Pharmacological properties of the drug Ferrum lek
Iron supplement. Contains iron Fe3+ in the form of a complex compound of iron (III) hydroxide with polymaltose (HPA). The iron in the polynuclear "core" is associated with a structure similar to serum ferritin. This macromolecular complex is stable and under physiological conditions does not release iron in the form of free ions. Therefore, when taken orally, iron, which is part of the GPC, enters the blood from the intestine only through active absorption. There is a correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). It is this property of the drug that explains the impossibility of poisoning with the drug even in the case of an overdose, unlike simple iron salts, the absorption of which occurs along a concentration gradient. Maximum absorption of iron after oral administration occurs in the duodenum and jejunum, and its absorption is not reduced by interaction with certain food components or with drugs containing a phenolic group (for example, tetracycline). Iron administered in the form of HPA is slowly absorbed and enters the blood serum, from where it quickly passes into iron-depositing tissues. Absorbed iron is stored bound to ferritin, mainly in the liver. Later in the bone marrow it is included in hemoglobin. In hemoglobin, iron is in divalent form, but it is Fe3+ (trivalent iron) that stimulates the formation of globin, which ultimately helps to increase hemoglobin levels. Since iron in the dosage form for oral administration is contained in non-ionized form, the drug does not have such side effects as irritation of the mucous membrane of the digestive tract, staining of tooth enamel, and the appearance of a metallic taste in the mouth. Chewable tablets and syrup are characterized by a high degree of safety and are well tolerated by patients. Comparative studies of the bioavailability of Ferrum Lek oral dosage forms using the radioisotope method, as well as comparative clinical trials, have proven that the absorption and bioavailability of iron in the form of iron (III) hydroxide complex with polyisomaltose is equivalent to the absorption and bioavailability of iron (II) salts.
Ferrum Lek®
Ferrum Lek® solution is intended for intramuscular administration only.
The drug should be administered only in a hospital setting, by specially trained personnel who can recognize the signs of incipient anaphylactic shock, in conditions of availability of resuscitation facilities and the possibility of carrying out a complex of anti-shock measures.
The patient should be observed for at least 30 minutes after each injection.
Before administering the first therapeutic dose of the drug, each patient should be given a test dose of 1/4-1/2 ampoule of Ferrum Lek® (25 - 50 mg of iron) for an adult and half the daily dose for a child. If there are no adverse reactions, the remainder of the daily dose should be administered within 15 minutes.
The dose of Ferrum Lek® must be selected individually in accordance with the general iron deficiency, which is calculated using the following formula:
Total iron deficiency (mg) = body weight (kg) x (calculated hemoglobin level (g/l) - actual hemoglobin level (g/l) x 0.24* + deposited iron (mg).
Body weight up to 35 kg: calculated hemoglobin level = 130 g/l and deposited iron = 15 mg/kg body weight.
Body weight over 35 kg: estimated hemoglobin level = 150 g/l and deposited iron = 500 mg.
*Factor 0.24 = 0.0034 x 0.07 x 1000: (Iron content = 0.34%; total blood volume = 7% body weight; factor 1000 = conversion from g/L to mg/L).
Example: Patient's body weight: 70 kg. Real hemoglobin concentration: 80 g/l. Total iron deficiency = 70 x (150 - 80) x 0.24 + 500 = 1676 ̴1700 mg of iron.
The total number of Ferrum Lek® ampoules that must be administered = Total iron deficiency (mg)/100 mg.
Table: Calculation of the total number of Ferrum Lek® ampoules that need to be administered, based on the actual hemoglobin concentration and body weight.
| Body weight (kg) | Total number of Ferrum Lek® ampoules for administration | |||
| Hb 60 g/l | Hb 75 g/l | Hb 90 g/l | Hb 105 g/l | |
| 5 | 1.5 | 1.5 | 1.5 | 1.0 |
| 10 | 3.0 | 3.0 | 2.5 | 2.0 |
| 15 | 5.0 | 4.5 | 3.5 | 3.0 |
| 20 | 6.5 | 5.5 | 5.0 | 4.0 |
| 25 | 8.0 | 7.0 | 6.0 | 5.5 |
| 30 | 9.5 | 8.5 | 7.5 | 6.5 |
| 35 | 12.5 | 11.5 | 10.0 | 9.0 |
| 40 | 13.5 | 12.0 | 11.0 | 9.5 |
| 45 | 15.0 | 13.0 | 11.5 | 10.0 |
| 50 | 16.0 | 14.0 | 12.0 | 10.5 |
| 55 | 17.0 | 15.0 | 13.0 | 11.0 |
| 60 | 18.0 | 16.0 | 13.5 | 11.5 |
| 65 | 19.0 | 16.5 | 14.5 | 12.0 |
| 70 | 20.0 | 17.5 | 15.0 | 12.5 |
| 75 | 21.0 | 18.5 | 16.0 | 13.0 |
| 80 | 22.5 | 19.5 | 16.5 | 13.5 |
| 85 | 23.5 | 20.5 | 17.0 | 14.0 |
| 90 | 24.5 | 21.5 | 18.0 | 14.5 |
If the required dose of Ferrum Lek® exceeds the maximum daily dose, the drug should be administered in fractional doses (over several days).
If 1-2 weeks after the start of treatment the hematological parameters do not change, an additional examination should be carried out to clarify the diagnosis.
Calculation of the total dose for iron replacement due to blood loss
The required amount of the drug to compensate for post-hemorrhagic iron deficiency is calculated using the following formula:
If the amount of blood lost is known
: administration of 200 mg intramuscularly (2 ampoules of Ferrum Lek®) leads to an increase in hemoglobin concentration, which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l).
Iron to be replaced (mg) = number of lost units of blood x 200 or Required number of ampoules of Ferrum Lek® = number of lost units of blood x 2.
If the final hemoglobin level is known
: Use the following formula, taking into account that deposited iron does not need to be reimbursed.
Iron to be replaced (mg) = body weight (kg) x (estimated hemoglobin level (g/L) - actual hemoglobin level (g/L) x 0.24.
