Active substanceIron [III] hydroxide polymaltosateIron [III] hydroxide polymaltosate
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  • Dosage form: & nbsp

    Solution for intramuscular injection.

    Composition:

    In 1 ml of the drug contains:

    Active ingredient: iron (III) hydroxide polymaltozate in terms of iron (III) - 50.0 mg;

    auxiliary components: 1 M sodium hydroxide solution or hydrochloric acid solution - q.s. (to pH 5.7 - 6.5), water for injection - up to 1.0 ml.

    Description:Opaque solution of brown color.
    Pharmacotherapeutic group:The preparation of iron.
    ATX: & nbsp

    B.03.A.B   Preparations of iron (trivalent) for oral administration

    B.03.A.B.05   Iron hydroxide polymaltosate

    Pharmacodynamics:

    The preparation of iron in the form of a polymaltose complex of iron (III) hydroxide (is an iron dextrin,in contrast to iron (III), the hydroxide of polyisomaltozate - iron dextran, does not contain dextrans, which makes it more likely that anaphylactic reactions will develop). Outside, the multinucleated centers of iron (III) hydroxide are surrounded by many non-covalently bound complexes forming a common mol. with a mass of 50 Da, which is so large that its diffusion through the membranes of the intestinal mucosa is approximately 40 times less than that of iron (II) hexahydrate.

    This macromolecular complex is stable, does not release iron in the form of free ions, is similar in structure to the natural combination of iron and ferritin. Due to this similarity, iron (III) from the intestine enters the blood only by active absorption, which explains the impossibility of an overdose (and intoxication) by the drug, in contrast to simple iron salts, which are absorbed through a concentration gradient. The absorbed iron is deposited in a ferritin-related form, mainly in the liver. Later, in the bone marrow it is included in the hemoglobin. Iron, which is part of iron (III) -hydroxide of the polymaltose complex, does not possess pro-oxidant properties (which are inherent in simple iron (II) salts)which leads to a decrease in the oxidation of low density lipoproteins (LDL) and very low density lipoproteins (VLDL).

    Like other iron preparations, Fer-Rhompharm has no effect on erythropoiesis and is not effective in anemia not associated with iron deficiency.

    Pharmacokinetics:

    After intramuscular injection enters the bloodstream through the lymphatic system. The period of reaching the maximum concentration (TCmOh) - 24 hours. The complex is split into iron (III) hydroxide and polymaltose (it is metabolized by oxidation). In the bloodstream, iron binds to transferrin, is deposited in tissues in the ferritin, and is incorporated into the hemoglobin in the bone marrow.

    Excreted from the body are only small amounts of iron.

    In small quantities, the unaltered complex can pass through the placental barrier, and small amounts of it enter the breast milk.

    Indications:

    Treatment of iron deficiency states with ineffectiveness or inability to treat iron preparations for oral administration. For example: patients who are intolerant to oral treatment, patients with malabsorption syndrome or with gastrointestinal diseases, which can worsen with oral iron therapy.Fer-Rhompharm can be used only if the iron deficiency state is confirmed by appropriate studies (for example, by measuring the serum ferritin, hemoglobin, hematocrit or the number of erythrocytes, and their parameters - mean erythrocyte volume, mean hemoglobin in erythrocyte or mean hemoglobin concentration in erythrocyte).

    Contraindications:

    • hypersensitivity to iron (III) hydroxide polymaltose complex or any other component of the drug;
    • anemia not related to iron deficiency (hemolytic anemia or megaloblastic anemia, caused by a lack of cyanocobalamin, aplastic anemia);
    • excess iron in the body (hemochromatosis, hemosiderosis);
    • violation of iron utilization mechanisms (lead anemia, sidero-achestic anemia, thalassemia, late porphyria of the skin);
    • Rundu-Weber-Osler syndrome;
    • disturbances of erythropoiesis;
    • bone marrow hypoplasia;
    • chronic polyarthritis;
    • bronchial asthma;
    • infectious diseases of the kidneys in the acute stage;
    • uncontrolled hyperparathyroidism;
    • decompensated cirrhosis of the liver;
    • infectious hepatitis;
    • children's age up to 4 months (no experience of use);
    • 1 trimester of pregnancy.

