Antianemic drug.
Preparation: FERRUM LEK®
Active substance drug:
non appropriated
ATX encoding: B03AB
KFG: Antianemic drug
Registration number: P No. 012698/02
Date of registration: 06.04.07
Owner reg. ID: VIFOR (International) Inc. (Switzerland)
Ferrum Lek release form, preparation packaging and composition.
Chewable tablets of dark brown color, interspersed with light brown color, round, flat, beveled.
1 tab.
iron hydroxide polymaltose
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 polymaltose
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 product is based on the officially approved instructions for use.
Pharmacological action Ferrum Lek
Antianemic drug. In the Ferrum Lek preparation, iron is 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 tract mucosa 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 in a structure similar to that of the natural compound of iron, ferritin. 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 exchange of ligands. The 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 possess the prooxidant properties inherent in iron (II) salts.
Pharmacokinetics of the drug.
Studies using the double isotope method (55Fe and 59Fe) have shown that the absorption of iron, measured by the level of hemoglobin in red blood cells, 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 iron absorbed (the greater the iron deficiency, the better the absorption). To the greatest extent, iron is absorbed 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. In women, additional iron loss occurs 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 children food... The measuring spoon enclosed in the package is used for precise dosing of the syrup.
Doses and duration of treatment depend on the degree of iron deficiency.
With iron deficiency anemia, the duration of treatment is about 3-5 months. After the hemoglobin level has returned to normal, the drug should be continued for several more weeks in order to replenish iron stores in the body.
Children under the age of 1 year are prescribed 2.5-5 ml (1 / 2-1 measuring spoon) 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 who are breastfeeding - 1-3 tab. chewable or 10-30 ml (2-6 scoops) of syrup / day.
Pregnant women are prescribed 2-3 tablets. chewable or 20-30 ml (4-6 scoops) of syrup to normalize hemoglobin levels. After that, you should continue to take 1 tab. chewing or 10 ml (2 scoops) syrup / day, at least before the end of pregnancy to replenish iron stores in the body.
With latent iron deficiency, the duration of treatment is about 1-2 months.
Children aged 1 to 12 years old - 2.5-5 ml (1 / 2-1 measuring spoon) of syrup / day.
Children over 12 years old, adults and mothers who are breastfeeding - 1 tab. chewing or 5-10 ml (1-2 scoops) syrup / day.
Pregnant women are prescribed 1 tab. chewing or 5-10 ml (1-2 scoops) syrup / day.
Daily doses of the drug Ferrum Lek for the prevention and treatment of iron deficiency in the body
Age
Iron-deficiency anemia
Latent iron deficiency
Prevention of iron deficiency
Children under 1 year old
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 old), 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 low doses of iron are required for this group of patients, 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 side digestive system: very rarely - a feeling of heaviness in the epigastric region, nausea, constipation, diarrhea. When taking the drug, staining of feces in dark color, which is due to the elimination of non-absorbed iron and has no clinical significance.
The reported side effects were generally mild and transient.
Contraindications to the drug:
Excess iron in the body (for example, hemochromatosis);
Iron utilization disorders (eg, lead intoxication anemia, sideroachrestic anemia);
Anemias not associated with iron deficiency (eg, hemolytic anemias, megaloblastic anemia caused by a lack of cyanocobalamin);
Hypersensitivity to the components of the drug.
Application during pregnancy and lactation.
In the course of controlled studies with the use of the drug in the II and III trimesters of pregnancy, it was not noted negative influence on the body of the mother or fetus. Not found harmful effects per fetus when using the drug in the first trimester of pregnancy.
Special instructions for the use of Ferrum Lek.
Chewable tablets and syrup do not stain the enamel of the teeth.
When prescribing Ferrum Lek to patients with diabetes mellitus it should be borne in mind that 1 tab. chewing 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 is cured.
Taking the drug does not affect the results of stool tests for hidden 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 the form of a syrup.
Influence on the ability to drive vehicles and use mechanisms
Does not affect.
Drug overdose:
In cases of an overdose of Ferrum Lek for oral administration, no signs of intoxication or signs of excessive intake of iron into the body have been described so far, since iron 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.
Conditions of sale in pharmacies.
The drug is available with a prescription.
Terms of storage conditions of 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 the syrup is 3 years.
