CosmoFer, 50 mg/ml, solution for intravenous and intramuscular administration, 2 ml, 5 pcs.

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CosmoFer, 50 mg/ml, solution for intravenous and intramuscular administration, 2 ml, 5 pcs.

IV

(in the form of drip infusions or slow injections),
IM
.

The use of the drug is possible only in a hospital when anti-shock therapy is available.

Patients should be under close medical supervision during the administration of the drug and immediately after it for 1 hour.

The use of the drug should be immediately discontinued in case of any manifestations of a hypersensitivity reaction or intolerance detected during administration.

The usually recommended dose is 100–200 mg of iron (corresponding to 2–4 ml of the drug) 2–3 times a week, depending on the hemoglobin level.

However, if the clinical situation requires rapid iron replacement, intravenous drip administration of a total dose of CosmoFer is possible - up to 20 mg/kg.

Intravenous drip infusions

CosmoFer can only be diluted in 0.9% sodium chloride solution or 5% glucose solution. A dose of 100–200 mg of iron (2–4 ml of the drug) is diluted in 100 ml of solvent.

The first 25 mg of iron should be infused evenly over 15 minutes; if no negative reactions occur during this time, the remaining dose can be administered at a rate of no more than 100 ml in 30 minutes.

Intravenous injections

CosmoFer can be administered intravenously slowly (0.2 ml/min) at a dose of 100–200 mg of iron (2–4 ml), preferably diluted in 10–20 ml of 0.9% sodium chloride solution or 5% glucose solution.

The initial dose of the drug is 25 mg of iron or 0.5 ml of solution, which is administered intravenously slowly over 1–2 minutes. If there are no negative reactions within 15 minutes, you can continue administering the remaining dose of the drug.

Total dose

Cosmosphere is determined from a table or calculated using a formula. Immediately before use, the total dose is added, observing aseptic rules, to the required volume (usually 500 ml) of sterile sodium chloride solution or 5% glucose solution. The total amount of CosmoFer (up to 20 mg/kg) is administered intravenously over 4–6 hours.

The rate of administration can be increased to 45–60 drops/min. When increasing the rate of administration, it is necessary to monitor the patient for 1 hour after injection.

IV drip administration of the drug is preferable, because reduces the risk of arterial hypotension.

Injections through a dialyzer

CosmoFer can be used during the hemodialysis procedure. The drug is injected directly into the venous circuit of the dialyzer. The administration procedure is the same as for intravenous administration.

Intramuscular injections

The total amount of CosmoFer is determined both from the dose table and using calculations. For intramuscular injections, undiluted drug (2 ml, maximum 4 ml) is used in the form of a series of injections: the volume of each series is usually determined by the patient’s body weight. For patients leading a moderately active lifestyle, injections are administered daily, alternately in different buttocks. For patients leading an inactive lifestyle or bedridden patients, the frequency of injections is reduced to 1 or 2 per week.

The drug is injected deep into the muscle (to reduce the risk of subcutaneous staining.) The drug should only be injected into the muscle mass of the outer upper quadrant of the buttock and should not be injected into the arm or other area of ​​the body.

For adults, a 20–21 gauge needle, at least 50 mm in length, should be used; for obese patients, needles 80–100 mm long are used, and for adolescents, smaller and shorter needles are used (23G × 32 mm). The patient should lie on his side, with the injection side facing up, or stand with his body weight on the leg that is not injected.

To avoid penetration of the drug into the subcutaneous tissue, a Z-shaped technique of skin displacement before injection is recommended.

CosmoFer is administered slowly and carefully. It is important to wait a few seconds before removing the needle to allow the muscle mass to “adapt” to the volume of drug injected.

It is not recommended to rub the injection site.

Dose calculation

A. For patients with iron deficiency anemia

The required dose should ideally correspond to the total iron deficiency, calculated using the formula:

Body weight, kg × (required hemoglobin, g/l − actual hemoglobin g/l) × 0.24 + amount of iron to replenish its reserves, mg.

The 0.24 factor is calculated as follows:

a) blood volume is 70 ml/kg, i.e. about 7% of body weight;

b) iron content in hemoglobin - 0.34%.

