Composition, form of production and packaging
The syrup is dark brown in color.
iron (III) hydroxide polymaltosate 35.7 mg,
which corresponds to an iron content of 10 mg
Auxiliary substances: sucrose - 200 mg, sorbitol solution 70% - 400 mg, methylparahydroxybenzoate - 0.583 mg, propyl parahydroxybenzoate 0.167 mg, ethanol 96% 3.25 mg, cream flavor 3 mg, sodium hydroxide to pH 5.0-7.0, purified water - up to 1 ml.
75 ml - bottles of dark glass (1) complete with a measuring cap - packs cardboard.
150 ml - bottles of dark glass (1) complete with a measuring cap - packs cardboard.
Drops for ingestion of dark brown color.
1 ml (20 drops)
iron (III) hydroxide polymaltosate 178.6 mg,
which corresponds to an iron content of 50 mg
1 drop contains 2.5 mg of iron.
Excipients: sucrose - 50 mg, sodium methylparahydroxybenzoate - 2 mg, sodium propyl parahydroxybenzoate - 0.22 mg, cream flavor - 3 mg, sodium hydroxide - up to pH 5.5-7.0, purified water - up to 1 ml.
10 ml - bottles of dark glass with a dispenser (1) - packs cardboard.
30 ml - bottles of dark glass with a dispenser (1) - packs cardboard.
10 ml - containers (tubes) polymer with a dispenser (1) - packs cardboard.
30 ml - containers (tubes) polymer with a dispenser (1) - packs cardboard.
Chew tablets of brown color with impregnations of white color, round, flat, with a risk.
iron (III) hydroxide polymaltosate 357 mg,
which corresponds to an iron content of 100 mg
Excipients: dextrates 232 mg, macrogol 6000-37 mg, talc purified 21 mg, sodium cyclamate 9 mg, vanillin 2.9 mg, cocoa powder 29 mg, chocolate flavor 0.6 mg, microcrystalline cellulose up to 730 mg.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
The preparation of iron. In iron (III), the polymethyltosate hydroxide multinucleated iron (III) hydroxide is surrounded from the outside by a number of covalently bound polymaltosate molecules, which provides a total average molecular weight of about 50 kDa. The structure of the active substance of the preparation of MaltoferВ® is similar to the structure of the nucleus of the ferritin protein, the physiological depot of iron. Iron (III) hydroxide polymaltose is stable and under physiological conditions does not emit a large number of iron ions. Due to the size, the degree of diffusion of iron (III) polymethyltosate hydroxide through the mucosa is approximately 40 times less than that of the iron-hexahedral complex (II). Iron, which is part of the complex of iron (III) hydroxide polymaltose, is actively absorbed in the intestine.
The effectiveness of the preparation Maltofer В® for the normalization of hemoglobin content and iron depot replacement has been demonstrated in numerous randomized controlled clinical trials using a placebo-controlled or active comparator performed in adults and children with different iron depot status.
Iron from iron (III) hydroxide polymaltose is absorbed in accordance with the controlled mechanism. The increase in serum iron content after application of the drug does not correlate with total iron absorption, measured as incorporation into hemoglobin (Hb). Studies with a labeled radioisotope of iron (III) hydroxide with polymaltozate revealed a strong correlation between the inclusion of iron in erythrocytes and the iron content throughout the body. The maximum activity of iron absorption from iron (III) hydroxide polymaltose is noted in the duodenum and small intestine. As with other iron preparations for oral administration, the relative absorption of iron from iron (III), the polymethyltosate hydroxide, defined as incorporation into hemoglobin, decreases with increasing doses of iron. In addition, a correlation was observed between the degree of iron deficiency (in particular serum ferritin concentration) and the relative amount of absorbed iron (i.e., the greater the iron deficiency, the better the relative absorption). In patients with anemia, absorption of iron from iron (III), polymethyltosate hydroxide, in contrast to iron salts, increased in the presence of food.
Distribution of iron from iron (III) hydroxide of polymaltozate after absorption was studied in a study using the technique of double isotopes ( 55 Fe and 59 Fe).
The absorbed iron binds to transferrin and is used to synthesize hemoglobin in the bone marrow or is stored mainly in the liver, where it binds to ferritin.
Non-sucked iron is excreted with feces.
- treatment of iron deficiency without anemia (latent iron deficiency) and treatment of clinically pronounced iron deficiency anemia;
- An increased need for iron during pregnancy, during breastfeeding, blood donation, intensive growth, vegetarianism and the elderly.
The drug is taken orally during or immediately after a meal. The daily dose can be divided into several doses or taken at a time.