Example: A patient with a body weight of 60 kg and a hemoglobin deficiency of 10 g/l should be replaced with 150 mg of iron, which is 1 1/2 ampoules of Ferrum Lek®.
Standard doses
For children
: 0.06 ml/kg body weight/day (3 mg iron/kg/day).
For adults:
1 - 2 ampoules of Ferrum Lek® (100 - 200 mg iron), depending on the hemoglobin content.
Maximum daily doses
For children:
0.14 ml/kg body weight per day (7 mg iron/kg/day).
Adults: 4
ml (2 ampoules of Ferrum Lek®) per day.
Indications for use of the drug Ferrum lek
Orally prescribed for the prevention and treatment of iron deficiency conditions of various etiologies, including the prevention of iron deficiency in children, women of childbearing age (especially during pregnancy and breastfeeding), adults (especially vegetarians) and the elderly; treatment of iron deficiency anemia. Ferrum Lek for parenteral administration is indicated for the treatment of iron deficiency conditions that require rapid and reliable compensation of iron deficiency: severe posthemorrhagic anemia, impaired iron absorption, as well as when treatment of iron deficiency anemia with oral iron preparations is ineffective. Ferrum Lek is used in patients with clear indications for the drug, with mandatory determination of the level of ferritin in the blood plasma and the number of red blood cells in the peripheral blood. If iron malabsorption is suspected, an iron absorption test should be performed.
Ferrum Lek (for injection), 50 mg/ml, solution for intramuscular administration, 2 ml, 5 pcs.
Inside,
during or immediately after meals.
Ferrum Lek® chewable tablets can be chewed or swallowed whole.
The daily dose can be divided into several doses or taken at one time.
Ferrum Lek® syrup can be mixed with fruit or vegetable juices or added to baby food.
Doses and duration of treatment depend on the degree of iron deficiency.
The measuring spoon included in the package is used for precise dosing of Ferrum Lek® syrup.
Iron-deficiency anemia
Duration of treatment is about 3–5 months. After normalization of hemoglobin levels, you should continue taking the drug for several more weeks to replenish iron reserves in the body.
Children under one year of age
: 2.5 ml (½ measuring spoon) - 5 ml (1 measuring spoon) Ferrum Lek® syrup per day.
Children aged 1 to 12 years
: 5–10 ml (1–2 scoops) of Ferrum Lek® syrup per day.
Children over 12 years of age, adults and mothers breastfeeding
: 1–3 chewable tablets or 10–30 ml (2–6 scoops) Ferrum Lek® syrup.
Latent iron deficiency
The duration of treatment is about 1–2 months.
Children aged 1 to 12 years
: 2.5–5 ml (1/2–1 scoop) Ferrum Lek® syrup per day.
Children over 12 years of age, adults and mothers breastfeeding
: 1 table. or 5–10 ml (1–2 scoops) of Ferrum Lek® syrup per day.
Pregnant women
Iron-deficiency anemia
: 2–3 chewable tablets per day or 20–30 ml (4–6 scoops) of Ferrum Lek® syrup until hemoglobin levels normalize. After this, you should continue to take 1 chewable tablet or 10 ml (2 scoops) of syrup per day, at least until the end of pregnancy to replenish iron stores in the body.
Latent iron deficiency and prevention of iron deficiency
: one chewable tablet or 5–10 ml (1–2 scoops) of Ferrum Lek® syrup per day.
Daily doses of Ferrum Lek® for the prevention and treatment of iron deficiency in the body
| Patients | Form of the drug | Iron-deficiency anemia | Latent iron deficiency | Preventing iron deficiency |
| Children under 1 year | Syrup | 2.5–5 ml (25–50 mg iron) | — | — |
| Children 1–12 years old | Syrup | 5–10 ml (50–100 mg iron) | 2.5–5 ml (25–50 mg iron) | — |
| Children over 12 years old, adults, nursing mothers | Chewable tablets | 1–3 tables | 1 table | — |
| Syrup | 10–30 ml (100–300 mg iron) | 5–10 ml (50–100 mg iron) | — | |
| Pregnant women | Chewable tablets | 2–3 tables | 1 table | 1 table |
| Syrup | 20–30 ml (200–300 mg iron) | 10 ml (100 mg iron) | 5–10 ml (50–100 mg iron) |
(-) Due to the fact that this group of patients requires low doses of iron, it is not recommended to use tablets or syrup in these cases.
V/m
(only).
Before administering the first therapeutic dose of the drug, each patient should be given a test dose of 1/4–1/2 amp. Ferrum Lek® (25–50 mg iron) for an adult and half the daily dose for a child. If there are no adverse reactions, the remainder of the daily dose can be administered within 15 minutes.
Doses of Ferrum Lek® must be selected individually, in accordance with the general iron deficiency, which is calculated using the following formula:
Total iron deficiency = body weight (kg) × (calculated hemoglobin level (g/l) − actual hemoglobin level (g/l) × 0.24) + deposited iron (mg)
Body weight up to 35 kg: estimated hemoglobin level = 130 g/l and deposited iron = 15 mg/kg
Body weight over 35 kg: estimated hemoglobin level = 150 g/l and deposited iron = 500 mg
Factor 0.24 = 0.0034 × 0.07 × 1000
(Iron content = 0.34%; total blood volume = 7% body weight; factor 1000 = conversion from g to mg).
