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

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

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

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).

Indications

Indications for the use of the drug CosmoFer are: - clinical need for rapid transport of iron to its depot (post-hemorrhagic 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.) - intolerance to iron for oral use - alternative to blood transfusions - anemia of pregnant women in the 2nd-3rd trimester.

Additionally

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 into 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 potentially dangerous mechanisms. Warning: while taking the drug, you must refrain from drinking alcohol.

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.

Contraindications

Contraindications to the use of the drug CosmoFer are: - first trimester of pregnancy - age under 14 years - anemia not caused by iron deficiency (for example, hemolytic anemia) - oversaturation of the body with iron or disorders of its excretion (i.e. hemochromatosis, hemosiderosis) - patients suffering from asthma, eczema or other atopic allergies - hypersensitivity to the drug, including iron mono- or disaccharide complexes and dextran - decompensated liver cirrhosis and hepatitis - acute or chronic infection, as parenteral iron supplementation may aggravate bacterial or viral infections - rheumatoid arthritis with symptoms or signs of active inflammation - acute renal failure.

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.