Description and instructions: to " FERRUM LEC, solution for injection 100mg 2ml 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 carried by a specific plasma protein called 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 in the gastrointestinal tract in a bivalent form, in hemoglobin it is also only in a bivalent form, however, it is the free Fe3 + ions (ferric iron) that stimulate the formation of globin, which ultimately contributes to an increase in the level of hemoglobin. After parenteral administration of a complex of iron (III) hydroxide with polyisomaltose, the hemoglobin concentration increases faster than oral administration salts of iron (II), since the kinetics of iron inclusion in hemoglobin depends not on the method of administration, but on the valence of iron.
Most of iron for the synthesis of hemoglobin comes as needed from the deposited form - the ferritin complex synthesized in the mitochondria of the liver. Iron in the apoferritin-iron complex is included in the micelles of hydrated iron oxide phosphate.
Indications
Ferrum LEC is indicated for treatment iron deficiency states requiring fast and reliable replacement of iron losses in the body, such as:
- heavy post-hemorrhagic anemia
- disorders of iron absorption
- ineffectiveness of therapy for iron deficiency anemia with oral iron preparations
Ferrum LEK is used in patients with clearly defined indications for prescribing the drug, with the obligatory laboratory tests of the plasma ferritin level and the number of erythrocytes.
In the case of suspected impaired iron absorption, 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 component 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 a hematoma;
the first trimester of pregnancy (see also the section "Use during pregnancy and lactation").
special instructions
Parenteral use of iron preparations can cause allergic reactions up to anaphylactoid. In case of an allergic reaction medium are recommended antihistamines... In the case of anaphylactoid reactions - adrenaline immediately.
The risk of developing allergic and anaphylactoid reactions is high enough for patients with bronchial asthma, Crohn's disease, chronic polyarthritis, reduced binding capacity
iron and / or folic acid deficiency.
Pregnancy and lactation
FDA pregnancy safety category - "C": in animal studies, teratogenic and embryotoxic effects of a complex of iron (III) hydroxide with polyisomaltose have been shown. Since there are no controlled studies on intramuscular administration 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 for vital indications if the expected effect of the application outweighs the possible risk to the fetus.
Since the complex of iron (III) hydroxide with polyisomaltose in small quantities unchanged is excreted in milk, caution is necessary when prescribing during lactation.
Elderly patients
The 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... Break between parenteral administration of the drug and the start of use oral forms iron should be at least 5 days.
Dosage regimen
Ferrum LEK for intramuscular injection injected strictly intramuscularly!
Ferrum LEK for intramuscular injections is not used intravenously (injection or infusion)!
Before the introduction of the first therapeutic dose of the drug, the tolerance of the drug is determined by the introduction of 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 of the daily dose for children. If no undesirable effects of the drug develop within the next 15 minutes, the remaining portion of the initial daily dosage is administered.
Dosage
The dose is selected individually.
1) First, calculate the total iron deficiency (OJ) (mg):
OJ = ZhVG + J
Where LHG - iron included in hemoglobin (mg): LHG = MT x (CGH - DUG) x 0.24
Where MT is body weight (kg); CZG - target value hemoglobin (g / l)
With a body weight of up to 35 kg - 130 g / l
With a body weight of more than 35 kg - 150 g / l
ARC - 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 = conversion factor from grams to milligrams
J - deposited iron (mg)
With a body weight of up to 35 kg - 15 mg / kg of body weight
With a body weight of more than 35 kg - 500 mg / kg of body weight
2) calculate the total number of ampoules for the course of treatment (OCH):
OCH = 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.
Payment the total ampoules of the drug Ferrum LEK for one patient in relation to the level of hemoglobin and body weight
|
Body weight (kg) |
The total number of ampoules Ferrum LEK for the 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 replenish iron losses due to blood loss
The required number of ampoules is calculated using the following formula:
1) if the amount of lost blood is known:
The introduction of 200 mg of iron intramuscularly (2 ampoules) causes an increase in hemoglobin per 1 unit of blood (400 ml of 150 g / l of hemoglobin content).
Iron required [mg] = number of blood units lost x 200 or
Required number of ampoules Ferrum LEK = number of blood units lost x 2
2) if a reduced hemoglobin level is known:
use the formula for the calculation, assuming that there is no need to replenish the deposited iron
Iron required [mg] = body weight [kg] x (target hemoglobin value [g / l] - actual hemoglobin level [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 of body weight / day (3 mg of iron / kg / day)
Adults and the elderly: 1-2 ampoules of Ferrum LEK (100-200 mg of iron), depending on the level of hemoglobin.
Maximum daily dose Ferrum LEK
Children: 0.14 ml of the drug / kg of body weight / day (7 mg of iron / kg / day).
