Maltofer capsules. Maltofer drops for children: instructions for use, main indications and precautions

Maltofer is a drug to replenish iron deficiency in iron deficiency anemia or replenishing hemoglobin reserves during periods of increased need.

Iron preparation in the form of a polymaltose complex of Fe3+ hydroxide. Active ingredient– Iron (III) hydroxide polymaltosate.

Maltofer contains a stable macromolecular complex and does not release iron in the form of free ions in gastrointestinal tract. Due to this, it enters the blood from the intestines through active transport. Absorbed iron binds to ferritin and is stored in the body, mainly in the liver.

In addition to iron, the drug Maltofer FOL contains folic acid, which belongs to the B group of vitamins and is involved in the production nucleic acids, purines, amino acids, pyrimidines. Additionally stimulates erythropoiesis (the process of producing red blood cells).

Forms of release of the drug:

• Oral solution: dark brown(5 ml in glass bottles, 10 bottles in a cardboard box);
• Drops for oral administration: dark brown (30 ml in dark glass bottles with a dispenser, 1 bottle in a cardboard box);
• Syrup: dark brown (150 ml in dark glass bottles, 1 bottle in a cardboard box complete with a measuring cap);
• Chewable tablets: flat-cylindrical, scored, brown with inclusions white(10 pieces in blisters, 3 blisters in a cardboard box);
• Solution for injection: brown (2 ml in colorless glass ampoules, 5 ampoules in a cardboard box).

Indications for use

What does Maltofer help with? According to the instructions, the drug is prescribed in the following cases:

• Treatment of latent and severe iron deficiency (iron deficiency anemia);
• Prevention of iron deficiency during pregnancy;
• Prevention of iron and folic acid deficiency (including during pregnancy and lactation).

Solution for injection:

• Treatment of iron deficiency anemia in case of ineffectiveness or impossibility of taking oral iron supplements medicines(including in patients with gastrointestinal diseases and those suffering from malabsorption syndrome).

Instructions for use Maltofer, dosage

The tablets should be taken orally after meals with clean water. The dosage and timing of treatment depend on the degree of iron deficiency. Daily dose can be divided into several doses or taken once (depending on tolerance).

To treat severe iron deficiency, take 1 Maltofer tablet 1 to 3 times a day for 3-5 months. After a course of use, the drug is continued until the level of iron in the body is restored - 1 tablet \ 1 time per day.

Dosage for pregnant women: 1 tablet \ 2 to 3 times a day, until hemoglobin stabilizes. Afterwards, you should drink 1 tablet \ 1 time per day until childbirth, in order to prevent iron deficiency and treat hidden iron deficiency.

Instructions for Maltofer drops and syrup

Drops and syrup are (mainly) used for children; adults are recommended to take tablets.

The dosage of Maltofer syrup and drops for children depends on the indications and the level of iron in the body. Do not exceed the dosage!

For iron deficiency anemia:

• Premature babies: 1-2 drops of solution/kg;
• Children under 1 year: 10-20 drops of solution or 2.5-5 ml of syrup;
• Children 1-12 years old: 20-40 drops of solution or 5-10 ml of syrup;
• Children from 12 years old: 40-120 drops of solution or 10-30 ml of syrup;
• Adults (including nursing women): 40-120 drops of solution, 10-30 ml of syrup;
• Pregnant women: 80-120 drops of solution, 20-30 ml of syrup.

For latent iron deficiency:

• Children under 1 year: 15-25 mg of iron – 6-10 drops of solution;
• Children 1-12 years old: 25-50 mg of iron - 10-20 drops of solution or 2.5-5 ml of syrup;
• Children over 12 years old: 50-100 mg of iron – 20-40 drops of solution or 5-10 ml of syrup;
• Adults (including nursing women): 50-100 mg of iron – 20-40 drops of solution, 5-10 ml of syrup;
• Pregnant women: 100 mg of iron – 40 drops of solution, 10 ml of syrup.

For prevention purposes, the instructions for use recommend the following dosages of Maltofer:

• Children under 1 year: 6-10 drops of solution;
• Children 1-12 years old: 10-20 drops of solution or 2.5-5 ml of syrup;
• Children from 12 years old: 20-40 drops of solution or 5-10 ml of syrup;
• Adults (including nursing women): 20-40 drops of solution or 5-10 ml of syrup;
• Pregnant women: 40 drops of solution, 10 ml of syrup.

