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Instruction for use: Ferrum Lek
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Dosage form: Solution for intramuscular injection; Syrup; Chewing tablets
Active substance: Ferri (III) hydroxydum dextranum
ATX
B03AC06 Iron [III] hydroxide and dextran complex
Pharmacological groups
Anti-anemic agent. Iron preparation [Macro and trace elements]
Anti-anemic agent. Iron preparation [Stimulators of hemopoiesis]
The nosological classification (ICD-10)
D50 Iron deficiency anemia: Iron deficiency in food; Anemia due to violations of hemoglobin synthesis and iron metabolism; Anemia of iron deficiency; Iron / folic deficiency anemia; Iron deficiency anemia
D50.0 Iron deficiency anemia secondary due to loss of blood (chronic): Anemia posthemorrhagic; Anemia in chronic hemorrhage; Chronic blood loss in the digestive tract; Posthemorrhagic anemia
D63.0 Anemia in neoplasm: Anemia in chronic diseases; Anemia due to radiation damage; Radiation anemia; Anemia in patients with solid tumors; Pernicious anemia
E61.1 Insufficiency of iron: Insufficient food intake of iron; Iron deficiency; Iron deficiency in women during pregnancy; Deficiency of iron and folic acid in pregnancy; Iron deficiency after surgery; Latent iron deficiency; Lack of iron during pregnancy and lactation; Inadequate intake of iron from food; Increased need for iron; Increased need for iron during menstruation; Disturbances of iron absorption from the digestive tract; Severe iron deficiency
Composition
Chewing Tablets - 1 tab.
active substance: Iron (III) hydroxide polymaltosate 400 mg
(In terms of iron - 100 mg)
Auxiliary substances: macrogol 6000; Aspartame; Chocolate flavors; talc; Dextrates
Syrup - 5 ml (1 measuring spoon)
active substance: Iron (III) hydroxide polymaltosate 200 mg
(In terms of iron - 50 mg)
Auxiliary substances: sucrose; Sorbitol (solution); Methylparahydroxybenzoate; Propyl parahydroxybenzoate; Ethanol; Cream flavor; Sodium hydroxide; water.
Solution for intramuscular injection - 1 amp. (2 ml)
active substance: Iron (III) as a complex of iron (III) hydroxide with dextran 100 mg
Excipients: water for injection
Note. To adjust the pH of the solution, sodium hydroxide is used in the form of a 6 M solution or a hydrochloric acid
Description
Tablets are chewable: round flat tablets, dark brown with interspersions of light brown color, with a bevel.
Syrup: a transparent solution of brown color.
Solution for intramuscular administration: a brown opaque solution with practically no visible particles.
Pharmachologic effect
Mode of action - Replenishing iron deficiency, anti-anemia.
Pharmacodynamics
Tablets. Syrup. The molecular mass of the complex is so great - about 50 kDa - that its diffusion through the mucosa of the gastrointestinal tract is 40 times slower than the diffusion of bivalent iron. The complex is stable and under physiological conditions does not release iron ions. The iron of the multinuclear active zones of the complex is connected to a structure similar to the structure of the natural iron-ferritin compound. Due to this similarity, the iron of this complex is absorbed only by 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 included in the hemoglobin.
Complex iron (III) hydroxide polymaltose does not possess the prooxidant properties inherent in salts of iron (II).
Solution for intramuscular injection. 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
Tablets. Syrup. Studies using the double isotope method (55Fe and 59Fe) showed that iron absorption measured by hemoglobin in erythrocytes is inversely proportional to the dose taken (the higher the dose, the lower the absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of absorbed iron (the higher the iron deficiency, the better the absorption). Most of the iron is absorbed in the duodenum and jejunum.
The remaining (unabsorbed) iron is excreted with feces. His excretion with exfoliating cells of the epithelium of the gastrointestinal tract and skin, as well as with sweat, bile and urine, is approximately 1 mg of iron per day. In women during menstruation, there is an additional loss of iron, which must be taken into account.
Solution for intramuscular injection. After IM of the drug, iron quickly enters the bloodstream: 15% of the dose - after 15 minutes, 44% - after 30 minutes. Biological T1 / 2 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.