Adults: 4.0 ml of the drug (2 ampoules) Ferrum LEK.
Ferrum LEK for intramuscular injections is injected strictly intramuscularly (not allowed intravenously!) Every other day deep into gluteus muscle alternately to the left or right.
Before use, carefully check the ampoule visually. It is allowed to use only a transparent solution that does not contain sediment. When a sediment appears and after the expiration date indicated on the package, the ampoule is not usable. The ampoule is opened just before the introduction.
Intramuscular injection is injected slowly in order to avoid pain and staining of the skin, into the upper outer square of the buttock with a 5-6 cm needle.Wipe the skin before injection, pull to the side
2 cm so that after removal of the needle, the injection channel is covered with skin to prevent fluid leakage into the subcutaneous layers. During the injection, the pulled skin is gradually released, after the injection, press the injection site for 1 minute.
Overdose
Overdose of iron preparations can lead to acute complications and hemosiderosis. Misdiagnosis of anemia as iron deficiency can lead to iron overload.
In case of an overdose, treatment is symptomatic; a specific antidote for iron is deferoxamine, a chelating agent.
The following side effects of the drug may occur: hypotension, joint pain, edema lymph nodes, heat, headache, dizziness, gastrointestinal disorders, nausea, vomiting, anaphylactoid reactions, infiltration at the injection site.
Allergic and anaphylactic reactions can very rarely occur.
Storage conditions and periods
Store at temperatures up to 20oС, protected from light.
Do not freeze!
Failure to comply with the storage conditions can lead to the formation of a precipitate and turbidity of the solution.
Keep out of the reach of children!
Conditions of dispensing from pharmacies
It is dispensed only with a doctor's prescription.
- - The description and photos on the product cards may differ from that presented in the pharmacy. Please check with the operators before placing an order.
- - This product cannot be exchanged or returned on the basis of Resolution 55 of 01/19/1998.
Ferrum Lek belongs to antianemic medicines prescribed in the treatment of anemia, which is associated with iron deficiency.
Pharmacological action Ferrum Lek
Ferrum Lek s medication active ingredient in the form of a complex compound of iron (III) polymaltose hydroxide helps to reduce the severity of signs of anemia. The iron found in the medicine is bound in a structure similar to the natural compound of iron, ferritin.
Iron uptake occurs through competitive ligand exchange on the surface of the intestinal epithelium. The absorbed iron binds to ferritin in the liver, and in the bone marrow it is later incorporated into hemoglobin.
During application, 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) polymaltose hydroxide) in an amount of 400 mg, which corresponds to 100 mg of iron. 10 tablets in a strip;
- Brown transparent syrup containing 5 ml of active substance (iron (III) polymaltose hydroxide) in an amount of 200 mg, which corresponds to 50 mg of iron. In dark bottles of 100 ml;
- Solution for intramuscular injection containing in 1 ml of active substance (iron (III) hydroxide of polymaltose) in the amount of 50 mg. In ampoules of 2 ml.
Analogs Ferrum Lek
According to the active substance, the analogue of Ferrum Lek is the drug Monofer, produced in the form of a solution for injection.
If necessary, for the treatment of anemia, the doctor may prescribe Ferrum Lek analogs, which belong to one drug group and have a similar therapeutic action... These include Argeferr, Likferr100, Venofer, Maltofer, Dextrafer, Ferinject, Ferinject and FerMed.
Indications for use Ferrum Lek
According to the instructions, Ferrum Lek is prescribed:
- For the treatment of latent iron deficiency and iron deficiency anemia;
- In order 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, lead poisoning anemia and other diseases;
- Anemias that are not associated with iron deficiency - megaloblastic anemia (associated with a lack of cyanocobalamin), hemolytic anemias, and others;
- Hypersensitivity to the active (iron (III) hydroxide polymaltose) or auxiliary components that make up Ferrum Lek.
Against the background of anemias that are 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 inside, but in some cases, after the doctor evaluates the ratio of the benefits of using the medication with possible risk for mother and fetus, perhaps its appointment during this period.
Ferrum Lek in the form of a solution is prescribed with caution against the background of chronic polyarthritis, bronchial asthma, cardiovascular insufficiency and children under 4 months.
Method of application Ferrum Lek
The medication in the dosage form of tablets can be swallowed whole with water, or chewed. If desired, the syrup can be mixed with vegetable or fruit juices, and for children it can be added to baby food. In this case, a measuring spoon should be used for accurate dosing.
The prescribed dose and duration of Ferrum Lek therapy according to the instructions depend on the degree of iron deficiency.
