Antianemic drug.
Preparation: FERRUM LEK®
Active substance drug:
non appropriated
ATX coding: B03AB
KFG: Antianemic drug
Registration number: P No. 012698/02
Registration date: 04/06/07
Owner reg. credential: VIFOR (International) Inc. (Switzerland)
Ferrum Lek release form, drug packaging and composition.
Chewable tablets are dark brown, interspersed with light brown, round, flat, with a bevel.
1 tab.
iron hydroxide polymaltosate
400 mg,
in terms of iron
100 mg
Excipients: macrogol 6000, aspartame, chocolate flavor, talc, dextrates.
10 pieces. — strips (3) — cardboard packs.
The syrup is transparent, brown in color.
5 ml
iron (III) hydroxide polymaltosate
200 mg,
in terms of iron
50 mg
Excipients: sucrose, sorbitol (solution), methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol, cream flavor, sodium hydroxide, water.
100 ml - dark glass bottles (1) complete with a measuring spoon - cardboard packs.
The description of the drug is based on the officially approved instructions for use.
Pharmacological action Ferrum lek
Antianemic drug. Ferrum Lek contains iron in the form of a complex compound of iron (III) hydroxide with polymaltose.
The molecular weight of the complex is about 50 kDa, so its diffusion through the gastrointestinal mucosa is 40 times slower than the diffusion of divalent iron. The complex is stable and does not release iron ions under physiological conditions. The iron of the multinuclear active zones of the complex is bound into a structure similar to the structure of the natural iron compound - ferritin. Due to this similarity, the iron in this complex is absorbed only through 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 bone marrow it is included in hemoglobin. The complex of iron (III) hydroxide with polymaltose does not have the pro-oxidant properties inherent in iron (II) salts.
Pharmacokinetics of the drug.
Studies using the dual isotope method (55Fe and 59Fe) have shown that iron absorption, as measured by red blood cell hemoglobin levels, is inversely proportional to the dose administered (the higher the dose, the lower the absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of iron absorbed (the greater the iron deficiency, the better the absorption). Iron is absorbed to the greatest extent in the duodenum and jejunum. The remaining (unabsorbed) iron is excreted in the feces. Its excretion with exfoliating epithelial cells of the gastrointestinal tract and skin, as well as with sweat, bile and urine is approximately 1 mg of iron/day. Women experience additional iron loss during menstruation, which must be taken into account.
Indications for use:
Treatment of latent iron deficiency;
Treatment of iron deficiency anemia;
Prevention of iron deficiency during pregnancy.
Dosage and method of administration of the drug.
The syrup can be mixed with fruit or vegetable juices or added to baby food. The measuring spoon included in the package is used for precise dosing of syrup.
Doses and duration of treatment depend on the degree of iron deficiency.
For iron deficiency anemia, the duration of treatment is about 3-5 months. After normalization of hemoglobin levels, you should continue taking the drug for several more weeks to replenish iron reserves in the body.
Children under 1 year of age are prescribed 2.5-5 ml (1/2-1 scoop) of syrup/day.
Children aged 1 to 12 years - 5-10 ml (1-2 scoops) of syrup/day.
Children over 12 years old, adults and mothers breastfeeding - 1-3 tablets. chewing or 10-30 ml (2-6 scoops) syrup/day.
Pregnant women are prescribed 2-3 tablets. chewing or 20-30 ml (4-6 scoops) of syrup until hemoglobin levels normalize. After this, you should continue to take 1 tablet. chewable or 10 ml (2 scoops) syrup/day, according to at least, until the end of pregnancy to replenish iron reserves in the body.
For latent iron deficiency, the duration of treatment is about 1-2 months.
Children aged 1 to 12 years - 2.5-5 ml (1/2-1 scoop) of syrup/day.
Children over 12 years old, adults and mothers breastfeeding - 1 tablet. chewing or 5-10 ml (1-2 scoops) syrup/day.
Pregnant women are prescribed 1 tablet. chewable or 5-10 ml (1-2 scoops) syrup/day.
Daily doses of Ferrum Lek for the prevention and treatment of iron deficiency in the body
Age
Iron-deficiency anemia
Latent iron deficiency
Preventing iron deficiency
Children under 1 year
2.5-5 ml syrup (25-50 mg iron)
*
*
Children (1-12 years old)
5-10 ml (50-100 mg iron)
2.5-5 ml (25-50 mg iron)
*
Children (>12 years), adults and nursing mothers
1-3 tab. chewable or 10-30 ml syrup (100-300 mg iron)
*
Pregnant
2-3 tab. chewable or 20-30 ml syrup (200-300 mg iron)
1 tab. chewable or 10 ml syrup (100 mg iron)
1 tab. chewable or 5-10 ml syrup (50-100 mg iron)
* - due to the fact that this group of patients requires low doses of iron, it is not recommended in these cases to prescribe the drug in the form of tablets or syrup.
Side effects of Ferrum lek:
From the outside digestive system: very rarely - a feeling of heaviness in the epigastric area, nausea, constipation, diarrhea. When taking the drug, stool is stained dark color, which is due to the excretion of unabsorbed iron and has no clinical significance.
The side effects reported were mostly mild and transient.
Contraindications to the drug:
Excess iron in the body (for example, hemochromatosis);
Disorders of iron utilization (for example, anemia caused by lead intoxication, sideroachrestic anemia);
Anemia not associated with iron deficiency (for example, hemolytic anemia, megaloblastic anemia caused by cyanocobalamin deficiency);
Hypersensitivity to the components of the drug.
Use during pregnancy and lactation.
During controlled studies, when using the drug in the 2nd and 3rd trimesters of pregnancy, no negative influence on the body of the mother or fetus. Not found harmful effects on the fetus when using the drug in the first trimester of pregnancy.
Special instructions for use of Ferrum lek.
Chewable tablets and syrup do not stain tooth enamel.
When prescribing Ferrum Lek to patients with diabetes mellitus Please note that 1 tab. chewable and 1 ml of syrup contains 0.04 XE.
In cases of anemia caused by infectious or malignant disease, iron accumulates in the reticuloendothelial system, from which it is mobilized and utilized only after the underlying disease has been cured.
Taking the drug does not affect the results of stool tests. occult blood(selective for hemoglobin).
Use in pediatrics
For children under 12 years of age, due to the need to prescribe low doses of the drug, it is preferable to prescribe the drug in syrup form.
Impact on the ability to drive vehicles and operate machinery
Does not affect.