Special instructions

It is important to understand that treatment with iron supplements is quite long and takes at least 3 months - this is necessary so that the body’s iron levels are replenished and the necessary reserves are created. Thus, after complete normalization clinical picture blood it is necessary to take the drug for another 1 month.

During the period of use of Maltofer, the instructions recommend refraining from drinking coffee and strong black tea. After taking the drug, it is not recommended to drink milk. These products lead to decreased iron absorption and decreased therapeutic effect. Milk and coffee should be drunk no earlier than 3 hours after taking the drug.

Side effects

The instructions warn about the possibility of developing the following side effects when prescribing Maltofer:

• nausea,
• vomit,
• pain in the epigastric region,
• stool disorders.

Darkening may occur feces– the symptom does not matter.

Contraindications

It is contraindicated to prescribe Maltofer in the following cases:

• increased individual sensitivity to the components of the drug;
• excess iron in the body (hemochromatosis, hemosiderosis);
• anemia not associated with iron deficiency ( hemolytic anemia or megaloblastic anemia caused by cyanocobalamin deficiency, aplastic anemia);
• violation of iron utilization mechanisms (lead anemia, sideroachrestic anemia, thalassemia, cutaneous porphyria tarda).

Additionally for solution for intramuscular administration:

• Rendu-Weber-Osler disease;
• chronic polyarthritis;
• infectious kidney diseases in the acute stage;
• uncontrolled hyperparathyroidism;
• decompensated cirrhosis of the liver;
• infectious hepatitis;
• early childhood(up to 4 months);
• pregnancy (first trimester).

Patients with allergies, liver and renal failure the drug should be taken with caution.

Sufferers bronchial asthma, patients with low serum iron-binding capacity and/or folic acid deficiency are at risk of developing allergic or anaphylactic reactions.

Before using the solution for intramuscular administration, ampoules should be inspected for sediment and damage. Ampoules with sediment and damage should not be used.

Overdose

The likelihood of an overdose when taking the drug orally is low. Clinical studies have confirmed that even with 2000 mg of iron per 1 kg of human weight, death is unlikely. In case of overdose, increased side effects are likely.

The likelihood of overdose increases with intramuscular injection means. Acute iron overload may occur and symptoms of hemosiderosis will appear.

Treatment is symptomatic, taking chelates (deferoxamine intravenously).

Analogues of Maltofer, price in pharmacies

If necessary, you can replace Maltofer with an analogue therapeutic effect– these are preparations containing iron:

1. Globigen,
2. Ferumbo,
3. Ferinject,
4. Profer,

Matches by ATX code:

• Sorbitrim,
• Fer-Rompharm,
• Ferrum Lek.

When choosing analogues, it is important to understand that instructions for use of Maltofer, price and reviews of drugs similar action do not apply. It is important to consult a doctor and not change the drug yourself.

Price in pharmacies in Moscow and Russia: Maltofer drops 50 mg/ml 30 ml - from 255 to 311 rubles, cost of syrup 10 mg/ml 150 ml - from 282 to 369 rubles, price of Maltofer chewable tablets 100 mg 30 pcs. – from 301 to 370 rubles, according to 702 pharmacies.

Store in a place protected from light and out of reach of children at a temperature not exceeding +25°C.

Dispensing conditions from pharmacies are by prescription.

Oral solution and drops. It is required to dissolve the specified dosage of the drug in a small amount of juice or other non-alcoholic drink.

The syrup should also be taken orally. In this case, the required dose is measured through a measuring cap. It is also allowed to dissolve the syrup in juice or some other non-alcoholic drink.

Chewable tablets are taken orally and can be chewed or swallowed whole. In this case, you need to drink them with water or other liquid.

The duration of therapy, as well as dose sizes (regardless of the form of the drug used) are selected for each person separately; this should be done by the attending doctor.

To eliminate iron deficiency anemia in premature infants, 2.5-5 mg/kg is usually prescribed once a day.

For infants under 1 year of age (treatment of iron deficiency anemia), the drug is generally prescribed in the amount of 25-50 mg once a day. In case of hidden iron deficiency or as a preventive measure for the development of iron deficiency, you should take 15-25 mg of the medicine once a day.