Indication of the drug Ferrum Lek
Tablets. Syrup.
Treatment of latent iron deficiency;
Treatment of iron deficiency anemia;
Prevention of iron deficiency during pregnancy.
Solution for the IM introduction. 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;
Conditions in which treatment with iron for oral administration is ineffective or unworkable.
Contraindications
Common for all dosage forms:
Hypersensitivity to the components of the drug;
Excess iron in the body (hemochromatosis, hemosiderosis);
Violation of the mechanisms of iron utilization (lead anemia, sidero-achestic anemia, thalassemia);
Anemia, not associated with iron deficiency (eg, hemolytic, megaloblastic, caused by a lack of cyanocobalamin).
For chewing tablets additionally:
Children under 12 years.
For syrup additionally:
Rare hereditary forms of intolerance to fructose, glucose-galactose malabsorption and sucrose-isomaltase deficiency (because the preparation contains sucrose and sorbitol).
For the solution for the IM introduction additionally:
I trimester of pregnancy;
Osler-Randu-Weber syndrome;
Infectious diseases of the kidneys in the acute stage;
Uncontrolled hyperparathyroidism;
Decompensated cirrhosis of the liver;
Infectious hepatitis.
With caution: diabetes (for syrup); bronchial asthma; Chronic polyarthritis; Cardiovascular failure; Low ability to bind iron and / or deficiency of folic acid; Children's age (up to 4 months - for a solution for the / m introduction).
Application of pregnancy and breastfeeding
Tablets. Syrup. In controlled studies in pregnant women (II, III trimesters of pregnancy), there was no adverse effect on the mother and fetus. There was no adverse effect on the fetus when taking drugs in the first trimester of pregnancy.
Solution for the IM introduction. The drug is contraindicated in the first trimester of pregnancy. In the II and III 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.
Side effects
Tablets. Syrup. The reported side effects were mostly mild and transient.
According to WHO, adverse reactions are classified according to their developmental frequency as follows: very often (≥1/10), often (≥1 / 100, <1/10) infrequently (≥1 / 1000, <1/100), Rarely (≥1 / 10000, <1/1000) and very rarely (<1/10000); The frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.
From the gastrointestinal tract: very rarely - pain in the abdomen, nausea, constipation, diarrhea, indigestion, vomiting, change in color of feces (due to excretion of not absorbed iron, has no clinical significance).
From the skin and subcutaneous tissue: very rarely - hives, rashes, itching of the skin.
Solution for the IM introduction. Arterial hypotension, joint pain, swollen lymph nodes, fever, headache, dizziness, malaise, dyspepsia (nausea, vomiting); Extremely rarely - allergic or anaphylactic reactions. Incorrect technique of drug administration can lead to skin staining, the appearance of soreness and inflammation at the injection site.
Interaction
Tablets. Syrup. Interaction with other drugs or food was not detected.
Simultaneous use of ferromaltosate hydroxide with parenteral iron preparations and other oral preparations of iron (III) is not recommended due to pronounced inhibition of absorption of orally administered iron.
Solution for the IM introduction. 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.
Dosing and Administration
Inside, during or immediately after a meal.
Chewable tablets Ferrum LekŪ can be chewed or swallowed whole.
The daily dose can be divided into several receptions or taken at a time.
Syrup Ferrum LekŪ can be mixed with fruit or vegetable juices or added to baby food.
Doses and duration of treatment depend on the degree of iron deficiency.
The measuring spoon enclosed in the packaging is used to accurately dispense the Ferrum LekŪ syrup.
Iron-deficiency anemia
Duration of treatment is about 3-5 months. After normalizing the hemoglobin level, you should continue taking the drug for a few more weeks to replenish iron stores in the body.
Children under the age of 2.5 ml (½ scoop) - 5 ml (1 measuring spoon) of Ferrum LekŪ syrup per day.
Children aged 1 to 12 years: 5-10 ml (1-2 scoops) of Ferrum LekŪ syrup per day.