Example
Patient body weight: 70 kg
Real hemoglobin concentration: 80 g/l
Total iron deficiency = (150 − 80) × 0.24 + 500 = 1700 mg iron
Total number of Ferrum Lek® ampoules to be administered = Total iron deficiency (mg) / 100 mg
Calculation of the total number of Ferrum Lek® ampoules that must be administered, based on the actual hemoglobin concentration and body weight
| Body weight, kg | Total number of Ferrum Lek® ampoules for administration | |||
| Hb 60 g/l | Hb 75 g/l | Hb 90 g/l | Hb 105 g/l | |
| 5 | 1,5 | 1,5 | 1,5 | 1 |
| 10 | 3 | 3 | 2,5 | 2 |
| 15 | 5 | 4,5 | 3,5 | 3 |
| 20 | 6,5 | 5,5 | 5 | 4 |
| 25 | 8 | 7 | 6 | 5,5 |
| 30 | 9,5 | 8,5 | 7,5 | 6,5 |
| 35 | 12,5 | 11,5 | 10 | 9 |
| 40 | 13,5 | 12 | 11 | 9,5 |
| 45 | 15 | 13 | 11,5 | 10 |
| 50 | 16 | 14 | 12 | 10,5 |
| 55 | 17 | 15 | 13 | 11 |
| 60 | 18 | 16 | 13,5 | 11,5 |
| 65 | 19 | 16,5 | 14,5 | 12 |
| 70 | 20 | 17,5 | 15 | 12,5 |
| 75 | 21 | 18,5 | 16 | 13 |
| 80 | 22,5 | 19,5 | 16,5 | 13,5 |
| 85 | 23,5 | 20,5 | 17 | 14 |
| 90 | 24,5 | 21,5 | 18 | 14,5 |
If the required dose of Ferrum Lek® exceeds the maximum daily dose, the drug should be administered in fractional doses (over several days).
If hematological parameters do not change 1–2 weeks after the start of treatment, the diagnosis should be clarified.
Calculation of the total dose for iron replacement due to blood loss
The required amount of the drug to compensate for post-hemorrhagic iron deficiency is calculated using the following formula.
If the amount of blood lost is known: administration of 200 mg IM (2 amps of Ferrum Lek®) leads to an increase in hemoglobin levels, which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l).
Iron to be replaced (mg) = number of blood units lost × 200 or required number of Ferrum Lek® ampoules = number of blood units lost × 2.
If the final hemoglobin level is known, the following formula must be used, taking into account that deposited iron does not need to be replaced.
Iron to be replaced (mg) = body weight (kg) × (estimated hemoglobin level (g/L) − actual hemoglobin level (g/L) × 0.24.
A patient with a body weight of 60 kg and a hemoglobin deficiency of 10 g/l should be replaced with 150 mg of iron, which is 1.5 ampoules of Ferrum Lek®.
Standard doses
Children: 0.06 ml/kg/day (3 mg iron/kg/day).
Adults: 1–2 amp. Ferrum Lek® (100–200 mg iron), depending on the hemoglobin level.
Maximum daily doses
Children: 0.14 ml/kg/day (7 mg iron/kg/day).
Adults: 4 ml (2 amps) per day.
Use of the drug Ferrum lek
The dose and duration of taking the drug depend on the severity of iron deficiency. Tablets and syrup for the treatment of iron deficiency conditions are prescribed in the usual daily dose: adults and children over 12 years of age in the absence of clinical signs of anemia - 10 ml of syrup or 1 tablet per day, in the presence of clinical signs of anemia - 30 ml of syrup per day or 1 tablet 3 times a day; children aged 1–12 years - at the rate of 3 mg of iron per 1 kg of body weight per day or 5–10 ml of syrup per day; it is recommended that syrup be prescribed to infants in an initial dose of 10 drops per day, gradually increasing the dose to 5 ml (1 teaspoon of syrup) per day. A teaspoon of syrup contains 100 drops. Women during pregnancy or breastfeeding are prescribed 20–30 ml of syrup or 1–3 tablets per day.
Patients | Treatment of iron deficiency | Prevention of iron deficiency | ||
Pills | Syrup | Pills | Syrup | |
| Children under 1 year of age | 2.5–5 ml/day | — | — | |
| Children aged 1–12 years | 5–10 ml/day | — | — | |
| Adults and children over 12 years old | 1–3 tablets per day | 10–30 ml/day | — | — |
| Women during pregnancy and breastfeeding | 1–3 tablets per day | 20–30 ml/day | 1 tablet per day | 5–10 ml/day |
The duration of use of chewable tablets or Ferrum Lek syrup is at least 3 months after normalization of the peripheral blood composition to restore the iron depot in the body (course of treatment is 6 months). To prevent iron deficiency conditions, the usual dose for pregnant and breastfeeding women is 5–10 ml of syrup or 1 tablet per day. Solution for IM administration IV administration of the solution is contraindicated! Before administering the first therapeutic dose of the drug, its tolerability is determined by administering a test dose - 1/4–1/2 from an ampoule of Ferrum Lek (which corresponds to 25–50 mg of iron) for adults and half the daily dose for children. If no undesirable effects develop over the next 15 minutes, administer the remainder of the initial daily dose. 1 ) first, calculate the total iron deficiency (TID) (mg): TID = TI + ID, where TI is iron included in hemoglobin, mg: TI is = MT (CZG - AIG) 0.24, where MT body weight (kg); CZH - target hemoglobin value, g/l (for body weight up to 35 kg - 130 g/l, for body weight more than 35 kg - 150 g/l); AUC —actual hemoglobin level, g/l; coefficient 0.24 = 0.0034 • 0.07 • 1000, where 0.34% is the iron content in hemoglobin; 7% - total blood volume as a percentage of body weight; 1000 is the conversion factor from grams to milligrams; ID - deposited iron, mg (for body weight up to 35 kg - 15 mg per 1 kg of body weight, for body weight more than 35 kg - 500 mg); 2) calculate the total number of ampoules per course of treatment (OCA): OKA = OCA: 100, where 100 is the iron content in 1 ampoule, mg. Calculation example: body weight = 70 kg; actual hemoglobin level = 80 g/l; iron included in hemoglobin - 70 • 0.24 • (150 – 80) = 1200 mg of iron; deposited iron - 500 mg of iron; general iron deficiency - 1200 + 500 = 1700 mg of iron; the total number of ampoules per course of treatment is 1700: 100 = 17. Table for calculating the total number of ampoules for one patient per course of treatment.