Drug overdose:
In cases of overdose of Ferrum Lek for oral administration, no signs of intoxication or signs of excessive intake of iron into the body have been described to date, since iron is from active substance is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.
Interaction of Ferrum Lek with other drugs.
No interaction with other drugs was noted.
Terms of sale in pharmacies.
The drug is available with a prescription.
Storage conditions for the drug Ferrum lek.
The drug should be stored out of the reach of children at a temperature not exceeding 25°C. The shelf life of chewable tablets is 5 years, the shelf life of syrup is 3 years.
Description and instructions: to " FERRUM LEK, solution d/in 100 mg 2 ml No. 5"
DescriptionCompound:
Each ampoule (2 ml) contains 100 mg of iron in the form of a complex compound of iron (III) hydroxide with polyisomaltose in an aqueous isotonic solution.
pharmachologic effect
Iron is transported by a specific plasma protein - transferrin (beta globulin synthesized in the liver). Each transferrin molecule binds 2 iron atoms. In the form of an iron-transferrin complex, iron is delivered to the site of synthesis of hemoglobin, myoglobin and some enzymes. Transferrin is also indirectly involved in the body's defense system against infection.
Iron is absorbed into the gastrointestinal tract in a divalent form, in hemoglobin it is also found only in a divalent form, however, it is free Fe3+ ions (trivalent iron) that stimulate the formation of globin, which ultimately contributes to an increase in hemoglobin levels. After parenteral administration of iron (III) hydroxide complex with polyisomaltose, the hemoglobin concentration increases faster compared to by mouth iron (II) salts, since the kinetics of iron incorporation into hemoglobin depends not on the method of administration, but on the valency of the iron.
Most of iron for hemoglobin synthesis comes as needed from a deposited form - ferritin complex, synthesized in liver mitochondria. Iron in the apoferritin-iron complex is incorporated into hydrated iron oxide phosphate micelles.
Indications
Ferrum LEK is indicated for the treatment iron deficiency conditions, requiring rapid and reliable replacement of iron losses in the body, such as:
- heavy posthemorrhagic anemia
- iron absorption disorders
- ineffectiveness of treatment of iron deficiency anemia with oral iron supplements
Ferrum LEK is used in patients with clearly defined indications for the drug, subject to mandatory laboratory tests of plasma ferritin levels and red blood cell counts.
In case of suspected iron absorption disorder, additional confirmation is required - an iron absorption test.
Contraindications
Ferrum LEK is contraindicated in the following diseases and conditions:
anemia not associated with iron deficiency;
known hypersensitivity to any of the components of the drug;
excess iron in the body (hemochromatosis, hemosiderosis);
disorders of hemoglobin synthesis (anemia caused by lead poisoning, sideroblastic anemia);
severe violations hemostasis (hemophilia) due to the formation of hematoma;
first trimester of pregnancy (see also section "Use during pregnancy and lactation").
special instructions
Parenteral use of iron supplements can cause allergic reactions, including anaphylactoid ones. In case of an allergic reaction medium degree, recommended antihistamines. In case of development of anaphylactoid reactions - adrenaline immediately.
The risk of developing allergic and anaphylactoid reactions is quite high for patients with bronchial asthma, Crohn's disease, chronic polyarthritis, reduced binding capacity
iron and/or folic acid deficiency.
Pregnancy and lactation
Safety category during pregnancy according to the FDA is “C”: in animal studies, the teratogenic and embryotoxic effects of the complex of iron (III) hydroxide with polyisomaltose have been shown. Since there are no controlled studies on intramuscular use in humans, Ferrum LEK is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the drug is prescribed only according to vital signs, if the expected effect of use exceeds the possible risk to the fetus.
Since the complex of iron (III) hydroxide with polyisomaltose is excreted unchanged in milk in small quantities, caution is necessary when prescribing during lactation.
Elderly patients
Use of the drug in elderly patients does not increase the risk of side effects.
Drug interactions
Do not mix the contents of the ampoule with others. medicinal substances.
Like all other iron preparations for parenteral use, Ferrum LEK is not prescribed simultaneously with oral iron preparations, with normal absorption of iron from gastrointestinal tract. The interval between parenteral use of the drug and the start of use oral forms iron should be at least 5 days.
Dosage regimen
Ferrum LEK for intramuscular injections administered strictly intramuscularly!
Ferrum LEK for intramuscular injections is not used intravenously (injection or infusion)!
Before administering the first therapeutic dose of the drug, the tolerability of the drug is determined by administering a test dose - 1/4-1/2 of the contents of the Ferrum LEK ampoule (which corresponds to 25-50 mg of iron) for adults and half the daily dose for children. If no undesirable effects of the drug develop over the next 15 minutes, administer the remaining portion of the initial daily dosage.
Dosages
The dose is selected individually.
1) first calculate the total iron deficiency (TID) (mg):
OJ = ZHVG + J
Where ZIG is iron included in hemoglobin (mg): ZIG = MT x (CZG - ARG) x 0.24
Where MT is body weight (kg); CZG – target value hemoglobin (g/l)
For body weight up to 35 kg - 130 g/l
For body weight over 35 kg - 150 g/l
AUC – actual hemoglobin level (g/l)
Factor 0.24 = 0.0034 x 0.07 x 1000
Where 0.34% = iron content in hemoglobin,
7% = total blood volume as a percentage of body weight,
1000 = gram to milligram conversion factor
ID – deposited iron (mg)
For body weight up to 35 kg - 15 mg/kg body weight
For body weight over 35 kg - 500 mg/kg body weight
2) calculate the total number of ampoules per course of treatment (TCA):
OCA = OJ / 100
where 100 is the iron content in 1 ampoule (mg)
Calculation example:
Body Weight = 70 kg
Actual Hemoglobin level = 80 g/l
Iron included in Hemoglobin = 70 x 0.24 x (150 - 80) = 1200 mg Fe
Deposited Iron = 500 mg Fe
Total Iron Deficiency = 1200 + 500 = 1700 mg Fe
Total number of ampoules per course of treatment = 1700 / 100 = 17
Table 1.
Calculation total number ampoules of Ferrum LEK for one patient regarding hemoglobin level and body weight
|
Body weight (kg) |
Total number of Ferrum LEK ampoules per course of treatment |
|||
If the total number of Ferrum LEK ampoules exceeds the maximum daily dose, it is necessary to divide the administration of the drug into several doses. If after 1-2 weeks of therapy there is no normalization of hematological parameters, it is necessary to reconsider the diagnosis.
