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Venofer 20 mg / ml solution of 5ml 5’s for intravenous administration




The instruction for medical use of Venofer Torgovoye medicine a name Venofer Mezhdunarodnoye the unlicensed name Is not present the Dosage form Solution for intravenous administration of 20 mg/ml Structure of 1 ml of drug contains active agent – iron (III) of 20 mg (in the form of iron (III) hydroxide of a saccharose complex of 510-570 mg) excipients: sodium hydroxide (10% solution), water for injections. Description Aqueous solution of brown color Pharmacotherapeutic group Antianemic drugs. Iron preparations. Iron preparations for parenteral use. Iron oxide saccharate. The ATX B03AC02 code the Pharmacological Ferrokinetiku Pharmacokinetics Distribution properties of an iron-saccharose complex, marked 52Fe and 59Fe, estimated at 6 patients with anemia and chronic kidney disease. Within the first 6–8 hours 52Fe it was taken a liver, a spleen and marrow. It is considered that capture of a radioactive label, is a spleen rich with macrophages characteristic of iron capture by a reticuloendothelial system. After a single intravenous injection to healthy volunteers of the dose of an iron-saccharose complex containing 100 mg of iron, the maximum general concentration of iron in serum were registered in 10 minutes after an injection and averaged 538 µmol/l. Distribution volume in the central compartment precisely corresponded to the plasma volume (about 3 liters). Biotransformation After an injection the most part of sucrose dissociates, and the multinuclear zhelezosoderzhashchey kernel is taken mainly the reticuloendothelial system of a liver, spleen and marrow. In 4 weeks after introduction the utilization by erythrocytes was from 59 to 97%. Removal the Average molecular weight (MW) of an iron-saccharose complex is approximately equal 43 kd that there is a lot of for prevention of removal by kidneys. The iron removal by kidneys happening within the first 4 hours after an injection of the dose of Venofer containing 100 mg of iron corresponded less than 5% of the entered dose. In 24 hours the general concentration of iron in serum decreased to the level noted before administration of drug. Sucrose removal by kidneys made about 75% of the entered dose. The pharmacodynamics the action Mechanism Active component of the drug Venofer — an iron-saccharose complex — consists of a multinuclear kernel of the ferrous hydroxide (III) surrounded with a large number of not covalently connected molecules of sucrose. The average molecular weight (MW) of this complex is approximately equal 43 kd. The structure of a multinuclear ferriferous kernel is similar to structure of a kernel of protein of ferritin – physiological depot of iron. This complex is intended for creation of the managed source of recyclable iron for the proteins which are responsible for transport and deposition of iron in an organism (according to transferrin and ferritin). After intravenous administration the multinuclear ferriferous kernel which is a part of this complex is taken mainly the reticuloendothelial system of a liver, spleen and marrow. At the next stage iron is used for synthesis of hemoglobin, a myoglobin and other ferriferous enzymes, or deposited mainly in a liver in the form of ferritin. Indications Venofer is intended for treatment of iron deficiency states in the following situations: – at the need for fast completion of reserves of iron – at patients who do not transfer oral iron preparations or do not observe the treatment mode – in the presence of active inflammatory bowel diseases when oral iron preparations are inefficient. Venofer it is necessary to apply only when the indication to use is confirmed with results of the corresponding laboratory researches. The route of administration and doses the Route of administration Venofer is entered only intravenously. It can be entered by drop infusion, a slow injection or directly into the venous site of a dialysis system. Drug is not intended for intramuscular introduction. Intravenous drop infusion Venofer gets divorced only sterile 0.9% solution of sodium of chloride (NaCl) (weight/volume). Cultivation should be made just before infusion, and the received solution should be entered as follows: A drug Venofer dose (iron mg) a drug Venofer Dose (drug Venofer ml) the Maximum volume of sterile 0.9% of NaCl solution for cultivation (weight/volume) the Minimum time of infusion of 100 mg 5 ml 100 ml of 15 minutes of 200 mg 10 ml 200 ml of 30 minutes of 300 mg 15 ml 300 ml 1.5 hours of 400 mg 20 ml 400 ml 2.5 hours of 500 mg 25 ml 500 ml 3.5 hours Cultivation of drug to lower concentration of iron is inadmissible. The intravenous injection Venofer can be entered by a slow intravenous injection with a speed of 1 ml of not divorced solution a minute and its dose should not exceed 10 ml (200 mg of iron) on an injection within, at least, 10 minutes. Introduction to the