Body weight, kg | Total number of Ferrum Lek ampoules per course of treatment | |||
Hb = 60 g/l | Hb = 75 g/l | Hb = 90 g/l | Hb =150 g/l | |
| 5 | 1,5 | 1,5 | 1,5 | 1,0 |
| 10 | 3,0 | 3,0 | 2,5 | 2,0 |
| 15 | 5,0 | 4,5 | 3,5 | 3,0 |
| 20 | 6,5 | 5,5 | 5,0 | 4,0 |
| 25 | 8,0 | 7,0 | 6,0 | 5,5 |
| 30 | 9,5 | 8,5 | 7,5 | 6,5 |
| 35 | 12,5 | 11,5 | 10,0 | 9,0 |
| 40 | 13,5 | 12,0 | 11,0 | 9,5 |
| 45 | 15,0 | 13,0 | 11,5 | 10,0 |
| 50 | 16,0 | 14,0 | 12,0 | 10,5 |
| 55 | 17,0 | 15,0 | 13,0 | 11,0 |
| 60 | 18,0 | 16,0 | 13,5 | 11,5 |
| 65 | 19,0 | 16,5 | 14,5 | 12,0 |
| 70 | 20,0 | 17,5 | 15,0 | 12,5 |
| 75 | 21,0 | 18,5 | 16,0 | 13,0 |
| 80 | 22,5 | 19,5 | 16,5 | 13,5 |
| 85 | 23,5 | 20,5 | 17,0 | 14,0 |
| 90 | 24,5 | 21,5 | 18,0 | 14,5 |
If the total number of Ferrum Lek ampoules exceeds the maximum daily dose, it is necessary to divide the administration of the drug into several doses. If after 1–2 weeks of therapy there is no normalization of blood counts, it is necessary to reconsider the established diagnosis. Calculation of the total dose of Ferrum Lek for intramuscular injection to replenish iron losses due to blood loss. The required number of ampoules is calculated using the following formulas:
- If the amount of blood lost is known, the administration of 200 mg of iron IM (2 ampoules) causes an increase in hemoglobin levels by 1 unit of blood (400 ml 150 g/l hemoglobin content). Required amount of iron (mg) = number of blood units lost • 200 or required number of Ferrum Lek ampoules = number of blood units lost • 2.
- If a reduced hemoglobin level is known , use the formula for calculation, assuming that there is no need to replenish stored iron: required amount of iron (mg) = body weight (kg) • (target hemoglobin value [g/l] - actual hemoglobin level [g/l ]) • 0.24. For patients weighing 60 kg with a hemoglobin deficiency of 10 g/l, the required amount of iron is 150 mg or 1.5 ampoules of Ferrum Lek.
The usual dose of Ferrum Lek for intramuscular administration : Children: 0.6 ml of the drug per 1 kg of body weight per day (3 mg of iron per 1 kg of body weight per day). Adults and elderly patients: contents of 1-2 ampoules of Ferrum Lek (100-200 mg iron) depending on the hemoglobin level. Maximum daily dose of Ferrum Lek for intramuscular administration Children: 0.14 ml of the drug per 1 kg of body weight per day (7 mg of iron per 1 kg of body weight per day). Adults: 4 ml of the drug (contents of 2 ampoules) Ferrum Lek. Ferrum Lek for intramuscular injection is administered every other day, deep intramuscularly, alternately into the left and right gluteal muscles. Before use, carefully check the ampoule visually. It is allowed to use only a transparent solution that does not contain sediment. If sediment appears and after the expiration date indicated on the package, the ampoule is not suitable for use. The ampoule is opened immediately before injection. The IM injection is performed slowly to avoid pain and staining of the skin, into the upper outer quadrant of the buttock with a needle 5–6 cm long. Before the injection, wipe the skin with alcohol, pull it to the side by 2 cm so that after removing the needle the injection channel is covered with skin to prevent fluid from leaking into the subcutaneous fat. During injection, the pulled skin is gradually released; after the injection, the injection site is pressed for 1 minute.
Instructions for use FERRUM LEK®
Chewable tablets
It is recommended to take the drug during or immediately after meals. The tablet can be chewed or swallowed whole. The daily dose can be taken at one time or divided into several doses.
The dose of the drug and duration of treatment depend on the degree of iron deficiency.
Iron-deficiency anemia
Treatment continues for 3-5 months until hemoglobin levels normalize. After this, the drug is prescribed for several more weeks to replenish iron reserves in the body.
Adults, nursing mothers, children and adolescents over 12 years of age
Prescribe, as a rule, 1-3 chewable tablets per day.
Pregnant women
Prescribe 2-3 chewable tablets per day until hemoglobin levels normalize. After this, 1 chewable tablet per day is prescribed, at least until the end of pregnancy, to replenish iron reserves in the body.
Children 0-12 years old
Ferrum Lek® is prescribed in syrup form.
Latent iron deficiency
Treatment continues for 1-2 months.
Adults, nursing mothers, children and adolescents over 12 years of age are prescribed
1 chewable tablet per day.
Children aged 1 to 12 years
Ferrum Lek® is prescribed in syrup form.
Due to the fact that children under 1 year of age
Iron supplements are prescribed in very low doses; Ferrum Lek® in the form of chewable tablets is not intended for this category of patients.
Latent iron deficiency and prevention of iron deficiency
Pregnant women
Prescribe 1 chewable tablet per day.
Table. Daily doses of Ferrum Lek® chewable tablets
| Manifest iron deficiency (iron deficiency anemia) | Latent iron deficiency | Prophylactic use | |
| Adults Children (> 12 years old) Nursing mothers | 1-3 tables | 1 table | -* |
| Pregnant women | 2-3 tables | 1 table | 1 table |
* - for this indication, the drug is prescribed in very low doses, so chewable tablets are not used.
Solution for intramuscular administration
Ferrum Lek® can only be administered intramuscularly. The drug cannot be used for intravenous administration.
Before administering the first therapeutic dose of Ferrum Lek®, each patient should be given a test dose
, amounting to 1/4-1/2 ampoule of Ferrum Lek® (25-50 mg of iron) for
an adult
and half the daily dose for
a child
. If there are no adverse reactions, the remainder of the daily dose can be administered within 15 minutes.
