Maltofer, 50 mg/ml 2 ml 5 pcs

Maltofer is a replacer of iron deficiency.

Pharmacodynamics

After the intravenous administration, the iron released from the active ingredient, iron (III) hydroxide polymaltosate, is absorbed mainly by the liver.

It is then incorporated into hemoglobin, myoglobin and iron-containing enzymes, and is stored in the body as ferritin. The blood count response when iron is given parenterally is not faster than when iron salts are taken orally in patients in whom they are effective. Like other iron preparations, Maltofer® has no effect on erythropoiesis and is ineffective in anemia not related to iron deficiency.

Pharmacokinetics

The complex enters the bloodstream via the lymphatic system after I/m administration. Cmax of iron in blood plasma is reached approximately 24 h after injection. From the blood plasma, the macromolecular complex enters the reticulo-endothelial system, where it is broken down into its components – multinuclear iron hydroxide and polymaltose (metabolized by oxidation). The slow release of iron is the reason for its good tolerability. In the bloodstream, iron is bound to transferrin, in tissues it is stored as part of ferritin, in the bone marrow it is incorporated into hemoglobin and participates in the process of erythropoiesis. Only small amounts of iron are excreted from the body.

There are no data on pharmacokinetics of the drug in patients with iron deficiency anemia. It is well known that absorption of iron depends on the severity of iron deficiency anemia. It is intense in case of low hemoglobin and decreases with normalization of hemoglobin.

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

The effects of renal and hepatic impairment on the pharmacological properties of iron (III) hydroxide polymaltosate are unknown. The toxicity of the drug is very low. The LD50 determined for white mice by intravenous administration of Maltofer® was >2500 mg/kg iron, which is 100 times lower than for simple iron salts.

Indications

Iron deficiency anemia when oral iron therapy is ineffective or impossible (including patients with GI diseases and malabsorption syndrome).

The drug is only given by injection/m only when iron deficiency has been confirmed with appropriate tests (e.g. serum ferritin, hemoglobin (Hb), hematocrit or erythrocyte count and their parameters – mean erythrocyte volume, mean Hb per erythrocyte or mean Hb per erythrocyte concentration).

Composition

Active substance:

Iron (III) hydroxide polymaltosate;

Auxiliary substances:

Sodium hydroxide/hydrochloric acid – to pH 5.2- 6.5;

water for injection – to 1 ml;

How to take, the dosage

Intramuscular

Before the first administration a test should be carried out: adults 1/4-1/2 dose (25-50 mg of iron), from 4 months of age 1/2 daily dose; if there are no adverse reactions the remainder of the initial dose is administered within 15 minutes.

The dose is calculated individually and adjusted according to the total iron deficiency.

Special Instructions

The ampoules should be inspected for residue and damage before use. Only ampoules without sediment and damage can be used. After opening the ampoule the drug Maltofer® should be administered immediately.

Maltofer® should not be mixed with other medicinal products. Parenteral iron preparations may cause allergic and anaphylactic reactions. In case of moderately pronounced allergic reactions antihistamines should be prescribed; in case of severe anaphylactic reaction immediate administration of epinephrine (adrenaline) is necessary. Cardiopulmonary resuscitation should be available.

Caution should be exercised when administering the drug to patients with allergies and hepatic and renal impairment.

Side effects occurring in patients with cardiovascular disease may worsen the course of the underlying disease.

Physicians with bronchial asthma or who have low serum iron-binding capacity and/or folic acid deficiency are at high risk of allergic or anaphylactic reactions.

Injection in children under 4 months of age is not recommended due to lack of experience. In children, parenteral iron preparations may adversely affect the course of the infectious process.

Contraindications

Side effects

Rarely, arthralgia, enlarged lymph nodes, fever, headache, dyspepsia (nausea, vomiting) may occur.

Very rarely, allergic or anaphylactic reactions are possible.

Local reactions (if the technique of administration is incorrect): skin discoloration, pain at the site of injection, inflammation.