Speysferron

General characteristics. Structure:

Active ingredient: aqueous solution of the low-molecular radiation modified dextran, kompleksnosvyazanny with microelements (100 mg of iron, 250 mkg of cobalt).

Pharmacological properties:

Pharmacodynamics. Is highly effective means for elimination of iron deficiency states and the related system disturbances. The high antianemic effect of Speysferron is caused by the combined haemo stimulating influence of the iron and cobalt which are its part.

The direct promoting effect of drug on proliferation of early and late predecessors of an erythrogenesis is established. Speysferron's introduction against the background of iron deficiency states leads to elimination of a lack of maintenance of this microelement of biological liquids, promotes stimulation of a marrowy hemopoiesis therefore process of recovery of quantity of erythrocytes and hemoglobin in peripheral blood considerably accelerates; there is an elimination of the disturbances noted at various levels of integration of functions of a complete organism.

Drug shows erythropoietic properties and at introduction against the background of initially normal indicators of red blood.

Important additional medical effect of Speysferron is his high interferonogenny activity.

Pharmacokinetics. After single intravenous administration of a daily therapeutic dose of Speysferron, the iron which is its part eliminirutsya from the general circulation within 24 hours. The place of its preferential adjournment is marrow, and also cells of a liver, a spleen, lymph nodes and a cell of mononuclear phagocytal system where Speysferron's iron is late for longer term, creating endogenous depot of this microelement for ensuring process of a hemopoiesis. It Eliminirutsya preferential by kidneys. A small part of a dekstranovy basis of drug is capable to collect in system of mononuclear phagocytes where is exposed to bioconversion to glucose.

Indications to use:

The intravenous form iron-декстранового a complex is entered only in cases when peroral forms of iron cannot be used (i.e. cases of intolerance or the proved inefficiency) and there is a clinical need of bystry completion of a lack of depot of iron for an organism.

The diagnosis of a zhelezodefitsit at these states has to be previously confirmed with the corresponding datas of laboratory.

Route of administration and doses:

Before appointment and periodically during performing therapy definition of a number of the parameters defining performing parenteral therapy is required.

1 ml of drug contains 20 mg of kompleksnosvyazanny iron.

Portability test. Before introduction it is necessary to carry out the portability test on the following procedure: preliminary slow, for 15-20 minutes, introduction of the test dose making 25 mg in terms of the content of iron and divorced in 100-200 ml of isotonic solution of sodium of chloride. After introduction of a test dose control of a condition of the patient for not less than one hour then in the absence of symptoms of anaphylactic reaction, introduction of a therapeutic dose of drug is carried out is required. Throughout introduction and after introduction for 2 hours each 15 minutes at the patient the arterial pressure, heart rate and a respiration rate is controlled.

Introduction of therapeutic doses. Drug is used only in the conditions of a hospital, with obligatory readiness of rendering the immediate help in a case of development of anaphylactic reaction.

The general dose of parenteral iron preparation, is calculated individually for each patient proceeding from the general deficit of iron in an organism, then is entered as divided into separate doses (as a rule, 100 mg are entered for 2-3 times a week depending on hemoglobin level) at cultivation into 500 ml of isotonic sodium of chloride. Introduction of the first 25 mg in the corresponding cultivation from total quantity is carried out for 15 minutes at constant observation of a condition of the patient. In the absence of signs of side reactions, pass to infusional introduction of the rest from the calculated dose. Speed of infusion can be gradually increased up to 45-60 caps/min., but should not exceed it. Introduction is carried out throughout all time of infusional introduction and at least within an hour after the end of infusion.

Drug cultivation by own blood is allowed just before use. The maximum daily dose should not exceed 100 mg recalculation on the content of iron or 5 ml of drug.

Speysferron's number demanded for completion of deficit of iron is entered into an organism evenly, however the general duration of a course of treatment should not exceed 10-12 days. In the course of observation of medical efficiency of drug it is necessary to control every 2-3 day indicators of red blood (quantity of erythrocytes, hemoglobin, quantity of reticulocytes).

Features of use:

Unreasonable purpose of parenteral iron can cause excess deposition of iron with possible subsequent development of an exogenous hemosiderosis. Patients with hemoglobinopathies and other refractory forms of anemia are especially subject to development of this complication that can it is mistakenly interpreted as an iron deficiency anemia.

It is reasonable to enter Speysferron after a lunch or after a big breakfast, administration of drug is not recommended to the patient before meal.

At Speysferron's introduction in a dose of 5 ml or at cultivation the autoblood (solution of chloride sodium of 0,9%) allows use of the doser for administration of liquids.

CAUTIONS: RISK OF DEVELOPMENT OF ANAFILAKTICHEKY REACTIONS

At parenteral use of solutions of a dextran of iron the anaphylactic reactions including which had life-threatening character were observed.

* Administration of the solutions containing an iron dextran (including Speysferron) should be carried out only in the conditions of a hospital, the personnel trained for identification and stopping of anaphylactic reaction with obligatory readiness of rendering immediate medical care.

* Before introduction of a therapeutic dose it is necessary to carry out the intolerance test. Heavy allergic reactions were observed, including at introduction of test doses of medicines on the basis of a dextran. In the absence of symptoms of anaphylactic reaction after introduction of a test dose pass to introduction therapeutic.

