Project Description

Speisferron

(solution for injections) Speisferron

international nonproprietary name

Not established

Ref

BP-0135

Pharmacotherapeutic group

Hemopoiesis stimulator.

Composition of the preparation

Speisferron is a water solution of low-molecular radiation-modified dextran bound complexly with microelements — iron and cobalt. One vial (phial) of speisferron contains 100 mg of iron and 0,25 mg of cobalt.

Pharmacological action

Pharmacodynamics

Speisferron has a marked antianemic action and is a highly-effective means for elimination of iron-deficient conditions and systemic disturbances related to them. Antianemic effect is conditioned by a combination of hemostimulating influence of microelements – iron and cobalt. It contributes to the liquidation of deficiency of these elements in biological fluids, as well as to the stimulation of bone-marrow blood formation, the result of what is a significant enhancement of regeneration process of the erythrocytes and hemoglobin number in the peripheral blood and elimination of disturbances found at different levels of integration of the integral organism functions. The preparation also reveals erythropoetic properties on being administered against the background of normal parameters of red blood.

The most important additional curative effect of speisferron is its high interferon activity.

Pharmacokinetics

After a single intravenous administration of the daily therapeutic dose of speisferron, iron contained in it is eliminated from the general circulation during 24 hours. The place of its main accumulation is bone-marrow, as well as cells of liver, spleen, lymph nodes and mononuclear phagocytal system cells where the iron of speisferron is held for a longer period thus creating an endogenous depot of this microelement for a normal blood-formation processes.

Indications 

Speisferron is used as a treatment and prophylaxis preparation in adults and children on chronic iron-deficient anemias conditioned by repeated blood losses developed as a result of increased need in iron (pregnancy, lactation, development period in children); anemias developed in children of early age as a result of insufficient mother’s reference level during pregnancy; on anemias developed due to iron deficit in the intake; on anemias in patients with gastroduodenal pathology preventing the use of peroral iron preparations to correct iron-deficit conditions; on various forms of secondary anemias against the background of surgical, in patients with oncology diseases in the aftercare period followed the chemical and radiation therapy. The preparation is also used on refractory iron-deficient and refractory anemias on myelodysplastic syndrom.

special indication

The speisferron therapy hall be carried out by doctors and qualified medical personnel.

special warning

Not established

Dosage and method of administration

The preparation is used in the in-patient departments. The speisferron therapy is admissible in the conditions of outpatient clinic if it is carried out by doctors and qualified medical personnel.

The route of administration of speisferron is intravenous. The doses are determined on the base of general parameters and the individual condition of the patient. The preparation shall be administered slowly at the speed not more than 1 ml per minute. The preparation can be diluted with autologous blood or 0,9% of sodium chloride solution (in the ratio 10 ml of speisferron in 250 ml of 0,9% of physiological sodium chloride solution) immediately before use. Speisferron is administered once per day every day during 8 – 10 days. As a rule, the first injection is equal to 2,5 ml of speisferron, the second one is 5 ml, the third one and on – 10 ml. Further up to the end of the course the preparation is administered in the dose of 10 ml of the preparation. The maximal daily dose of speisferron is 15 ml.

The overall duration of the course of treatment shall not exceed 10—12 days. In the process of monitoring of the preparation efficiency the parameters of red blood shall be controlled each 2—3 days (the number of erythrocytes, hemoglobin, the number of reticulocytes).

overdosage

Dizziness, weakness, mental confusion, lethargy, weak pulse, hypotension, metabolic acidosis, fever, leukocytosis.

Treatment: to carry out specific (deferoxamine) and symptomatic therapy.

safety measures

The exceeding of the intravenous infusion speed is inadmissible (more than 1 ml/min). To prevent side effects it is recommended to administer the preparation intravenously drop-by-drop at a low speed and after the administration of first 2—5 ml a 3 minute break shall be made to monitor the condition (bioassay on imcompatibility).

Side effects

As a rule, on a slow administration of speisferron no side effects and negative effects are not revealed in relation to the main essential systems.

In rare cases the development of higher sensitivity (nausea, hyperaemia, skin itching, erythematic rash, тошнота, discomfort in the breastbone, pains in the loin and muscles of inferior extremities). To eliminate side effects it is recommended to administer analgesics and antihistaminic preparations, and in more severe cases – prednisolone (25—50 mg intravenously).

Contraindications

The absolute contraindication for the administration of speisferron is hemochromatosis.

The preparation is contraindicated on acute nephritis, liver diseases in the decompensation stage, coronary insufficiency.

Interactions with other medicinal preparations

No case of negative interaction with other medications have been specified until now.

The form of release

Solution in vials and phial of 5 ml. 5 or 10 vials or phials in a blister. 1 and 2 blisters in a pack.