Children over 12 years of age, adults and mothers who breastfeed: 1 to 3 chewable tablets or 10 to 30 ml (2 to 6 measuring spoons) of Ferrum LekŪ syrup.
Latent iron deficiency
Duration of treatment is about 1-2 months.
Children aged 1 to 12 years: 2.5-5 ml (1 / 2-1 measuring spoon) of Ferrum LekŪ syrup per day.
Children over 12 years, adults and mothers who breastfeed: 1 tab. Or 5-10 ml (1-2 scoops) of Ferrum LekŪ syrup per day.
Pregnant women
Iron deficiency anemia: 2-3 chewable tablets per day or 20-30 ml (4-6 measuring spoons) of the Ferrum LekŪ syrup, until the hemoglobin level is normalized. After this, continue to take 1 chewable tablet or 10 ml (2 measuring spoons) of syrup per day, at least until the end of pregnancy to replenish iron stores in the body.
Latent iron deficiency and prevention of iron deficiency: one chewable tablet or 5-10 ml (1-2 scoops) of Ferrum LekŪ syrup per day.
Daily doses of Ferrum LekŪ for the prevention and treatment of iron deficiency in the body
| Patients | Form of the preparation | Iron-deficiency anemia | Latent iron deficiency | Prevention of iron deficiency |
| Children under 1 year old | Syrup | 2.5-5 ml (25-50 mg of iron) | - | - |
| Children 1-12 years old | Syrup | 5-10 ml (50-100 mg of iron) | 2.5-5 ml (25-50 mg of iron) | - |
| Children over 12 years of age, adults, nursing mothers | Tablets, chewing | 1-3 tab. | 1 tab. | - |
| Syrup | 10-30 ml (100-300 mg of iron) | 5-10 ml (50-100 mg of iron) | - | |
| Pregnant women Patients | Tablets, chewing | 2-3 tab. | 1 tab. | 1 tab. |
| Syrup | 20-30 ml (200-300 mg of iron) | 10 ml (100 mg of iron) | 5-10 ml (50-100 mg of iron) |
Before the introduction of the first therapeutic dose of the drug, each patient should be given a test dose of 1 / 4-1 / 2 amp. Ferrum LekŪ (25-50 mg of iron) for an adult and half the daily dose for a child. In the absence of adverse reactions for 15 minutes, you can enter the remainder of the daily dose.
The doses of Ferrum LekŪ must be selected individually, according to the total iron deficiency, which is calculated by the following formula:
Total iron deficiency = body weight (kg) × (calculated hemoglobin level (g / l) - real 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 over 35 kg: calculated 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
Real hemoglobin concentration: 80 g / l
Total iron deficiency = (150 - 80) × 0.24 + 500 = 1700 mg of iron
The total number of Ferrum LekŪ ampoules to be introduced = Total iron deficiency (mg) / 100 mg
Calculation of the total number of Ferrum LekŪ vials that must be introduced based on the actual hemoglobin concentration and body weight
| Body weight, kg | Total number of Ferrum LekŪ ampules for administration | |||
| 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 the required dose of Ferrum LekŪ exceeds the maximum daily dose, the administration of the drug should be fractional (within a few days).
If after 1-2 weeks after the start of treatment hematological parameters do not change, you should 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: the introduction of 200 mg IM (2 amp, Ferrum LekŪ) 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, which should be reimbursed (mg) = number of blood units lost × 200 or the required number of ampoules Ferrum LekŪ = number of lost blood units × 2.
If you know the final level of hemoglobin, you need to use the following formula, given that the deposited iron does not need to be reimbursed.
Iron, which should be compensated (mg) = body weight (kg) × (calculated 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 compensated with 150 mg of iron, which is 1.5 ampoules of Ferrum LekŪ.
Standard doses
Children: 0.06 ml / kg / day (3 mg of iron / kg / day).
Adults: 1-2 amp. Ferrum LekŪ (100-200 mg of iron), depending on the level of hemoglobin.
Maximum daily doses
Children: 0.14 ml / kg / day (7 mg iron / kg / day).
Adults: 4 ml (2 amp.) Per day.