For children 1-12 years old (elimination of iron deficiency anemia), the dose is mainly 50-100 mg of the medicine once a day, and when treating latent iron deficiency or preventing the development of deficiency, it is necessary to drink 25-50 mg of the medicine once a day.

For adolescents over 12 years of age and adults (and lactating women), during the treatment of iron deficiency anemia, a single dose of 100-300 mg of drugs is prescribed. When eliminating latent iron deficiency, and also for prevention, take 50-100 mg of the medicine once a day.

Pregnant women suffering from iron deficiency anemia are often prescribed 200-300 mg of drugs once a day. To eliminate hidden iron deficiency or prevent the development of the disease, you need to drink 100 mg of the medicine once a day.

The duration of the therapeutic course for eliminating iron deficiency anemia is often 5-7 months.

In case of iron deficiency anemia in a pregnant woman, it is recommended to take the medicine until the moment of delivery in order to restore the level of iron inside the body.

When eliminating hidden iron deficiency, the treatment course usually lasts 1-2 months.

Bipso GmbH/ Vifor (International) Inc. Vifor (International) Inc./Akrikhin OJSC Vifor (International) Inc. Vifor S.A. Vifor S.A./Vifor(International) Inc. Geymonat/Vifor(International) Inc. Nycomed GmbH/ Vifor (International) Inc.

Country of origin

Germany/Switzerland Italy/Switzerland Russia Switzerland

Product group

Blood and circulation

Hematopoiesis stimulator-iron drug

Release forms

• 10 - blisters (3) - cardboard packs 10 - blisters (3) - cardboard packs. 10 - blisters (3) - cardboard packs. 150 ml - dark glass bottles (1) complete with measuring cap - cardboard packs. 2 ml - ampoules (5) - contour cell packs (1) - 30 ml cardboard packs - dark glass bottles with dispenser (1) - 5 ml cardboard packs - bottles (10) - cardboard packs. 5 ml - bottles (10) - cardboard packs. 75 ml - dark glass bottles (1) complete with dosage cap - cardboard packs. 100 ml - dark glass bottles (1) complete with dosage cap - cardboard packs. 150 ml - ampoule bottle of 2 ml (50 mg/ml) - 5 pcs per pack. Drops for oral administration

Description of the dosage form

• 10 ml - dark glass dropper bottle (1) - cardboard packs. 30 ml - dark glass dropper bottle (1) - cardboard packs. Drops for oral administration are dark brown in color. Solution for intramuscular administration is brown in color. Solution for injection Oral solution Oral solution Syrup Dark brown syrup Tablets Chewable Tablets chewing brown, flat-cylindrical, with white inclusions and scoring. Chewable tablets

Pharmacological action

Iron supplement. After intramuscular administration of iron (III), polymaltosate hydroxide enters the bloodstream through lymphatic system. From the plasma, the macromolecular complex enters the reticuloendothelial system, where it is broken down into iron hydroxide and polymaltose. The slow release of iron is the reason why it is well tolerated. In the liver it is included in hemoglobin, myoglobin and iron-containing enzymes, and is also deposited in the body in the form of ferritin. In the blood, iron binds to transferrin, in bone marrow is included in hemoglobin and is used in the process of erythropoiesis. It is well known that the incorporation of iron into protoporphyrin depends on the severity of iron deficiency anemia. It is intense in case low level hemoglobin and decreases as hemoglobin levels normalize. The response from blood parameters to parenteral iron administration is no faster than to oral administration of iron salts in patients in whom they are effective. The degree of iron utilization cannot be higher than the iron-binding capacity of transport proteins. The influence of renal and liver failure on pharmacological properties iron(III) hydroxide polymaltosate is not known. Like other iron preparations, Maltofer® has no effect on erythropoiesis and is ineffective for anemia not associated with iron deficiency. The toxicity of the drug is very low. With intravenous administration of the drug Maltofer® LD50 in white mice was >2500 mg of iron per kg of body weight, which is 100 times lower than for simple iron salts.