    Carefully:

    Care should be taken when administering the drug to patients with polyvalent allergies, and caution should be exercised when administering iron preparations to patients with hepatic and renal insufficiency, with acute or chronic infectious diseases and patients who have increased serum ferritin levels due to the fact that parenteral administration Iron can have adverse effects in the presence of a bacterial or viral infection.

    Pregnancy and lactation:

    In animal studies, the reproductive toxicity of the Fer-Rhompharm preparation has not been studied. The study of reproductive function in pregnant women with the use of this drug was not conducted.

    Pregnancy

    During the first three months of pregnancy, parenteral use of iron-containing drugs should be avoided. In the second and third trimesters, these drugs should be taken only on the advice of a doctor.

    Lactation (the period of breastfeeding)

    Possible penetration of iron into breast milk in small quantities. It is necessary to stop breastfeeding while the drug is being used.

    Dosing and Administration:

    Fer-Rhompharm is administered intramuscularly.

    Intravenous administration is contraindicated.

    Before the administration of each therapeutic dose, a drug tolerance test is carried out by administering 0.5-1.0 ml of Fer-Rhompharm (25-50 mg of iron) to adults, 0.4 ml (20 mg of iron) to children weighing more than 14 kg and half day dose (1.5 mg / kg body weight) for children weighing less than 14 kg.

    If no side reactions occur within 15 minutes after drug administration, the remaining amount of the initial dose is administered.

    Prescription to children under 4 months is contraindicated because of the lack of experience of use.

    The dose for each patient is calculated individually depending on the degree of iron deficiency according to the following formula:

    Total iron deficiency (mg) = Body weight (kg) x (normal hemoglobin level - actual hemoglobin level) (g / l) x 0.24 * + iron stocks (mg)

    where, * Coefficient 0.24 = 0.0034 x 0.07 x 1 000 (iron content in hemoglobin ~ 0.34% / Blood volume ~ 7% of body weight / Coefficient 1 000 = recalculation from g to mg).

    For patients with a body weight of less than 34 kg: normal hemoglobin level = 130 g / l; iron stores = 15 mg / kg body weight.

    For patients with a body weight of more than 34 kg: normal hemoglobin level = 150 g / l; iron stocks = 500 mg / kg body weight.

    Total number of Fer-Rhompharm ampoules per treatment course (mg) = Total iron deficiency / 100 mg.

    Total number of ampoules (ml) of Fer-Rhompharm 50 mg / ml for the course of treatment:

    Body weight (kg)

    Hb 60 (g / l)

    Hb 75 (g / l)

    Hb 90 (g / l)

    Hb 105 (g / l)

    5

    1.5 (3 ml)

    1.5 (3 ml)

    1.5 (3 ml)

    1 (2 ml)

    10

    3 (6 ml)

    3 (6 ml)

    2.5 (5 ml)

    2 (4 ml)

    15

    5 (10 ml)

    4.5 (9 ml)

    3.5 (7 mL)

    3 (6 ml)

    20

    6.5 (13 ml)

    5.5 (11 mL)

    5 (10 ml)

    4 (8 ml)

    25

    8 (16 ml)

    7 (14 ml)

    6 (12 ml)

    5.5 (11 mL)

    30

    9.5 (19 ml)

    8.5 (17 ml)

    7.5 (15 mL)

    6.5 (13 ml)

    35

    12.5 (25 ml)

    11.5 (23 mL)

    10 (20 ml)

    9 (18 ml)

    40

    13.5 (27 mL)

    12 (24 ml)

    11 (22 ml)

    9.5 (19 ml)

    45

    15 (30 ml)

    13 (26 mL)

    11.5 (23 mL)

    10 (20 ml)

    50

    16 (32 ml)

    14 (28 ml)

    12 (24 ml)

    10.5 (21 ml)

    55

    17 (34 ml)

    15 (30 ml)

    13 (26 mL)

    11 (22 ml)

    60

    18 (36 ml)

    16 (32 ml)

    13.5 (27 mL)

    11.5 (23 mL)

    65

    19 (38 ml)

    16.5 (33 ml)

    14.5 (29 ml)

    12 (24 ml)

    70

    20 (40 ml)

    17.5 (35 mL)

    15 (30 ml)

    12.5 (25 ml)

    75

    21 (42 ml)