Overdose
Tablets. Syrup. Symptoms: when an overdose of syrup or chewable tablets, Ferrum LekŪ, 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.
Solution for the IM introduction. Symptoms: an overdose of a solution for intravenous administration may lead to acute overload with iron and hemosiderosis.
Treatment: symptomatic; As an antidote, deferoxamine is slowly administered (15 mg / kg / h), depending on the severity of the overdose, but not more than 80 mg / kg / day. Hemodialysis is ineffective.
Special instruction
Tablets. Syrup. Children under the age of 12 years, in connection with the need to prescribe low doses of the drug, preferably the appointment of Ferrum LekŪ in the form of a syrup.
Neither the chewable tablets nor the Ferrum LekŪ syrup cause staining of the tooth enamel.
In cases of anemia caused by an infectious or malignant disease, iron accumulates in the reticulo-endothelial system, from which it is mobilized and utilized only after the cure of the underlying disease.
When using the preparation of Ferrum LekŪ, the stool can be colored dark, which does not have any clinical significance. The intake of iron preparations does not affect the results of the test for latent bleeding (selective for hemoglobin).
Notification for diabetics: 1 chewable tablet or 1 ml of Ferrum LekŪ syrup contain 0.04 XE.
Notification for patients with phenylketonuria: the preparation of Ferrum LekŪ contains aspartame (E951), a source of phenylalanine, in an amount equivalent to 1.5 mg per tablet.
Influence on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. The drug does not affect the ability to concentrate.
Solution for the IM introduction. Use only in a hospital.
When appointing Ferrum LekŪ, it is mandatory to conduct laboratory tests: general clinical blood analysis and determination of serum ferritin; It is necessary to exclude the violation of iron absorption.
Ferrum LekŪ is only for IM administration.
It is mandatory to insert deep into the gluteus muscle (needle length of 5-6 cm), as well as shifting the tissues when the needle is inserted and squeezing the tissues after removing the needle; Injected in turn into the right and left gluteal muscles.
The opened ampoule should be used immediately.
The contents of Ferrum LekŪ ampoules should not be confused with other drugs.
Treatment with oral forms of iron-containing preparations should be started no earlier than 5 days after the last injection of Ferrum LekŪ.
If the product is stored incorrectly, precipitation may occur, the use of such ampoules is unacceptable.
Release Form
Tablets are chewable, 100 mg. For 10 tab. In a strip or blister; On 3, 5 or 9 strips in a pack of cardboard.
Syrup, 50 mg / 5 ml. For 100 ml of syrup in dark glass vials with a ring mark, sealed with a metal screw cap with a control ring of the first opening and a PE liner inside .; On 1 fl. Together with a measuring spoon with ring marks in the cavity for 2.5 ml and 5 ml ("2.5 CC" and "5 CC"), the maximum filling mark of 6 ml ("6 ŅŅ") on the handle of the spoon in a pack of cardboard.
Solution for intramuscular injection, 50 mg / ml. 2 ml each in a glass ampoule (hydrolytic class I) with a red breaking point. On the top of the ampoule is a ring of red color. At 5 or 10 amp. In an open blister of PVC or a PVC blister covered with a thermo-lacquered film; 1 blister (5 amp) or 5 blisters (10 amp) in a pack of cardboard.
Manufacturer
Lek dd, Verovshkova 57, Ljubljana, Slovenia.
Syrup
1. Lek dd, Verovshkova 57, Ljubljana, Slovenia.
2. Sandoz Ilach Sanayi Ve Tidzaret AS, Gebze Plasticizer of the Organize Sanay Bolgesi,
Claims of consumers to send to CJSC "Sandoz": 123317, Moscow
Conditions of supply of pharmacies
On prescription.
Storage conditions of the drug Ferrum Lek
At a temperature of no higher than 25 ° C. Do not freeze.
Keep out of the reach of children.
Shelf life of the drug Ferrum Lek
Solution for intramuscular injection 50 mg / ml - 5 years.
Tablet chewing 100 mg - 5 years.
Syrup 50 mg / 5 ml - 3 years.
Do not use after the expiry date printed on the package.