Doses of Ferrum Lek® must be selected individually in accordance with the general iron deficiency, which is calculated using the following formula:
- General iron deficiency = body weight (kg) × (calculated hemoglobin level (g/l) - actual hemoglobin level (g/l) × 0.24 + deposited iron (mg)
Body weight up to 35 kg:
calculated hemoglobin level = 130 g/l and deposited iron = 15 mg/kg body weight
Body weight over 35 kg:
estimated hemoglobin level = 150 g/l and deposited iron = 500 mg
Factor 0.24 = 0.0034×0.07×1000
(Iron content = 0.34%; total blood volume = 7% body weight; factor 1000 = conversion from g to mg).
Example:
Patient body weight: 70 kg
Real hemoglobin concentration: 80 g/l
Total iron deficiency = (150 – 80)×0.24 + 500 = 1700 mg iron
Total number of Ferrum Lek® ampoules that must be administered = Total iron deficiency (mg) / 100 mg
Table. Calculation of the total number of Ferrum Lek® ampoules that must be administered, based on the actual hemoglobin concentration and body weight
| Body weight (kg) | Total number of Ferrum Lek® ampoules to be administered | |||
| Нb 60 g/l | Нb75 g/l | Нb 90 g/l | Нb 105 g/l | |
| 5 | 1.5 | 1.5 | 1.5 | 1.0 |
| 10 | 3.0 | 3.0 | 2.5 | 2.0 |
| 15 | 5.0 | 4.5 | 3.5 | 3.0 |
| 20 | 6.5 | 5.5 | 5.0 | 4.0 |
| 25 | 8.0 | 7.0 | 6.0 | 5.5 |
| 30 | 9.5 | 8.5 | 7.5 | 6.5 |
| 35 | 12.5 | 11.5 | 10.0 | 9.0 |
| 40 | 13.5 | 12.0 | 11.0 | 9.5 |
| 45 | 15.0 | 13.0 | 11.5 | 10.0 |
| 50 | 16.0 | 14.0 | 12.0 | 10.5 |
| 55 | 17.0 | 15.0 | 13.0 | 11.0 |
| 60 | 18.0 | 16.0 | 13.5 | 11.5 |
| 65 | 19.0 | 16.5 | 14.5 | 12.0 |
| 70 | 20.0 | 17.5 | 15.0 | 12.5 |
| 75 | 21.0 | 18.5 | 16.0 | 13.0 |
| 80 | 22.5 | 19.5 | 16.5 | 13.5 |
| 85 | 23.5 | 20.5 | 17.0 | 14.0 |
| 90 | 24.5 | 21.5 | 18.0 | 14.5 |
If the total number of Ferrum Lek® ampoules to be administered exceeds the maximum daily dose, they should be divided into several days.
If, 1-2 weeks after the start of Ferrum Lek® administration, the hematological parameters do not change, the diagnosis should be clarified.
Calculation of the total dose for iron replacement due to blood loss
Required number of Ferrum Lek® ampoules to compensate for post-hemorrhagic iron deficiency
calculated using the following formula:
If the amount of blood lost is known: administration of 200 mg IM (2 ampoules of Ferrum Lek®) leads to an increase in hemoglobin level, which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l):
iron to be replaced (mg) = number of blood units lost×200 or required number of Ferrum Lek® ampoules = number of blood units lost×2
If a reduced hemoglobin level is known, then the following formula should be used, taking into account that the deposited iron does not need to be replaced:
iron to be replaced (mg) = body weight (kg)× (estimated hemoglobin level (g/L) - actual hemoglobin level (g/L)×0.24
A patient with a body weight of 60 kg and a hemoglobin deficiency of 10 g/l should be replaced with 150 mg of iron, which is 1 1/2 ampoules of Ferrum Lek®.
Ferrum Lek® injection solution is prescribed in the following doses.
Children:
0.06 ml Ferrum Lek®/kg body weight/day (3 mg iron/kg/day).
Adults and elderly patients:
1-2 ampoules of Ferrum Lek® (100-200 mg of iron), depending on the hemoglobin level.
Maximum daily doses of Ferrum Lek®:
- children -
0.14 ml Ferrum Lek/kg/day (7 mg iron/kg/day); - adults -
4 ml (2 ampoules) Ferrum Lek®.
Rules for administration and handling of the drug
If the ampoules are stored incorrectly, sediment may form. The use of such ampoules is unacceptable. If sediment appears in the ampoules or the shelf life has expired, they must be destroyed.
An opened ampoule should be used immediately.
It is important to administer IM injections carefully and appropriately to avoid pain and discoloration of the skin. IM injections of Ferrum Lek® are made into the upper outer quadrant of the gluteal muscle. The minimum needle length for adults is 50 mm, for overweight patients - from 80 to 100 mm, for children - 32 mm. Before injection, the skin should be disinfected and the subcutaneous tissue should be moved down 2 cm to reduce leakage of the drug after injection. After injection, the subcutaneous tissue is released and the injection site is held under pressure for 1 minute.
The contents of Ferrum Lek® ampoules should not be mixed with other drugs.
Contraindications to the use of the drug Ferrum lek
Hypersensitivity to the drug , anemia not caused by iron deficiency, including hemolytic; hypersensitivity to any of the components of the drug; excess iron in the body (hemochromatosis, hemosiderosis); disorders of hemoglobin synthesis (anemia caused by lead poisoning, sideroblastic anemia), thalassemia; severe hemostasis disorders (hemophilia); oral administration is not advisable when there is a decrease in the concentration of iron in the blood serum and anemia caused by a chronic inflammatory process or neoplasm.
Side effects of Ferrum Lek
Usually well tolerated, side effects are mostly transient and mild. Gastrointestinal disorders such as a feeling of heaviness and fullness in the stomach, distension in the epigastric region, nausea, constipation or diarrhea are very rarely observed. Dark coloration of stool caused by iron supplementation is not clinically significant. With intramuscular administration, arterial hypotension, arthralgia, swollen lymph nodes, fever, headache, dizziness, and infiltrate at the injection site rarely occur; very rarely - anaphylactic and anaphylactoid reactions.