In the treatment of iron deficiency anemia, the duration of taking Ferrum Lek varies from 3 to 5 months. Treatment should be continued after hemoglobin levels have normalized for several weeks to replenish iron stores in the body.
For children under one year old, Ferrum Lek is usually prescribed 1 / 2-1 measuring spoon (which corresponds to 2.5-5 ml) of syrup per day. For children from one to 12 years old, the indicated dosage is doubled. Adults, nursing mothers and adolescents from 12 years old are prescribed 1-3 tablets or 2-6 scoops of syrup per day (which corresponds to 10-30 ml of medication).
For pregnant women, 2-3 chewable tablets of Ferrum Lek are recommended per day or 4-6 scoops of syrup (which corresponds to 20-30 ml of the medicine). The medication should be taken until the hemoglobin level is normalized, after which the intake is continued in a reduced dosage - 1 tablet or 2 scoops (which corresponds to 10 ml) until the end of pregnancy to maintain the required level of iron in the body.
Daily doses of Ferrum Lek for the prevention of anemia are usually prescribed by the attending physician.
In case of an overdose of 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 a solution for injection, depending on the level of hemoglobin, usually 1 to 2 ampoules per day are 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).
The introduction of a medication in the form of a solution is possible only intramuscularly.
Interaction with other drugs
The use of Ferrum Lek inside can be combined with other medicines and food.
The medication in the form of a solution for injection should not be combined with taking the medication by mouth. It should also be borne in mind that ACE inhibitors concurrently with parenteral administration medication can cause an increase in the severity of systemic effects.
Side effects of Ferrum Lek
According to reviews, Ferrum Lek most often causes indigestion, which manifest itself in the form of a feeling of heaviness, diarrhea, nausea, a feeling of pressure and fullness in the epigastric region, and constipation. The staining of feces in a dark color is due to the excretion of the active substance, which was not absorbed as a result of digestion, and does not require the withdrawal of the medication.
As a rule, the side effects caused by Ferrum Lek according to reviews are mild and transient.
When using Ferrum Lek in the form of a solution for injection, the following can be observed:
- Local reactions associated with the incorrect technique of administering the medication, manifested as staining of the skin and the appearance of soreness 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
Ferrum Lek according to the instructions belongs to the number of antianemic medicines prescription dispensing, with an expiration date, subject to the conditions necessary for storage:
- Syrup - 3 years;
- Chewable tablets and injection solution - 5 years.
Thank you
Ferrum Lek represents iron preparation, which normalizes the level of hemoglobin in the blood, and also prevents and eliminates an iron deficiency state of any genesis. The drug is intended for the normalization and maintenance of hemoglobin levels in children and adults of any sex.
Release forms, names and composition
Currently Ferrum Lek is available in the following dosage forms:- Oral syrup (glass bottles 100 ml);
- Chewable tablets (packs of 30 and 50);
- Solution for intramuscular injection (2 ml ampoules);
- Solution for intravenous administration (ampoules of 5 ml).
Oral forms (syrup and tablets) contain as active ingredient iron hydroxide polymaltose , and solutions for injection - iron hydroxide polyisomaltose (ferrisacarate) ... These active substances are a modification of the same chemical compound- iron sucrose. It's just that 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 forms Ferrum Lek contain the following amount of active substance:
- Tablets - 100 mg;
- Syrup - 10 mg in 1 ml, that is, 50 mg of iron in one 5 ml measuring spoon;
- Solution for intramuscular injection - 50 mg in 1 ml, that is, 100 mg in one whole ampoule with a volume of 2 ml;
- Solution for intravenous administration - 20 mg in 1 ml, that is, 100 mg in one whole ampoule with a volume of 5 ml.
Ferrum Lek - INN, photo and recipe
INN is an abbreviation for International non-proprietary name which is the common name chemical, which is an active, active ingredient. 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 polymaltose.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 out in the same way, only in the first line after the letters "Rp." write "Sol." or "Syr." respectively. On the second line after the letters "D.t.s." indicate the dosage of the syrup and the frequency of administration or the volume of the solution in milliliters, which is intended for a single administration.
Therapeutic effects of Ferrum Lek
Basic therapeutic effect of all dosage forms of Ferrum Leka is an increase in the level of hemoglobin in the blood and the creation of a depot of iron 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 the iron atom is slowly released from it directly, which is included in the composition of hemoglobin or ferritin in the bone marrow or liver, respectively.Iron polymaltose enters the bloodstream in the same amount, both with intramuscular injection and when taken orally. Therefore, the advantages of a shorter course of treatment and better absorption of iron do not have a solution for intramuscular administration over tablets and syrup. The most complete digestibility is possessed only by the solution for intravenous administration, with the use of which the course of treatment is somewhat shortened. but intravenous administration Ferrum Leka is used only if 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 maximally high.