Calculation of the total dose to replace iron losses due to blood loss
The required number of ampoules is calculated using the following formula:
1) if the amount of blood lost is known:
Administration of 200 mg of iron intramuscularly (2 ampoules) causes an increase in hemoglobin by 1 unit of blood (400 ml 150 g/l hemoglobin content).
Iron required [mg] = number of blood units lost x 200 or
Required number of Ferrum LEK ampoules = number of blood units lost x 2
2) if a reduced hemoglobin level is known:
use the formula for calculation, assuming that there is no need to replenish deposited iron
Iron requirement [mg] = body weight [kg] x (target hemoglobin [g/l] – actual hemoglobin [g/l]) x 0.24
For a patient weighing 60 kg with a hemoglobin deficiency of 10 g/l, the required amount of iron is 150 mg or 1.5 ampoules of Ferrum LEK.
Standard dosage of the drug
Children: 0.6 ml of the drug/kg body weight/day (3 mg iron/kg/day)
Adults and elderly: 1-2 ampoules of Ferrum LEK (100-200 mg iron), depending on the hemoglobin level.
Maximum daily dose Ferrum LEK
Children: 0.14 ml of the drug/kg body weight/day (7 mg iron/kg/day).
Adults: 4.0 ml of the drug (2 ampoules) Ferrum LEK.
Ferrum LEK for intramuscular injections is administered strictly intramuscularly (not permissible intravenously!) every other day deep into the gluteal muscle alternately left or right.
Before use, carefully check the ampoule visually. It is allowed to use only a clear solution that does not contain sediment. If sediment appears and after the expiration date indicated on the package, the ampoule is not suitable for use. The ampoule is opened immediately before administration.
An intramuscular injection is administered slowly, to avoid pain and staining of the skin, into the upper outer square of the buttock with a 5-6 cm needle. Before injection, wipe the skin and pull it to the side.
2 cm so that after removing the needle, the injection channel is covered with skin to prevent fluid from leaking into the subcutaneous layers. During the injection, the pulled skin is gradually released; after the injection, press the injection site for 1 minute.
Overdose
An overdose of iron supplements can lead to acute complications and hemosiderosis. Misdiagnosing anemia as iron deficiency can lead to iron overload.
In case of overdose, treatment is symptomatic; the specific antidote for iron is deferoxamine, a chelating agent.
The following side effects of the drug may occur: hypotension, joint pain, swelling lymph nodes, fever, headache, dizziness, gastrointestinal disorders, nausea, vomiting, anaphylactoid reactions, infiltrate at the injection site.
Very rarely, allergic and anaphylactic reactions may occur.
Storage conditions and periods
Store at temperatures up to 20oC, protected from light.
Do not freeze!
Failure to comply with storage conditions may lead to the formation of sediment and clouding of the solution.
Keep out of the reach of children!
Conditions for dispensing from pharmacies
Dispensed only with a doctor's prescription.
- - Descriptions and photographs in product cards may differ from what is presented in the pharmacy. Please check information with operators before placing an order.
- - This product cannot be exchanged or returned on the basis of Resolution 55 of January 19, 1998.
Ferrum Lek is an antianemic medication prescribed for the treatment of anemia associated with iron deficiency.
Pharmacological action of Ferrum Lek
Medication Ferrum Lek s active component in the form of a complex compound of iron (III), polymaltose hydroxide helps reduce the severity of signs of anemia. The iron in the medicine is bound into a structure similar to the natural iron compound ferritin.
Iron absorption occurs through competitive ligand exchange occurring at the surface of the intestinal epithelium. Absorbed iron binds to ferritin in the liver, and in the bone marrow it is later incorporated into hemoglobin.
During use, the syrup and chewable tablets do not affect tooth enamel and do not cause coloration.
Release form
Ferrum Lek is available in three dosage forms:
- Dark brown chewable tablets containing the active substance (iron (III) hydroxide polymaltosate) in the amount of 400 mg, which corresponds to 100 mg of iron. 10 tablets per strip;
- Brown transparent syrup containing 5 ml of active substance (iron (III) hydroxide polymaltosate) in the amount of 200 mg, which corresponds to 50 mg of iron. In dark bottles of 100 ml;
- Solution for intramuscular injection containing 1 ml of active substance (iron (III) hydroxide polymaltosate) in an amount of 50 mg. In ampoules of 2 ml.
Analogues of Ferrum Lek
In terms of active substance, an analogue of Ferrum Lek is the drug Monofer, produced in the form of an injection solution.
If necessary, to treat anemia, the doctor can prescribe analogues of Ferrum Lek, which belong to one drug group and have similar therapeutic effect. These include Argeferr, Likferr100, Venofer, Maltofer, Dextrafer, Ferinject, Ferinject and FerMed.
Indications for use of Ferrum Lek
The medication Ferrum Lek is prescribed according to the instructions:
- For the treatment of latent iron deficiency and iron deficiency anemia;
- To prevent iron deficiency during pregnancy.
Contraindications
Contraindications to the use of Ferrum Lek are:
- The presence of excess iron in the body, including hemochromatosis;
- Disorders associated with iron utilization - sideroachrestic anemia, anemia caused by lead poisoning, and other diseases;
- Anemias that are not associated with iron deficiency - megaloblastic anemia (associated with a lack of cyanocobalamin), hemolytic anemia and others;
- Hypersensitivity to the active (iron (III) hydroxide polymaltose) or auxiliary components included in Ferrum Lek.
Against the background of anemia caused by malignant or infectious diseases, iron can accumulate in the reticuloendothelial system, from which it is utilized after the underlying disease is cured.
Parenteral administration of Ferrum Lek is contraindicated in the first trimester of pregnancy. In the future, it is also recommended to use the medication orally, but in some cases, after the doctor has assessed the relationship between the benefits of using the medication and possible risk for mother and fetus, it can be prescribed during this period.
Ferrum Lek in the form of a solution is prescribed with caution against the background of chronic polyarthritis, bronchial asthma, cardiovascular failure and children under 4 months.
How to use Ferrum Lek
The medication in tablet form can be swallowed whole with water or chewed. The syrup can be mixed with vegetable or fruit juices if desired, and for children it can also be added to baby food. In this case, you should use a measuring spoon for accurate dosing.
The dose prescribed for treatment and the duration of Ferrum Lek therapy according to the instructions depend on the degree of iron deficiency.
When treating iron deficiency anemia, the duration of taking Ferrum Lek varies from 3 to 5 months. Treatment should be continued after normalization of hemoglobin levels for several weeks to replenish iron stores in the body.