Special instructions for the use of the drug Ferrum Lek
1 tablet contains 0.04 XE, 1 ml of syrup - 0.04 XE. Each Ferrum Lek tablet contains 1.5 mg of aspartame (a precursor to phenylalanine), and may therefore have an adverse effect on patients with phenylketonuria. In controlled trials, the use of the drug in the second and third trimester of pregnancy did not have a negative effect on the fetus. Iron is released into breast milk in the form of a complex with lactoferrin, only a small amount of iron from the complex of iron (III) hydroxide with polymaltose passes into breast milk in ionized form, so the occurrence of side effects in an infant when the mother takes Ferrum Lek is unlikely. Parenteral administration of iron preparations can cause the development of allergic reactions. For an allergic reaction of moderate severity, the administration of antihistamines is recommended. If an anaphylactic reaction develops, immediate administration of epinephrine is indicated. The risk of developing anaphylaxis is quite high in patients with asthma, Crohn's disease, polyarthritis, reduced iron binding capacity and/or folic acid deficiency.
Ferrum Lek for injection solution d/i/m 100mg/2ml amp 2ml N5x1 Lek d.d.
Ferrum Lek solution is intended for intramuscular administration only. The drug should be administered only in a hospital setting, by specially trained personnel who can recognize the signs of incipient anaphylactic shock, in conditions of availability of resuscitation facilities and the possibility of carrying out a complex of anti-shock measures. The patient should be observed for at least 30 minutes after each injection. Before administering the first therapeutic dose of the drug, each patient should be given a test dose of 1/4-1/2 ampoule of Ferrum Lek (25 - 50 mg of iron) for an adult and half the daily dose for a child. If there are no adverse reactions, the remainder of the daily dose should be administered within 15 minutes. The dose of Ferrum Lek must be selected individually in accordance with the general iron deficiency, which is calculated using the following formula: General iron deficiency [mg] = body weight (kg) x (calculated hemoglobin level (g/l) - actual hemoglobin level (g/l )) x 0.24* + deposited iron (mg). Body weight up to 35 kg: calculated hemoglobin level = 130 g/l and deposited iron = 15 mg/kg body weight. Body weight over 35 kg: estimated hemoglobin level = 150 g/l and deposited iron = 500 mg. *Factor 0.24 = 0.0034 x 0.07 x 1000: (Iron content = 0.34%; total blood volume = 7% body weight; factor 1000 = conversion from g/L to mg/L). If the required dose of Ferrum Lek exceeds the maximum daily dose, the drug should be administered in fractional doses (over several days). If 1-2 weeks after the start of treatment the hematological parameters do not change, an additional examination should be carried out to clarify the diagnosis. If the amount of blood lost is known: administration of 200 mg intramuscularly (2 ampoules of Ferrum Lek) leads to an increase in hemoglobin concentration, which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l). Iron to be replaced (mg) = number of units of blood lost x 200 or Number of ampoules of Ferrum Lek required = number of units of blood lost x 2. If the final hemoglobin level is known: use the following formula, taking into account that deposited iron does not need to be replaced. Iron to be replaced (mg) = body weight (kg) x (estimated hemoglobin level (g/L) - actual hemoglobin level (g/L)) x 0.24. Standard doses. Children: 0.06 ml/kg body weight/day (3 mg iron/kg/day). Adults: 1 - 2 ampoules of Ferrum Lek (100 - 200 mg of iron), depending on the hemoglobin content. Maximum daily doses. Children: 0.14 ml/kg body weight per day (7 mg iron/kg/day). Adults: 4 ml (2 ampoules of Ferrum Lek) per day.
Interactions of the drug Ferrum lek
Do not mix the solution for intramuscular administration with other medications; Like other iron preparations for parenteral use, Ferrum Lek is not prescribed simultaneously with iron preparations for oral administration. The interval between parenteral use of the drug and the start of use of oral dosage forms of iron should be at least 5 days. Since iron is included in the drug in the form of a complex of iron (III) hydroxide with polymaltose, when taken in the form of chewable tablets or syrup, it does not form insoluble chelate compounds with components of food products (phytin, oxalates, tannin) or medicines (tetracyclines, antacids ).
Ferrum lek solution for intramuscular administration 100 mg/2 ml in ampoules No. 5
Name
Ferrum lek solution for intramuscular injection 100 mg/2 ml per amp. in pack No. 5
Main active ingredient
Gland
iii
dextran hydroxide
Release form
solution
Compound
Each ampoule (2 ml) contains 100 mg of iron (III) in the form of a complex compound of dextran with iron (III) hydroxide. Excipients: sodium hydroxide, hydrochloric acid (to adjust pH), water for injection.
Description
Brown opaque solution.
Pharmacological properties
Pharmacodynamics
After intramuscular administration, part of the iron (III) hydroxide is stored in the form of ferritin, formed in liver mitochondria. Ferritin consists of a protein shell - apoferritin, in which iron is in the form of hydrated micelles of iron oxide phosphate. Iron transport in plasma is carried out using beta-globulin transferrin, synthesized in the liver. Each transferrin molecule binds two iron atoms. Iron, in combination with transferrin, is transported to the body's cells, where it is used for the synthesis of hemoglobin, myoglobin and some enzymes. Transferrin also plays an indirect role in protecting the body against infections. After parenteral administration of a complex compound of dextran with iron (III) hydroxide, the hemoglobin concentration increases faster than after oral administration of iron (II) salts, despite the fact that the kinetics of iron absorption does not depend on the method of its administration. The complex of dextran with iron (III) hydroxide is quite large in size and therefore is not excreted through the kidneys. The resulting complex compound is stable and does not release iron ions under physiological conditions. Iron in polynuclear nuclei is bound in a structure similar to that of ferritin under physiological conditions. Available data support the view that Ferrum Lek provides the same physiological changes that are observed with the natural absorption of iron.