Indications for use
Ferrum Lek tablets and syrup are indicated for use in the following cases: - Latent (latent) iron deficiency;
- Iron-deficiency anemia ;
- Prevention of iron deficiency during pregnancy and lactation, with heavy menstruation, etc.
- Severe anemia after heavy blood loss;
- Impaired absorption of iron in the intestine (for example, with inflammatory diseases intestines, stomach, etc.);
- Ineffectiveness of taking iron preparations inside;
- Inability, for any reason, to take iron preparations by mouth.
Ferrum Lek - instructions for use
General Provisions
All dosage forms of Ferrum Lek are intended for use in various dosages in the following possible cases:- Prevention of anemia and iron deficiency;
- Treatment of anemia;
- Treatment of latent iron deficiency.
However, in the absence of contraindications for taking iron orally, Ferrum Lek should be chosen in the form of syrup or tablets, since they have the least pronounced allergenic properties, the minimum risk of side effects, ease of use and the best tolerance. Intramuscular injections of Ferrum Leka should be used only in cases where a person, for whatever reason, cannot take the drug inside. Ferrum Lek should be injected intravenously only in cases where you need to quickly replenish the 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 syrup is more convenient to take, then it is best to use it. If it is subjectively more convenient to chew tablets, then Ferrum Lek should be taken in this form. Neither the tablets nor the syrup stain the teeth black.
The duration of the drug depends on the severity of iron deficiency. So, for the prevention of Ferrum Lek, you can use it as long as you like, as long as malnutrition or increased consumption of iron persists, for example, during pregnancy, active growth, sports training etc.
For the treatment of latent iron deficiency, taking Ferrum Lek in any dosage form is performed within 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 the normal range. And since ferritin is a form of iron storage, a decrease in its concentration in the blood indicates a complete depletion of the depot and the imminent development of anemia.
For the treatment of anemia, any dosage form of Ferrum Leka should be taken until the normalization of hemoglobin levels in the blood (approximately 3 to 5 months) in therapeutic dosages, and then for another 2 - 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 before childbirth, and optimally until the concentration of ferritin increases to normal.
Ferrum Lek tablets and syrup - instructions for use
The syrup and tablets should be taken orally during or immediately after a meal, as this minimizes the risk of side effects and irritation of the gastric mucosa with an iron compound. In principle, you can take the 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 neat or dissolved in a drink. At the same time, you can take any non-alcoholic drink with the exception of tea or milk to drink a tablet or dissolve a syrup, since they impair the absorption of iron from the intestine. 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 in as many identical doses as the number of times a person takes food in order to drink the drug after a meal.
Children under 12 years old need to take the drug exclusively in the form of a syrup, and after reaching the full 12 years old, tablets can also be used. Dosages of syrup and Ferrum Lek 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 (latent) 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 old - 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 injection should be done only if a person, for whatever reason, cannot take Ferrum Lek in tablets or syrup. Intravenous administration of the solution can be used to normalize the hemoglobin level 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 introduction of solutions intravenously or intramuscularly for the prevention or elimination of 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 amounts to 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 once a day, a person is injected with the entire daily dosage of the drug. Moreover, the solution is injected every day.
The solution for intravenous administration is administered according to the 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, until the end of the course of treatment, the solution is administered 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 Leka depends on the general iron deficiency in the body, which is calculated using a special formula or determined from 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 injection, an injection is made every day, introducing a daily dosage, until the calculated number of ampoules is used. And the solution is injected intravenously according to the above scheme, but also until all the calculated ampoules are used. For example, it is estimated that a person needs 15 ampoules of Maltofer to treat anemia. This means that within 15 days he needs to inject one ampoule of the solution intramuscularly every day, after which the course of treatment is considered complete. And intravenously, it is necessary to inject one ampoule 1 - 3 times a week, respectively, the course of treatment will be completed when all 15 ampoules are used.
The number of ampoules for intramuscular or intravenous administration for the full course of treatment is calculated by the formula:
total iron deficiency / 100 mg.
Total iron deficiency is calculated using the following formula:
body weight (kg) * ( normal level hemoglobin - the current level of hemoglobin) * 0.24 + iron reserves.