Factor 0.24 = 0.0034 × 0.07 × 1000 (conversion from g to mg).

Below is a table showing the number of ml of CosmoFer injection solution that can be used for iron deficiency anemia of various degrees.

The results in the table are calculated based on the achieved hemoglobin level of 150 g/l and iron reserve of 500 mg for a body weight above 35 kg.

Table

Total dose of CosmoFer for iron deficiency anemia, ml

Body weight, kgHemoglobin content, g/l
607590105120135
35252320181512,5
40272422191613
452926232016,513
50322824211713,5
55343026221814
603632272318,514,5
653833292419,514,5
70403530252015
75423732262115,5
804539332721,516
85474134282216
90494236292316,5

Note:

The table and the corresponding formula are applicable to determine the dose only in patients with iron deficiency anemia.

The table and formula should not be used to determine dosage in those patients who require iron replacement due to blood loss. Total iron requirements reflect the amount of iron needed to restore hemoglobin concentrations to normal or near-normal levels, plus an additional amount to adequately replenish iron stores in most people with moderate or severely decreased hemoglobin. It must be remembered that iron deficiency anemia will not manifest itself until all iron stores are depleted. Therapy should therefore be aimed not only at replenishing hemoglobin with iron, but also at replenishing iron stores in general.

If the total required dose exceeds the maximum permissible daily dose, administration should be carried out in several doses. The therapeutic effect can be observed several days after using CosmoFer and manifest itself in the form of an increase in the number of reticulocytes. Serum ferritin levels are a good indicator of iron replenishment. In dialysis patients receiving CosmoFer, this correlation may not occur.

B. For patients with blood loss

Iron therapy in patients with blood loss should aim to replace an amount of iron equivalent to the amount of iron in the blood lost. The table and formulas above are not suitable for quickly replenishing iron reserves. Quantitative estimates of blood loss and hematocrit in a person during bleeding are a useful way to calculate the required dose of iron.

The required dose of CosmoFer to compensate for iron deficiency is calculated according to the following formulas.

1. If the volume of blood lost is unknown

IV administration of 200 mg of iron (4 ml of CosmoFer) will lead to an increase in hemoglobin equal to the effect of 1 unit of blood (about 400 ml with a hemoglobin level of 150 g/l, which corresponds to 0.34% of 0.4 × 150, i.e. 204 mg iron).

Iron that must be replaced (mg) = units of blood lost x 4.

2. If hemoglobin is reduced

, the previous formula should be used, according to which the iron supply does not need to be restored.

Amount of iron (mg) that must be replaced = body weight (kg) × 0.24 × (required hemoglobin g/L − actual hemoglobin g/L).

For example: body weight = 60 kg, hemoglobin deficiency = 10 g/l.

The amount of iron that must be replaced = 60 x 0.24 x 10 = 143 mg (about 3 ml of CosmoFer).

Cosmopher

CosmoFer is used in the form of intravenous drip infusions or slow intravenous or intramuscular injections. The use of the drug CosmoFer is possible only in a hospital with the condition that anti-shock therapy is available. Patients should be under close medical supervision during administration of the drug and immediately after it for 1 hour. The use of CosmoFer should be immediately discontinued if any manifestations of a hypersensitivity reaction or intolerance detected during administration.

The usually recommended dose of CosmoFer: 100-200 mg of iron (corresponds to 2 - 4 ml of the drug) 2-3 times a week, depending on the hemoglobin content.

However, if the clinical situation requires rapid iron replacement, intravenous drip administration of a total dose of Cosmofer is possible - up to 20 mg/kg of the patient’s body weight.

Intravenous drip infusions:

The first 25 mg of iron should be infused evenly over 15 minutes; if no adverse reactions occur during this time, the remaining dose can be administered at a rate of no more than 100 ml in 30 minutes.

CosmoFer can only be diluted in 0.9% sodium chloride solution or 5% glucose solution. A dose of 100-200 mg of iron (2-4 ml) is diluted in 100 ml of solution.

