Iron (III) hydroxide polymaltose complex
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Pharmacological properties
mechanism of action. The solution of the injectable and infusion preparation contains iron in a stable state - in a complex of iron, consisting of a polynuclear core of iron hydroxide with a carbohydrate ligand. due to the stability of the complex, a very small amount of weakly bound iron is present (unstable or free iron).
The complex is created in the form of easily digestible iron, which is suitable for use, transportation and storage in special proteins of the body (transferrin and ferritin, respectively). Clinical studies have shown that the hematological response and replenishment of iron was carried out faster after iv administration of the drug Ferinject compared with oral administration of drugs.
Pharmacokinetics Positron emission tomography (PET) showed that 52Fe- and 59Fe-labeled iron in the carboxymaltose complex is rapidly excreted from the blood, enters the bone marrow and is deposited in the liver and spleen.
After administration of a single dose of iron carboxymaltose, from 100 to 1000 mg in patients with anemia Cmax iron in the blood plasma ranged from 37 to 333 μg / ml for 15 min – 1.21 hours. The volume of distribution of the central compartment corresponded to the volume of blood plasma (approximately 3 L).
Carboxymaltose iron is rapidly excreted from blood plasma. In one study, the range of the final T½ was 7–12 hours, and the range of average retention time was 11–18 hours. Kidney excretion was insignificant.
Indications
Ferinject is used in cases of iron deficiency in patients who cannot be prescribed oral iron preparations or in case of inefficiency of the latter. the diagnosis should be confirmed by laboratory tests.
Application
Careful monitoring of the patient’s condition regarding the signs and symptoms of allergic reactions during and after each use of the energetic is necessary.
The use of the drug is possible only with qualified personnel who can assess the condition of the patient and immediately carry out the corresponding elimination of the anaphylactic reaction and resuscitation measures. Each patient should be monitored for at least 30 minutes after injection of Ferinject.
Ferinject is intended for intravenous administration only. Ferinject is administered by injection, infusion or during the hemodialysis session in undiluted form directly into the venous section of the dialysis system. It is impossible to apply Ferinject s / to or in / m.
Determination of the dosage of the drug Feringect phased: 1) determination of the individual need for iron; 2) calculation and application of iron doses (s); 3) assessment of iron saturation.
Stage 1. Determining the need for iron.
The individual need for replenishment of iron when using Ferinject is determined taking into account the patient’s body weight and hemoglobin (Hb) level. To determine the cumulative dose of iron should use the table. 1.
Table 1| Hb | Patient body weight, kg / dose, mg | |||
|---|---|---|---|---|
| g / l | mmol / l | 35 | 35–69 | ≥70 |
| 100 | 6,2 | 500 | 1500 | 2000 |
| 100–140 | 6,2–8,7 | 500 | 1000 | 1500 |
| 140 | 8,7 | 500 | 500 | 500 |
Iron deficiency should be confirmed by laboratory tests.
Stage 2. Calculation and application of the maximum individual dose of iron.
Based on the iron requirements defined above, the necessary doses of the drug should be used, given the following.
A single use of the drug Ferinject should not exceed:
15 mg of iron / kg body weight (for jet administration) or 20 mg of iron / kg body weight (for infusion);
1000 mg of iron (20 ml of the preparation Ferinject).
The maximum recommended cumulative dose of Ferinject is 1000 mg of iron (20 ml of the drug) per week.
Stage 3. Assessment of iron saturation.
A second evaluation should be carried out by the doctor, taking into account the patients condition.The hemoglobin level should be reevaluated no earlier than 4 weeks after the last administration of Ferinject to ensure sufficient time for erythropoiesis and iron absorption. If the patient needs further administration of iron, the need for iron should be recalculated according to the table. 1.
Inkjet introduction. Ferinject can be injected undiluted in a maximum single dose at the rate of 15 mg of iron / kg of body weight, but not more than 1000 mg of iron. The rate of administration is shown in table. 2.
Table 2. The speed of the injection of the drug Ferinject| The required volume of the drug Ferinject ml | Equivalent dose of iron, mg | Speed of administration, minimum time of administration |
|---|---|---|
| 2–4 | 100–200 | No minimum administration time |
| 4–10 | 200–500 | 100 mg iron / min |
| 10–20 | 500–1000 | 15 minutes |
Infusion administration. During infusion, Ferinject should be diluted. The maximum single dose is 20 mg of iron / kg body weight and should not exceed 1000 mg of iron.
Just before infusion, only sterile can be diluted.
1331 Items
2020-07-30
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