Pharmacokinetics

Absorption and distribution After an intramuscular injection, the Cmax of iron is reached in approximately 24 hours. In the blood, iron binds to transferrin, in tissues it is deposited as part of ferritin, and in the bone marrow it is included in hemoglobin. In small quantities, the unchanged complex can pass through the placental barrier and small amounts of it enter the breast milk. Iron bound to transferrin can cross the placental barrier and, as part of lactoferrin, enters breast milk in small quantities. Metabolism and excretion From the plasma, the macromolecular complex enters the reticuloendothelial system, where it is split into components: iron hydroxide and polymaltose. Only small amounts of iron are excreted from the body. Polymaltose is metabolized by oxidation or excreted. There are no data on the pharmacokinetics of the drug in patients with iron deficiency anemia.

Special conditions

Parenteral iron supplements can cause allergic and anaphylactic reactions. In case of moderate allergic reactions, should be assigned antihistamines; If a severe anaphylactic reaction develops, immediate administration of epinephrine (adrenaline) is necessary. When introducing, it is necessary to ensure the availability of funds cardiopulmonary resuscitation. The drug should be administered with caution to patients with allergies, as well as liver and kidney failure. Side effects, occurring in patients with cardiovascular diseases, can aggravate the course of the underlying disease. Patients with bronchial asthma or those with low serum iron-binding capacity and/or folic acid deficiency belong to the group high risk development of allergic or anaphylactic reactions. Before using the drug, ampoules should be inspected for sediment and damage. You can only use ampoules without sediment or damage. After opening the ampoule, the injection solution should be administered immediately. Maltofer® for injection should not be mixed with other therapeutic drugs. Use in pediatrics In children parenteral use Iron supplements can negatively affect the course of the infectious process. It is not recommended to prescribe the drug to children under 4 months of age due to the lack of experience with this category of patients. Impact on the ability to drive vehicles and operate machinery. Impact on the ability to drive vehicles or operate machinery is unlikely. Injection technique Injection technique is critical. As a result of improper administration of the drug, there may be painful sensations and coloring of the skin at the injection site. The ventrogluteal injection technique described below is recommended instead of the generally accepted one (in the upper outer quadrant of the gluteus maximus muscle). The length of the needle should be at least 5-6 cm. The lumen of the needle should not be wide. For children, as well as for adults with low body weight, the needles should be shorter and thinner. Instruments are disinfected using the usual method. According to Hochstetter recommendations, the injection site is determined as follows: along the line spinal column at the level corresponding to the lumboiliac joint, fix point A. If the patient lies on the right side, then place middle finger left hand at point A. Move the index finger away from the middle finger so that it is under the line of the iliac crest at point B. A triangle located between the proximal phalanges, middle and index fingers is the injection site. Before inserting the needle, you should move the skin about 2 cm in order to properly close the puncture channel after removing the needle. This prevents the injected solution from penetrating into subcutaneous tissue and skin coloring. Place the needle vertically in relation to the surface of the skin, at a large angle to the point iliac joint than to the point hip joint. After the injection, slowly remove the needle and press the area of ​​skin adjacent to the injection site with your finger for about 5 minutes. After the injection, the patient needs to move. Do not freeze.

Compound

• iron (in the form of iron (III) hydroxide polymaltose) 10 mg Excipients: sucrose, sorbitol solution 70%, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethanol 96% - 3.25 mg, cream flavor, sodium hydroxide, purified water iron (in the form of iron (III) hydroxide polymaltose) 100 mg Excipients : dextrates, macrogol 6000, purified talc, sodium cyclamate, vanillin, cocoa powder, chocolate flavor, microcrystalline cellulose. iron (in the form of iron (III) hydroxide polymaltose) 100 mg folic acid 350 mcg Excipients: dextrates, macrogol 6000, purified talc, sodium cyclamate, vanillin, cocoa powder, chocolate flavor, microcrystalline cellulose. iron (in the form of iron (III) hydroxide polymaltosate) 50 mg/ml Excipients: sodium hydroxide/hydrochloric acid - up to pH 5.2-6.5, water for injection - up to 1 ml. iron (in the form of iron (III) hydroxide polymaltosate) 50 mg/ml Excipients: sucrose, sodium methyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, cream flavor, sodium hydroxide, purified water. iron (in the form of iron (III) hydroxide complex with polymaltose) 50 mg/ml iron (III) hydroxide complex with polymaltose 71.4 mg, which corresponds to an iron content of 20 mg

Maltofer indications for use

• Treatment of iron deficiency in case of insufficient effectiveness, ineffectiveness or impossibility of oral administration of iron-containing drugs, including: - malabsorption; - in patients who do not agree to long-term and regular use of oral iron supplements; - in patients with gastrointestinal diseases (for example, ulcerative colitis), in whom oral iron supplements can provoke an exacerbation of the disease. Maltofer® for injection is used only in cases of iron deficiency confirmed by appropriate studies (for example, determination of the level of serum ferritin, hemoglobin, hematocrit or red blood cell count, as well as their parameters - average red blood cell volume, average hemoglobin content in a red blood cell).