For children under one year of age, Ferrum Lek is usually prescribed 1/2-1 scoop (corresponding to 2.5-5 ml) of syrup per day. For children from one year to 12 years, the indicated dosage is doubled. Adults, nursing mothers and adolescents over 12 years of age are prescribed 1-3 tablets or 2-6 scoops of syrup per day (which corresponds to 10-30 ml of medication).
Pregnant women are recommended to take 2-3 chewable Ferrum Lek tablets per day or 4-6 scoops of syrup (which corresponds to 20-30 ml of medication). The medication should be taken until the hemoglobin level normalizes, after which it is continued in a reduced dosage - 1 tablet or 2 measuring spoons (corresponding to 10 ml) until the end of pregnancy to maintain the required level of iron in the body.
Daily doses of Ferrum Lek to prevent the development of anemia are usually prescribed by the attending physician.
In case of an overdose of the drug Ferrum Lek, according to reviews, signs of intoxication are not observed, which is associated with its absorption by passive diffusion.
When using Ferrum Lek in the form of an injection solution, depending on the hemoglobin level, 1 to 2 ampoules per day are usually prescribed (maximum 2 ampoules). Children's dosage is calculated based on body weight - 0.06 ml per 1 kg of weight (maximum - 7 mg per 1 kg of weight).
Administration of the medication in the form of a solution is possible only intramuscularly.
Interaction with other drugs
The use of Ferrum Lek orally can be combined with other medications and food products.
The medication in the form of an injection solution should not be combined with oral medication. It should also be taken into account that ACE inhibitors simultaneously with parenteral administration medications may cause increased systemic effects.
Side effects of Ferrum Lek
According to reviews, the medication Ferrum Lek most often causes digestive disorders, which manifest themselves as a feeling of heaviness, diarrhea, nausea, a feeling of pressure and fullness in the epigastric area, and constipation. The dark coloring of stool is due to the excretion of the active substance, which was not absorbed as a result of digestion, and does not require discontinuation of the medication.
As a rule, the side effects caused by Ferrum Lek, according to reviews, are weak and transient.
When using Ferrum Lek in the form of an injection solution, the following may be observed:
- Local reactions associated with improper administration of the medication, manifested as skin coloring and pain at the injection site;
- Disorders of the central nervous system in the form of headache and dizziness;
- Other disorders in the form of arterial hypotension, arthralgia, swollen lymph nodes, fever, malaise.
Storage conditions and periods
According to the instructions, Ferrum Lek is one of the antianemic medications prescription, with an expiration date, subject to the necessary storage conditions:
- Syrup – 3 years;
- Chewable tablets and solution for injections – 5 years.
Thank you
Ferrum Lek represents iron supplement, which normalizes the level of hemoglobin in the blood, and also prevents and eliminates iron deficiency of any origin. The drug is intended to normalize and maintain hemoglobin levels in children and adults of any gender.
Release forms, names and composition
Currently, Ferrum Lek is available in the following dosage forms:- Syrup for oral administration (glass bottles 100 ml);
- Chewable tablets (packs of 30 and 50 pieces);
- Solution for intramuscular administration (ampoules of 2 ml);
- Solution for intravenous administration (5 ml ampoules).
Forms for oral administration (syrup and tablets) contain as an active substance iron hydroxide polymaltosate , and solutions for injection – iron hydroxide polyisomaltose (ferrisaccharate) . These active substances are modifications of the same chemical compound– iron saccharate. Simply, for oral forms, the compound was left in its native form, and for injection, dextran (a high molecular weight polymer) was added to it, optimizing its properties specifically for entering the bloodstream, bypassing the intestines.
In terms of iron various shapes Ferrum Lek contains the following amount of active substance:
- Tablets – 100 mg;
- Syrup – 10 mg per 1 ml, that is, 50 mg of iron in one 5 ml measuring spoon;
- Solution for intramuscular administration – 50 mg in 1 ml, that is, 100 mg in one whole ampoule of 2 ml;
- Solution for intravenous administration – 20 mg in 1 ml, that is, 100 mg in one whole ampoule of 5 ml.
Ferrum Lek – INN, photo and recipe
INN is an acronym meaning international generic name, which is the common name chemical substance, which is the active, active component. In other words, the name of the active substance of any medicine, including Ferrum Leka, is its INN. INN Ferrum Leka is iron (III) hydroxide polymaltosate.The photographs below show the packaging of various dosage forms of Ferrum Lek.
The recipe for Ferrum Lek chewable tablets is written as follows:
Rp.: Tab. Ferrum Lek № 30
D.t.s. 1 tablet 2 times a day.
Recipes for solution and syrup are written in the same way, only in the first line after the letters "Rp." write "Sol." or "Syr." respectively. In the second line after the letters "D.t.s." indicate the dosage of the syrup and the frequency of administration or the volume of solution in milliliters, which is intended for a single administration.
Therapeutic effects of Ferrum Lek
Basic therapeutic effect of all dosage forms Ferrum Leka increases the level of hemoglobin in the blood and creates an iron depot in the form of ferritin. This effect is provided by the active substance of the drugs - an iron compound, which is well absorbed into the bloodstream, where an iron atom is slowly released from it, which is included in hemoglobin or ferritin in the bone marrow or liver, respectively.Iron polymaltosate enters the bloodstream in the same amount both during intramuscular injection and when taken orally. Therefore, the solution for intramuscular administration does not have the advantage of a shorter course of treatment and better absorption of iron over tablets and syrup. Only the solution for intravenous administration has the most complete absorption, the use of which shortens the course of treatment somewhat. However intravenous administration Ferrum Leka is used only when it is impossible to use other forms of the drug, since in this case the risk of severe allergic reactions, liver damage and other complications is highest.
Indications for use
Ferrum Lek tablets and syrup indicated for use in the following cases: - Latent (hidden) iron deficiency;
- Iron-deficiency anemia ;
- Prevention of iron deficiency during pregnancy and lactation, with heavy menstruation, etc.
- Severe anemia after major blood loss;
- Impaired absorption of iron in the intestines (for example, with inflammatory diseases intestines, stomach, etc.);
- Ineffectiveness of taking iron supplements orally;
- Inability for any reason to take iron supplements orally.
Ferrum Lek - instructions for use
General provisions
All dosage forms of Ferrum Lek are intended for use in different dosages in the following possible cases:- Prevention of anemia and iron deficiency;
- Treatment of anemia;
- Treatment of latent iron deficiency.