Pharmacokinetics
After intramuscular administration, the complex compound of dextran with iron (III) hydroxide is absorbed mainly in the lymphatic system and penetrates the circulating blood system after 3 days. Despite the lack of data on bioavailability, it is known that a relatively large part of the intramuscularly administered dextran complex with iron (III) hydroxide is not absorbed into muscle tissue even after a longer period of time. The biological half-life of the complex compound of dextran with iron (III) hydroxide is 3-4 days. The macromolecular complex of dextran with iron (III) hydroxide is captured by the reticuloendothelial system and breaks down into components - iron and dextran. The iron then binds to ferritin and, to a lesser extent, to transferrin. This iron is then used in the bone marrow to synthesize hemoglobin, i.e. participates in erythropoiesis. Dextran is either metabolized or excreted. Iron is excreted in small quantities. Preclinical Safety Data Iron dextran has been reported to be teratogenic and embryocidal in non-anemic pregnant animals at high single doses above 125 mg/kg. The highest recommended dose in clinical use is 20 mg/kg. However, detailed information about these studies is not available. In vitro and in vivo genotoxicity studies have shown mutagenic activity following administration of high doses of dextran iron complexes. However, the significance of these results is unclear. The dextran iron complex was not mutagenic when administered at subtoxic doses.
Indications for use
Treatment of all forms of iron deficiency when oral iron supplements are ineffective and/or not tolerated by patients.
Contraindications
- hypersensitivity to the active substance or auxiliary components of the drug; - anemia not associated with iron deficiency; - iron overload or hereditary disorders of iron utilization; - history of severe hypersensitivity reactions to other iron-based drugs for parenteral administration.
Use during pregnancy and lactation
Pregnancy Based on a moderate amount of data (300-1000 pregnancies), there were no undesirable effects of parenteral iron supplements on the mother or newborn when used by women in the second and third trimester of pregnancy. Adequate and well-controlled trials of the effectiveness and safety of the drug in pregnant women have not been conducted. Therefore, a careful benefit/risk assessment is required before using Ferrum Lek during pregnancy and it should not be used during pregnancy unless clearly necessary (see Precautions). To treat iron deficiency anemia that occurs in the first trimester of pregnancy, oral iron supplements can be used in many cases. Treatment with Ferrum Lek should be limited to the second and third trimesters if the benefits outweigh the potential risks to both mother and fetus. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Preclinical Safety Data). Lactation Preclinical data do not indicate direct or indirect harmful effects in breast-fed infants.
Directions for use and doses
During and after each administration of this drug, carefully monitor for signs and symptoms of hypersensitivity reactions. This drug should only be administered by personnel trained to recognize anaphylactic reactions and provide emergency care in an environment where resuscitation can be performed. Adverse reactions should be assessed for at least 30 minutes after each administration of the drug. This drug can only be administered intramuscularly. It cannot be used for intravenous administration, either by injection or by infusion. Dose calculation Iron replenishment for iron deficiency anemia Doses of Ferrum Lek must be selected individually in accordance with the total iron deficiency, which is calculated using the following formula: total iron deficiency (mg) = body weight (kg) x (target hemoglobin level (g/l) - actual hemoglobin level (g/l)) x 0.24* + deposited iron (mg) Body weight up to 35 kg: target hemoglobin level = 130 g/l and deposited iron = 15 mg/kg body weight Body weight 35 kg or more: target hemoglobin level = 150 g/l and deposited iron = 500 mg *Coefficient 0.24 = 0.0034 x 0.07 x 1000 (Iron content in hemoglobin = 0.34%; total blood volume = 7% body weight; coefficient 1000 = conversion from grams to milligrams). Example: Patient's body weight: 70 kg Actual hemoglobin level: 80 g/l Total iron dose = 70 x (150 - 80) x 0.24 + 500 = 1700 mg iron. Total number of Ferrum Lek ampoules to be administered = total iron deficiency (mg) / 100 mg Table: total dose of Ferrum Lek in milliliters (number of ampoules) to be administered, based on actual hemoglobin level and body weight Body weight (kg) Total dose of Ferrum Lek in milliliters (number of ampoules) to be administered: Hb 60 g/l Hb 75 g/l Hb 90 g/l Hb 105 g/l 5 3 (1.5) 3(1.5) 3 (1 .5) 2(1.0) 10 6 (3.0) 6(3.0) 5 (2.5) 4(2.0) 15 10 (5.0) 9 (4.5) 7(3 .5) 6 (3.0) 20 13 (6.5) 11(5.5) Yu (5.0) 8 (4.0) 25 16(8.0) 14 (7.0) 12 (6 .0) 11(5.5) 30 19(9.5) 17 (8.5) 15 (7.5) 13 (6.5) 35 25 (12.5) 23 (11.5) 20 (10 .0) 18 (9.0) 40 27(13.5) 24 (12.0) 22(11.0) 19 (9.5) 45 30 (15.0) 26 (13.0) 23(11 .5) 20 (10.0) 50 32 (16.0) 28 (14.0) 24 (12.0) 21 (10.5) 55 34 (17.0) 30 (15.0) 26(13 .0) 22(11.0) 60 36 (18.0) 32 (16.0) 27(13.5) 23 (11.5) 65 38 (19.0) 33 (16.5) 29(14 .5) 24 (12.0) 70 40 (20.0) 35 (17.5) 30(15.0) 25 (12.5) 75 42 (21.0) 37(18.5) 32 (16 .0) 26 (13.0) 80 45 (22.5) 39(19.5) 33 (16.5) 27 (13.5) 85 47 (23.5) 41 (20.5) 34 (17 ,0) 28 (14.0) 90 49 (24.5) 43 (21.5) 36 (18.0) 29 (14.5) If, 1-2 weeks after the start of Ferrum Lek administration, hematological parameters do not change, the diagnosis should be clarified. Calculation of the total dose to replace iron due to blood loss The dose of Ferrum Lek to compensate for post-hemorrhagic iron deficiency is calculated using the following formula: if the amount of lost blood is known: administration of 200 mg IM (4 ml or 2 ampoules of Ferrum Lek) leads to an increase in hemoglobin level, which is equivalent to 1 unit of blood (400 ml of blood with a hemoglobin content of 150 g/l) Amount of iron to be replaced (mg) = number of lost units of blood x 200 or Volume of Ferrum Lek in milliliters (number of ampoules) = number of lost units of blood x 4 (x 2 ); if a reduced hemoglobin level is known, use the following formula, taking into account that deposited iron does not need to be replaced: iron to be replaced (mg) = body weight (kg) x (target hemoglobin level (g/l) - actual hemoglobin level (g /l)) x 0.24 For example, a patient with a body weight of 60 kg and a hemoglobin deficiency of 10 g/l should be replaced with 150 mg of iron, which is 1 1/2 ampoules of Ferrum Lek (3 ml). Usual daily doses Children from 4 months of age: 0.06 ml Ferrum Lek/kg body weight/day (3 mg iron/kg/day). Adults and elderly patients: 1-2 ampoules of Ferrum