Maltofer contraindications

• - hypersensitivity; - excess iron in the body (hemochromatosis, hemosiderosis); - anemia not associated with iron deficiency (hemolytic anemia or megaloblastic anemia caused by a lack of cyanocobalamin, aplastic anemia); - violation of iron utilization mechanisms (lead anemia, sideroachrestic anemia, thalassemia, cutaneous porphyria tarda).

Maltofer dosage

• 10 mg/ml 100 mg 100 mg + 0.35 mg 20 mg/ml 50 mg/ml

Maltofer side effects

• From the body as a whole: rarely - joint pain, increased lymph nodes, fever, headaches, malaise; very rarely - allergic or anaphylactic reactions. From the outside digestive system: rarely - nausea, vomiting (resolved with symptomatic therapy). Local reactions: Violation of the technique of administering the drug can lead to skin staining, pain and inflammation at the injection site.

Drug interactions

Like all other parenteral iron preparations, Maltofer® should not be used simultaneously with oral iron preparations, since the absorption of the latter from the gastrointestinal tract is reduced. Therefore, treatment with oral iron should be started no earlier than 1 week after the last injection. Simultaneous use ACE inhibitors(for example, enalapril) may increase the systemic effects of parenteral iron preparations.

Overdose

To date, no cases of iron overdose have been reported. Symptoms: in case of overdose, acute iron oversaturation is possible, which manifests itself as symptoms of hemosiderosis. Chronic excess iron leads to the development of hemochromatosis. This can happen when setting misdiagnosis iron deficiency anemia in case of treatment-resistant anemia. Treatment: Hemochromatosis should be treated in the same way as thalassemia - with intravenous deferoxamine. Iron (III) complex hydroxide polymaltosate is not excreted from the body during hemodialysis due to its high molecular weight. Periodic monitoring of serum ferritin levels may help in timely recognition of progressive iron accumulation.

Storage conditions

• keep away from children
• store in a place protected from light

Information provided

INN: Iron (III) hydroxide polymaltosate

Manufacturer: Vifor SA

Anatomical-therapeutic-chemical classification: Ferric oxide polymaltose complexes

Registration number in the Republic of Kazakhstan: No. RK-LS-5No. 021554

Registration period: 14.08.2015 - 14.08.2020

Instructions

Trade name

Maltofer®

International nonproprietary name

Dosage form

Tablets, coated film-coated 100 mg

Compound

One tablet contains

active substance- iron (III) hydroxide polymaltose 357.0 mg

(equivalent to 100 mg iron),

excipients: macrogol 6000, microcrystalline cellulose, crospovidone, magnesium stearate,

composition of the film shell - dye Opadry ОY-S-36413 burgundy*.

*Dye composition: hydroxypropyl methylcellulose, hydroxypropylcellulose, polyethylene glycol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description

The tablets are round, biconvex, film-coated, brownish-burgundy in color.

Pharmacotherapeutic group

Hematopoiesis stimulants. Iron supplements. Ferric iron preparations for oral administration. Iron polyisomaltosate.

ATX code B03AB05

Pharmacological properties

Pharmacokinetics

Suction

Iron from iron(III) hydroxide polymaltose complex (IPC) is absorbed through a controlled mechanism. Level increase serum iron after taking the drug does not correlate with the rate of total iron absorption, measured by the level of its inclusion in Hb. Studies using radiolabeled FA have shown a good correlation between the percentage of iron uptake into red blood cells (incorporation into Hb) and absorption, measured as body iron content. Maximum absorption of iron from the gastrointestinal tract occurs in the duodenum and jejunum. As with other oral iron preparations, the relative absorption of iron from the gall bladder, measured as its incorporation into Hb, decreased with increasing iron dose. There was also a correlation between the degree of iron deficiency (i.e., serum ferritin level) and the relative amount of iron absorbed (i.e., the greater the iron deficiency, the better the relative absorption). It was shown that, in contrast to iron salts, the absorption of iron from the bile duct was increased when the drug was taken with food in patients with anemia.