However, if there are no contraindications for taking iron orally, you should choose Ferrum Lek in the form of syrup or tablets, since they have the least pronounced allergenic properties, minimal risk of side effects, ease of use and best tolerability. Intramuscular injections of Ferrum Leka should be used only in cases where a person for some reason cannot take the drug orally. Ferrum Lek should be administered intravenously only in cases where it is necessary to quickly compensate for iron deficiency.
When choosing between syrup and tablets, you can only be guided by the principle of personal preference and ease of use. For example, if it is more convenient to take syrup, then it is best to use it. If it is subjectively more convenient to chew the tablets, then Ferrum Lek should be taken in this form. Neither tablets nor syrup stain teeth black.
The duration of use of the drug depends on the severity of iron deficiency. Thus, for prevention, Ferrum Lek can be used for as long as desired, as long as malnutrition or increased iron consumption persists, for example, during pregnancy, active growth, sports training etc.
To treat latent iron deficiency, Ferrum Leka in any dosage form is taken for 1 to 3 months. Latent iron deficiency is also called latent anemia, since in this condition only a decrease in ferritin in the blood is recorded, and hemoglobin remains within normal limits. And since ferritin is a form of iron storage, a decrease in its concentration in the blood indicates complete depletion of the depot and the rapid development of anemia.
To treat anemia, any dosage form of Ferrum Leka should be taken until hemoglobin levels in the blood are normalized (approximately 3 to 5 months). therapeutic dosages, and then for another 2 to 4 months in doses for the treatment of latent iron deficiency. Pregnant women suffering from anemia, after normalizing the level of hemoglobin in the blood, should take Ferrum Lek in dosages for the treatment of latent iron deficiency at least until childbirth, and optimally until the ferritin concentration increases to normal.
Ferrum Lek tablets and syrup – instructions for use
Syrup and tablets should be taken orally during or immediately after meals, as this minimizes the risk of side effects and irritation of the gastric mucosa by the iron compound. In principle, you can take syrup or tablets before meals, but in this case there is a high risk of nausea, epigastric pain and other symptoms of irritation of the gastric mucosa. The tablets can be swallowed whole or chewed. The syrup can be taken pure or dissolved in a drink. In this case, to wash down the tablet or dissolve the syrup, you can take any non-alcoholic drink with the exception of tea or milk, since they impair the absorption of iron from the intestines. The syrup can be mixed with baby food or juices.
The daily dosage of Ferrum Lek tablets or syrup can be taken at one time or divided into several. Optimally split daily dosage Ferrum Leka for as many identical doses as the number of times a person eats, in order to drink the drug after meals.
Children under 12 years of age must take the drug exclusively in syrup form, and after reaching the full 12 years of age, tablets can also be used. The dosages of Ferrum Lek syrup and tablets are determined by the person’s age and the severity of iron deficiency.
For the prevention of anemia and iron deficiency, as well as the treatment of latent (hidden) anemia Ferrum Lek syrup and tablets should be taken in the following dosages depending on age:
- Children 1 – 12 years old – 25 – 50 mg per day (2.5 – 5 ml of syrup);
- Children and adults over 12 years old – 50–100 mg per day (1 tablet or 5–10 ml of syrup);
- Pregnant women - 100 mg per day (1 tablet or 10 ml of syrup).
For the treatment of anemia Ferrum Lek should be taken in the following dosages depending on age:
- Children from birth to 1 year - 25 - 50 mg per day, which corresponds to 2.5 - 5 ml of syrup (1/2 - 1 measuring spoon);
- Children 1 – 12 years old – 50 – 100 mg per day (5 – 10 ml of syrup or 1 – 2 measuring spoons);
- Children and adults over 12 years old – 100–300 mg per day (1–3 tablets or 10–30 ml of syrup);
- Pregnant women - 200 - 300 mg per day (2 - 3 tablets or 20 - 30 ml of syrup).
Ferrum Lek injections (injections) – instructions for use
Intramuscular and intravenous injections should be done only if a person for some reason cannot take Ferrum Lek in tablets or syrup. Intravenous administration of the solution can be used to normalize hemoglobin levels after severe blood loss (more than 400 ml). It should be remembered that Ferrum Leka injections are used only for the treatment of anemia. The administration of solutions intravenously or intramuscularly for the purpose of preventing or eliminating latent iron deficiency is not used. The daily dosage of Ferrum Lek solution for intramuscular administration for anemia of any severity is the same and is 1 ampoule (100 mg) for adults, 1/4 ampoule for children weighing less than 6 kg and half an ampoule for children weighing 6 - 10 kg. This means that the entire daily dosage of the drug is administered to a person once a day. Moreover, the solution is administered every day.
The solution for intravenous administration is administered according to the following scheme: on the first day - half an ampoule (2.5 ml), on the second day - a whole ampoule (5 ml), on the third - two ampoules (10 ml). Subsequently, the solution is administered until the end of the course of treatment, 1 - 2 ampoules (5 - 10 ml) 1 - 3 times a week, depending on the rate of hemoglobin normalization.
The maximum daily dosage for intravenous or intramuscular administration is 200 mg of iron, which corresponds to two ampoules.
The duration of intravenous or intramuscular administration of Ferrum Leca depends on the general deficiency of iron in the body, which is calculated using a special formula or determined using a reference table. Based on the calculated total iron deficiency in the body, the number of ampoules required to replenish it is calculated. Then, with intramuscular administration, an injection is given every day, introducing the daily dosage, until the calculated number of ampoules is used. And the solution is administered intravenously according to the above scheme, but also until all the calculated ampoules are used. For example, according to estimates, a person needs 15 ampoules of Maltofer to treat anemia. This means that for 15 days every day he needs to administer one ampoule of the solution intramuscularly, after which the course of treatment is considered complete. And one ampoule must be administered intravenously 1–3 times a week; accordingly, the course of treatment will be completed when all 15 ampoules have been used.
The number of ampoules for intramuscular or intravenous administration for a full course of treatment is calculated using the formula:
general iron deficiency / 100 mg.
Total iron deficiency is calculated using the following formula:
body weight (kg)*( normal level hemoglobin – current hemoglobin level) * 0.24 + iron reserves.
In this formula, the normal hemoglobin level is considered to be 130 for body weight less than 35 kg, and 150 for body weight more than 35 kg. Iron reserves are taken to be 500 for a body weight of more than 35 kg and are calculated based on the ratio of 15 per 1 kg of weight for a person weighing less than 35 kg. That is, for children weighing less than 35 kg, iron reserves are calculated individually by multiplying the weight in kg by 15. These parameters are substituted into formulas and calculated.