Drops and syrup can be mixed with fruit, vegetable juices or soft drinks, baby food or baby formula. Light coloring of the mixture does not affect its taste or effectiveness.
Chewable tablets can be chewed or swallowed whole.
The exact dose of Maltofer В® syrup can be measured with a measuring cap attached to the preparation.
To accurately measure the dose of drops, MaltoferВ® vial / container (tube) should be kept upright. Drops should flow immediately. If this does not happen, you should tap the bottle / container (tube) slightly before the drop appears. Do not shake the vial / container (tube).
The daily dose of the drug depends on the degree of iron deficiency (table).
Patient category Form of drug Iron deficiency anemia Latent iron deficiency Prevention of iron deficiency
Preterm infants Drops 1-2 drops (2.5-5 mg iron) / kg body weight - -
Children under 1 year Drops 10-20 drops 6-10 drops 2-4 drops
Syrup 2.5-5 ml * *
The iron content (25-50 mg) (15-25 mg) (5-10 mg)
Children from 1 year to 12 years Drops 20-40 drops 10-20 drops 4-6 drops
Syrup 5-10 ml 2.5-5 ml *
The iron content (50-100 mg) (25-50 mg) (10-15 mg)
Children over 12 years Drops 40-120 drops 20-40 drops 4-6 drops
Syrup 10-30 ml 5-10 ml *
Tablets 1-3 tablets. 1 tab. *
The iron content (100-300 mg) (50-100 mg) (10-15 mg)
Adults, (including lactating women) Drops 40-120 drops 20-40 drops 4-6 drops
Syrup 10-30 ml 5-10 ml 5-10 ml
Tablets 1-3 tablets. 1 tab. *
The iron content (100-300 mg) (50-100 mg) (10-15 mg )
Pregnant women Drops 80-120 drops 40 drops 40 drops
Syrup 20-30 ml 10 ml 10 ml
Tablets 2-3 tablets. 1 tab. 1 tab.
The iron content (200-300 mg) (100 mg) (100 mg)
* Due to the need to prescribe very small doses for these indications, it is recommended to use the preparation Maltofer В® drops for oral administration.
Treatment of iron deficiency anemia in children and adults
Treatment to achieve a normal hemoglobin (Hb) takes about 3 to 5 months. After this, the treatment should be continued for 1-2 months in the dose described for the case of iron deficiency without anemia, in order to replenish iron stores.
Treatment of iron deficiency anemia in pregnancy
Treatment should be continued until the hemoglobin (Hb) content is normalized. After this treatment should be continued at least until the end of pregnancy in a dose described for the case of iron deficiency without anemia, in order to replenish iron stores and meet the increased requirements for iron in connection with pregnancy.
Treatment and prevention of iron deficiency without anemia takes about 1 to 2 months.
Contraindicated use of the drug Maltofer В® chewing tablets in children under 12 years .
Safety and tolerability of the preparation Maltofer В® has been evaluated in a variety of clinical studies.
The frequency of side effects was determined as follows: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100).
The main undesirable drug reactions noted in these studies occurred in the following three classes of systems and organs.
Undesirable drug reactions observed in clinical trials
From the nervous system: infrequently - a headache.
From the side of the digestive system: very often - a change in the color of stool 1 ; often - diarrhea, nausea, dyspepsia; infrequently - vomiting, constipation, abdominal pain, discoloration of tooth enamel 2 .
From the skin and subcutaneous tissues: infrequently - rash 3 , itching.
1. Often recorded as an undesirable phenomenon (in 23% of patients), this is a well-known undesirable drug reaction to iron preparations for oral administration.
2. An adverse event was recorded in 0.6% of patients, this is a well-known undesirable drug reaction for iron preparations for oral administration.
3. Including exanthema.
Spontaneous post-marketing reports of adverse drug reactions
There were no additional undesirable drug reactions.
Deviations of laboratory indicators
No data available.
- established hypersensitivity to iron (III) hydroxide polymaltozate or to any auxiliary substance;
- Iron overload (eg, hemosiderosis and hemochromatosis);
- impairment of iron utilization (eg, lead anemia, sidero-achestic anemia, thalassemia);
- Anemia not associated with iron deficiency (eg, hemolytic anemia or megaloblastic anemia caused by a lack of vitamin B 12 );
- deficiency of sugar / isomaltase, fructose intolerance, glucose-galactose malabsorption (Maltofer В® drops for oral administration and Maltofer В® syrup);
- Children under 12 years of age (Maltofer В® chewing tablets).
