Ferinject, 50 mg/ml, 2 ml, 5 pcs.

Composition

Active ingredient:

iron carboximaltosate

Auxiliary substances:

sodium hydroxide / hydrochloric acid up to pH 5.0-7.0;

water for injection up to 1 ml

. Pharmacological action

Ferinject is an iron preparation.

It is a carboxymaltosate complex of multi-nuclear iron (III) hydroxide.

After parenteral administration, the macromolecular complex is captured by the reticulo-endothelial system and breaks down into iron and carboxymaltose.

Iron enters the bloodstream, where it binds to the transport protein transferrin.

Iron in combination with transferrin is transferred to the cells of the body, where it is used for the synthesis of hemoglobin, myoglobin and a large number of enzymes or accumulates in the form of ferritin.

Indications

Iron deficiency anemia occurs when oral iron supplements are ineffective or cannot be used.

The diagnosis must be confirmed by laboratory tests.

Contraindications

• to anemia that are not associated with iron deficiency;
• symptoms of iron overload or impaired iron utilization;
• I trimester of pregnancy;
• children under 14 years of age;
• hypersensitivity to the components of Ferinject.

The drug should be used with caution in patients with liver failure, acute or chronic infectious diseases (possible suppression of erythropoiesis), bronchial asthma, eczema, atopic allergies.

Side effects

Allergic reactions: often-rash; infrequently-urticaria, hypersensitivity reactions, including anaphylactoid reactions.

Nervous system disorders: often – headache; dizziness; infrequently-paresthesia.

From the cardiovascular system: infrequently-a decrease in blood pressure, “flushes” of blood to the skin of the face.

Respiratory system disorders: rarely-shortness of breath.

From the digestive system: often – nausea, abdominal pain, diarrhea, constipation; infrequently – change of taste, vomiting, dyspepsia, flatulence.

From the musculoskeletal system: infrequently – myalgia, back pain, arthralgia.

General reactions: infrequently – fever, fatigue, chest pain, chills, poor health, peripheral edema.

Local reactions: often-reactions at the injection site.

From the side of laboratory parameters: often-an increase in serum ALT, a transient decrease in serum phosphate content; infrequently-an increase in the activity of ACT, GGT, LDH.

Interaction

Any parenteral iron preparations should not be administered simultaneously with oral iron formulations, as this reduces the absorption of iron from the gastrointestinal tract.

How to take, course of administration and dosage

IV — jet or drip and by injection into the venous section of the dialysis system. Before opening, the vials should be examined for possible sediment and damage. You can only use a homogeneous solution without sediment.

Drip introduction Do not prescribe drip administration of 20 ml of Ferinject more than 1 time a week. It can be administered intravenously in a maximum single dose of up to 20 ml of Ferinject (1000 mg of iron), which should not exceed 0.3 ml of Ferinject (15 mg of iron) per 1 kg of body weight or the calculated cumulative dose.

Jet injectionperinject can be administered intravenously in a jet, in a maximum single dose of up to 4 ml (200 mg of iron) per day, but no more than 3 times a week. Dose calculationthe cumulative dose of the drug in mg of elemental iron required to restore the level of hemoglobin (Hb) and replenish iron reserves is calculated individually in accordance with the total iron deficiency in the body using the formula:Cumulative iron deficiency [mg] = body weight [kg] × (target Hb* − actual Hb) [g / dl]* * × 2,4*** + spare iron depot [mg]****———————————————————————* Target Hb for body weight less than 35 kg = 13 g / dl (respectively 8.1 mmol/l). Target Hb for a body weight of 35 kg or more = 15 g / dl (9.3 mmol/L, respectively). ** To convert Hb [mM] to Hb [y / dl]: multiply Hb [mM] by a factor of 1.61145. *** Coefficient 2.4 = 0.0034×0.07×10000, where: 0.0034 — hemoglobin iron content is approximately equal to 0.34%; 0.07 — blood volume is approximately equal to 7% of body weight; 10000-conversion coefficient: 1 g / dl = 10000 mg / l. * * * * Iron deposited at a body weight of less than 35 kg = 15 mg/kg of body weight; iron deposited at a body weight of 35 kg or more = 500 mg. For patients <66 kg: the calculated cumulative iron dose should be rounded down to the nearest 100 mg. For patients >66 kg: the calculated cumulative iron dose should be rounded up to the nearest 100 mg. If it is subsequently necessary to maintain the target level of Hb and other laboratory indicators of iron reserve within acceptable limits, it is possible to continue treatment with Ferinject at the minimum maintenance dose.

Maximum tolerated single doseadequate cumulative dose of the drug should be calculated for each patient individually and should not exceed the calculated one.

Overdose

Symptoms: Ferinject in an amount exceeding the body’s needs can cause iron overload, which is manifested by symptoms of hemosiderosis.

Determination of iron metabolism indicators such as serum ferritin and transferrin saturation percentage can help in the diagnosis of excessive iron deposition in the body.

Treatment: conducting symptomatic therapy. If necessary, you can use chelated compounds (for example, deferoxamine).

Form of production

Solution for intravenous administration

Storage conditions

At a temperature not exceeding 30 °C, in the original packaging (do not freeze)

Shelf life

3 years

Active ingredient

Iron carboximaltosate

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Description

For adults as directed by your doctor

Indications

Anemia

Weight

Weight: 54 gr.