In addition to accurately calculating the number of ampoules required for a full course of anemia treatment, you can use the special table below. It shows the approximate number of ampoules of solution for intravenous or intramuscular administration required for the treatment of anemia of varying severity depending on body weight.
| Body weight, kg | Number of ampoules with solution for intravenous or intramuscular administration per course of treatment | |||
| Hemoglobin 60 – 75 g/l | Hemoglobin 75 – 90 g/l | Hemoglobin 90 – 105 g/l | Hemoglobin 105 g/L or higher | |
| 5 | 1.5 ampoules | 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 |
In addition to treating anemia, intravenous administration of the solution is carried out to replenish the amount of iron after severe blood loss (more than 400 ml). In this case, the required number of solution ampoules is calculated using special formulas.
First formula: number of ampoules for treatment = number of blood units lost*2, where
one lost unit of blood is equal to 400 ml. For example, a person lost 500 ml of blood, which corresponds to 1.25 units. This means that to replenish iron deficiency he needs 1.25 * 2 = 2.5 ampoules of solution for intravenous administration.
Second formula:
number of ampoules = body weight (kg)*(130 – current hemoglobin level)*0.24/100.
For example, a person weighing 70 kg has lost a lot of blood and the hemoglobin level has dropped to 100. In this case, for treatment he needs 70 * (130 - 100) * 0.24/100 = 5.04 ampoules.
The calculated number of ampoules is the required amount of solution for the full course of treatment. In this case, adults are administered the solution intravenously, 1 ampoule per day, and for children under 12 years of age weighing less than 35 kg, the daily dosage is calculated individually, based on the ratio of 0.06 ml per 1 kg of weight.
Ferrum Lek - how to administer intramuscularly correctly
The correct technique for administering the solution ensures a minimal risk of developing allergic reactions and pain, as well as the formation of compactions, blackening of the skin, etc. For intramuscular injections, you should take needles at least 5–6 cm long with a narrow hole. Moreover, the lower the person’s weight, the thinner the needle must be used.The ampoule with the solution must be opened immediately before use, and not in advance. After opening the ampoule, draw the required amount of solution into the syringe, place it on a sterile tray and find the injection site.
To find the exact injection site, you need to feel the iliac crest on the right or left side with your index finger. Then from this point towards the back they take thumb and they also feel the wing of the ilium. The thumb and index finger, as well as a mentally drawn line connecting the tips of their nails, form a triangle. The lower part of this triangle, located before the imaginary line drawn from the connection index finger with the palm and until it intersects with the large one, and is the area where the Ferrum Lek solution should be injected.
After determining the injection zone, use two fingers to gather the skin into a small fold to prevent it from staining and preventing the solution from getting into the subcutaneous fatty tissue.
Then, with your free working hand, take a syringe already filled with the required amount of solution, and insert the needle strictly vertically to the surface of the body, deep into the thickness of the tissue. Then Ferrum Leka solution is introduced slowly over 5-7 minutes. After administering the entire volume of the solution, the needle is removed, the skin fold is straightened, lightly massaged, and the injection site is wiped with an antiseptic. After administering the drug, a person must perform intense body movements for 5 to 10 minutes.
Before administering the first dose of Ferrum Leka, when it is unknown whether a person has an allergic reaction to the drug, you must first administer 0.5 ml of solution (1/4 ampoule). Then wait 15 minutes, and if signs of an allergic reaction do not appear, then inject the entire remaining volume of the solution. If a person has an allergic reaction, then Ferrum Lek is canceled.
Ferrum Lek - how to administer intravenously correctly
The ampoule with the solution is opened only immediately before use. Before opening the ampoule, the solution is carefully inspected, and if flakes, turbidity or inclusions are visible in it, then it is not suitable for use. Either a pure solution or a diluted saline solution can be administered intravenously. Moreover, the pure solution is administered in a stream (with a syringe), and diluted with physiological solution - in the form of an infusion (dropper). Drip administration of the solution is preferable, since in this case the risk is minimal sharp decline pressure
Before administering the first dose of Ferrum Lek, if it is not known whether a person is allergic to the drug, you must first administer 1 ml of solution. Then wait 15 minutes, and if the allergy does not begin to develop, then you can continue administering the entire remaining dose of the solution. If signs of allergy appear, you will have to stop using Ferrum Leka.
Jet Ferrum Lek is administered in the form of an undiluted pure solution, drawn from an ampoule into a syringe with a thin needle. The solution is administered at a rate of no more than 1 ml per minute. After administering the entire volume of the drug, fix the arm in an extended position for 5–10 minutes.
Ferrum Lek is administered by drip (infusion) using a system (dropper). The drug is first diluted in a ratio of 1:20, that is, 20 ml is taken per 1 ml of solution for injection. saline solution. That is, one 5 ml ampoule is diluted in 100 ml of physiological solution. The solution is administered slowly at the following speed, depending on its volume:
- 100 ml – administered over at least 15 minutes;
- 200 ml – 30 minutes;
- 300 ml – 1.5 hours;
- 400 ml – 2.5 hours;
- 500 ml – 3.5 hours.
special instructions
Ferrum Lek solutions for intravenous and intramuscular administration cannot be mixed with other drugs in the same syringe. If Ferrum Leka gets into the perivenous space, it is necessary, without removing the needle, to inject a little physiological solution, after which the affected area is treated with Chondroitin-AKOS ointment or another containing mucopolysaccharides.Intramuscular and intravenous administration of the drug is allowed only in a hospital setting.
The tablets and syrup may cause black stool, which is normal and does not require any treatment.
All dosage forms of Ferrum Leka do not affect the speed of psychomotor reactions, therefore, while taking the drug, you can operate machinery, including driving a car.
Overdose
An overdose when taking Ferrum Lek tablets or syrup is practically impossible, since excess iron is not absorbed from the intestines into the blood.An overdose can develop with intravenous or intramuscular administration of solutions, when iron enters directly into the blood, and is manifested by the following symptoms:
- Nausea;
- Bloody diarrhea;
- Pale skin;
- Sticky and cold sweat;
- Weak pulse;
- CNS depression.
Interaction with other drugs
Ferrum Lek cannot be used simultaneously in the form of injections and syrup or tablets. Therefore, after the last injection, you can start taking Ferrum Lek or another iron supplement orally at least five days later.Administration of solutions intravenously or intramuscularly simultaneously with taking drugs from the group ACE inhibitors(for example, Enalapril, etc.) increases the side effects of Ferrum Leka.