Caution should be given to maltofer В® syrup for patients with liver disease, alcoholism, with a craniocerebral trauma or with brain diseases, t. the preparation contains ethanol.
PREGNANCY AND LACTATION
To date, there have been no reports of serious adverse reactions after taking Maltofer В® inwards at therapeutic doses in the treatment of anemia in pregnancy. The data obtained from animal studies did not indicate a hazard to the fetus and the mother. Data of clinical studies on the use of the preparation of Maltofer В® in the first trimester of pregnancy are absent.
In studies conducted in pregnant women after the end of the first trimester of pregnancy, no undesirable effects of the preparation Maltofer В® on mothers and / or newborns were found. In this regard, adverse effects on the fetus when using the drug Maltofer В® is unlikely.
Breast milk of a woman contains iron, associated with lactoferrin. The amount of iron that passes from iron (III) hydroxide polymaltose to breast milk is unknown. It is unlikely that the use of the drug Maltofer В® women breastfeeding, can lead to undesirable effects in the child.
As a precaution to women of childbearing age, women during pregnancy and during breastfeeding should take the drug Maltofer В® only after consulting a doctor. It is recommended that the benefit / risk ratio be evaluated.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Caution should be given to maltofer В® syrup for patients with liver disease, t.p. the preparation contains ethanol.
APPLICATION FOR CHILDREN
Contraindicated use of the drug Maltofer В® chewing tablets in children under 12 years. Dosage form and concentration of preparations Maltofer В® drops for oral administration and Maltofer В® syrup are better suited for taking the recommended dose in this age group.
Anemia can be caused by infectious diseases or malignant neoplasms. Since iron can only be taken after the root cause of the disease has been eliminated, the relationship between benefit and risk of treatment should be determined.
The daily dose of the preparation Maltofer В® syrup contains ethanol in an amount from 0.008 g (dose 2.5 ml) to 0.1 g (dose 30 ml).
When prescribing a patient with diabetes, it should be noted that 1 ml of drops for oral administration contains 0.01 XE, 1 ml of syrup - 0.04 XE, 1 tablet chewing - 0.04 XE.
Syrup and drops for ingestion contain sucrose, which can harm the teeth.
During treatment with the preparation Maltofer В® , a dark colouration of the stool can be noted, however this has no clinical significance.
Auxiliary substances of sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which are part of the preparation Maltofer В® in the form of syrup and drops for oral administration, can cause allergic reactions (possibly, delayed type).
Use in Pediatrics
Contraindicated use of the drug Maltofer В® chewing tablets in children under 12 years . Dosage form and concentration of preparations Maltofer В® drops for oral administration and Maltofer В® syrup are better suited for taking the recommended dose in this age group.
Impact on the ability to drive vehicles and manage mechanisms
No data available. It is unlikely that the preparation of Maltofer В® influences the ability to drive vehicles and mechanisms.
In case of an overdose of the preparation, Maltofer В® iron overload or intoxication is unlikely, which is due to the low toxicity of iron (III), polymethyltosate hydroxide and controlled iron uptake. No cases of unintentional poisoning with a lethal outcome were reported.
The interaction of iron (III) hydroxide of polymaltosate with tetracycline and aluminum hydroxide was studied. There was no significant decrease in tetracycline absorption. The concentration of tetracycline in the blood plasma did not drop below the effective level. Absorption of iron from iron (III) hydroxide polymaltozate did not decrease under the influence of aluminum hydroxide or tetracycline. Thus, iron (III) hydroxide polymaltosate can be used simultaneously with tetracycline and other phenolic compounds, as well as with aluminum hydroxide.
In studies in rats using tetracycline, aluminum hydroxide, acetylsalicylic acid, sulfasalazine, calcium carbonate, calcium acetate and calcium phosphate in combination with vitamin D 3 , bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol and auranofin, no interaction with iron (III) hydroxide with polymaltosate.
The interaction of iron (III) hydroxide of polymaltosate with food components such as phytic acid, oxalic acid, tannin, sodium alginate, choline and choline salts, vitamin A, vitamin D 3 and vitamin E, soybean oil and soybean flour has also not been observed. These results indicate that iron (III) hydroxide polymaltose can be taken during or immediately after ingestion.
The administration of the drug does not affect the results of the detection of hidden blood (with a selective determination of hemoglobin), so there is no need to interrupt treatment.
It is necessary to avoid simultaneous use of iron preparations for parenteral administration and ingestion, since absorption of iron taken orally slows down.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of no higher than 25 В° C. Shelf life of drops for ingestion and syrup - 3 years, tablets chewing - 5 years.