In this formula, the normal hemoglobin level is considered to be 130 with a body weight of less than 35 kg, and 150 with a weight of more than 35 kg. Iron reserves are taken equal to 500 with a body weight of more than 35 kg and is calculated based on the ratio of 15 per 1 kg of weight for a person weighing less than 35 kg. That is, for children less than 35 kg in weight, the iron reserves are calculated individually by multiplying the weight in kg by 15. These parameters are substituted into the formulas and calculated.
In addition to accurately calculating the number of ampoules required for the full course of treatment for anemia, 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 | The number of ampoules with a 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 in order to replenish the amount of iron after severe blood loss (more than 400 ml). In this case, the required number of ampoules of the solution 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 has 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 lost a lot of blood and the hemoglobin level dropped to 100. In this case, he needs 70 * (130 - 100) * 0.24 / 100 = 5.04 ampoules for treatment.
The counted number of ampoules is the required amount of solution for the full course of treatment. In this case, for adults, the solution is administered intravenously, 1 ampoule per day, and for children under 12 years old with a mass of less than 35 kg, the daily dosage is calculated individually, based on a ratio of 0.06 ml per 1 kg of body weight.
Ferrum Lek - how to inject intramuscularly correctly
The correct technique for administering the solution ensures the minimum risk of developing allergic reactions and pain, as well as the formation of seals, blackening of the skin, etc. For intramuscular injections, needles with a length of at least 5 - 6 cm with a narrow hole should be taken. Moreover, the less a 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, the required amount of solution is taken into the syringe, placed on a sterile tray and the injection site is found.
To find the exact injection site, use your index finger to feel the iliac crest on the right or left side. Then from this point to the side of the back is taken thumb and they also grope for the wing of the ilium. The thumb and forefinger, as well as the mentally drawn line connecting the tips of their nails, form a triangle. The lower part of this triangle, located before an imaginary line drawn from the connection index finger with the palm and until it intersects with the large one, and is the area where Ferrum Lek solution should be injected.
After determining the injection zone with two fingers, collect the skin in a small fold to exclude its staining and the ingress of the solution into the subcutaneous fatty tissue.
Then, with a free working hand, take a syringe already filled with the required amount of solution, and insert the needle into the needle strictly vertically to the surface of the body deep into the thickness of the tissues. Then slowly, within 5 - 7 minutes, Ferrum Leka solution is introduced. After the introduction of 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 the introduction of the drug, a person must perform intense body movements for 5 to 10 minutes.
Before the introduction of the first dose of Ferrum Leka, when it is not known whether a person has an allergic reaction to the drug, you must first enter 0.5 ml of solution (1/4 ampoule). Then wait 15 minutes, and if signs of an allergic reaction did not appear, then the entire remaining volume of the solution is injected. If a person has an allergic reaction, then Ferrum Lek is canceled.
Ferrum Lek - how to inject intravenously correctly
The ampoule with the solution is opened only immediately before use. Before opening the ampoule, the solution is carefully examined, and if flakes, turbidity or inclusions are visible in it, then it is not suitable for use. Intravenously, you can enter both a pure solution and diluted with saline. Moreover, a pure solution is injected in a stream (syringe), and diluted with saline - in the form of an infusion (dropper). Drip injection of the solution is preferable, since in this case the risk is minimal a sharp decline pressure.
Before the introduction of the first dose of Ferrum Lek, if it is not known whether a person is allergic to the drug, you must first enter 1 ml of the solution. Then wait 15 minutes, and if the allergy does not begin to develop, then you can continue to administer the entire remaining dose of the solution. If there are signs of allergy, then you will have to stop using Ferrum Leka.
Jet Ferrum Lek is injected in the form of an undiluted pure solution drawn from an ampoule into a syringe with a fine needle. The solution is injected at a rate of no more than 1 ml per minute. After the introduction of the entire volume of the drug for 5 - 10 minutes, the arm is fixed in an extended position.
Drip (infusion) Ferrum Lek is administered using a system (dropper). The preparation is preliminarily diluted in a ratio of 1:20, that is, 20 ml is taken for 1 ml of solution for injection saline... That is, one ampoule with a volume of 5 ml is diluted in 100 ml of saline. The solution is injected slowly at the following rate, depending on its volume:
- 100 ml - inject for 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 should not be mixed with other drugs in the same syringe. If Ferrum Leka enters the perineous space, it is necessary, without removing the needle, to inject a little saline, after which the affected area should be 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 stool to turn black, which is normal and does not require any treatment.
