Maltofer Drops 50 mg / ml, 30 ml (iron III hydroxide polymaltozat)

Latin name

Maltofer

Release form

Drops for oral administration are dark brown.

Packaging

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

Indications

treatment of latent and clinically severe iron deficiency (iron deficiency anemia)

prevention of iron deficiency during pregnancy, lactation, in women of childbearing age, in children, adolescents, in adults (e.g., vegetarians and the elderly).

Contraindications

excess iron (e.g. hemosiderosis and hemochromatosis)

impaired iron utilization (e.g. lead anemia, siderochrestic anemia)

non-deficient anemia (e.g. hemolytic anemia or megaloblastic anemia caused by a lack of vitamin B12)

intolerance or hypersensitivity to any of the components of the drug.

Use during pregnancy and lactation

In controlled trials in pregnant women after the first trimester of pregnancy, there was no adverse effect of the drug on the mother and fetus.

There is no evidence of an adverse effect of the drug on the fetus in the first trimester of pregnancy.

Composition

1 drop of 1 ml (20 drops)

iron (in the form of iron (III) hydroxide polimaltozata) 2. 5 mg 50 mg

Excipients:

sucrose - 50 mg,

methyl p-hydroxybenzoate sodium - 2 mg,

propyl p-hydroxybenzoate - 0.22 mg,

cream flavor - 3 mg,

sodium hydroxide - up to pH 5.5 -7.0,

purified water - up to 1 ml.

Dosage and administration

The drug is taken orally during or immediately after a meal.

Drops and syrup can be mixed with fruit, vegetable juices or soft drinks. Chewable tablets can be chewed or swallowed whole.

The daily dose of the drug depends on the degree of iron deficiency (table).

Patient category Form of the drug Iron deficiency anemia Latent iron deficiency Prevention

Premature

children Drops 1-2 drops / kg

for 3-5 months - -

Children

up to 1 year Drops 10-20 drops 6-10 drops

6-10 drops

syrup 2. 5-5 ml * *

Iron content (25-50 mg) (15-25 mg) (15-25 mg)

Children

1 year to 12 years old Drops 20-40 drops 10-20 drops 10-20 drops 10-20 drops

Syrup 5-10 ml 2.5-5 ml 2.5-5 ml

Iron content (50-100 mg) (25-50 mg) (25-50 mg)

Children

over 12 years old Drops 40-120 drops 20-40 drops 20 -40 drops

Syrup 10-30 ml 5-10 ml 5-10 ml

Iron content (100-300 mg) (50-100 mg) (50-100 mg)

Adults, including lactating women) Drops 40-120 drops 20-40 drops 20-40 drops

Syrup 10-30 ml 5-10 ml 5-10 ml

Tablets 1-3 tab. 1 tab **

Iron content (100-300 mg) (50-100 mg) (50-100 mg)

Pregnant women Drops 80-120 drops 40 drops 40 drops

Syrup 20-30 ml 10 ml 10 ml

Tablets 2-3 tab. 1 tab 1 tab

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 Maltofer® Drops for oral administration.

** Due to the need to prescribe small doses for these indications, it is recommended to use the Maltofer® drops for oral administration or Maltofer® syrup.

The duration of treatment for clinically severe iron deficiency (iron deficiency anemia) is 3-5 months, until hemoglobin levels normalize. After this, the drug should be continued in a dose intended for the treatment of latent iron deficiency for a few more months, and for pregnant women, at least before delivery, to restore iron stores.

The duration of treatment for latent iron deficiency is 1-2 months.

In the case of clinically severe iron deficiency, normalization of hemoglobin level and replenishment of iron stores occurs only after 2-3 months after the start of treatment.

Side effects of the digestive system: very rare ( 0.001% and

Drug Interaction

No interaction has been detected with other medicinal products.

Overdose

To date, no drug intoxication or signs of iron overload have been reported in cases of drug overdose.

Storage conditions

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25 ° C.

Expiration

5 Chron

Active ingredient

Iron III hydroxide polymaltozat

Terms of delivery from

pharmacies Prescription

dosage form

dosage form srlkl dlpf18 sldlfp dlpfrd srdllpp dl18

Viefor (International) Inc., Switzerland



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