venous site of the dialysis Venofer system can be entered during the hemodialysis session directly into the venous site of a dialysis system at observance of the same conditions, as for an intravenous injection. A dose For each patient it is necessary to calculate individually a cumulative dose of the drug Venofer which cannot be exceeded. The schedule of introduction also has to be made individually for each patient. Standard doses Adult 5–10 ml of the drug Venofer (100–200 mg of iron) 1–3 times a week, depending on hemoglobin level. Time of administration of drug and a way of cultivation are specified in the section Route of administration. The most transferable single and week doses: Adults the Maximum tolerable dose for day entered in the form of an injection are not more often than 3 times a week: · 10 ml of the drug Venofer (200 mg of iron) entered within at least 10 minutes the Maximum tolerable dose in day entered in the form of infusion are not more often than once a week: · Patients with body weight more than 70 kg: 500 mg of iron (25 ml of the drug Venofer) entered within at least 3.5 hours · Patients with the body weight of 70 kg and less: 7 mg of iron/kg of body weight entered within at least 3.5 hours It is necessary to adhere strictly to time of infusion specified in the subsection Route of administration even if the patient does not receive the maximum tolerable single dose. Calculation of a dosage the General cumulative dose of the drug Venofer equivalent to the general deficiency of iron (mg) is defined on the basis of the level of hemoglobin (Hb) and the body weight (BW). The dose of the drug Venofer should be calculated individually for each patient according to the general deficiency of iron calculated by the below-mentioned formula Ganzoni, for example: The general deficiency of iron [mg] = the body weight [kg] × (the target Hb level – the actual Hb level) [g/dl] x 2.4 * + the deposited iron [mg] At body weight less than 35 kg: The target Hb level = 13 g/dl, amount of the deposited iron = 15 mg/kg of body weight At the body weight of 35 kg and more: The target Hb level = 15 g/dl, amount of the deposited iron = 500 mg * Coefficient 2.4 = 0.0034 (iron content in Hb = 0.34%) × 0.07 (blood volume = 7% of body weight) × 1000 (the translation from [] in [mg]) × 10 Total amount of the drug Venofer which should = be entered (into ml) the General deficiency of iron [mg] of 20 mg of iron/ml Total amount of the drug Venofer (ml) which should be entered, depending on body weight, the actual Hb level and the target Hb level *: MT Total amount of the drug Venofer (20 mg of iron on ml) which should be entered: Hb of 6.0 g/dl Hb of 7.5 g/dl Hb of 9.0 g/dl Hb of 10.5 g/dl of mg Fe of ml of mg Fe of ml of mg Fe of ml of mg Fe of ml of 30 kg of 960 48 840 42 740 37 640 32 35 kg of 1260 63 1140 57 1000 50 880 44 40 kg 1360 68 1220 61 1080 54 940 47 45 kg of 1480 74 1320 66 1140 57 980 49 50 kg 1580 79 1400 70 1220 61 1040 52 55 kg of 1680 84 1500 75 1300 65 1100 55 60 kg of 1800 90 1580 79 1360 68 1140 57 65 kg of 1900 95 1680 84 1440 72 1200 60 70 kg 2020 101 1760 88 1500 75 1260 63 75 kg 2120 106 1860 93 1580 79 1320 66 80 kg 2220 111 1940 97 1660 83 1360 68 85 kg 2340 117 2040 102 1720 86 1420 71 90 kg 2440 122 2120 106 1800 90 1480 74 * At body weight less than 35 kg: The target Hb level = 13 g/dl At the body weight of 35 kg and more: The target Hb level = 15 g/dl For transfer of Hb (mmol) to Hb (g/dl), increase the first value by 1.6. If the general necessary dose exceeds the maximum legal single dose, it should be divided into several introductions. If in 1–2 weeks after an initiation of treatment the drug Venofer does not observe the answer from hematologic parameters, the initial diagnosis should be revised. Children drug Venofer Use by children is rather not studied therefore it is not recommended to be applied to children. Side effects the Most frequent undesirable medicinal reaction (UMR) which was registered within clinical trials of the drug Venofer was change of flavoring feelings which was observed with a frequency of 4.5 phenomena at 100 subjects. The most important serious undesirable medicinal reactions connected with drug Venofer use were reactions of hypersensitivity which were observed within clinical trials with a frequency of 0.25 phenomena at 100 subjects. The undesirable medicinal reactions registered after use of the drug Venofer for 4046 subjects within clinical trials are given below. Often (≥1/100, & lt, 1/10) – disturbance of flavoring feelings – arterial hypotension, arterial hypertension – nausea – pain in the place of an injection Infrequently (≥1/1000, & lt, 1/100) – politsitemiya1) – hypersensitivity – a headache, dizziness, burning sensation, paresthesia, a hypesthesia – thrombophlebitis, phlebitis – short wind – a chromaturia – vomiting, an abdominal pain, diarrhea, a constipation – an itching, rash – muscular spasms, myalgia, an arthralgia, extremity pain, a