Distribution

The distribution of iron from the LPC after absorption was shown during the study and using the double isotope method (55Fe and 59Fe).

Biotransformation

After absorption, iron from the gallbladder is used in the bone marrow for the synthesis of Hb or stored by binding to ferritin, mainly in the liver.

Removal

Unabsorbed iron is excreted in the feces.

Pharmacodynamics

Mechanism of action

Polynuclear iron(III) hydroxide centers are surrounded by non-covalently bound polymaltose molecules, forming a complex with a total molecular weight of about 50 kDa. The multinuclear centers of the GC have a structure similar to ferritin, a physiological iron storage protein. Iron(III)-hydroxide polymaltose is a stable complex that does not release large number iron under physiological conditions. This molecule is so large that its diffusion across the intestinal mucosal membrane is approximately 40 times less than that of a hexameric iron(II) compound. Iron from the digestive tract is absorbed in the intestine by active transport.

Pharmacodynamic effects

Once absorbed, iron binds to transferrin and is used for hemoglobin synthesis in the bone marrow or stored primarily in the liver, where it binds to ferritin.

Clinical efficacy and safety

The effectiveness of Maltofer® in normalizing Hb levels and replenishing iron stores has been demonstrated in numerous randomized placebo- or comparator-controlled trials clinical trials conducted with the participation of adult patients and children with different iron levels in the body. These studies involved 3,800 patients, approximately 2,300 of whom received Maltofer®.

Indications for use

Maltofer® is used to treat iron deficiency conditions in the following cases:

treatment of iron deficiency without anemia and iron deficiency anemia (IDA)

prevention of iron deficiency

prevention of iron deficiency during pregnancy

Directions for use and doses

The daily dose can be divided into several doses or taken once. Maltofer® tablets are taken orally during meals or immediately after, swallowing whole.

Treatment of iron deficiency anemia in children over 12 years of age and adult patients:

100 - 300 mg of iron (1 - 3 tablets) daily for 3 - 5 months until hemoglobin (Hb) levels normalize. After this, the drug must be continued to be taken for several weeks at the dosage used for iron deficiency without anemia in order to replenish iron reserves in the body.

Treatment of iron deficiency anemia during pregnancy:

200 - 300 mg of iron (2 - 3 tablets) daily until Hb levels normalize. After this, the drug must be continued until the end of pregnancy at the dosage used for iron deficiency without anemia in order to replenish iron reserves in the body and meet the increased need for iron during pregnancy.

Treatment and prevention of iron deficiency without anemia in children over 12 years of age and adult patients:

100 mg (1 tablet) daily for 1 - 2 months.

Side effects

Very often(>1/10)

change in stool color

Often (≥1/100,<1/10)

• indigestion

Uncommon (≥1/1000, <1/100)

stomach pain

discoloration of tooth enamel

rash, itching

headache

Contraindications

known hypersensitivity to iron (III) hydroxide polymaltose complex (IPC) or any of the excipients listed in the "Composition" section

iron overload, e.g. hemochromatosis, hemosiderosis

iron absorption disorders such as lead poisoning anemia, sideroblastic anemia, thalassemia

anemia not caused by iron deficiency, such as hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency

Drug interactions

The interaction of ZPA (with or without folic acid) with tetracycline or aluminum hydroxide was studied in 3 human studies. There was no significant decrease in tetracycline absorption. Tetracycline plasma concentrations did not fall below the efficacy level. When using aluminum hydroxide or tetracycline, the absorption of iron from the iron was not reduced. Iron (III) hydroxide is a polymaltose complex, therefore, can be used simultaneously with tetracycline and other phenolic compounds, as well as aluminum hydroxide.

Similarly, no interactions were observed with food ingredients such as phytic acid, oxalic acid, tannin, sodium alginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soybean oil and soybean flour in studies in vitro using ZhPC. These results confirm that GPC can be taken during or immediately after a meal.

There is no deterioration in the results of the hemoccult test to detect occult blood (selective for Hb), therefore, there is no need to interrupt treatment.

Special instructions

Anemia can be caused by infections or tumors. Since iron can only begin to be absorbed after treatment of the underlying disease, it is recommended to evaluate the benefit/risk ratio.

