Ferinzhekt, 50 mg/ml 2 ml 5 pcs

Pherinject is a preparation of iron.

It is a carboxymaltosate complex of multinuclear iron(III) hydroxide.

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

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

The iron in complex with transferrin is transported to the body’s cells, where it is used for the synthesis of hemoglobin, myoglobin and a large number of enzymes or accumulated as ferritin.

Indications

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

The diagnosis must be confirmed by laboratory tests.

Active ingredient

Composition

Active ingredient:

iron carboxymaltosate

Associates:

Sodium hydroxide/hydrochloric acid to pH 5.0-7.0;

water for injection to 1 ml.

How to take, the dosage

In/v – by jet or drip and by injection into the venous area of the dialysis system.

Before opening, the vials should be inspected for possible sediment and damage. Only a homogenous solution without residue may be used.

Drip administration

Do not administer drip administration of 20 ml of Ferinject more than once a week.

May be administered by IV drip at 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.

Stroke administration

Pherinject may be administered by IV stream, in a maximum single dose of up to 4 ml (200 mg of iron) per day, but no more than 3 times per week.

Dose calculation

The cumulative dose of the drug in mg of elemental iron, necessary for restoration of hemoglobin (Hb) level and replenishment of iron reserves, is calculated individually in accordance with the total iron deficit in the body by the formula:

Cumulative iron deficiency [mg] = body weight [kg] × (target Hb* – actual Hb) [g/dl]** × 2.4*** + stored iron depot [mg]****
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* Target Hb at body weight less than 35 kg = 13 g/dl (respectively 8.1 mmol/L). Target Hb at a body weight of 35 kg or more = 15 g/dl (9.3 mmol/l, respectively).

** To convert Hb [mM] to Hb [g/dl]: multiply Hb [mM] by a factor of 1.61145.

*** Factor 2.4 = 0.0034×0.07×10000, where:
0.0034 – hemoglobin iron content is approximately 0.34%;
0.07 – blood volume is approximately 7% of body weight;
10000 – conversion factor: 1 g/dL = 10000 mg/L.

**** Iron deposited at body weight less than 35 kg = 15 mg/kg body weight; iron deposited at body weight 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 dose of iron should be rounded upward to the nearest 100 mg.

If there is a subsequent need to maintain the target Hb level and other laboratory indicators of iron stores within acceptable limits, treatment with Therinject at the minimum maintenance dose may be continued.

The maximum tolerated single dose

The adequate cumulative dose of the drug must be calculated for each patient individually and must not exceed the calculated dose.

Interaction

Any parenteral iron medication should not be administered at the same time as oral iron dosage forms, since this reduces iron absorption from the gastrointestinal tract.

Contraindications

With caution, use the drug in patients with hepatic insufficiency, acute or chronic infectious diseases (possible suppression of erythropoiesis), bronchial asthma, eczema, atopic allergies.

Side effects

Allergic reactions: common – rash; infrequent – urticaria, hypersensitivity reactions, including anaphylactoid reactions.

Nervous system disorders: often – headache; dizziness; infrequent – paresthesias.

Cardiovascular system: infrequent – decrease of blood pressure, “rushes” of blood to the face.

Respiratory system: rarely – shortness of breath.

The digestive system: frequently – nausea, abdominal pain, diarrhea, constipation; infrequently – change in taste, vomiting, dyspepsia, flatulence.

Muscular system: infrequent – myalgia, back pain, arthralgia.

General reactions: infrequent – fever, fatigue, chest pain, chills, malaise, peripheral edema.

Local reactions: often – reactions at the site of administration.

Laboratory parameters: frequently – increase of serum ALT, transient decrease of serum phosphate; infrequent – increase of ACT, GGT, LDH activity.

Overdose

Symptoms: Ferinecretin in amounts that exceed the body’s needs can cause iron overload, which manifests as symptoms of hemosiderosis.

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

Treatment: conducting symptomatic therapy. If necessary, chelated compounds (e.g., deferoxamine) may be used.