Ferrum Lek for children and infants
General provisions
Children under 12 years of age should be given Ferrum Lek only in syrup form, since this dosage form allows you to accurately measure a small dosage of the drug, necessary for the child. The tablets contain a relatively high dose of iron - 100 mg, which cannot be accurately divided into parts and given to the child only the required amount.The syrup can be used to treat anemia in children from birth, that is, the drug is suitable for both infants and older children. Intramuscular and intravenous injections of Ferrum Lek can only be used in children over 4 months old and weighing more than 5 kg. Injection of iron solutions in children weighing less than 5 kg can lead to severe allergic reactions with fatal outcome.
Syrup and tablets should be given to the child during or immediately after meals. If a child refuses to drink the solution due to subjective bad taste, then the required amount of syrup can be dissolved in water or any other non-alcoholic drink, except tea and milk. Compotes, fruit drinks, vegetable or fruit juices, etc. are perfect for dissolving Ferrum Lek syrup. It is recommended to choose the drink that your child likes.
If the child calmly drinks the syrup without diluting it in a drink, then after taking the medicine he must be given it to drink. You can also use any drink other than milk and tea for this, as they impair the absorption of iron into the bloodstream in the intestines.
Infants are given syrup by dissolving it in sweet water, juice or baby formula. The medicine is usually given after the child has eaten at least a little, since taking Ferrum Leka on an empty stomach will cause severe and unpleasant irritation of the gastric mucosa in the infant.
Instructions for Ferrum Lek for children - how to take
Dosages of the drug for children over 12 years of age are the same as for adults. And in children under 12 years of age, various forms of the drug are used only for the treatment of anemia and latent iron deficiency, but not for prevention.For infants (children from birth to one year), Ferrum Lek is given in syrup form only for the treatment of anemia, 2.5 - 5 ml per day. Treatment is continued until the hemoglobin level rises to normal levels.
For children aged 1 to 12 years, Ferrum Lek syrup is given in the following dosages for the treatment of various iron deficiency conditions:
- Anemia– 5–10 ml per day until the blood hemoglobin level normalizes. After the hemoglobin level has increased to normal, continue taking Ferrum Leka 2.5 - 5 ml per day for 1 - 2 months;
- Hidden iron deficiency – 2.5 – 5 ml per day for 1 – 3 months.
Ferrum Lek during pregnancy
Ferrum Lek in the form of syrup and tablets is approved for use by pregnant women at any stage of gestation. And solutions for intravenous and intramuscular administration can only be used from the 2nd trimester of pregnancy (from the 13th week).Tablets and syrup during pregnancy various states should be taken in the following dosages:
- Anemia– 2 – 3 tablets or 20 – 30 ml of syrup per day until hemoglobin levels normalize. After increasing the hemoglobin concentration to normal, continue to take the drug until delivery, 1 tablet or 10 ml of syrup per day;
- General malaise;
- Allergic reactions;
- At the injection site - skin staining, pain and thickening.
Contraindications for use
Ferrum Lek syrup, tablets and injection solutions are contraindicated in the following conditions:- Non-iron deficiency anemia;
- Impaired absorption and utilization of iron;
- Excess iron in the body (hemochromatosis, hemosiderosis);
- Allergic reactions to the drug.
- Osler-Rendu-Weber syndrome;
- Acute kidney infections;
- Uncontrolled hyperparathyroidism;
- Decompensated cirrhosis of the liver
- Ferlatum;
- Ferrlecite;
- Ferretab comp;
- Ferrogrademet;
- Ferronal;
- Ferronate;
- Ferroplex;
- Ferrum Lek;
- Ferinject;
- FerMed;
- Heferol.
Ferrum Lek (tablets, syrup and injections) – reviews
Most of the reviews (2/3 or more) about Ferrum Lek tablets and syrup are positive, since they effectively and relatively quickly increased the level of hemoglobin in the blood, caused minimal side effects, were well tolerated and easy to use. Negative reviews in rare cases due to the ineffectiveness of Ferrum Lek syrup and tablets, and in most situations they are associated with subjective poor tolerance drug. For example, a person was bothered by nausea, a metallic taste in the mouth, an unpleasant sweetish taste of tablets or syrup, constipation or irritation of the gastric mucosa, due to which the drug had to be discontinued. Regarding Ferrum Lek injections, people generally respond positively, noting that injections of the drug very quickly increased hemoglobin levels. However, in addition to fast and Despite the good effect of injections, people note that the injections are very painful and long-lasting bruises that they have to put up with.
INSTRUCTIONS
By medical use medicinal product
Read these instructions carefully before you start using this medicine. Save the instructions, you may need them again.
If you have any questions, consult your doctor. This medicine is for you personally and should not be given to others because it may harm them even if they have the same symptoms as you.
Registration number:
Trade name of the drug:
Ferrum Lek ®.
International nonproprietary name or generic name:
iron (III) hydroxide polymaltosate.
Dosage form
Compound
5 ml of syrup (1 measuring spoon) contains:
Active substance: iron 50.0 mg (corresponding to 200.00 mg of iron (III) hydroxide polymaltosate).
Excipients: sucrose – 1,000 g; sorbitol (solution) – 2,000 g; methyl parahydroxybenzoate – 2.915 mg; propyl parahydroxybenzoate – 0.830 mg; ethanol – 16.250 mg; cream flavoring – 15,000 mg; sodium hydroxide – up to pH 5.0-7.0; water – up to 5 ml.
Description
Transparent brown solution.
Pharmacotherapeutic group
Antianemic agent. Iron supplement.
ATX code: В03АВ05.
Pharmacological properties
Pharmacodynamics
The molecular mass of the complex is so large - about 50 kDa - that its diffusion through the mucous membrane of the gastrointestinal tract is 40 times slower than the diffusion of ferrous iron. The complex is stable and does not release iron ions under physiological conditions. The iron of the multinuclear active zones of the complex is bound into a structure similar to the structure of the natural iron compound - ferritin. Due to this similarity, the iron (III) of this complex is absorbed only by active absorption. Iron-binding proteins, located on the surface of the intestinal epithelium and in gastrointestinal fluid, 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 incorporated into hemoglobin.
The polymaltose complex of iron (III) hydroxide, unlike iron (II) salts, does not have pro-oxidant properties. The sensitivity of lipoproteins (eg, very low-density lipoproteins and low-density lipoproteins) to oxidation is reduced.
Pharmacokinetics
Studies using the dual isotope method (55 Fe and 59 Fe) have shown that iron absorption, measured by red blood cell hemoglobin levels, is inversely proportional to the dose administered (the higher the dose, the lower the absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). Maximum absorption of iron occurs in the duodenum and jejunum. Unabsorbed iron is excreted in the feces. Its excretion in exfoliated epithelial cells of the gastrointestinal tract and skin, as well as in sweat, bile and urine is approximately 1 mg of iron per day.