Intravenous injections:

CosmoFer can be administered intravenously slowly (0.2 ml/min) at a dose of 100-200 mg of iron (2-4 ml), preferably diluted in 10-20 ml of 0.9% sodium chloride solution or 5% glucose solution.

The initial dose of the drug is 25 mg of iron or 0.5 ml of solution, which is administered intravenously slowly over 1-2 minutes. If there are no negative reactions within 15 minutes, you can continue administering the remaining dose of the drug.

The total dose of CosmoFer is determined from the table or calculated using formulas. Immediately before administration, the total dose of the drug is added aseptically to the required volume (usually 500 ml) of sterile sodium chloride solution or 5% glucose solution. The total amount of CosmoFer (up to 20 mg/kg body weight) is administered intravenously over a period of 4-6 hours.

The rate of administration can be increased to 45-60 drops per minute. When increasing the rate of administration, it is necessary to monitor the patient for 1 hour after injection.

Intravenous drip administration of the drug is preferable because it reduces the risk of arterial hypotension.

Injections via dialyzer:

CosmoFer can be used during the hemodialysis procedure. The drug is injected directly into the venous circuit of the dialyzer. The administration procedure is the same as for intravenous use.

Intramuscular injections:

The total amount of CosmoFer is determined both from the dose table and using calculations. For intramuscular injections, undiluted drug (2.0 ml, maximum 4.0 ml) is used in the form of a series of injections: the volume of each series is usually determined by the patient’s body weight. For patients leading a moderately active lifestyle, injections are administered daily, alternately in different buttocks. For patients leading an inactive lifestyle or bedridden patients, the frequency of injections is reduced to one or two per week.

CosmoFer must be injected deep into the muscle to reduce the risk of subcutaneous staining. The drug should be injected only into the muscle mass of the upper outer quadrant of the buttock; CosmoFer should not be injected into the arm or other external area of ​​the body.

For adults, a 20-21 G needle, at least 50 mm in length, should be used; for obese patients, 80-100 mm long needles are used, and for adolescents, smaller and shorter needles are used (23 Gx 32 mm). The patient should lie on their side, with the side to be injected facing up, or stand with their weight on the leg that is not injected. To avoid penetration of the drug into the subcutaneous tissue, a Z-shape technique of mixing the skin before injection is recommended. CosmoFer is administered slowly and carefully. It is important to wait a few seconds before removing the needle to allow muscle mass to adjust to the amount of drug injected. It is not recommended to rub the injection site.

Dose calculation:

For patients with iron deficiency anemia:

The required dose should ideally correspond to the total iron deficiency, calculated using the formula:

Body weight in kg × (required Hb g/l - actual Hb g/l) × 0.24 + mg of iron to replenish iron stores. Factor 0.24 is obtained as follows:

a) Blood volume 70 ml/kg body weight = approximately 7% body weight

b) Iron content in hemoglobin 0.34% Factor 0.24=0.0034×0.07×1000 (transition from g to mg).

The table below shows the number of milliliters of CosmoFer that should be used for different degrees of iron deficiency anemia.

The results in the table below are based on an achieved hemoglobin content of 150 g/l and an iron reserve of 500 mg for body weight above 35 kg.

Total dose of CosmoFer in milliliters for iron deficiency anemia:

Body weight (kg)Hemoglobin content
60 g/l75 g/l90 g/l105 g/l120 g/l135 g/l
35252320181512.5
40272422191613
452926232016.513
5032 .2824211713.5
55343026221814
603632272318.514.5
653833202419.514.5
70403530252015
75423732262115.5
804539332721.516
85474134282216
90494236292316.5

Note: The table and the corresponding formula are applicable to determine the dose only in patients with iron deficiency anemia. The table and formula should not be used on the day of dosing in those patients who require iron replacement due to blood loss. Total iron requirements reflect the amount of iron needed to restore hemoglobin concentrations to normal or near-normal levels, plus additional amounts to provide adequate iron replenishment in most people with moderate or severely decreased hemoglobin. It must be remembered that iron deficiency anemia will not manifest itself until all iron stores are depleted. Therapy, therefore, should be aimed not only at replenishing hemoglobin with iron, but also at replenishing iron stores in general.

