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Description
The instruction for medical use of Rotafer Torgovoye medicine a name Rotafer Mezhdunarodnoye the unlicensed name Is not present the Dosage form Solution for injections of 100 mg / 2 ml Structure One ampoule contains active agent – iron (III) hydroxide a polymaltose complex of 333.33 mg, excipient – water for injections is equivalent to elementary iron of 100.00 mg. The description Solution from dark red till brown color the Pharmacotherapeutic Blood group and bodies of a hemopoiesis. Antianemic drugs. Iron preparations. Parenteral iron preparations. The ATX B03AC code the Pharmacological Pharmacokinetics Later properties of intramuscular administration of iron (III) hydroxide a polymaltose complex gets to a blood stream through lymphatic system. The maximum concentration of iron in blood plasma is reached approximately in 24 hours after an injection. From blood plasma the macromolecular complex gets to a reticuloendothelial system where it is split on components: gland hydroxide and a polymaltose (it is metabolized by oxidation). Slow release of iron is the reason of its good tolerance. In blood iron contacts transferrin, in fabrics is stored in composition of ferritin, in marrow joins in hemoglobin and participates in process of an erythrogenesis. Only small amounts of iron are brought out of an organism. In small quantities not changed complex can pass through a placental barrier, and its insignificant quantities get to breast milk. The iron connected with transferrin can pass through a placental barrier, and as a part of lactoferrin gets to breast milk in small amounts. Patients with an iron deficiency anemia have no data on drug pharmacokinetics. It is well known that absorption of iron depends on severity of an iron deficiency anemia. It intensive in case of low hemoglobin also decreases in process of hemoglobin normalization. Extent of utilization of iron cannot be higher, than iron-binding ability of transport proteins. The pharmacodynamics After intramuscular introduction the iron which is emitted from active component – iron (III) hydroxide polymaltosethat, is absorbed, mainly, by a liver. Then it is included hemoglobin, a myoglobin and ferriferous enzymes and also is stored in an organism in the form of ferritin. The answer from blood indicators at parenteral administration of iron happens not quicker, than at intake of salts of iron at patients at whom they are effective. As well as other iron preparations, Rotafer does not make impact on an erythrogenesis and is inefficient in the anemias which are not connected with deficiency of iron. Influence of a renal and liver failure on pharmacological properties of iron (III) hydroxide polymaltosethat are unknown. Toxicity of drug very low. Indications the Iron deficiency anemia at inefficiency or impossibility of administration of drugs of iron inside (including at patients with diseases of the digestive tract (DT) and with a sprue). Routes of administration and doses Intramusculary, it is deep in the muscle bulk of an upper external quadrant of a buttock. Intravenous administration of drug is not allowed! Before the first introduction of an initial dose of the drug Rotafer, it is necessary to enter a test dose: the drug is administered intramusculary by the adult from 1/4 to 1/2 doses of drug (from 25 to 50 mg of iron (0.5-1 ml)). In the absence of side reactions within 30 minutes after introduction, it is possible to enter the rest of an initial dose of drug. The drug is administered intramusculary only at the iron deficiency state confirmed with the corresponding researches (for example, measurement of ferritin of blood serum, hemoglobin (Hb), a hematocrit or quantity of erythrocytes and also their parameters – mean corpuscular volume, the average content of Hb in an erythrocyte or average concentration of Hb in an erythrocyte). Calculation of a dose the Dose of drug is calculated individually and adapts in compliance with the general deficiency of iron on the following formula: The general deficiency of iron (mg) = the body weight (kg) x (the normal Hb level – the Hb level of the patient) (g/l) x 0.24 * + a reserve of iron (mg). At the body weight of the patient over 34 kg: the normal Hb level = 150 g/l that there correspond to an iron reserve = 500 mg. * A factor 0.24 = 0.0034 x 0.07 x 1000 (iron content in blood hemoglobin = 0.34%/volume of blood = 7% from a body weight / factor of 1000 = the transfer from to mg). Total number of ampoules for course introduction = the General deficiency of iron (mg) / 100 mg the Body weight of kg of Hb of 60 g/l of Hb of 75 g/l of Hb of 90 g/l of Hb of 105 g/l of ml in ml ampoules in ml ampoules in ml ampoules in ampoules 35 25 12,5 23 11,5 20 10 18 9 40 27 13,5 24 12 22 11 19 9,5 45 30 15 26 13 23 11,5 20 10 50 32 16 28 14 24 12 21 10,5 55 34 17 30 15 26 13 22 11 60 36 18 32 16 27 13,5 23 11,5 65 38 19 33 16,5 29 14,5 24 12 70 40 20 35 17,5 30 15 25 12,5 75 42 21 37 18,5 32 16 26 13 80 45 22,5 39 19,5 33 16,5 27 13,5 85 47 23,5 41 20,5 34 17 28 14 90 49 24,5 43 21,5 36 18 29 14,5 If the necessary dose exceeds the maximum daily dose, administration of drug has to be fractional. Standard dose Adults: 1 ampoule daily (2.0 ml = 100 mg of iron) Maximum allowed daily doses Adult: 2 ampoules (4.0 ml = 200 mg of iron) If the answer from hematologic parameters are absent in 1-2 weeks (for example, increase in the Hb level approximately on 0.1 g/dl a day), the initial diagnosis should be revised. The general dose of drug on a course of treatment should not exceed the calculated number of ampoules. Side effects Seldom – an arthralgia, muscle pains, a stethalgia, a dorsodynia, a hyperadenosis, inflows, the increased perspiration, a fever, fever, dizziness, a syncope, a headache, dyspepsia (nausea, vomiting), arterial hypotension, a syncope, circulator collapse, tachycardia, a bronchospasm with an asthma, a generalized lymphadenopathy, feeling of tension in hands, legs and a face It is very rare – rash, urticaria, a Quincke’s disease, serious allergic or anaphylactic reactions – local reactions (at the wrong technology of administration of drug): abdominal pain in the lower quadrant, coloring of skin, inflammation