Women experience additional iron loss during menstruation, which must be taken into account.
Indications for use
Treatment of latent iron deficiency;
treatment of iron deficiency anemia;
prevention of iron deficiency during pregnancy.
Contraindications for use
Hypersensitivity to the components of the drug,
iron overload in the body (for example, in cases of hemochromatosis, hemosiderosis);
impaired iron utilization (for example, anemia caused by lead intoxication, sideroachrestic anemia, thalassemia);
anemia not associated with iron deficiency (for example, hemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency);
rare hereditary forms fructose intolerance, glucose-galactose malabsorption and sucrase-isomaltase deficiency (since the drug contains sucrose and sorbitol).
Carefully
Patients with diabetes.
Use during pregnancy and lactation
In controlled studies in pregnant women (2nd and 3rd trimesters of pregnancy), no negative effects on the mother and fetus were observed. No harmful effects on the fetus were detected when taking the drugs in the first trimester of pregnancy.
When a nursing mother uses the drug, breast milk only a small part of the iron comes from its complex with polymaltose; thus, the occurrence of undesirable effects in those on breastfeeding children are unlikely.
Directions for use and doses
Inside. It is recommended to take the drug during or immediately after meals. Ferrum Lek ® syrup can be mixed with fruit or vegetable juices or added to baby food. The daily dose can be divided into several doses.
The measuring spoon included in the package is used for precise dosing of Ferrum Lek ® syrup.
Doses and duration of treatment depend on the degree of iron deficiency.
Latent iron deficiency
The duration of treatment is about 1-2 months.
Children under 1 year of age:
Due to the low dosage, the use of syrup according to this indication impossible.
Children from 1 to 12 years old
2.5-5 ml (1/2-1 scoop) Ferrum Lek ® syrup per day.
Iron-deficiency anemia
The duration of treatment is about 3-5 months. After normalization of hemoglobin concentration, you should continue taking the drug for several more weeks to replenish iron reserves in the body.
Children under 1 year of age
The initial dose of Ferrum Lek ® syrup is 2.5 ml (1/2 measuring spoon) per day. The dose is gradually increased to 5 ml (1 scoop) of Ferrum Lek ® syrup per day.
Children from 1 to 12 years old
5-10 ml (1-2 scoops) of Ferrum Lek ® syrup per day.
Children over 12 years of age, adults and mothers breastfeeding
10-30 ml (2-6 scoops) of Ferrum Lek ® syrup per day.
Pregnant women
Latent iron deficiency 10 ml (2 measuring spoons) of Ferrum Lek ® syrup per day.
Preventing iron deficiency
5-10 ml (1-2 measuring spoons) Ferrum Lek ® syrup per day
Iron-deficiency anemia 20-30 ml (4-6 scoops) of Ferrum Lek ® syrup per day until the hemoglobin concentration normalizes. After this, you should continue to take 10 ml (2 scoops) of Ferrum Lek ® syrup per day, at least until the end of pregnancy to replenish iron reserves in the body.
Daily doses of Ferrum Lek ® syrup for the prevention and treatment of iron deficiency in the body
Side effect
Ferrum Lek ® is generally well tolerated. Side effects are predominantly mild and transient.
According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (≥1/10), often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10000, <1/1000) и очень редко (<1/10000); частота неизвестна – по имеющимся данным установить частоту возникновения не представлялось возможным.
From the gastrointestinal tract
very rarely: abdominal pain, nausea, constipation, diarrhea, dyspepsia, vomiting, change in color of feces (due to the excretion of unabsorbed iron, has no clinical significance).
From the skin and subcutaneous tissue
very rarely: urticaria, rash, itching of the skin.
If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
Overdose
In case of an overdose of Ferrum Lek ®, there were no signs of intoxication or excess iron in the body, since iron from the active substance is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.
Interaction with other drugs
No interactions with other drugs or food products have been identified.
Concomitant use of polymaltosate hydroxide with parenteral iron preparations and other oral iron (III) preparations is not recommended due to the pronounced inhibition of the absorption of orally administered iron.
special instructions
Ferrum Lek ® syrup does not stain tooth enamel.
In cases of anemia caused by an infectious or malignant disease, iron accumulates in the reticuloendothelial system, from which it is mobilized and utilized only after the underlying disease has been cured.
When using the drug Ferrum Lek ®, the stool may turn dark, which does not have any clinical significance. The drug Ferrum Lek ® does not affect the results of the occult blood test (selective for hemoglobin); therefore, it is not necessary to interrupt iron therapy.
Due to the low dosage, Ferrum Lek ® should not be used in children under 1 year of age to treat latent iron deficiency.
Note for diabetic patients: 1 ml of Ferrum Lek ® syrup contains 0.04 XE.
Impact on the ability to drive vehicles and engage in other activities that require concentration and speed of psychomotor reactions
Ferrum Lek ® does not affect the ability to drive a car or operate machinery that requires increased concentration.
Special precautions when disposing of unused drugs
Not applicable.
Release form
Syrup 50mg/5ml
Primary packaging
Lek d.d., Slovenia
100 ml of syrup in dark glass bottles with or without a 100 ml graduated level, sealed with a metal screw cap with a first-opening control ring and a polyethylene gasket inside.
Sandoz Ilac Sanai ve Ticaret A.S., Türkiye
100 ml of syrup in dark glass bottles with or without a graduated level of 100 ml, sealed with a polyethylene screw cap with a first-opening control ring and a polyethylene seal inside.
Secondary packaging
One bottle in a cardboard box along with instructions for use, a measuring spoon with ring marks in the cavity for 2.5 ml and 5 ml (“2.5 SS” and “5 SS”, a maximum filling mark of 6 ml (“6 SS” ) on the handle of a spoon.
Storage conditions
At a temperature not higher than 25°C.
Keep out of the reach of children.
Best before date
3 years.
Do not use the drug after the expiration date.
Vacation conditions
On prescription.
Manufacturer
1. Lek d.d., Verovshkova 57, 1526, Ljubljana, Slovenia.
2. Sandoz Ilach Sanai Ve Tijaret A.S., Gebze Plasticchiler Organize
Sanay Bolgezi, Ataturk Boulevard 9, ca. No. 1, 41400 Gebze Kocaeli, Türkiye
Consumer complaints should be sent to Sandoz CJSC:
125315, Moscow, Leningradsky Prospekt, 72, bldg. 3.
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