If the total required dose exceeds the maximum permissible daily dose, administration should be carried out in several doses. The therapeutic effect can be observed several days after using CosmoFer and manifest itself in the form of an increase in the number of reticulocytes. Serum ferritin levels are a good indicator of iron replenishment. In dialysis patients receiving CosmoFer, this correlation may not occur.

For patients with blood loss:

Iron therapy in patients with blood loss should aim to replace an amount of iron equivalent to the amount of iron in the blood lost. The table and formulas above are not suitable for quickly replenishing iron. Quantitative estimates of blood loss and hematocrit in a person during bleeding are a useful way to calculate the required dose of iron.

The required dose of CosmoFer to compensate for iron deficiency is calculated according to the following formulas:

If the amount of blood lost is unknown:

Taking 200 mg iron IV (4 ml CosmoFer) will lead to an increase in hemoglobin equal to the effect of 1 unit of blood (= 400 ml containing 150 g/l Hb, which is equal to 0.34% of 0.4 × 150 or 204 mg iron).

Iron that must be replaced (mg) = number of blood units lost × 4,

If Hb is reduced: use the previous formula, according to which iron stores do not need to be restored.

Amount of mg of iron that should be mixed = body weight (kg) × 0.24 × (required Hb in g/l - actual Hb g/l).

For example: body weight = 60 kg, Hb deficiency = 10 g/l.

Iron that must be replaced = 60 × 0.24 × 10 = 143 mg (approximately 3 ml CosmoFer).

Overdose

In case of acute iron overload, which can manifest itself as hemosiderosis, iron-binding drugs (chelators) should be prescribed. With repeated administration of iron in large doses, excess iron accumulates in the liver and causes an inflammatory process that can lead to fibrosis.

Cosmofer 50mg/ml 2ml amp. 5pcs - Instructions

Dosage form

Solution for injection, 5 ampoules per package.

Compound

CosmoFer contains the active substance - iron(III) hydroxide-dextran complex 625.0 mg (equivalent to 100.0 mg of ferric iron).

Excipients: sodium hydroxide solution (pH regulator) qs to pH 5.5 or hydrochloric acid (pH regulator) qs to pH - 5.5; water for injections - up to 2 ml.

Pharmacological properties

Mechanism of action - after intravenous administration of iron (III) - hydroxide of the dextran complex is quickly taken up by the cells of the reticuloendothelial system (RES), especially the liver and spleen, where iron is slowly released and binds to proteins. After administration of the drug, increased hematopoiesis is observed over the next 6-8 weeks. Circulating iron is removed from the plasma by cells of the reticuloendothelial system, which separates the complex into its components - iron and dextran. Iron immediately binds to proteins, forming hemosiderin, or ferritin - physiological forms of iron, or, to a lesser extent, transferrin. This iron, which is subject to physiological control, replenishes hemoglobin and replenishes depleted iron stores.

Pharmacokinetics

Iron is necessary for the normal functioning of various heme and non-heme substrates: hemoglobin, myoglobin, cytochromes, peroxidases and catalases. They are involved in oxygen transport, tissue respiration and removal of peroxides formed during free radical reactions. Adequate amounts of iron are necessary for effective erythropoiesis—the hemoglobinization of erythroblasts. The transfer of iron to mature red blood cells occurs primarily by release from transferritin at the receptor site on the precursor membrane. Dose prescription is based on a target hemoglobin content of 150 g/l or 9.3 mmol/l and iron depot 500 mg, which applies to body weight exceeding 35 kg. The dosage interval is 2-3 times a week depending on the hemoglobin level. The half-life of circulating iron in plasma is 5 hours, and for total iron (bound and circulating) it is 20 hours. Excessive accumulation of iron in the body can lead to impaired iron excretion (hemochromatosis, hemosiderosis). Due to the size of the complexes (165,000 Daltons), iron is not excreted from the body through the kidneys. Small amounts of iron are excreted in feces and urine. After intramuscular injection, iron-dextran is absorbed at the injection site and enters the capillaries and lymphatic system. Most of the intramuscularly administered iron-dextran is absorbed after 72 hours, the remainder is absorbed over the next 3-4 weeks. Dextran is either metabolized or excreted. Recommended dosages for intramuscular administration 1 time per week, for intravenous drip administration 2-3 times a week. With very rapid administration of the drug, attacks of hypotension are possible.

