Composition, form of production and packaging
Solution for ingestion of dark brown color.
1 ml of 1 fl.
iron (III) hydroxide polymaltosate 71.4 mg 357 mg,
equivalent to the iron content of 20 mg of 100 mg
Auxiliary substances: sucrose - 100.0 mg, sorbitol solution 70% - 200.0 mg, sodium methylparahydroxybenzoate - 1.54 mg, sodium propyl parahydroxybenzoate 0.17 mg, cream flavor 3.0 mg, sodium hydroxide up to pH 4.5-7.0, purified water up to 1 ml.
5 ml - bottles of glass (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
The preparation of Maltofer contains iron in the form of a polymaltose complex of ferric hydroxide (III). This macromolecular complex is stable and does not release iron as free ions in the gastrointestinal tract. The structure of Maltofer is similar to the natural iron compound ferritin. Due to this similarity, iron (III) comes from the intestine into the blood via active transport. The absorbed iron binds to ferritin and is stored in the body, mainly in the liver. Then, in the bone marrow it is included in the hemoglobin. Iron, which is part of the polymetose complex of ferric hydroxide (III) does not have pro-oxidant properties, unlike simple iron salts. There is a correlation between the severity of iron deficiency and the level of its absorption (the greater the severity of iron deficiency, the better the absorption). The most active absorption process occurs in the duodenum and small intestine.
Maltofer solution for oral administration does not cause staining of teeth.
INDICATIONS
- treatment of latent and clinically pronounced iron deficiency (iron deficiency anemia);
- prevention of iron deficiency during pregnancy.
DOSING MODE
Maltofer solution for oral administration in single-dose vials is intended for oral administration.
The daily dose can be taken all at once or right after meals.
Drinking solution can be mixed with fruit and vegetable juices or with soft drinks. Weak coloring of the drink does not change its taste and does not reduce the effectiveness of the drug.
The daily dose of the drug depends on the degree of iron deficiency.
Children over 12 years of age, adults and nursing mothers:
Treatment of clinically pronounced iron deficiency (iron deficiency anemia): 1 bottle 1-3 times a day for 3-5 months before the normalization of the hemoglobin level of the blood. After this, the drug should be continued for several more months in order to restore iron stores in the body in a dosage of 1 bottle per day.
For the therapy of latent iron deficiency and for the prevention of iron deficiency: 1 vial a day for 1 -2 months.
Pregnant women:
Treatment of clinically pronounced iron deficiency (iron deficiency anemia): 1 bottle 2-3 times a day for 3-5 months before the normalization of hemoglobin level of blood. After this, the drug should be continued at a dosage of 1 bottle per day, at least until the birth to restore iron stores.
For latent deficiency therapy: 1 bottle per day for 1-2 months.
In the case of clinically severe iron deficiency, normalization of hemoglobin level occurs only after 2-3 months after the start of treatment.
SIDE EFFECT
Occasionally, signs of irritation of the gastrointestinal tract, such as a feeling of overflow, pressure in the epigastric region, nausea, constipation, or diarrhea may be noted.
Perhaps the dark staining of the stool, due to the release of not absorbed iron (a clinical value does not matter).
CONTRAINDICATIONS
- an excess of iron (for example, hemosiderosis and hemochromatosis);
- impairment of iron utilization (eg, lead anemia, sidero-achestic anemia);
- non-iron deficiency anemia (eg, hemolytic anemia or megaloblastic anemia, caused by a lack of vitamin B 12 ).
PREGNANCY AND LACTATION
In controlled studies in pregnant women after the first trimester of pregnancy, there was no undesirable effect of the drug on the mother and fetus. There is no evidence of an undesirable effect of the drug on the fetus during the first trimester of pregnancy.
APPLICATION FOR CHILDREN
In connection with the need to prescribe smaller doses, in preterm infants it is recommended to use the preparation of Maltofer droplets, in children up to the age of 12 it is a preparation of Maltofer syrup.
SPECIAL INSTRUCTIONS
When prescribing a drug for people with diabetes, it should be noted that 1 bottle contains 0.11 units of bread.
In connection with the need to prescribe smaller doses, in preterm infants it is recommended to use the preparation of Maltofer droplets, in children up to the age of 12 it is a preparation of Maltofer syrup.
OVERDOSE
To date, in cases of drug overdose, neither toxicity nor signs of an excess of iron have been reported.
DRUG INTERACTION
Interaction with other drugs has not been identified.
TERMS OF RELEASE FROM PHARMACY
According to doctor's prescription.
TERMS AND CONDITIONS OF STORAGE
At a temperature not higher than 25 В° C in a place protected from light and out of reach of children. Shelf life - 5 years.