dorsodynia – a fever, reactions in the place of an injection, irritation in the place of an injection, an ekstravazation in the place of an injection, discoloration of skin in the place of an injection, burning sensation in the place of an injection, hypostasis in the place of an injection, an asthenia, fatigue, pain Seldom (≥1/10,000, & lt, 1/1000) – pneumonia – an overload iron – a faint, migraine, drowsiness – heart consciousness – hyperaemia – dryness in a mouth – sensation of discomfort in extremities, muscular spasms – feeling of heat, a stethalgia, a pyrexia, hypostasis, an itching in the place of an injection, bruise in the place of an injection – peripheral hypostasis Pathological changes of laboratory parameters Infrequently (≥1/1000, & lt, 1/100) – increase in level gamma glutamiltransferazy, increase in level of alaninaminotranspherase, increase in level of aspartate aminotransferase, pathological changes in results of hepatic tests Seldom (≥1/10,000, & lt, 1/1000) – increase in level of ferritin in syvorotke1), increase in level of creatinine in blood, increase in level of a lactate dehydrogenase in blood 1) is possible how an overdose consequence iron or overloads iron the Side reactions observed in the post-registration period some of which can potentially lead to a lethal outcome Frequency is unknown: – anaphylactoid reactions, a Quincke’s disease – the reduced level of consciousness, confusion of consciousness, a loss of consciousness, alarm, a tremor – bradycardia, tachycardia – vascular collapse, thrombosis of superficial veins – a bronchospasm – a small tortoiseshell, an erythema – hypotonia of muscles – a hyperhidrosis, cold sweat, a general malaise, pallor of the Contraindication – hypersensitivity to iron-saccharose complex, the drug Venofer or any of the excipients listed in the section Structure – the known hypersensitivity to other parenteral iron preparations – the anemia which is not connected with deficiency of iron – presence of signs of an overload iron or congenital disturbances of processes of its utilization – the first trimester of pregnancy Medicinal interactions As well as at use of all parenteral iron preparations, it is not recommended to use the drug Venofer along with oral iron preparations as absorption of oral iron can decrease. Venofer gets divorced only sterile 0.9% chloride sodium solution (weight/volume). When mixing with other solutions or medicines there is a risk of precipitation and/or interaction. The compatibility with containers from other materials, besides glass, polyethylene and polyvinylchloride, is not studied. It is necessary to appoint the special instructions Drug treatment Venofer only after careful diagnosis by the attending physician. Parenterally administered iron preparations can cause anaphylactic/anaphylactoid reactions which can potentially be lethal. After the previous uncomplicated introductions of parenteral complexes of iron, including an iron-saccharose complex, hypersensitivity reactions were also noted. Patients need to be interviewed actively before each introduction of Venofer of rather side effects of drug. Venofer has to be used by the personnel trained for identification and stopping of anaphylactic reactions, antiallergic drugs and also the equipment for performing cardiopulmonary resuscitation and the corresponding procedures have to be available. After each injection of the drug Venofer it is necessary to watch all patients regarding lack of the undesirable phenomena within at least 30 minutes. In case of development of allergic reaction the treatment has to be immediately stopped. The possibility of performing antishock therapy has to be provided (0.1% adrenaline solution, antihistaminic and/or corticosteroid drugs). The risk of reactions of hypersensitivity increases at patients with the known allergies, including a medicinal allergy, at patients with bronchial asthma, eczema or other atopic allergic reactions. The risk of reactions of hypersensitivity to parenteral complexes of iron at patients with immunological and inflammatory diseases is also increased (for example, a system lupus erythematosus, a pseudorheumatism). Patients with an abnormal liver function should apply parenteral iron only after careful assessment of a ratio between risk and advantage. Patients with an abnormal liver function when the overload iron is a provocative factor, in particular, of development of a late porphyria of skin, should not apply parenteral iron. To avoid an overload iron, it is recommended to carry out careful monitoring of level of iron in an organism. Parenteral iron should be applied with care in the presence of acute or persistent infection. Patients with the proceeding bacteremia are recommended to stop drug Venofer use. At patients with persistent infection it is necessary to carry out the ratio assessment between risk and advantage, considering a possibility of suppression of an erythrogenesis. Hypotension episodes can