During treatment with the drug Maltofer®, a change in the color of the stool to a darker color may be observed, but this phenomenon has no clinical significance.

Use in pediatrics

Maltofer® film-coated tablets are not recommended for use in children under 12 years of age. For this age group, it is recommended to take Maltofer® in the form of syrup or drops.

Pregnancy

There are no data from clinical studies regarding the use of Maltofer® in pregnant women in the first trimester. To date, there have been no reports of serious adverse reactions occurring after taking Maltofer® in therapeutic doses for the treatment of anemia during pregnancy. Therefore, it is unlikely that the use of Maltofer® can cause harm to the health of the mother and/or fetus.

Lactation period

Breast milk usually contains iron bound to lactoferrin. The amount of iron transferred from the gallbladder to breast milk is unknown. It is unlikely that the use of Maltofer® in women during breastfeeding will have undesirable effects on the child.

As a precaution, women of childbearing age, as well as during pregnancy and breastfeeding, should take Maltofer® only after consulting a doctor. It is recommended to evaluate the benefit/risk ratio.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

No data available.

Overdose

It is unlikely that cases of overdose, iron oversaturation or intoxication will occur when using the drug Maltofer® due to the low toxicity of the glandular complex and controlled intake of iron. No accidental poisoning episodes or deaths were reported.

Release form and packaging

tab. chewable 100 mg: 30 pcs.
Reg. No.: 6978/04/10 from 01/28/2010 - Expired

Chewable tablets brown, flat-cylindrical, with white inclusions and notches.

Excipients: dextrates, macrogol 6000, purified talc, sodium cyclamate, vanillin, cocoa powder, chocolate flavor, microcrystalline cellulose.

10 pcs. - blisters (3) - cardboard packs.

syrup 10 mg/1 ml: fl. 150 ml per set with measure cap
Reg. No: 7421/05/11 from 01/10/2011 - Valid

Syrup dark brown.

Excipients: sucrose, sorbitol solution 70%, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethanol 96% (3.25 mg), cream flavor, sodium hydroxide, purified water.

150 ml - dark glass bottles (1) complete with measuring cap - cardboard packs.

drops for oral administration 50 mg/1 ml: fl. 30 ml with dispenser
Reg. No.: 6979/04/10 from 01/28/2010 - Expired

Drops for oral administration dark brown.

Excipients: sucrose, sodium methyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, cream flavor, sodium hydroxide, purified water.

30 ml - dark glass bottles with dispenser (1) - cardboard packs.

Description of the drug MALTOFER ® based on officially approved instructions for use of the drug and made in 2013. Update date: 03/19/2013

Pharmacological action

Antianemic agent, iron supplement. Absorbed iron binds to ferritin and is deposited in the body, mainly in the liver. Then, in the bone marrow it is included in hemoglobin.

Pharmacokinetics

Suction

The drug Maltofer ® contains iron in the form of iron (III) hydroxide polymaltosate. This macromolecular complex is stable and does not release iron in the form of free ions in the gastrointestinal tract. The structure of iron(III) hydroxide polymaltosate is similar to the natural iron compound ferritin. Due to this similarity, iron (III) moves from the intestine into the blood through active transport.

A study of the drug Maltofer ® with a radioactive label showed that the degree of absorption, i.e. the portion of iron included in hemoglobin is inversely proportional to the dose. The amount of iron absorbed depends on the degree of its deficiency (the greater the iron deficiency, the better the absorption). During therapeutic use of the drug Maltofer ®, absorption is about 10%. Maltofer ® is absorbed in the small intestine, mainly in the duodenum and jejunum. At least at the beginning of the course of treatment, the iron contained in iron (III) polymaltose hydroxide has less bioavailability than the iron in ferrous iron preparations.

Removal

Unabsorbed iron is excreted in the feces.

Dosage regimen

The drug is taken orally during or immediately after meals.

The daily dose of the drug depends on the degree of iron deficiency (Tables 1 and 2).

Table 1. Daily dose of iron depending on the degree of iron deficiency

Table 2. Amount of iron in dosage forms of the drug

Premature newborns: 2.5-5 mg iron (1-2 drops)/kg body weight daily for 3-5 months.

The daily dose can be taken all at once or divided into several doses.