Lek (100-200 mg iron), depending on the hemoglobin level. If there are no adverse reactions, the drug is administered according to an individually selected regimen until the total required dose is reached. The daily dose should generally not exceed 0.5 ml (25 mg iron) for children weighing up to 5 kg, 1.0 ml (50 mg iron) for children weighing up to 10 kg and 2.0 ml (100 mg iron) for other patients. If the calculated total dose of Ferrum Lek to be administered exceeds the maximum daily dose, it should be divided over several days and administered daily to active patients or 1-2 times a week to inactive/immobilized patients. Directions for use/handling and administration Improper storage of ampoules may result in sedimentation. The ampoules should be carefully inspected before use. You can only use ampoules that contain a homogeneous solution without sediment. If sediment appears in the ampoules or the shelf life has expired, they must be destroyed. An opened ampoule should be used immediately. The contents of Ferrum Lek ampoules should not be mixed with other medications. To avoid pain and discoloration of the skin, it is very important to administer intramuscular injections carefully and correctly. Ferrum Lek is injected only intramuscularly (in no case intravenously!) deep into the gluteal muscle, alternating between the right and left. Intramuscular injections of Ferrum Lek are carried out in the upper outer quadrant of the gluteal muscle. The minimum needle length for adults is 50 mm, for overweight patients - from 80 to 100 mm, for children - 32 mm. Before injection, the skin should be disinfected and moved down 2 cm to reduce the leakage of medication after injection. After injection, the skin is released and the injection site is held under pressure for 1 minute. If the patient is standing during the injection, he should shift his weight to the leg opposite the injection site; if lying down, he should lie in a lateral position on the side opposite the injection site.
Side effect
Information on adverse reactions is presented in accordance with the MedDRA system-organ classification and frequency of occurrence. Frequency categories are determined by the following classification: very often (?1/10), often (?1/100, but
Overdose
An overdose can cause iron overload, which can manifest as hemosiderosis. If necessary, overdose should be treated with iron chelates or according to standard medical practice. With chronic repeated administration of high doses of iron, excess iron accumulates in the liver and causes an inflammatory process that can lead to fibrosis.
Interaction with other drugs
This drug should not be prescribed simultaneously with oral iron supplements, since the absorption of the latter will be reduced. Therapy with iron preparations for oral administration should begin no earlier than 5 days after the last parenteral administration of iron. High doses of iron dextran (5 ml or more) cause serum samples taken four hours after iron dextran administration to turn brown. The drug may cause a false increase in bilirubin concentration and a false decrease in serum calcium concentration.
Precautionary measures
Parenteral administration of iron may cause hypersensitivity reactions, including severe and potentially fatal anaphylactic/anaphylactoid reactions. There are reports of the occurrence of hypersensitivity reactions after administration of parenteral iron complexes, which previously occurred without complications. The risk of hypersensitivity reactions increases in patients with known allergies, including drug allergies, severe asthma, eczema, or a history of other atopic allergies. There is also an increased risk of hypersensitivity reactions to parenteral iron in patients with immune or inflammatory diseases (eg, systemic lupus erythematosus, rheumatoid arthritis). This drug should only be administered by personnel trained to recognize anaphylactic reactions and provide emergency care in settings where full resuscitation equipment is available. Adverse reactions in each patient should be assessed for at least 30 minutes after each administration of the drug. If hypersensitivity reactions or signs of intolerance occur when using the drug, treatment should be stopped immediately. Cardiopulmonary resuscitation and equipment to manage acute anaphylactic/anaphylactoid reactions, including 1:1000 epinephrine injection, should be available. If necessary, additional treatment with antihistamines and/or corticosteroids should be prescribed. In patients with impaired liver function, parenteral iron administration should only be performed after a careful assessment of the risk/benefit ratio. And in patients with impaired liver function, where the provoking factor is iron overload, it should be avoided. To avoid iron overload, it is recommended that iron levels be carefully monitored. Parenteral iron should be administered with caution in acute or chronic infections. In case of bacteremia, this drug is discontinued. In patients with chronic infection, the benefit-risk ratio must be assessed. Hypotensive reactions may occur if intramuscular administration is too rapid. In the case of intramuscular administration of iron-carbohydrate complexes, the risk of carcinogenesis cannot be excluded. Such complications were found in experimental settings of sarcoma reproduction, where in animal studies intramuscular and subcutaneous injections of iron-carbohydrate complexes led to the development of sarcomas in rats, mice, rabbits and hamsters, but not in guinea pigs. Accumulated information and independent assessments show that the risk of developing sarcoma in humans is minimal. The long latency period between a potentially carcinogenic injection and the appearance of a tumor makes it impossible to accurately assess the risk to humans. Adverse reactions that occur after the administration of iron supplements can lead to increased cardiovascular complications in patients with pre-existing cardiovascular pathology. Due to lack of experience, the use of intramuscular injections of Ferrum Lek in children under 4 months is not recommended.
Storage conditions
Store at a temperature not exceeding 25 °C. Do not freeze. Keep out of the reach of children.
Ferrum lek overdose, symptoms and treatment
With parenteral administration, hemosiderosis may develop. Incorrect diagnosis of anemia as iron deficiency can lead to iron overdose. In case of an overdose of tablets or syrup, symptoms of acute poisoning can develop in extremely rare cases, since iron from HPA is absorbed not through passive diffusion, but through active transport, and the degree of absorption of iron from HPA directly depends on the severity of iron deficiency. Treatment is symptomatic; a specific iron antidote is the chelating agent deferoxamine.
