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medicalmeds.eu Medicines Iron preparation. Мальтофер®

Мальтофер®

Препарат Мальтофер®. Nycomed Austria GmbH (Никомед Австрия ГмбХ) Австрия


Producer: Nycomed Austria GmbH (Nikomed Austria Gmbh) Austria

Code of automatic telephone exchange: B03AB05

Release form: Liquid dosage forms. Drops.

Indications to use: Iron deficiency anemia.


General characteristics. Structure:

Drops for intake of 50 mg/ml: 1 ml of drug contains gland (III) hydroxide полимальтозат, equivalent 50 mg of iron, and also, sucrose, sodium methyl-n-hydroxybenzoate, sodium propyl-n-hydroxybenzoate, fragrance cream, sodium hydroxide and the purified water. 20 drops, 1 drop contain 2,5 mg of iron in 1 ml.
Syrup of 10 mg/ml: 1 ml of drug contains gland (III) hydroxide полимальтозат, equivalent 10 mg of iron, and also sucrose, solution of sorbite of 70%, methyl-n-gidroksibenzoat, propyl-n-hydroxybenzoate, ethanol of 96% (3,25 mg), fragrance cream, sodium hydroxide and the water purified.
Tablets chewing 100 mg: One tablet contains gland (III) hydroxide полимальтозат, equivalent 100 mg of iron, and also a dekstrata, a macrogoal 6000, talc purified of sodium cyclomate, vanillin, cocoa powder, fragrance chocolate, and cellulose microcrystallic.
Solution for intake of 20 mg/ml: 1 ml of drug contains gland (III) hydroxide полимальтозат, equivalent 20 mg of iron, and also sucrose, solution of sorbite of 70%, sodium methyl-n-hydroxybenzoate, sodium propyl-n-hydroxybenzoate, fragrance cream, sodium hydroxide, and the water purified. One bottle (5 ml) contains 100 mg of iron.

Description:

Drops for intake, syrup and solution for intake: solution of darkly brown color
Chewable tablet: brown ploskotsilindrichesky tablets with inclusions of white color and risky.




Pharmacological properties:

The drug Maltofer® contains iron in the form of a polymaltose complex of a hydroxide of iron (III). This macromolecular complex is stable and does not emit iron in the form of free ions in digestive tract. The structure Maltofer® is similar to natural compound of iron of ferritin. Thanks to such similarity, iron (III) comes from intestines to blood by active transport. The soaked-up iron contacts ferritin and is stored in an organism, is preferential in a liver. Then, in marrow it is included hemoglobin. The iron which is a part of a polymaltose complex of a hydroxide of iron (III) has no pro-oxidatic properties, unlike simple salts of iron. There is a correlation between expressiveness of deficit of iron and level of its absorption (the more expressiveness of deficit of iron, the is better absorption). The most active process of absorption happens in a duodenal and small bowel.
The drugs Maltofer® do not cause coloring of enamel of teeth.


Indications to use:

• Treatment of latent (LDZh) and clinically expressed deficit of iron (an iron deficiency anemia – ZhDA),
• Prevention of deficit of iron during pregnancy, lactations, in the genital period at women, at children, at teenage age, at adults (for example, vegetarians and elderly people).


Route of administration and doses:

Inside.
Daily dose it is possible to accept all in time or immediately after food at once. By means of the measured cap attached to the drug Maltofer® syrup it is possible to calculate an exact dose of drug. Drops for intake, syrup and solution for intake it is possible to mix with fruit and vegetable juice or with soft drinks. It is possible to chew or swallow of chewable tablets entirely. Weak coloring of drink does not change its taste and does not reduce efficiency of drug.
The daily dose of drug depends on degree of deficit of iron (see the table of daily dosages).

Table of daily dosages:

