Ferrum lek injection solution ampoules 2ml N50
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Active ingredients
Iron (III) hydroxide polymaltozane
Composition
1 ml of 1 amp. iron [III] hydroxide polyisomaltose 50 mg 100 mg. Excipients: sodium hydroxide, hydrochloric acid (concentrated), water d / and.
Pharmacological effect
Antianemic drug. In the preparation, iron is in the form of a complex compound of iron (III) hydroxide polyisomaltozate. This macromolecular complex is stable and does not release iron in the form of free ions. The complex is similar in structure to the natural compound of iron - ferritin. Iron (III) hydroxide polyisomaltozate does not possess prooxidant properties that are inherent in the salts of iron (II). Iron, which is part of the drug, quickly compensates for the deficiency of this element in the body (including in case of iron deficiency anemia) and restores the level of hemoglobin (Hb). When using the drug, there is a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, pain and dryness of the skin) and laboratory symptoms of iron deficiency.
Pharmacokinetics
Absorption: After i / m administration of the drug, iron quickly enters the bloodstream: 15% of the dose after 15 minutes, 44% of the dose after 30 minutes. Iron in combination with transferrin is transferred to the cells of the body, where it is used to synthesize hemoglobin, myoglobin and certain enzymes. Excretion: T1 / 2 - 3-4 days. The iron (III) complex polyisomaltozate hydroxide is large enough and therefore not excreted through the kidneys, the compound is stable and does not emit iron ions under physiological conditions.
Indications
Treatment of all conditions of iron deficiency requiring its rapid replenishment: - severe iron deficiency due to blood loss - impaired absorption of iron in the intestine - conditions in which treatment with iron preparations for oral administration is ineffective or impracticable.
Contraindications
- excessive iron content in the body (hemosiderosis, hemochromatosis) - impairment of iron inclusion mechanisms in hemoglobin (anemia caused by lead poisoning, sideroachrestic anemia, thalassemia) - anemia not related to iron deficiency - Osler-Randue-Weber syndrome - kidney infections in acute stage - uncontrolled hyperparathyroidism - decompensated liver cirrhosis - infectious hepatitis - Ist trimester of pregnancy - hypersensitivity to the components of the drug.The drug should be used with caution in case of bronchial asthma, chronic polyarthritis, cardiovascular insufficiency, low ability to bind iron and / or folic acid deficiency in children of children up to 4 months.
Use during pregnancy and lactation
Parenteral administration of the drug is contraindicated in the first trimester of pregnancy. In the II and III trimesters of pregnancy and during breastfeeding, the drug is prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.
Dosage and administration
The drug in the form of a solution can be administered only in / m. Not allowed in / in the introduction of the drug! Before the first therapeutic dose is administered, each patient should be given a test dose of 1 / 4-1 / 2 ampoules (25-50 mg of iron) for an adult and 1/2 a daily dose for children. In the absence of adverse reactions within 15 minutes after administration, the remainder of the initial daily dose is administered. Doses of the preparation Ferrum Lek are selected individually in accordance with the general iron deficiency calculated using the following formula: Total iron deficiency (mg) = body weight (kg) × (calculated Hb level (g / l) - detected Hb (g / l)) × 0.24 + deposited iron (mg). With a body weight of up to 35 kg: calculated level Hb = 130 g / l, deposited iron = 15 mg / kg body weight. With a body weight of more than 35 kg: calculated level Hb = 150 g / l, deposited iron = 500 mg. Factor 0.24 = 0.0034 × 0.07 × 1000 (iron content in Hb = 0.34%, total blood volume = 7% of body weight, factor 1000 - conversion from g to mg). Calculation of the total number of ampoules of the drug based on the detected level of hemoglobin and body weight Body weight (kg) Total number of ampoules with Hb level 60 g / l 75 g / l 90 g / l 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 7.5 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 15 15 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 total number of ampoules to be entered exceeds the maximum allowable daily dose, then the total number of ampoules should divided by the required number of days. If, 1-2 weeks after the start of treatment, the hematological parameters do not improve, the diagnosis should be clarified again. Calculation of the total dosage for iron replacement due to blood loss With a known amount of lost blood in a / m, administration of 200 mg of iron (2 ampoules) results in an increase in hemoglobin equivalent to 1 blood unit (400 ml with a hemoglobin content of 150 g / l).The amount of iron that needs to be recovered (mg) = number of lost blood units x 200 or the required number of ampoules = number of lost blood units x 2 With a known final hemoglobin level, the above formula is used given that the deposited iron is not required to be replenished. Amount of iron to be replaced (mg) = body weight (kg) × (calculated Hb level (g / l) - detected Hb level (g / l)) x 0.24 Normal doses of Ferrum Lek 100-200 mg are prescribed for adults and elderly patients (1-2 ampoules) depending on the level of hemoglobin; children - 3 mg / kg / day (0.06 ml / kg body weight / day). The maximum daily intake for adults is 200 mg (2 ampoules); for children - 7 mg / kg / day (0.14 ml / kg body weight / day). Rules of drug administration The drug is administered deeply in a / m alternately in the right and left buttocks. In order to reduce pain and avoid staining of the skin, the following rules should be followed: - the drug should be injected into the upper outer quadrant of the buttock, using a needle 5-6 cm long; - before injection after disinfection of the skin, the subcutaneous tissues should be moved down by 2 cm to prevent the subsequent leakage of the drug; - after administration of the preparation, the subcutaneous tissues should be released, and the injection site should be pressed and held in this position for 1 minute. Before using the solution for i / m injection ampoules should be carefully examined. Only ampoules containing a homogeneous solution without sediment should be used. Solution for i / m injection should be used immediately after opening the ampoule.
Side effects
On the part of the digestive system: nausea, vomiting. From the side of the central nervous system: headache, dizziness. Local reactions: with the wrong technique of drug administration it is possible - staining of the skin, the appearance of pain and an inflammatory reaction at the injection site. Other: arterial hypotension, arthralgia, swollen lymph nodes, fever, malaise; extremely rare - allergic or anaphylactic reactions.
Overdose
Symptoms: An overdose of iron preparations can lead to acute iron overload and hemosiderosis. Treatment: symptomatic therapy. As an antidote, it is administered intravenously slowly (15 mg / kg / h) of deferoxamine, depending on the severity of the overdose, but not more than 80 mg / kg / day. Hemodialysis is ineffective.
Interaction with other drugs
Ferrum Lek for i / m injections should not be used simultaneously with iron preparations for oral administration. The simultaneous use of the drug Ferrum Lek with ACE inhibitors may cause an increase in the systemic effects of parenteral iron preparations.
special instructions
The drug should be used only in a hospital. When appointing Ferrum Lek, it is obligatory to conduct laboratory tests: a general clinical blood test and determination of the serum ferritin level; it is necessary to exclude violation of iron absorption. Treatment with oral forms of iron-containing drugs should be started no earlier than 5 days after the last injection of Ferrum Lek. The contents of the ampoules should not be mixed with other drugs.