Maltofer injection 50mg/ml 2ml vial, 5 vials

Maltofer - the preparation of iron. After the / m introduction of iron hydroxide polymaltozate enters the bloodstream through the lymphatic system. From the plasma macromolecular complex enters the reticulo-endothelial system, where it is split into iron hydroxide and polymaltose. The slow release of iron is the reason for its good tolerability. In the liver is included in the composition of 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 the bone marrow is included in the hemoglobin and used in the process of erythropoiesis.

It is well known that the inclusion of iron in protoporphyrin depends on the severity of iron deficiency anemia. It is intense in the case of a low level of hemoglobin and decreases as the hemoglobin level normalizes.

The response from the blood indicators for parenteral administration of iron occurs no faster than with the oral administration of iron salts in patients in whom they are effective.

The degree of iron utilization can not be higher than the iron-binding capacity of transport proteins.

The effect of renal and hepatic insufficiency on the pharmacological properties of iron (III) polymethyltosate hydroxide is not known.

Like other iron preparations, Maltofer has no effect on erythropoiesis and is ineffective in anemia not associated with iron deficiency.

The toxicity of the drug is very low. With IV injection of the preparation Maltofer LD50y white mice was> 2500 mg iron per kg body weight, which is 100 times lower than for simple iron salts.

Indications:

Treatment of iron deficiency in case of insufficient efficiency, inefficiency or impossibility of oral intake of iron-containing preparations, including:

• with malabsorption;
• in patients who do not agree long and regularly to use oral iron preparations;
• in patients with gastrointestinal diseases (for example, ulcerative colitis), in which iron preparations for oral administration can provoke an exacerbation of the disease.

Maltofer for injection is used only if the iron deficiency state is confirmed by appropriate studies (for example, serum ferritin, hemoglobin, hematocrit, or erythrocyte count, as well as their mean erythrocyte volume, mean hemoglobin content in erythrocyte).

Contraindications:

• anemia not associated with iron deficiency (e.g., hemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency, disturbances of erythropoiesis, bone marrow hypoplasia);
• excess iron (ie hemochromatosis, hemosiderosis);
• impairment of iron utilization (eg, sidero-achestic anemia, thalassemia, lead anemia, late porphyria of the skin);
• Osler-Randu-Weber syndrome;
• chronic polyarthritis;
• bronchial asthma;
• infectious diseases of the kidneys in the acute stage;
• uncontrolled hyperparathyroidism;
• decompensated cirrhosis of the liver;
• infectious hepatitis;
• I trimester of pregnancy;
• IV introduction;
• hypersensitivity to the components of the drug.

Side effects:

On the part of the body as a whole: rarely - joint pain, enlarged lymph nodes, fever, headaches, malaise; very rarely - allergic or anaphylactic reactions.

From the digestive system: rarely - nausea, vomiting (stop with symptomatic therapy).

Local reactions: violation of the technique of drug administration can lead to skin staining, the appearance of soreness and inflammation at the injection site.

Special instructions:

Parenteral iron preparations can cause allergic and anaphylactic reactions. In the case of moderate allergic reactions, antihistamines should be prescribed; with the development of severe anaphylactic reaction requires the immediate introduction of epinephrine (adrenaline). With the introduction it is necessary to ensure the availability of cardiopulmonary resuscitation.

With caution, the drug should be administered to patients with allergies, as well as hepatic and renal insufficiency.

Side effects, which occur in patients with cardiovascular diseases, can aggravate the course of the underlying disease.

Patients with bronchial asthma or having a low iron-binding capacity of serum and / or deficiency of folic acid belong to a group at high risk of developing allergic or anaphylactic reactions.

Before using the drug, the ampoule should be inspected for sediment and damage. Use only ampoules without sediment and damage. After opening the ampoule, the injection solution should be administered immediately.

Maltofer for injection should not be mixed with other therapeutic agents.

Use in Pediatrics

In children, the parenteral use of iron preparations can adversely affect the course of the infection process.

It is not recommended to prescribe the drug to children under 4 months due to lack of experience in this category of patients.

Impact on the ability to drive vehicles and manage mechanisms

Influence on the ability to drive vehicles or work with mechanisms is unlikely.

Suggested Use:

The drug is given in / m.

Before the first administration of the therapeutic dose, an IM test should be performed: adults are injected from 1/4 to 1/2 of the drug dose (25 to 50 mg of iron (0.5-1 ml)), children from 4 months - half the daily dose. In the absence of adverse reactions within 15 minutes after administration, the remainder of the initial dose of the drug can be administered.

During the injection, it is necessary to ensure the availability of funds for the provision of emergency care in the development of anaphylactic shock.

The dose of the drug is calculated individually and adapted to the overall iron deficiency according to the following formula:

Total iron deficiency (mg) = body weight (kg) × (normal Hb level - patient Hb level) (g / l) × 0.24 * + iron stocks (mg)

With a body weight of less than 35 kg: normal Hb = 130 g / l, which corresponds to the deposited iron = 15 mg / kg body weight

At a body weight of more than 35 kg: a normal level of Hb = 150 g / l, which corresponds to the deposited iron = 500 mg

* Factor 0.24 = 0.0034 × 0.07 × 1000 (iron content in hemoglobin = 0.34% / blood volume = 7% of body weight / factor 1000 = conversion from g to mg)

Total number of ampoules for administration = total iron deficiency (mg) / 100 mg.

Packaging:

• Comes in original packaging. Item is brand new and unopened.

Storage:

• Keep away from direct sunlight.
• Keep locked and away from children.
• Store in dry place at room temperature.
• Do not exceed storage temperature higher than 25 C

Important notice- the outer box design may vary before prior notice!