* Throughout the entire period of introduction of Speysferron it is necessary to exercise control of a condition of the patient on lack of symptoms of anaphylactic reaction.

* Solutions of a dextran of iron are appointed only to patients, with the iron deficiency state confirmed with clinical and laboratory trials which treatment by peroral iron preparations is not possible.

* Patients with a medicamentous allergy in the anamnesis and burdened allergoanamnezy have the increased risk of development of anaphylactic reactions.

Precautionary measures. Speeding of intravenous administration of drug (more than 1 ml/min.) is inadmissible. Therapy is possible only after conducting test on portability according to a certain procedure. During Speysferron's introduction the patient has to be in a prone position.

Risk of development of anaphylactic reactions. The order of administration of drug is defined:

- introduction is carried out only in the conditions of a hospital at a possibility of rendering immediate medical care in case of development of symptoms of anaphylactic reaction;

- introduction of a test dose, component no more than 25 mg in terms of iron is obligatory preliminary slow (for at least 5 minutes);

- throughout all time of administration of drug (introduction of a test dose and the subsequent introduction of therapeutic doses) control of a condition of the patient of possible development of symptoms of anaphylactic reaction is exercised. After maintaining a test dose control of a condition of the patient for not less than one hour then, in the absence of symptoms of anaphylactic reaction, introduction of a therapeutic dose of drug is carried out is required;

- solutions of a dextran of iron are appointed only to patients with the confirmed clinical and laboratory trials an iron deficiency state which treatment by peroral iron preparations is not possible.

- today all factors contributing to development of anaphylactic reactions at introduction of a dextran of iron are not known. On the basis of limited clinical data it is possible to make the assumption of big risk of development of anaphylactic reactions at administration of drugs on the basis of an iron dextran at patients with a medicamentous allergy in the anamnesis and in general having burdened аллергоанамнез. It is supposed also that co-administration of medicines from group of inhibitors of an angiotensin-converting enzyme also increases risk of development of this state.

The delayed reactions. Introduction of high doses of a dextran of iron was followed by the increased frequency of development of side reactions which had limited character (developed in 1-2 days) and were shown any of the following symptoms: an arthralgia, pain in a waist, fever, dizziness, a headache, weakness, nausea or vomiting. These symptoms weaken as a rule in 3-4 days. The risk of development of the delayed reactions has to be considered when evaluating advantage risk for the individual patient.

The maximum daily dose of drug should not exceed 100 mg recalculation on the content of iron or 5 ml of drug.

The drug has to be administered extremely carefully to patients with serious violations of function of a liver. Drug is not appointed in the acute period of infectious diseases of kidneys.

Side reactions which can be observed at introduction iron-декстранового a complex can worsen a condition of patients with the available diseases of cardiovascular system.

Use during pregnancy and a lactation. Due to the lack of adequate clinical data on safety, use of drug during pregnancy and during feeding by a breast contraindicated.

Side effects:

Anaphylactic reactions: at use of drugs of a dextran of iron it was reported about development of the anaphylactic reactions including posing a threat for life. These reactions developed within the first several minutes and were shown by sudden disturbance of breath and/or a cardiovascular collapse. In this regard administration of drug has to be carried out only in the conditions allowing to give immediate help;

Cardiovascular reactions: a stethalgia, feeling of tension in breasts, shock, a cardiac standstill, hypotension (can develop at too bystry intravenous administration), hypertensia, tachycardia, bradycardia, a hyperemia, arrhythmias.

From digestive tract: abdominal pains, nausea, vomiting, diarrhea.

From skeletal and muscular system: arthralgia, arthritis, mialgiya;

From a respiratory organs: bronchospasm, asthma, apnoea;

From the central nervous system: spasms, loss of consciousness, headache, weakness, dizziness;

From integuments: urticaria, itch, erimatozny rash, cyanosis.

For removal of side effects introduction of analgetics and antihistaminic drugs, in more hard cases – Prednisolonum is recommended (25-50 mg, intravenously).

Interaction with other medicines:

Aminocapronic acid, гидралазин, warfarin, ethanol of 95%, dexamethasone and some other medicines are incompatible with the dextran which is a part of drug.

Due to the increase in risk of overdose co-administration of iron preparations inside is not recommended.

Contraindications:

Hypersensitivity; system mycoses, amoebic infections, infectious damages of joints and circumarticular soft tissues; active forms of tuberculosis; the period before and after preventive inoculations (especially antiviral); glaucoma, acute purulent infection (retrobulbar introduction); bronchial asthma; allergic eczema; atopic diseases; a medicamentous allergy (including reactions of hypersensitivity to mono - both disakharidny connections and a dextran) in the anamnesis. And also use is contraindicated to patients with autoimmune or chronic inflammatory diseases (such as system lupus erythematosus, pseudorheumatism).

Overdose:

Symptoms: dizziness, weakness, confusion of consciousness, lethargy, low pulse, hypotonia, metabolic acidosis, fever, leukocytosis.

Treatment: carrying out specific (Deferoxaminum) and symptomatic therapy.

Issue conditions:

According to the recipe

Packaging:

Solution for injections in ampoules of 5 ml in packaging No. 10.