    18.5 (37 mL)

    16 (32 ml)

    13 (26 mL)

    80

    22.5 (45 ml)

    19.5 (39 ml)

    16.5 (33 ml)

    13.5 (27 mL)

    85

    23.5 (47 mL)

    20.5 (41 ml)

    17 (34 ml)

    14 (28 ml)

    90

    24.5 (49 mL)

    21.5 (43 ml)

    18 (36 ml)

    14.5 (29 ml)


    If the total dose exceeds the maximum daily dose, it is necessary to divide the administration of the drug into several doses. If after 1-2 weeks of therapy there is no response from hematological parameters (for example, an increase in the hemoglobin concentration by about 1 g / L per day), the diagnosis should be reviewed.

    Standard dosage:

    Adults and elderly patients: 1-2 ampules of Fer-Rhompharm (100-200 mg of iron) 2 or 3 times a week, depending on the level of hemoglobin.

    Children (of any age): 0.06 ml of Fer-Rhompharm / kg of body weight / day = 3 mg of iron / kg of body weight / day 2 or 3 times a week, depending on the level of hemoglobin.

    The maximum daily dose:

    Children with body weight up to 5 kg: 0.5 ml (1/4 ampoules = 25 mg of iron).

    Children with a body weight of 5-10 kg: 1 ml (1/2 ampoules = 50 mg of iron).

    Patients with a body weight of 10-45 kg: 2 ml (1 ampoule = 100 mg of iron).

    Adults and elderly patients: 4 ml (2 ampoules = 200 mg of iron).

    Technique of intramuscular injection

    a) Needle length must be at least 5-6 cm. The needle clearance should not be too wide. For children, as well as for adults with a small body weight, needles should be shorter and thinner;

    b) the injection site is defined as follows (see Figure 1): along the line of the spinal column at the level corresponding to the lumbosacral articulation, fix the point A. If the patient lies on the right side, place the middle finger of the left arm at point A. Set the index finger from the middle so that it is under the iliac crest line at point B. The triangle, located between the proximal phalanges of the middle and index fingers, is the injection site (see Figure 2);

    c) tools are disinfected using the usual method; before inserting the needle, it is necessary to move the skin about 2 cm (see Figure 3) in order to close the puncture hole well after removing the needle. This prevents penetration of the injected solution into the subcutaneous tissues and staining the skin;

    d) position the needle vertically with respect to the skin surface, at a greater angle to the point of the iliac joint than to the point of the femoral joint (see Figure 4);

    e) after the injection, slowly take out the needle and press the finger of the skin area adjacent to the injection site for approximately 1 minute;

    e) after the injection, the patient needs to move.

    Side effects:

    Undesired reactions (HP) are grouped by systems and organs in accordance with the MedDRA dictionary and WHO HP classification by frequency of development:

    Very frequent (> 1/10), frequent (> 1/100 - <1/10), infrequent (> 1/1 000 - <1/100), rare (> 1/10 000 - <1/100), very rare (<1 / 10,000), the frequency is unknown (frequency estimates are not available from available data).

    Disorders from the immune system - rarely: hypersensitivity, including allergic or anaphylactic reactions.

    Violations from the blood and lymphatic system - rarely: generalized lymphadenopathy.

    Disturbances from the nervous system - often: headache, dizziness; rarely: paresthesia.

    Heart disorders - rarely: palpitations, bradycardia, tachycardia.

    Violations from the vessels - rarely: lowering blood pressure, weakness, fainting, vascular collapse.

    Disturbances from the respiratory system, chest and mediastinal organs - rarely: shortness of breath, bronchospasm.

    Disorders from the gastrointestinal tract - often: nausea, vomiting, abdominal pain, diarrhea; rarely: aversion to food, indigestion, flatulence, reversible discoloration of teeth.

    Disturbances from the skin and subcutaneous tissues - often: wounds; rarely: itching, urticaria, rash, erythema, exanthema, angioedema.

    Disturbances from the musculoskeletal and connective tissue - rarely: pain in the muscles, back pain, joint pain, a feeling of stiffness on the arms, legs or face.

