (weakness, fatigue, dizziness, tachycardia, soreness and dryness of the skin) and laboratory parameters of iron deficiency.
Indications:
Treatment of all forms of iron-deficiency States, which require rapid replenishment of iron reserves, including the following:
- severe iron deficiency due to blood loss
- violation of iron absorption in the intestine
- a condition in which treatment with iron preparations for oral administration is ineffective or not feasible.
Contraindications:
- hypersensitivity to the drug
- excess iron in the body (hemochromatosis, gemosideros)
- anemia not associated with iron deficiency
- violation of mechanisms of iron utilization (lead anemia, sideroachrestic anemia, thalassemia)
- The first trimester of pregnancy
- the syndrome of Osler-Rendu Weber
- infectious diseases of the kidney in the acute stage
- uncontrolled hyperparathyroidism
- decompensated liver cirrhosis
- infectious hepatitis.
With caution:
- bronchial asthma
- chronic polyarthritis
- cardiovascular failure
- low capacity to bind iron and/or folic acid deficiency
- children's age (up to 4 months).
Application of pregnancy and breast-feeding:
The drug is contraindicated in the first trimester of pregnancy. In II and III trimesters of pregnancy and lactation drug use is possible only if the expected benefit to the mother outweighs the potential harm to the fetus or infant.
Side effects:
Hypotension, joint pain, swollen lymph nodes, fever, headache, dizziness, malaise, dyspepsia (nausea, vomiting) very rare — allergic or anaphylactic reaction. Improper technique of injection may lead to staining of the skin, the appearance of pain and inflammation at the injection site.
Drug interactions:
Should not be administered concomitantly with oral iron preparations. Simultaneous reception of ACE inhibitors may cause increased systemic effects of parenteral iron preparations.
Method of application and dose:
V/m (only).
Before the introduction of the first therapeutic dose of the drug for each patient should be administered a test dose, component 1/4–1/2 amp. Ferrum Lek (25-50 mg iron) for adult and half the daily dose for a child. In the absence of side reactions within 15 minutes you can enter the rest of the daily dose.
Dose of ferrum Lek should be selected individually, in accordance with the common iron deficiency, which is calculated by the following formula:
Total iron deficit = body weight (kg) × (current hemoglobin level (g/l) ? the actual level of hemoglobin (g/l) × 0,24) + deposited iron (mg)
Body weight up to 35 kg: calculated level of hemoglobin = 130 g/l, deposited iron = 15 mg/kg
Body weight over 35 kg: calculated level of haemoglobin = 150 g/l, deposited iron = 500 mg
The factor 0,24 = 0,0034 × 0,07 × 1000
(Iron content = 0,34% of the total blood volume = 7% of body weight factor 1000 = transfer from g to mg).
Example
The body weight of the patient 70 kg
The real hemoglobin concentration: 80 g/l
Common iron deficiency = (150 ? 80) × 0,24 + 500 = 1700 mg of iron
The total number of vials ferrum Lek that must be entered = Total iron deficit (mg) / 100 mg
The calculation of the total number of vials ferrum Lek which must be entered on the basis of the actual hemoglobin concentration and body weight
| Body weight, kg | The total number of vials ferrum Lek for the introduction | |||
| Hb 60 g/l | Hb 75 g/l | Hb 90 g/l | Hb 105 g/l | |
| 5 | 1,5 | 1,5 | 1,5 | 1 |
| 10 | 3 | 3 | 2,5 | 2 |
| 15 | 5 | 4,5 | 3,5 | 3 |
| 20 | 6,5 | 5,5 | 5 | 4 |
| 25 | 8 | 7 | 6 | 5,5 |
| 30 | 9,5 | 8,5 | 7,5 | 6,5 |
| 35 | 12,5 | 11,5 | 10 | 9 |
| 40 | 13,5 | 12 | 11 | 9,5 |
| 45 | 15 | 13 | 11,5 | 10 |
| 50 | 16 | 14 | 12 | 10,5 |
| 55 | 17 | 15 | 13 | 11 |
| 60 | 18 | 16 | 13,5 | 11,5 |
| 65 | 19 | 16,5 | 14,5 | 12 |
| 70 | 20 | 17,5 | 15 | 12,5 |
| 75 | 21 | 18,5 | 16 | 13 |
| 80 | 22,5 | 19,5 | 16,5 | 13,5 |
| 85 | 23,5 | 20,5 | 17 | 14 |
| 90 | 24,5 | 21,5 | 18 | 14,5 |
If you need a dose of ferrum Lek exceed the maximum daily dose, the drug should be a fraction (over several days).
If after 1-2 weeks after the start of treatment hematological parameters do not change, should clarify the diagnosis.
Calculate the total dose for recovery of iron due to blood loss
Required quantity of drug to compensate for post-hemorrhagic iron deficiency is calculated according to the following formula.
If you know the amount of blood lost: the introduction of 200 mg/m (2 amp. 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 that you want to recover (mg) = number of lost blood units x 200 or the required number of vials ferrum Lek = number of lost blood units x 2.
If we know the ultimate level of hemoglobin, it is necessary to use the following formula, given that the deposited iron to compensate is not necessary.
Iron that you want to recover (mg) = body weight (kg) × (current hemoglobin level (g/l) ? the actual level of hemoglobin (g/l) × 0,24.
Patient with body weight of 60 kg and a deficiency of hemoglobin 10 g/l should be compensated to 150 mg of iron, equivalent to 1.5 vials ferrum Lek.
Standard doses
Children: 0.06 ml/kg/day (3 mg of iron/kg/day).
Adult dosage: 1-2 amp. Ferrum Lek (100-200 mg iron), depending on the level of hemoglobin.
Maximum daily dose
Children: 0,14 ml/kg/day (7 mg of iron/kg/day).
Adults: 4 ml (2 amp.) a day.
Overdose:
Symptoms: overdosage can cause acute iron overload and hemosiderosis.
Treatment: symptomatic as an antidote is injected into/in slowly (15 mg/kg/h) deferoxamine, depending on the severity of the overdose, but not more than 80 mg/kg/day. Hemodialysis is ineffective.
Special instructions:
Use only in a hospital.
When assigning ferrum Lek required to conduct laboratory tests: General blood test and determination of serum ferritin to exclude the violation of absorption of iron. Ferrum Lek is intended only for intramuscular administration.
Definitely the introduction of deep in the gluteus muscle (needle length 5-6 cm) and pinch the tissue with the introduction needle, and squeezing the tissue after removing the needle is introduced in turn to the right and left gluteal muscles.
Opened vial must be used immediately.
The contents of the vials ferrum Lek should not be mixed with other drugs.
Treatment of oral forms of iron supplements should be started not earlier than after 5 days after the last injection ferrum Lek.
Improper storage of the drug may precipitate, the use of such vials is unacceptable.
