Venofer solution for intravenous injection of 100mg 5ml ampoules 5ml N5
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Active ingredients
Iron hydroxide + sucrose complex
Release form
Solution
Composition
1 syringe contains: Active substances: iron (III) sucrose hydroxide complex - 540 mg. Additives: sodium hydroxide, water d / and - up to 1 ml.
Pharmacological effect
The drug is iron. The multicore centers of iron (III) hydroxide are surrounded on the outside by a multitude of non-covalently bound molecules of sucrose. As a result, a complex is formed, the molecular weight of which is approximately 43 kD, as a result of which its excretion by the kidneys in unchanged form is impossible. This complex is stable and under physiological conditions does not emit iron ions. Iron in this complex is associated with structures similar to natural ferritin.
Pharmacokinetics
Distribution After a single intravenous injection of the drug Venofer; containing 100 mg of iron, Cmax of iron, an average of 538 μmol, is reached 10 minutes after the injection. The Vd of the central chamber almost completely corresponds to the volume of serum - about 3 l. l (which indicates a low distribution of iron in body fluids). Due to the low stability of iron saharaty compared with transferrin, there is a competitive exchange of iron in favor of transferrin. As a result, about 31 mg of iron (III) is transferred in 24 hours. Excretion of T1 / 2 is about 6 hours. In the first 4 hours less than 5% of iron from the total clearance is eliminated by the kidneys. After 24 hours, the serum iron level returns to its original (before administration) value, and about 75% of sucrose leaves the bloodstream.
Indications
Iron deficiency states: - if necessary, rapid replenishment of iron; - in case of intolerance to oral iron preparations or failure to comply with the treatment regimen; - in the presence of active inflammatory bowel diseases, when oral iron preparations are ineffective.
Contraindications
- anemia, not associated with iron deficiency; - signs of iron overload (hemosiderosis, hemochromatosis); violation of the iron utilization process; I trimester of pregnancy; hypersensitivity to the components of the drug. , allergic reactions to other parenteral iron preparations; patients with low serum iron binding and / or folate deficiency; patients with liver failure, with acute or chronic infectious diseases, with elevated serum ferritin levels due to the factthat parenteral iron may have an adverse effect in the presence of a bacterial or viral infection.
Use during pregnancy and lactation
Contraindicated in the first trimester of pregnancy. Limited experience with the drug Venofer; in pregnant patients showed no adverse effect of iron saharath on the course of pregnancy and the health of the fetus / newborn. To date, no well controlled studies have been conducted in pregnant women. In experimental studies of the effect on reproduction in animals, no direct or indirect adverse effect on the development of the embryo / fetus, childbirth, or postnatal development was detected. However, further research is needed on the relationship between the expected benefit of therapy for the mother and the possible risk to the fetus. The release of unmetabolized iron saharathus into breast milk is unlikely. Thus, Venofer; It is not dangerous for breastfed babies.
Dosage and administration
Venofer is administered only in / in (slowly drip or jet) or in the venous area of the dialysis system. Not intended for i / m administration. The simultaneous administration of a full therapeutic dose of the drug is unacceptable. Before the introduction of the first therapeutic dose, it is necessary to prescribe a test dose. If intolerance occurs during the observation period, the administration of the drug should be immediately discontinued. Before opening the ampoule, inspect it for possible sediment and damage. You can use only the brown solution without sediment. Trickle introduction: Venofer; It is preferable to administer it during a drip infusion in order to reduce the risk of a pronounced decrease in blood pressure and the risk of solution getting into the near-venous space. Immediately before the infusion of Venofer; It should be diluted with a 0.9% solution of sodium chloride in the ratio of 1:20, for example, 1 ml (20 mg of iron) in 20 ml of a 0.9% solution of sodium chloride. The resulting solution should be injected at the following rate: 100 mg of iron - no less than 15 minutes; 200 mg of iron - within 30 minutes; 300 mg of iron - for 1.5 hours; 400 mg of iron - for 2.5 hours; 500 mg of iron - for 3.5 hours. The introduction of the maximum tolerated single dose of 7 mg of iron / kg should be made for at least 3.5 hours,regardless of the total dose of the drug. Before the first drip of a therapeutic dose of the drug Venofer; It is necessary to introduce a test dose: 20 mg of iron to adults and children weighing more than 14 kg, and half the daily dose (1.5 mg iron / kg) to children with a body weight less than 14 kg, for 15 minutes. In the absence of adverse events, the rest of the solution should be injected at the recommended rate. Injection: venofer; You can also enter in the form of undiluted solution in / in slowly, at a rate of (normal) 1 ml of the drug Venofer; (20 mg of iron) per minute; 5 ml of drug Venofer; (100 mg of iron) should be administered at least 5 minutes. The maximum amount of the drug should not exceed 10 ml of the drug Venofer; (200 mg of iron) for 1 injection. Before the first jet injection of a therapeutic dose of the drug Venofer; A test dose should be administered: 1 ml of the drug Venofer; (20 mg of iron) for adults and children weighing more than 14 kg and half the daily dose (1.5 mg of iron / kg) for children weighing less than 14 kg for 1-2 minutes. In the absence of adverse events over the next 15 minutes of observation, the remaining part of the solution should be injected at the recommended rate. After the injection, it is recommended that the patient fix the arm in an extended position for a while. Introduction to the dialysis system Venofer; You can enter directly into the venous area of the dialysis system, strictly following the rules described for IV injection. Dose calculation: dose is calculated individually according to the general iron deficiency in the body using the formula: Total iron deficiency (mg) = body weight (kg) × [normal Hb level - patient's Hb level] (g / l) × 0.24 * + deposited iron (mg). For patients with a body weight less than 35 kg: normal level Hb = 130 g / l, the amount of deposited iron = 15 mg / kg mass For patients with a body weight of more