All dosage forms of Ferrum Lek do not affect the speed of psychomotor reactions, therefore, while taking the drug, you can control mechanisms, including driving a car.
Overdose
An overdose when taking Ferrum Lek tablets or syrup is almost 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 the blood directly, and is manifested by the following symptoms:
- Nausea;
- Bloody diarrhea;
- Pallor of the skin;
- Clammy and cold sweat;
- Weak pulse;
- Depression of the central nervous system.
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 preparation by mouth at least five days later.The introduction of solutions intravenously or intramuscularly simultaneously with the intake of drugs from the group ACE inhibitors(for example, Enalapril and others) enhances the side effects of Ferrum Leka.
Ferrum Lek for children and babies
General Provisions
Children under 12 years of age should only be given Ferrum Lek 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 dosage 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 babies. Intramuscular and intravenous injections 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 fatal.
The syrup and tablets should be given to the child during or immediately after a meal. If the child refuses to drink the solution due to subjective unpleasant taste, then the syrup the required amount of syrup can be dissolved in water or any other non-alcoholic beverage other than tea and milk. Perfect for dissolving Ferrum Lek syrup compotes, fruit drinks, vegetable or fruit juices, etc. It is recommended to choose the drink that the child loves.
If the child calmly drinks the syrup without dilution in the 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.
Babies are given syrup by dissolving it in sweet water, juice or formula for baby food. The medicine is usually given after the child has eaten at least a little, since taking Ferrum Lek on an empty stomach will cause severe and unpleasant irritation of the gastric mucosa in the baby.
Ferrum Lek instruction for children - how to take
Dosages of the drug for children over 12 years old are the same as for adults. And in children under 12 years old, various forms of the drug are used only for the treatment of anemia and latent iron deficiency, but not for prevention.For babies (children from birth to one year old), Ferrum Lek is given in the form of a syrup only for the treatment of anemia, 2.5 - 5 ml per day. Treatment is continued until the hemoglobin level rises to normal values.
For children aged 1 - 12 years, Ferrum Lek syrup for the treatment of various iron deficiency conditions is given in the following dosages:
- Anemia- 5-10 ml per day until the blood hemoglobin level is normalized. After increasing the hemoglobin level to the norm, continue taking Ferrum Lek at 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 gestational age. And solutions for intravenous and intramuscular administration can be used only from the 2nd trimester of pregnancy (from 13 weeks).Tablets and syrup during pregnancy with various conditions should be taken in the following dosages:
- Anemia- 2 - 3 tablets or 20 - 30 ml of syrup per day until the hemoglobin level is normalized. After increasing the concentration of hemoglobin 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 discoloration, soreness and induration.
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-Randu-Weber syndrome;
- Acute kidney infections;
- Uncontrolled hyperparathyroidism;
- Decompensated liver cirrhosis
- Ferlatum;
- Ferrlecite;
- Ferretab comp;
- Ferrogradumet;
- 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 were easy to use. Negative reviews in rare cases due to the ineffectiveness of the syrup and Ferrum Lek tablets, and in most situations they are associated with subjective poor tolerance drug. For example, a person was worried about 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. People generally respond positively to Ferrum Lek injections, noting that the injections of the drug very quickly allowed to increase the level of hemoglobin. However, in addition to the fast and of a good effect of injections, people note the strong painfulness of the injections and long-lasting bruises, which they have to put up with.
INSTRUCTIONS
on medical use medicinal product
Read this leaflet carefully before using this medication. Retain instructions as you may need them again.
If you have any questions, see your doctor. This medicine has been prescribed for you personally and should not be passed on to others as it may harm them even if you have the same symptoms as you.
Registration number:
Trade name of the drug:
Ferrum Lek ®.
International non-proprietary name or group name:
iron (III) hydroxide polymaltose.
Dosage form
Compound
5 ml of syrup (1 scoop) contains:
Active substance: iron 50.0 mg (which corresponds to 200.00 mg of iron (III) polymaltose hydroxide).
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 flavor - 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: B03AV05.
Pharmacological properties
Pharmacodynamics
The molecular weight of the complex is so high - 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 in a structure similar to that of the natural compound of iron, 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 the gastrointestinal fluid absorb iron (III) from the complex through competitive ligand exchange. The 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, in contrast to iron (II) salts, does not possess prooxidant properties. The sensitivity of lipoproteins (eg, very low density lipoproteins and low density lipoproteins) to oxidation is reduced.
Pharmacokinetics
Studies using the double isotope method (55 Fe and 59 Fe) have shown that the absorption of iron, measured by the level of 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 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 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 per day.
