Sufer (iron (III)) solution for intravenous injections 20 mg/ml. 5 ml. №5

Description

Sufer (iron (III)) solution for intravenous injections 20 mg/ml. 5 ml. №5

Composition

active substance: iron (III) hydroxide sucrose complex;

1 ml of solution contains 20 mg of iron in the form of iron (III) hydroxide sucrose complex;

Excipient: water for injections.

Dosage form

Solution for intravenous injection.

Basic physical and chemical properties: aqueous solution of brown color.

Pharmacotherapeutic group

Antianemic drugs for parenteral administration. Iron preparations.
Code ATX V0ZA C.

Pharmacological properties

Iron preparation for intravenous administration. It is used for quick clinical, hematological correction of a reduced hemoglobin index. Reduces the need for erythropoietin by 25% while using it.

Indications

Sufer is used for iron deficiency states:

• with the ineffectiveness of treatment with oral dosage forms of iron (due to the syndrome of impaired absorption in the intestine, chronic enterocolitis, ulcerative colitis, after resection of the stomach or small intestine);
• if you need to quickly replenish iron stores (for example, with severe post-hemorrhagic anemia, treatment with erythropoietin).

Contraindications

You cannot use Sufer:

• with allergies to the components of the drug;
• with anemia not associated with iron deficiency;
• when the body is oversaturated with iron (hemochromatosis, hemosiderosis), violation of the process of its elimination.

Application during pregnancy and lactation

There have been no studies in pregnant women. Limited experience of use in such patients showed no undesirable effect on the normal course of pregnancy, fetal / child health. When prescribing, the risk / benefit ratio should be taken into account.
The use of Sufer is contraindicated in the first trimester.
The ingestion of unmetabolized iron sucrose in a woman’s milk is unlikely. Thus, the drug is not dangerous for a breastfed baby.

Method of administration and dosage

Sufer solution is administered slowly, intravenously.

The drug is not intended for intramuscular or subcutaneous administration.

Patients should be monitored for signs and symptoms of hypersensitivity reactions during and after administration of Sufer solution. Appropriate emergency therapy should be provided (see section 4.4).

The total cumulative dose of the drug should be calculated for each patient individually and should not exceed it. The dose is calculated based on the patient’s body weight and hemoglobin level.

If the total required dose exceeds the maximum allowable single dose of 200 mg (for injection) or 500 mg (for infusion), it is recommended to administer the drug in portions.

Standard dosage

• Adults: 5‒10 ml of Sufer (100‒200 mg of iron) 1‒3 times a week. Duration of use and dilution factor see lower.
• Children over 3 years of age: There are only limited data on the use of the drug in children. If clinically necessary, it is recommended to administer no more than 0.15 ml of the drug Sufer (3 mg of iron) per 1 kg of body weight no more than 3 times a week. Duration of use and dilution factor see lower.

Application

Sufer solution can only be administered intravenously by slow injection, drip infusion or directly into the venous area of ​​the dialysis system.

Sufer solution should not be administered intramuscularly or subcutaneously.

If the required total dose exceeds the maximum allowable single dose, the total dose should be divided into several doses.

Children

Due to insufficient data, the use of Sufer for the treatment of children under 3 years of age is not recommended.

Overdose

An overdose can cause an acute oversaturation of the body with iron, which is manifested by the development of hemosiderosis (excessive deposition of hemosiderin pigment in tissues). In case of an overdose, symptomatic agents are used, as well as chelates (substances that bind iron).

Side effects

Possible: dizziness, loss of consciousness, palpitations, arterial hypotension, tachycardia, collapse, feeling of heat, edema, bronchospasm, hot flushes, shortness of breath, epigastric pain, changes in stool, loss of taste, nausea, rash, erythema, itching, pigmentation disorders, sweating, arthralgia, muscle pain, joint edema, paresthesia, headache, laryngeal edema, face, anaphylactoid (pseudo-allergic) reactions, chest pain, pain in the extremities, weakness, malaise, chills, feeling of heaviness in the chest, fever, pallor , pain and swelling at the injection site.