than 35 kg: normal level Hb = 150 g / l, the number deposited iron = 500 mg. * Coefficient 0.24 = 0.0034 × 0.07 × 1000 (iron content in Hb = 0.34%; blood volume = 7% of body weight; coefficient 1000 = conversion from g to mg). Total volume (ml) of the drug Venofer ;, which must be entered = total iron deficiency (mg) / 20 mg / ml In the case when the total therapeutic dose exceeds the maximum permissible single dose, fractional administration of the drug is recommended. If after 1-2 weeks. after the start of treatment with the drug Venofer; there is no improvement in hematological parameters,it is necessary to revise the initial diagnosis. Calculate the dose to replenish the iron level after blood loss or delivery of autologous blood. The dose of the drug Venofer; calculated by the following formula: If the amount of blood lost is known: in / in the introduction of 200 mg of iron (10 ml of the drug Venofer;) leads to the same increase in Hb concentration as transfusion of 1 unit of blood (= 400 ml with Hb concentration = 150 g / l). The amount of iron that needs to be replenished (mg) = the number of units of blood lost × 200 or The required amount of the drug Venofer; (ml) = number of units of lost blood × 10. When Hb level is reduced: the previous formula should be used, provided that no iron replenishment is required. Amount of iron (mg) to be replenished = body weight (kg) × 0.24 × [normal Hb level - patient's Hb level] (g / l). For example: body weight 60 kg, Hb deficiency = 10 g / l: the required amount of iron is about 150 mg, and the required volume of the drug Venofer; = 7.5 ml. Standard dose: 5-10 ml of the drug Venofer is prescribed for adults and elderly patients; (100-200 mg of iron) 1-3 times a week, depending on the level of hemoglobin. There are only limited data on the use of the drug in children under 3 years of age. If necessary, it is recommended to inject no more than 0.15 ml of the drug Venofer; (3 mg of iron) per kg of body weight 1-3 times a week, depending on the level of hemoglobin. Maximum tolerated single dose. Adults and elderly patients: for jet injection - 10 ml of the drug Venofer; (200 mg of iron), the duration of administration is at least 10 minutes; for drip, depending on the indications, a single dose can reach 500 mg of iron. The maximum permissible single dose is 7 mg / kg and is administered 1 time per week, but it should not exceed 500 mg of iron. The time of administration of the drug and the method of dilution, as described above.
Side effects
The side effects likely associated with the administration of the drug Venofer; were very rare. From the nervous system: dizziness, headache, loss of consciousness, paresthesia. From the cardiovascular system: heartbeat, tachycardia, decreased blood pressure, collaptoid states, hot flashes, flushing of the face. From the respiratory organs: bronchospasm, shortness of breath. From the digestive system: diffuse pain in the abdomen, pain in the epigastric region, diarrhea, taste perversion, nausea, vomiting. From the skin: erythema, itching, rash, pigmentation disorders,increased sweating. From the musculoskeletal system: arthralgia, back pain, joint swelling, myalgia, pain in the extremities. Allergic reactions: anaphylactoid reactions, swelling of the face, laryngeal edema. Local reactions: pain and swelling at the injection site (especially with extravascular drug). General disorders: asthenia, chest pain, feeling of heaviness in the chest, weakness, peripheral edema, feeling of indisposition, pallor, fever, chills.
Overdose
Symptoms: hemosiderosis due to acute overload. Treatment: it is recommended to conduct symptomatic therapy and, if necessary, use iron-binding drugs (chelates), for example, deferoxamine IV.
Interaction with other drugs
You should not prescribe the drug at the same time with oral dosage forms of iron, because decreases iron absorption from the gastrointestinal tract. Treatment with oral iron preparations can be started no earlier than 5 days after the last injection. Pharmaceutical interaction Venofer; can be mixed in one syringe only with saline. No other solutions for the on / in the introduction and therapeutic drugs are not allowed, because there is a risk of precipitation and / or other pharmaceutical interactions. Compatibility with containers of materials other than glass, polyethylene and polyvinyl chloride has not been studied.
special instructions
Venofer; It should be prescribed only to those patients whose diagnosis of anemia is confirmed by relevant laboratory data (for example, the results of serum ferritin or hemoglobin and hematocrit, the red blood cell count and their parameters - the average red blood cell volume, the average red blood cell hemoglobin count). In / iron preparations can cause allergic or anaphylactoid reactions that can be potentially life-threatening. The speed of administration of the drug Venofer should be strictly observed; (with the rapid introduction of the drug may decrease blood pressure). A higher incidence of undesirable side reactions (especially a decrease in blood pressure), which can also be severe, is associated with an increase in dose. Thus, it is necessary to strictly observe the recommended time of drug administration,even if the patient does not receive the drug in the maximum tolerated single dose. Studies conducted in patients with hypersensitivity reactions to iron dextran showed no complications during treatment with the drug Venofer; one should avoid penetration of the drug into the near-venous space, because getting Venofer out of the vessel leads to tissue necrosis and brown staining of the skin. In case of development of this complication to speed up the excretion of iron and prevent its further penetration into the surrounding tissues, it is recommended to apply heparin-containing preparations to the injection site (gel or ointment is applied with light movements, without rubbing). From a microbiological point of view, the preparation should be used immediately. dilution with saline: chemical and physical stability after dilution at room temperature is 12 hours. From a microbiological point of view, the preparation rat should be used immediately. If the preparation was not used immediately after dilution, the user is responsible for the conditions and storage time, which in any case should not exceed 3 hours at room temperature if the dilution was carried out under controlled and guaranteed aseptic conditions. The effect on driving vehicles and controlling mechanisms; It is unlikely that the drug Venofer; may have an undesirable effect on the ability to drive vehicles and work with mechanisms.