Imunorix 400 mg/7 ml, 10 vials (oral solution)

The instruction for medical use of Imunorix Torgovoye medicine a name of Imunorix the International unlicensed name Pidotimod Lekarstvennaya a form Solution for oral administration, 400 mg / 7 ml Structure of 7 ml of solution contain active agent – pidotimod 400 mg, excipients: sodium chloride, sodium saccharin, dinatrium edetat, trometamin q.s. to rn 6.5, sodium methylparahydroxybenzoate, sodium propilparagidroksibenzoat, sorbitol of liquid 70% (not crystal), Wild berry fragrance, dye anthocyanin 55(E163), dye crimson Ponso 42 (E124), the water purified. The description Transparent solution of red-violet color with a pleasant characteristic smell and taste Pharmacotherapeutic group Immunomodulators. Immunostimulators. Other immunostimulators. Pidotimod the ATX L03AX05 Code the Pharmacological Pharmacokinetics Pharmacokinetic Researches properties on volunteers showed the high level of absorption at oral introduction, the bioavailability is 45%, elimination half-life – 4 hours. Drug is removed with urine in the form of unmodified substance (95% of the entered dose). Speed and extent of absorption of a pidotimod considerably decrease at reception together with food. The bioavailability at oral administration together with food decreases to 50%, the maximum concentration in serum are reached at 2 o'clock later in comparison with reception on an empty stomach. Pharmacokinetic researches with participation of elderly people did not reveal any differences from pharmacokinetics at adults. Drug is completely removed with urine, elimination half-life increases in a renal failure. Nevertheless, even in a heavy renal failure (creatinine content in blood plasma of 5 mg/dl) elimination half-life of a pidotimod does not exceed 8-9 hours. As patients take the drug each 12 hours or 24 hours, the risk of accumulation in a renal failure is absent. Researches at disturbances of a liver failure were not conducted as drug is almost completely removed from an organism with urine the Pharmacodynamics the Drug Imunorix contains an immunostimulator in not changed look pidotimod which stimulates and regulates the cellular immune response. Pidotimod induces maturing of T lymphocytes at their insufficiency to which the role of coordinators of specific immunity in physiological conditions due to partial substitution or strengthening of functions of a thymus is assigned. Besides, pidotimod stimulates macrophages which main function consists in grab of antigen and its presentation on a cellular membrane in a complex with histocompatibility antigens. The ability of an organism to render counteraction to infectious agents is expressed in effective specific immune, cellular and antitelny protective responses. Pidotimod has immunopromoting effect on natural immunity (products of antibodies, cell-mediated immunity and products of cytokines). Pidotimod increases products superoxide-anions, a necrosis factor опухоли-α and NO (bactericidal action) and stimulates a chemotaxis and, respectively, phagocytosis. Drug also increases cytotoxic activity of natural killers. Pidotimod enhances functional activity of T- and B-lymphocytes, increases efficiency of stimulation of the antitelny answer and counteracts the apoptosis induced by dexamethasone, 12-O-tetradekanoilforbol-13-atsetatom and calcic ionophore A-23l87. Indications Immunocorrective therapy at the following states (as a part of complex therapy): recurrent respiratory infections of upper and lower airways (pharyngitis, faringotrakheit, bronchitis, tonsillitis) recurrent infections of ENT organs (rhinitis, sinusitis, otitis) of an infection of urinary tract the Route of administration and doses Adult: Sharp phase: Initial dose: on two one-dose bottles of 400 mg two times a day within two weeks. After that maintenance dose: on two one-dose bottles of 400 mg once a day within, at least, 60 days or according to a medical prescription. Prevention: on two one-dose bottles of 400 mg once a day within, at least, 60 days or according to a medical prescription. Children are more senior than 3 years: Sharp phase: Initial dose: on one one-dose bottle of 400 mg two times a day within two weeks. After that maintenance dose: on one one-dose bottle of 400 mg once a day within, at least, 60 days or according to a medical prescription. Prevention: on one one-dose bottle of 400 mg once a day within, at least, 60 days or according to a medical prescription. Side effects Experience of clinical trials Not numerous undesirable phenomena about which it was reported in reports on clinical trials (a stomach ache, burning sensation in a stomach) were comparable to the undesirable phenomena in groups of placebo of double-blind researches, apparently, these phenomena were connected with the accompanying antibiotic treatment. Experience post-marketing about uses is applied To characteristic of frequency of emergence of side effects the following classification: very often (1/10), it is frequent (1/100, but & lt, 1/10), infrequently (1/1000, but & lt, 1/100), is rare (1/10000, but & lt, 1/1000), is very rare (& lt, 1/10000), it is unknown (it is impossible to establish on the available data). Very seldom nausea, diarrhea, an abdominal pain of manifestation of allergic dermatitis, including urticaria, an enanthesis, hypostasis of lips, naggers On 1 million patients receiving pidotimod one case of a uveitis and one case of a syndrome of Shenleyn-Genokh is registered. Contraindications the increased individual sensitivity to any of drug components children's age up to 3 years hereditary intolerance of fructose, glucose malabsorption – galactoses Medicinal interactions Pidotimod does not contact proteins of blood plasma. Drug is not metabolized, pharmacokinetic interactions are not expected. Drug can affect efficiency of the medicines suppressing or stimulating functional lymphocyte activity or affecting activity of the immune system. In researches on animals at combined use with other widely applied medicines pidotimod does not cause undesirable interactions with hypoglycemic drugs (tolbutamide), means for the general anesthesia (phenobarbital), antihypertensives (nifedipine, captopril, atenolol), diuretics (chlorotiazid), anticoagulants (warfarin), NPVS (indometacin), anesthetics (acetylsalicylic acid) or febrifugal (paracetamol). Special instructions As food influences Imunorix's absorption, it should be accepted out of meal. At patients with a giperimmunoglobulinemiya syndrome E drug should be used with care. At patients with an atopy or allergic reactions in the anamnesis drug should be used with care. Drug contains sodium saccharin of 5 mg / a bottle of 7 ml. Pregnancy and the period of a lactation Pregnancy Experience of use of a pidotimod for pregnant women is absent or is limited (less than 300 result of pregnancy). Researches on animals did not reveal straight lines or indirect adverse effects on reproductive function. In need of prescribing of drug it is necessary to consider an advantage ratio for mother and risk for a fruit. There are not enough data on safety, drug is not recommended for use in the first trimester of pregnancy. A lactation It is unknown whether it is allocated pidotimod or its metabolites in female breast milk. Women are recommended to refuse feeding by a breast during treatment in order to avoid impact of active substance on the baby. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. Does not affect ability to driving, work with potentially dangerous mechanisms. Overdose At the moment it was not reported about drug overdose cases. Treatment: There is no specific treatment. It is recommended to consult immediately with the doctor. The adequate supporting and symptomatic therapy is necessary for patients. Careful observation and monitoring have to continue before recovery of the patient. The form of release and packing On 7 ml of drug spill in glass bottles from transparent III glass, corked by a stopper from polyethylene and sealed by the plastic cap supplied with the device for control of the first opening. On 10 bottles together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions at a temperature not above 30 °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 Producer Doppel Pharmatseutitsi S.R. L., Italy. Via Martiri Dell Foibe, 1, 29016, Kortemadzhore (Piacenza) Owner of the registration certificate of the Village of Poliham. And., Luxembourg, Luxembourg the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products: Abbott Kazakhstan LLP, 050059, Almaty, Republic of Kazakhstan. Dostyk Ave. 117/6,
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