In women, additional iron loss occurs 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 of the body (for example, in cases of hemochromatosis, hemosiderosis);
violation of iron utilization (for example, anemia caused by lead intoxication, sideroachrestic anemia, thalassemia);
anemias not associated with iron deficiency (eg, hemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency);
rare hereditary forms fructose intolerance, glucose-galactose malabsorption and sucrose-isomaltase deficiency (since the drug contains sucrose and sorbitol).
Carefully
Patients with diabetes mellitus.
Application during pregnancy and lactation
In the course of controlled studies in pregnant women (2nd and 3rd trimesters of pregnancy), there was no negative effect on the organisms of the mother and fetus. There was no harmful effect on the fetus when taking drugs in the first trimester of pregnancy.
When a nursing mother uses the drug, breast milk only a small part of iron comes from its complex with polymaltose; thus, the occurrence of undesirable effects on those on breastfeeding children are unlikely.
Method of administration and dosage
Inside. The drug is recommended to be taken during or immediately after a meal. 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 old:
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 measuring spoon) of Ferrum Lek® syrup per day.
Iron-deficiency anemia
The duration of treatment is about 3-5 months. After normalization of the hemoglobin concentration, you should continue taking the drug for several more weeks in order to replenish the iron stores in the body.
Children under 1 year old
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 breastfeeding mothers
10-30 ml (2-6 scoops) of Ferrum Lek® syrup per day.
Pregnant women
Latent iron deficiency 10 ml (2 scoops) of Ferrum Lek ® syrup per day.
Prevention of iron deficiency
5-10 ml (1-2 scoops) of Ferrum Lek ® syrup per day
Iron-deficiency anemia 20-30 ml (4-6 scoops) of Ferrum Lek® syrup per day until the hemoglobin concentration is normalized. After that, 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 stores in the body.
Daily doses of the drug 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 mostly 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
rarely: pain in the abdomen, nausea, constipation, diarrhea, dyspepsia, vomiting, discoloration of feces (due to the elimination of non-absorbed iron, has no clinical significance).
On the part of the skin and subcutaneous tissue
rarely: urticaria, rash, itching of the skin.
If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects that are not indicated in the instructions, inform 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 medicinal products
Interaction with other drugs or food products has not been identified.
Concomitant use with parenteral iron preparations and other oral iron (III) preparations polymaltosate hydroxide is not recommended due to the pronounced inhibition of the absorption of orally supplied iron.
special instructions
Ferrum Lek ® syrup does not stain the enamel of the teeth.
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 is cured.
When using Ferrum Lek ®, the stool may turn dark, which does not have any clinical significance. Ferrum Lek ® does not affect the results of the occult blood test (selective for hemoglobin); thus, there is no need to interrupt iron therapy.
Due to the low dosage, Ferrum Lek ® should not be used for the treatment of latent iron deficiency in children under 1 year of age.
Note for patients with diabetes mellitus: 1 ml of Ferrum Lek ® syrup contains 0.04 XE.
Influence on the ability to drive vehicles and engage in other activities that require concentration of attention and speed of psychomotor reactions
Ferrum Lek ® does not affect the ability to drive a car and control mechanisms that require increased concentration.
Special precautions for disposal of unused medicinal products
Not applicable.
Release form
Syrup 50mg / 5ml
Primary packaging
Lek dd, Slovenia
100 ml of syrup in dark glass vials with or without a graduated level of 100 ml, sealed with a metal screw cap with a control ring for the first opening and a polyethylene gasket inside.
Sandoz Ilach Sanai ve Ticaret A.S., Turkey
100 ml of syrup in dark glass vials with or without a graduated level of 100 ml, sealed with a polyethylene screw cap with a control ring for the first opening and a polyethylene seal inside.
Secondary packaging
One bottle in a cardboard box together with instructions for use, a measuring spoon with ring marks in the cavity for 2.5 ml and 5 ml ("2.5 CC" and "5 CC", a maximum filling mark of 6 ml ("6 CC" ) on the handle of the 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 dd, Verovshkova 57, 1526, Ljubljana, Slovenia.
2. Sandoz Ilach Sanai Ve Tijaret A.S., Gebze Plasticchiler Organize
Sanay Bolgezi, Ataturk Boulevari 9, cad. No. 1, 41400 Gebze-Kotsaeli, Turkey
Consumer claims should be sent to Sandoz CJSC:
125315, Moscow, Leningradsky prospect, 72, bldg. 3.
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