    General disorders and disorders at the site of administration - often: reactions at the injection site (skin pigmentation, pain and inflammation with lymphadenopathy of inguinal nodes, superficial phlebitis, burning and swelling); rarely: fever, chills, sweating, redness of the face, weakness, chest pain, back pain, stiffness, general malaise, peripheral swelling, pain in the lower abdomen, chromaturia.

    Overdose:

    Symptoms: Overdose can cause acute overload with iron, which is manifested by symptoms of hemosiderosis.

    Treatment: in case of overdose it is recommended to use symptomatic agents and, if necessary, substances that bind iron (chelates), for example, deferoxamine intravenously.

    The drug is not excreted during hemodialysis.

    It is necessary to control the content of ferritin in the blood serum for the timely detection of progressive accumulation of iron.

    Interaction:

    Fer-Rhompharm can not be used concomitantly with oral iron-containing preparations, since it reduces absorption of ingested iron. Therefore, oral iron therapy can be started no earlier than 7 days (1 week) after the last intramuscular injection of the drug.

    When combined with angiotensin-converting enzyme (ACE) inhibitors, undesirable effects of the Fer-Rhompharm preparation (abdominal pain, nausea, vomiting, lowering of blood pressure) are possible.

    Special instructions:

    Fer-Rhompharm should be administered only to those patients in whom the diagnosis of iron deficiency anemia is confirmed by appropriate laboratory data (for example, serum ferritin concentration or hemoglobin and hematocrit, the amount of erythrocytes and their parameters - mean erythrocyte volume, mean hemoglobin in erythrocyte or medium concentration hemoglobin in erythrocyte).

    Before use, the ampoule should be inspected for sediment and damage. Apply only a brown colorless aqueous solution. Fer-Rhompharm should be administered immediately after opening the ampoule.

    During the injection and immediately after the injection, patients should be under the supervision of a doctor.

    The group of special risk for the development of allergic and anaphylactic reactions consists of patients with bronchial asthma, as well as patients with low ability to bind iron and / or deficiency of folic acid. There is an increased risk of developing allergic and anaphylactic reactions in patients with allergic reactions in the anamnesis.

    When the first signs of anaphylactic reactions appear, the drug should be discontinued immediately.

    In patients with rheumatoid arthritis and possibly other systemic connective tissue diseases (ankylosing spondylitis, systemic lupus erythematosus), there is a risk of delayed reactions including fever and exacerbation (re-occurrence) of joint pain.

    With mild allergic reactions, antihistamines should be prescribed; anaphylactic reaction should be immediately introduced epinephrine (adrenalin).

    It should be possible to carry out anti-shock therapy (0.1% epinephrine (adrenaline), antihistamines and / or corticosteroid drugs).

    Delayed hypersensitivity reactions are characterized by arthralgia, anaphylactic myalgia and sometimes fever, which can last from a few hours to 4 days after drug administration.

    Symptoms usually occur within 2-4 days.

    With special care, Fer-Rhompharm should be used in patients with disorders of liver function, including those caused by elevated levels of ferritin, as well as patients with acute or chronic infection.Parenteral administration of iron can adversely affect the course of a bacterial or viral infection. Care should also be taken when administering the drug to persons with a low serum ability to bind iron and / or a deficiency of folic acid.

    The drug may cause a false increase in the serum bilirubin level and a false decrease in the serum calcium concentration. The drug may cause a decrease in the assimilation of Ga-67 gallium citrate during the study for diagnostic imaging of tumors and / or abscess with Ga-67 gallium citrate, due to binding competition in the same area.

    The presence of iron can lead to false-positive results in the case of the test with orthotolidine.

    Effect on the ability to drive transp. cf. and fur:

    Fer-Rompharm does not affect the ability to drive vehicles and engage in other activities that require increased concentration.

    Form release / dosage:

    Solution for intramuscular injection 50 mg / ml.

    Packaging:

    To 2 ml of the drug in colorless ampoules from glass hydrolytic class I with a ring for kink. A label is affixed to each ampoule.

    For 5 ampoules are placed in contour cell packs.For 1 or 2 contour packagings together with the instructions for use are placed in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Inaccessible to children!

    Shelf life:

    4 years.

    Do not use after the expiration date!

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002807
    Date of registration:12.01.2015
    The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania
    Manufacturer: & nbsp
    Representation: & nbspРомфарма ОООРомфарма ООО
    Information update date: & nbsp12.01.2015
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