Indications for use

Indications for use of the drug CosmoFer are:

  • clinical need for rapid transport of iron to its depot (posthemorrhagic anemia of any etiology, preoperative preparation of the patient)
  • renal anemia (patients with chronic renal failure)
  • hemo- and peritoneal dialysis
  • ineffectiveness or impossibility of absorption of iron into the gastrointestinal tract (toxicosis of pregnant women, surgical interventions, etc.)
  • oral iron intolerance
  • alternative to blood transfusions
  • anemia of pregnant women in the II-III trimester.

Directions for use and dosage

Dosage: the recommended regimen is a single (daily) dose of 100-200 mg of iron, which corresponds to 2-4 ml of solution, 2-3 times a week intravenously. The duration of treatment depends on the target hemoglobin content of 150 g/l or 9.3 mmol/l and iron depot 500 mg. However, if clinical circumstances require rapid delivery of iron to depots in the body, then CosmoFer can be prescribed in a total dose corresponding to iron 20 mg/kg body weight. The use of CosmoFer does not depend on food intake or diets. When carrying out treatment, skipping the next dose of the drug is not recommended.

For adults and elderly people: the total total dose of CosmoFer is determined by the level of initial hemoglobin and body weight. The dosage and regimen of use of the CosmoFer drug should be established individually for each patient based on calculation of the total iron deficiency.

Children under 14 years of age: CosmoFer is not recommended for use in children under 14 years of age, since the drug affects erythropoiesis at the normoblast-reticulocyte level. In children under 14 years of age, physiological reticulocytosis is observed.

Application: CosmoFer solution for injection can be administered by intravenous drip or intravenous bolus, of which intravenous drip is the preferred method, as this may help reduce the risk of hypotension.

CosmoFer is also intended for intramuscular administration without diluting the solution.

Test dose: when administering CosmoFer intramuscularly, it is recommended to carry out a test dose corresponding to 25 mg of iron or 0.5 ml of solution, respectively. Observation time 30 minutes. If no adverse reactions are observed during observation, then the remaining dose of the drug is administered, otherwise the drug should be discontinued.

Intravenous drip: CosmoFer should be administered with 0.9% sodium chloride solution (saline solution) or 5% glucose solution. CosmoFer in a dosage of 100-200 mg of iron (2-4 ml) must be diluted in 100-200 ml of saline or glucose. The first 25 mg of iron is administered over 15 minutes. If no adverse reactions are observed during this time, then the remaining dose of the solution is administered within an hour.

Intravenous bolus administration: CosmoFer can be administered in a dosage of 100-200 mg of iron (2-4 ml) by intravenous bolus injection (0.2 ml/min) diluted in 10-20 ml of 0.9% sodium chloride solution or 5% glucose solution. When given as a bolus intravenous injection, the first 25 mg of iron should be infused slowly over 1-2 minutes. If no adverse reactions are observed within 15 minutes after administration of the test dose, then the remaining dose of the drug can be administered.

Note: Intravenous drip is preferred over intravenous bolus.

Administration of the total course dose: when prescribing the total course dose of CosmoFer determined by calculations according to the table below, the calculated amount of the drug is diluted in 500 ml of isotonic sodium chloride solution or 5% glucose solution. The total amount of CosmoFer is up to 20 mg/kg body weight, administered intravenously over about 4-6 hours. The first 25 mg of iron is administered over 15 minutes. When administering the drug, the patient must be under the direct supervision of a physician. If no adverse reactions occur during this time, then the remaining dose is administered. The use of a general course dose is possible if the doctor has experience in using the drug in a single dose. Intravenous administration of a total dose of CosmoFer should only be carried out in a hospital setting.

Administration into the dialyzer: CosmoFer can be administered during hemodialysis directly into the venous portion of the dialyzer, following the same procedures as prescribed for intravenous administration. Intramuscular administration: the drug is used once a week, at a dosage of 100 mg of iron (2.0 ml). The drug should be injected deep into the muscle, into the upper outer square of the buttock. To administer the drug, use syringes with a volume of 5.0 or 10.0 ml. CosmoFer must be administered slowly and evenly. Do not rub the injection site.