develop if the drug is administered too quickly. Allergic reactions, sometimes including an arthralgia, were observed more often when exceeding the recommended dose. It is necessary to avoid perivenous leak as leak of the drug Venofer in the place of an injection can lead to appearance of pain, development of inflammation, necrosis of fabrics and coloring of skin in brown color. Features of use after the first opening of a container From the microbiological point of view, drug it is necessary to use immediately. To feature of use after cultivation of 0.9% by solution of sodium of chloride (NaCl) (weight/volume) It was shown that chemical and physical stability after cultivation makes 12 hours at the room temperature. From the microbiological point of view, drug should be used immediately. If drug was not used at once after cultivation, the user is responsible for conditions and storage time after cultivation which anyway should not exceed 3 hours at the room temperature, except those cases when cultivation was executed in controlled and validirovanny aseptic conditions. Use during pregnancy and feeding by a breast the pregnancy Period Properly controlled researches of use Venofer at pregnant women were not conducted so far. Allergic reactions to the parenteral iron preparations which developed in pregnancy time endanger life of mother and child. Iron preparations for intravenous administration should not be used during pregnancy if in it there is no emergency. Venofer it is necessary to apply in the second and third trimesters of pregnancy only when potential a floor
for for mother outweighs potential risk for a fruit. Use of drug in the first trimester of pregnancy is contraindicated. Results of researches on animals did not reveal straight lines or the mediated harmful effects on pregnancy, development of an embryo/fruit, childbirth or post-natal development. The data obtained at limited number of pregnant women indicate lack of adverse action of Venofer on pregnancy or health of the fruit/newborn. The lactation period the Amount of data on iron discharge with breast milk of the person after intravenous administration of an iron-saccharose complex is limited. Within one clinical trial of 10 healthy, nursing mothers with deficiency of iron received 100 mg of iron in the form of an iron-saccharose complex. In 4 days after treatment the iron content in breast milk did not increase, and the difference in comparison with control group (n=5) was not observed. It is impossible to exclude the fact that iron from the drug Venofer can arrive to the newborn/baby with mother’s milk therefore it is necessary to appoint drug with care taking into account ratio assessment between risk and advantage. Results of preclinical trials did not reveal the direct or mediated harmful effects on the child who is on breastfeeding. At the lactating rats to which entered marked 59Fe an iron-saccharose complex the low extent of secretion of iron in milk and transfers of iron to posterity was observed. Receipt of a nemetabolizirovanny iron-saccharose complex in breast milk is improbable. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms It is improbable that the drug Venofer can affect ability to run vehicles or to work with other automated systems. However at development after use of the drug Venofer of such symptoms as dizziness, confusion of consciousness or subconscious state, patients should not run vehicles or work with other automated systems before disappearance of these symptoms. Overdose Symptoms: the overdose can cause an overload iron which in itself can be shown by hemosiderosis symptoms. Treatment: overdose it is necessary to treat, to the discretion of the attending physician, with use of a helator of iron or according to standards of medical practice. The form of release and packing On 5 ml of drug place in the colourless transparent glass ampoules having a notch in the form of one or two rims and a point on an ampoule neck. On 5 ampoules place in blister strip packaging from polyvinylchloride. 1 packing together with the instruction for medical use in the state and Russian languages is put in a cardboard box. To Store storage conditions at a temperature not above 25 °C. Drug is not subject to freezing! To store out of children’s reach! 3 years not to apply a period of storage after the expiration date specified on packing. Prescription status According to the prescription the Producer Takeda Austria GmbH, Austria St. Peter-Strasse 25, 4020 Linz, Austria/Sankt Peter Strasse 25, 4020 Linz, Austria the Owner of the registration certificate and Vifor (International) releasing quality control of INK., Switzerland Rechenstrasse 37, 9014 St. Gallen, Switzerland / Rekhenstrasse 37, 9014 St. Gallen, Switzerland
to Develop the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office Takeda Osteuropa Holding GmbH (Austria) in Kazakhstan Almaty, Shashkin St. 44


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