The dose and duration of treatment depend on the degree of iron deficiency. At severe iron deficiency The drug is continued until the hemoglobin content normalizes, i.e. on average 3-5 months. After this, the drug is continued for several weeks in doses to treat latent iron deficiency in order to create an iron reserve. Treatment latent iron deficiency lasts approximately 1-2 months.

Maltofer ® syrup and drops can be mixed with fruit or vegetable juices, or with a nutritional formula in a bottle. A slight coloration of the mixture is possible, which does not reduce the effectiveness of the drug and does not change its taste.

Chewable tablets can be swallowed whole or chewed.

Side effects

Determination of the frequency of adverse reactions:

• often (>1/100,<1/10), нечасто (>1/1000, <1/100), редко (>1/10 000, <1/1000), очень редко (<1/10 000).

Allergic reactions: very rarely - urticaria, bronchial asthma.

From the nervous system: in some cases - headache.

From the digestive system: often - nausea, constipation;

in some cases - abdominal pain, stomach pain, dyspepsia, vomiting, diarrhea, reversible staining of teeth. Stool coloration due to iron excretion is often observed.

From the skin: very rarely - itching, exanthema, local skin reactions.

From the urinary system: rarely - dark coloration of urine.

Use during pregnancy and breastfeeding

The studies conducted did not reveal any negative effects on pregnancy, fetal or newborn health.

Breast milk normally contains iron bound to lactoferrin. It is unknown how much iron from Maltofer ® passes into breast milk. It is unlikely that taking Maltofer can cause undesirable effects in infants. Before using Maltofer ® during pregnancy or breastfeeding, consult a doctor.

IN experimental studies animals did not show any signs of direct or indirect toxic effects on pregnancy, embryonic or fetal development.

Special instructions

Anemia should always be treated under medical supervision.

If there is no effect (hemoglobin level has not increased by approximately 20-30 g/l after 3 weeks), the treatment plan should be reconsidered.

The drug should be prescribed with caution to patients who have undergone repeated blood transfusions, because Red blood cells carry iron into the body, which can cause iron overload.

When prescribing the drug to patients with diabetes, it should be taken into account that 1 ml of drops for oral administration contains 0.01 XE, 1 ml of syrup - 0.04 XE, 1 chewable tablet - 0.03 XE.

Impact on the ability to drive vehicles and operate machinery

No relevant studies have been conducted. However, it is unlikely that Maltofer ® has any effect on the ability to drive vehicles or operate machinery.

Overdose

In case of an overdose of iron (III) hydroxide polymaltosate, signs of poisoning and iron overload were not observed, which is due to the absence of free iron in the gastrointestinal tract, as well as the fact that the iron included in the composition of iron (III) hydroxide polymaltosate does not enter the body through a passive mechanism diffusion.

Known symptoms of overdose characteristic of other iron preparations (ferrous salts), such as convulsions, hypotension, shock, metabolic acidosis or coma, have not yet been reported.

Drug interactions

Studies conducted in rats did not show any interaction with tetracycline, aluminum hydroxide, acetylsalicylate, sulfasalazine, calcium carbonate, calcium acetate and calcium phosphate in combination with vitamin D 3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol and auranofin.

There was also no in vitro interaction observed with food components such as phytic acid, oxalic acid, tannin, sodium alginate, choline and its salts, vitamin A, vitamin D 3 , vitamin E, soybean oil and soybean flour. These results suggest that iron(III) hydroxide polymaltosate can be taken with or immediately after meals.

Three crossover studies involving 22 patients each did not show a significant decrease in tetracycline absorption. The concentration of tetracycline in the blood plasma did not fall below the level providing the required effectiveness.

Aluminum hydroxide and tetracycline did not reduce the absorption of iron(III) polymaltose hydroxide in human studies. Therefore, iron (III) hydroxide polymaltosate can be taken simultaneously with tetracycline or other phenolic substances, as well as aluminum hydroxide.

The drug does not affect the results of the test for the presence of occult blood (selective hemoglobin test), so there is no need to stop treatment for the test.

Concomitant parenteral and oral administration of iron supplements should be avoided as this significantly reduces the absorption of oral iron.

Contacts for inquiries

TAKEDA LLC, representative office, (Austria)

Representative office of "TAKEDA Osteuropa Holding GmbH"
in the Republic of Belarus