Description
Release form
Solution for intravenous and intramuscular administration
Packing
5 ampoules of 2 ml.
Pharmacological action
CosmoFer contains iron in the form of a stable complex of iron (III) – hydroxide dextran, suitable for both intravenous and intramuscular use. An important advantage of the drug is that the iron in the complex is presented in a non-ionic water-soluble form and has a very low toxicity. The complex of iron (III) – dextran hydroxide in its chemical structure is an analogue of the physiological complex of ferritin with iron (III) – hydroxide. In the body, ferritin, binding Fe (III) hydroxide, provides the neutralization of toxic iron ions.
Pharmacokinetics
The absorption of iron to replenish its reserves in the body and the synthesis of hemoglobin begins immediately after administration of the iron (III) complex dextran hydroxide.
Iron, administered intravenously in the form of iron dextran, is rapidly absorbed by the system of phagocytic macrophages (SPS), especially the liver, spleen and bone marrow. CellsSPS capture iron (III) hydroxide dextran and remove iron from the carbohydrate compound of dextran, making it available to the body. Elemental iron returns to plasma, binds to transferrin and is deposited in the form of ferritin or hemosiderin – physiological forms of iron, and entering the bone marrow, it is involved in the synthesis of hemoglobin.
Serum ferritin content peaks around 7 9 days after intravenous administration and returns to baseline after about 3 weeks.
Elevated hematopoiesis can be observed over the next 6 8 weeks.
After intramuscular administration, the iron (III) complex dextran hydroxide enters the bloodstream through the capillaries and lymphatic system.
About 60% of the intramuscularly administered drug is absorbed within 3 days and more than 90% within 3 weeks. The remaining amount is absorbed over several months. 2/3 of the iron is removed through the digestive tract with red blood cells, bile and exfoliating epithelial cells.
Due to the size of the complex (165,000 Yes), it is practically not excreted by the kidneys.
Indications
Iron deficiency anemia with severe intolerance to oral iron preparations and in cases of need for quick replenishment of iron stores.
Contraindications
hypersensitivity to drugs containing mono- or disaccharide complexes of iron and dextran
anemia not associated with iron deficiency (including hemolytic, sideroblastic, lead)
iron overload (hemochromatosis, hemochromatosis, allergic skin diseases (including eczema)
decompensated liver cirrhosis and hepatitis
infectious diseases
acute renal failure
rheumatoid arthritis with symptoms of active inflammation
pregnant spine (I term)
children’s age (14 years).
Precautions: impaired renal function pregnancy (II ² III trimesters) lactation.
Use during pregnancy and lactation
Should not be prescribed during the first trimester of pregnancy, but can be used with caution during the second and third trimesters and during lactation.
Special instructions
The use of CosmoFera, as well as other iron-hydrocarbon complexes, carries the risk of anaphylactic reactions. During the administration of the drug and immediately after administration, patients should be under the supervision of a doctor.
There is an increased risk for patients with an identified allergy. Acute anaphylactic reactions are extremely rare. They occur during the first minutes of use and are usually characterized by a sudden attack of shortness of breath and / or cardiovascular collapse.
The possibility of anti-shock therapy should be provided (0.1% solution of epinephrine (epinephrine), antihistamines and / or corticosteroids).
When the first signs of anaphylactic reactions appear, CosmoFer should be stopped immediately.
The use of CosmoFer in patients with autoimmune diseases or inflammatory conditions (systemic lupus erythematosus, rheumatoid arthritis) can cause type III allergic reactions. Cases of arterial hypotension can occur if the IV injection is done too quickly.
Delayed hypersensitivity reactions are characterized by arthralgia, anaphylactic myalgia and sometimes fever, which can last from several hours to 4 days after administration of the drug. Symptoms usually occur within 2 ² 4 days.
The diagnosis of iron deficiency should be based on appropriate laboratory tests (serum ferritin, serum iron, iron transferrin saturation).
Before use, check ampoules visually for sediment and damage. Use only ampoules with a homogeneous solution that does not contain sediment.
Peculiarities of the action of the drug at the first dose or when
is canceled. At the first use of the drug, the recommended initial dose is 25 mg of iron or 0.5 ml of solution. If during the next 60 minutes no adverse reactions appear, you can enter the remaining dose.
Effect on the ability to drive vehicles, mechanisms. Does not affect the ability to drive vehicles and mechanisms.
Dosage and administration
CosmoFer is used as an intravenous drip infusion or as a slow intravenous or intramuscular injection.
The use of CosmoFer is possible only in a hospital with the condition of the availability of resuscitation and anti-shock therapy. Patients should be closely monitored by the doctor during the administration of the drug and immediately after it for 1 hour.
The use of CosmoFer should be stopped immediately, with any manifestations of a hypersensitivity reaction or intolerance detected during administration.
Usually the recommended dose of CosmoFer: 100-200 mg of iron (corresponding to 2-4 ml of the drug) 2-3 times a week, depending on the content of hemoglobin.
However, if the clinical situation requires rapid replacement of iron, intravenous drip of a total dose of Cosmofer is possible – up to 20 mg / kg of the patient s body weight.
At the first use of the drug, the recommended initial dose is 25 mg of iron or 0.5 ml of solution. If during the next 60 minutes no adverse reactions appear, you can enter the remaining dose.
For intravenous infusions, CosmoFer can be diluted only in 0.9% sodium chloride solution or in 5% glucose solution.
For intramuscular injection, an undiluted preparation (2.0 ml, maximum 4.0 ml) is used as a series of injections: the volume of each series is usually determined by the patient s body weight. For patients with 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.
Side effects
Adverse reactions may occur in approximately 5% of patients.
The most common adverse reactions are skin itching, shortness of breath.
In rare cases, there may be: a decrease in blood pressure, nausea, dyspeptic disorders, headache, joint and muscle pain, an increase in lymph nodes, an increase in bilirubin levels and a decrease in serum calcium.
Local reactions – pain and inflammation at the injection site, in addition with intravenous administration – phlebitis, thrombophlebitis.
Large doses of iron dextran (5 ml or more) give a brown color to blood serum, taken 4 hours after using the drug.
Anaphylactoid reactions are possible, up to the development of anaphylactic shock with a fatal outcome.
Drug Interactions
CosmoFer for parenteral use is not prescribed in conjunction with oral iron preparations, as absorption of iron taken orally will be reduced. The interval between the parenteral use of CosmoFer and the start of oral administration of iron should be at least 5 days.
CosmoFer must only be mixed with 0.9% sodium chloride solution or 5% glucose solution. Do not mix with solutions of other drugs.
Overdose
Symptoms: hemosiderosis (acute iron overload).
Treatment: the purpose of complexing agents (chelators) that bind iron to the chelate complex.
With repeated repeated administration of iron in a large dose, excess of it accumulates in the liver and causes an inflammatory process that can lead to fibrosis.
Storage conditions
In a dry place, at a temperature not exceeding 25 ° C. Do not allow freezing.
Keep out of the reach and sight of children.
Shelf life
30 months
Deystvuyushtee substance
irons III gidroksid dextran
Terms and conditions
prescription
Dosage form
solution for injection and infusion
Possible product names
CosmoFer ampoules 50 mg / ml 2 ml, 5 pcs.
COSMOFER RR I / O AND I / O INTRODUCTION. 50MG / ML AMP. 2ML No. 5
4646 Denmark