Calculation of the course dose: the total course dose of the drug in ml., is calculated according to the table depending on the level of initial hemoglobin and the patient’s body weight.

The table below shows the number of milliliters of CosmoFer injection solution required to treat varying degrees of iron deficiency anemia. The clinical effect of the drug can be observed on the 7th day. Patients experience an increase in the number of reticulocytes.

Side effects

When using the drug CosmoFer, the following side effects may occur: skin itching, nausea, dizziness, hypotension, diarrhea, shortness of breath, chest pain; anaphylactic reactions are extremely rare (0.00019% per 1 million doses). They usually occur within the first few minutes after taking the drug and are mainly characterized by a sudden onset of difficulty breathing and/or cardiovascular failure. Pain in the joints, muscles and sometimes fever can last from several hours to four days after using the drug and are immediately relieved after taking analgesics.

Contraindications

Contraindications to the use of CosmoFer are:

  • first trimester of pregnancy
  • age up to 14 years
  • anemia not caused by iron deficiency (eg, hemolytic anemia)
  • iron oversaturation in the body or impaired iron excretion (i.e. hemochromatosis, hemosiderosis)
  • patients suffering from asthma, eczema or other types of atopic allergies
  • hypersensitivity to the drug, including iron mono- or disaccharide complexes and dextran
  • decompensated liver cirrhosis and hepatitis
  • acute or chronic infection, since parenteral iron supplementation may exacerbate bacterial or viral infections
  • rheumatoid arthritis with symptoms or signs of active inflammation
  • acute renal failure.

Interaction with other drugs

Pharmaceutical. The use of CosmoFer is contraindicated if you are taking other iron supplements or oral iron supplements. CosmoFer injection solution contains iron in a stable aqueous hydroxide-dextran complex, which is similar to the physiological form of iron, ferritin. The drug is characterized by a stable collodial complex, in the center of which there is iron, surrounded by closely associated dextran chains. The sterile solution has a neutral pH, approximately 5.2 - 6.5. Sodium hydroxide or hydrochloric acid is used to stabilize the pH. The solution does not contain any preservatives. Dextran iron complexes for parenteral administration are distinguished by their stability and rate of release into serum.

Pharmacodynamic. CosmoFer injections should not be taken in parallel with oral medications, as the absorption of oral iron will be reduced. Oral iron therapy should begin no earlier than 5 days after taking the last CosmoFer injection. You should promptly inform your doctor or pharmacist about any other medications you are using or have recently used, even if you purchased them yourself.

Pharmacokinetic. The use of large doses of iron(III) - dextran hydroxide complex (5 ml or more) may cause a brown color to the serum in blood samples taken four hours after taking the drug. The medicine may cause erroneously increased bilirubin levels and decreased calcium levels in the blood serum.

Other types of drug interactions: There is no data on the interaction of the CosmoFer drug with food and tobacco.

Overdose

Symptoms of an overdose of CosmoFer: laryngeal edema, bronchospasm, laryngospasm, hypoxia Treatment: The first measure in case of anaphylactic shock should be the urgent administration of adrenaline - 0.2-0.5 ml of a 0.1% solution subcutaneously or, better, intravenously. If necessary, carry out symptomatic therapy.

Special instructions

CosmoFer should be diluted only with a solution of 0.9% sodium chloride or 5% glucose solution. Dilution with other solutions or therapeutic agents is not permitted.

When using the drug, patients are not allowed to use the drug independently. Patients should be under direct supervision during and after administration of the drug. The risk increases in patients with individual intolerance. Use strictly as prescribed by your doctor to avoid complications.

Lactation

There is no data on the excretion of the drug in breast milk.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms:

There is no data on the effect on the ability to drive a vehicle or operate potentially dangerous machinery.

Warning: while taking the drug, you must refrain from drinking alcohol.

Storage conditions

Store in a dry place, protected from light, at a temperature from +18° to +25°C. Keep out of reach of children!

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