and morbidity in the place of an injection, local inflammation with an inguinal lymphadenopathy of the Contraindication – hypersensitivity to drug components – the anemias which are not connected with deficiency of iron (hemolytic anemia, the megaloblastny anemia caused by insufficiency of B12 vitamin) – disturbances of an erythrogenesis, a marrow hypoplasia – excess of iron in an organism (hemochromatosis, a hemosiderosis) – iron utilization disturbance (sideroakhrestichesky anemia, a thalassemia, lead anemia, a late porphyria of skin) – a syndrome of Oslera-Randyu-Vebera – chronic polyarthritis – bronchial asthma – heavy inflammation or infectious diseases of kidneys or a liver – an uncontrollable hyperparathyreosis – dekompensirovanny cirrhosis – children’s and teenage age up to 18 years (there are no data on efficiency and safety). – pregnancy (I trimester) With care: the liver and/or renal failure, cardiovascular and allergic diseases Medicinal interactions APF Inhibitors enhance system effects of parenteral iron preparations. It is not necessary to apply along with oral ferriferous drugs (absorption of iron from a GIT decreases) therefore treatment by oral ferriferous drugs should be begun not earlier than in 1 week after the last injection. The concomitant use of inhibitors of angiotenzinkonvertiruyushchy enzyme (AKF) (for example, enalapril) can cause strengthening of system effects of parenteral iron preparations. Special instructions As parenteral use of complexes of iron, can become the reason of fatal anaphylactoid reactions, Rotafer has to be appointed only that patient at whom the diagnosis of anemia is confirmed with the corresponding datas of laboratory (for example, results of definition of ferritin of blood serum or hemoglobin and a hematocrit, quantity of erythrocytes and their parameters – mean corpuscular volume, average hemoglobin in an erythrocyte or average concentration of hemoglobin in an erythrocyte). Before use, ampoules should be examined on existence of a deposit and damage. It is possible to apply only ampoules without deposit and damages. After opening of an ampoule the drug Rotafer should be administered immediately. Rotafer it is not necessary to mix with other medicines. Parenteral iron preparations can cause allergic and anaphylactic reactions which can have a lethal outcome. In case of moderate allergic reactions, it is necessary to appoint antihistaminic drugs immediately. At development of heavy anaphylactic reaction the immediate administration of epinephrine (adrenaline) is necessary. Means of cardiopulmonary resuscitation have to be available. Anaphylactic reactions most often develop the first several minutes after administration of drug and are characterized by sudden difficulty of breath, tachycardia and arterial hypotension. Gland the polymaltose complex has to be applied only when the personnel are trained and has experience in assessment of anaphylactic reactions and holding resuscitation actions in the conditions of their availability. Each patient needs to provide careful observation during an injection and within not less than 30 minutes after an injection. At emergence of signs or symptoms of intolerance, administration of the drug Rotafer should be stopped immediately. Patients with bronchial asthma or the blood sera having low iron-binding ability and/or insufficiency of folic acid treat group of high risk of development of allergic or anaphylactic reactions. Patients with a pseudorheumatism and other possible inflammatory diseases (for example, an ankylosing spondylitis, a system lupus erythematosus) can have partial risk of development of the delayed reactions, including fever, aggravation or a reactive joint pain. It is necessary to be careful at administration of drug to patients with an allergy and also a liver and renal failure. The side effects arising at patients with cardiovascular diseases can aggravate a course of a basic disease. Use during pregnancy and a lactation. Clinical data on use of drug for pregnant women, now insufficiently. It is contraindicated to use drug in the I trimester of pregnancy. In II and III trimesters of pregnancy it is necessary to use drug only when the expected advantage for mother, exceeds potential risk for a fruit and/or the child. In small quantities not changed iron from a polymaltose complex can get into breast milk. In need of use of drug in the period of a lactation, breastfeeding needs to be stopped. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Influence of drug on ability to run vehicles and mechanisms was not studied. Overdose Today about overdose cases by iron it was not reported. At administration of the drug Rotafer in high doses, the complex cannot be removed by means of a hemodialysis because of the high molecular weight. Periodic control of ferritin of blood serum can help with timely recognition of the progressing iron accumulation. The overdose can cause a sharp overload iron which is shown by hemosiderosis symptoms. At overdose it is recommended to apply symptomatic means and if it is necessary, the substances connecting iron (chelates), for example Deferoxaminum in / century. The form of release and packing On 2 ml of drug spill in ampoules from dark glass. On 5 ampoules place in blister strip packaging. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place Storage conditions in a box of cardboard In the dry place protected from light at a temperature not above 25 °C to Store out of children’s reach. 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer FarmaVizhn San. ve Tidzh. A.Sh., Turkey Holder of the registration certificate of Rotafarm Ilachlary Limited Shirketi Adres: 15 Temmuz Move., Dzhami Yolu Dzhad. No. 50, Kat. 2, Bagdzhylar, Istanbul, Turkey the Name, the address and a contact information (phone, the fax, e-mail) of the organization of the claim (offer) on quality of medicines accepting in the territory of the Republic of Kazakhstan from consumers and responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP, Almaty, Suyunbaya Avenue 222-b ph. 8+7 727 251 99 35, +7 727 251 99 45 fax: 8+7 727 252 90 90 +7 701 786 33 98 (24-hour access) pvpharma@worldmedicine.kz.
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