Category of patients                                                                  Prevention ZhDA LDZh Form
                                    drug
Premature children     of the Drop           1-2 drops on kg           -                                     -
                                                         body weights in 
                                                        current
                                                         3-5 months
Children till 1 year              of the Drop           of 10-20 drops           of 6-10 drops             of 6-10 drops
                                   Syrup          of 2,5-5 ml                   *                               *
                                                        (25-50 mg of iron)    (15-25 mg of iron)   (15-25 mg of iron)
Children from 1 to 12 years      of the Drop          of 20-40 drops            of 10-20 drops           of 10-20 drops
                                   Syrup          of 5-10                                        ml 2,5-5 ml 2,5-5 ml
                                                      (50-100 mg of iron)   (25-50 mg of iron)   (25-50 mg of iron)
Children are more senior than 12 years     of the Drop          of 40-120 drops           of 20-40 drops            of 20-40 drops
                                   Syrup          of 10-30                                         ml 5-10 ml 5-10 ml
                                                      (100-300 mg of iron)  (50-100 mg of iron)  (50-100 mg of iron)
The adults feeding    Drops         of 40-120 drops             of 20-40 drops              of 20-40 drops
                    women Sirop          of 10-30                                            ml 5-10 ml 5-10 ml
                                   Tablets      1-3 tablets                1 tablet                  **
                                  Bottles       1-3 bottles               1 bottle                    **
                                                      (100–300 mg of iron)   (50–100 mg of iron) (50-100 mg of iron)
Pregnant women  of the woman Kapli        of 80-120 drops             of 40 drops                of 40 drops
                                     Syrup         of 20-30                                        ml 10 ml 10 ml
                                     Tablets     2-3 tablets              1 tablet             1 tablet
                                     Bottles     2-3 bottles                1 bottle                1 bottle
                                                       (200–300 mg of iron)    (100 mg of iron)     (100 mg of iron)

* Due to the need of purpose of very small doses, according to these indications it is recommended to use the drop drug Maltofer® for intake
** Due to the need of purpose of small doses, according to these indications it is recommended to use the drop drug Maltofer® for intake or Maltofer® syrup

Duration of treatment of clinically expressed deficit of iron (iron deficiency anemia) makes 3-5 months before normalization of level of hemoglobin. After that, administration of drug should be continued in a dosage for treatment of latent deficit of iron within several more months, and for pregnant women, at least, before childbirth for recovery of reserves of iron.
Duration of treatment of latent deficit of iron makes 1-2 months. In case of clinically expressed insufficiency of iron, normalization of level of hemoglobin and completion of reserves of iron happens only 2-3 months later after an initiation of treatment.


Features of use:

At purpose of the drugs Maltofer® a sick diabetes mellitus it is necessary to consider that 1 ml of drops contains 0,01 grain units, 1 ml of syrup and 1 chewable tablet contain 0,04 grain units, and 1 bottle contains 0,11 grain units.

Use during pregnancy:

In controlled researches at pregnant women after the first trimester of pregnancy undesirable influence of drug on mother and a fruit was not noted. There are no data on undesirable influence of drug on a fruit during the first trimester of pregnancy.


Side effects:

Very seldom (it is more or equally than 0,001% and less than 0,01%) signs of irritation of digestive tract, such as feeling of overflow, pressure in epigastric area, nausea, a lock or diarrhea can be noted.
Perhaps dark coloring of a chair caused by release of not soaked up iron (clinical value has no).


Interaction with other medicines:

Interaction with other medicines is not revealed.


Contraindications:

• Overload iron (for example, hemosiderosis and hemochromatosis)
• Iron utilization disturbance (for example, lead anemia, sideroakhrestichesky anemia)
• Not iron deficiency anemias (for example, the hemolitic anemia or megaloblastny anemia caused by a lack of vitamin B 12).


Overdose:

So far in drug overdose cases, it was not reported neither about intoxication, nor about overload signs by iron.


Storage conditions:

List B.
At a temperature is not higher plus 25 °C in protected from light and the place, unavailable to children.

Period of validity: Drops for intake, chewable tablets, solution for intake of-5 years, syrup - 3 years. Not to apply after the period of validity specified on packaging.


Issue conditions:

According to the recipe


Packaging:

Drops for intake:
Bottles of dark glass, on 10 ml or 30 ml corked by polyethylene drop dosers, closed by the screwed plastic covers with a safety ring of control of the first opening, or polymeric containers (tubes), on 10 ml or 30 ml, with the integrated drop dosers, closed by the screwed plastic covers with control of the first opening and the mechanism for protection from opening by children. On one bottle or a polymeric container (tuba) and the instruction on a medical use is placed in a cardboard pack.
Syrup:
Bottles of dark glass, po75 ml or 150 ml closed by the screwed covers from polyethylene of high pressure with the control of the first opening and a measured cap which is put on a cover. On one bottle and the instruction on a medical use is placed in a cardboard pack.
Chewable tablets:
On 10 tablets in blisters. On 1 or 3 blisters together with the application instruction place in a cardboard pack.
Solution for intake:
10 bottles from transparent glass of a hydrolytic class corked by the stretching polyethylene covers on 5 ml together with the application instruction place in a cardboard pack.



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