Imunoriks yelling solution. 400mg vial 7 ml 10 pcs

Description

Composition
Active substance:
1 vial contains:
Pidotimod 400.0 mg.
Excipients:
Sodium chloride 5.6 mg Sodium saccharinate 5.0 mg Disodium edetate 3.5 mg, Trometamol q.s. to pH 6,5, sodium methyl parahydroxybenzoate 10.3 mg propyl parahydroxybenzoate 1.6 mg sodium, 70% sorbitol 2500 mg, fruit flavor (smell with forest fruit) 21.0 mg, 5.6 mg anthocyanin dye, the dye Ponceau [Ponceau 4R] 0,5 mg purified water to 7.0 ml.
Description:
Transparent liquid reddish-purple color with a smell of wild berries.
Product form:
Oral solution 400 mg: 7 ml vial of clear glass type III, polyethylene rubber stoppers and sealed with a plastic cap provided with a device for controlling the first opening. 10 monodose vials together with instructions for medical use in paper cartons having perforations at the place of dissection.
Contraindications
Hypersensitivity to pidotimodu or to any other component of the product, fructose intolerance, children up to 3 years.
Carefully
The drug should be used with caution in patients with the syndrome Hyper E, with previously met allergies or atopy.
Dosage
400 mg
Indications
The immunostimulatory therapy of disturbances in cellular immunity against infections of the upper and lower respiratory and urinary tract.
Used for prevention of relapses and reducing the duration and severity of episodes, and as an antibiotic adjuvant in acute infections.
Interaction with other drugs
Pidotimod does not bind to plasma proteins and is not metabolised, therefore, pharmacokinetic interactions are expected.
The preparation can influence the efficacy of drugs suppressing or stimulating lymphocyte functional activity or affecting the immune system activity.
In animal studies, when used in conjunction with other commonly used drugs, pidotimod not cause undesirable interactions with hypoglycemic agents (tolbutamide), antiepileptic drugs (phenobarbital), antihypertensives (nifedipine, captopril, atenolol), diuretics (chlorothiazide), anticoagulants ( warfarin), NSAIDs (indomethacin), analgesics (acetylsalicylic acid) or antipyretic (paracetamol).
Overdose
No cases of overdose and drug administration for other purposes were reported.
Specific data on the treatment of overdose of the drug Imunoriks not. In case of overdose it is recommended to consult a doctor immediately. Patients must have an adequate and supportive symptomatic therapy. Careful monitoring should continue until the patient recovers.
pharmachologic effect
Pharmacological group:
Immunostimulatory agent.
Pharmacodynamics:
Pidotimod stimulates and regulates cell-mediated immunity.
Pidotimod induces the formation and maturation of immunocompetent T-lymphocytes in their failure, which is assigned the role of specific immunity coordinator under physiological conditions due to partial replacement or enhancement of functions of the thymus. In addition, pidotimod stimulate macrophages, the primary function of which is trapping an antigen and its presentation on the cell membrane in a complex with major histocompatibility antigens. The ability of the organism to antagonize the effect expressed by infectious agents in effective specific immune, cellular and protective antigen antibody responses.
Pidotimod has therapeutic effects by immunostimulatory effects on innate immunity and the production of antibodies for cell-mediated immunity and produce cytokines.
Pidotimod increases the production of superoxide anions, tumor necrosis factor-a, NO (bactericidal action), as well as chemotaxis and thus phagocytosis. The drug also increases the cytotoxic activity of natural killer cells.
Pidotimod enhances the functional activity of T- and B-lymphocytes, stimulation enhances antigen-antibody reaction and prevents the development of apoptosis induced by dexamethasone, 12-O-tetradecanoylphorbol-13-acetate and calcium ionophore A-23I87. Pidotimod increases the content of interleukin-2 (IL-2) in old rats and expression of the IL-2 gene in the spleens of rats. In particular, it was shown that pidotimod immunostimulant effect, particularly in cases of failure of the immune system, as well as its functioning on a physiological level.
Pharmacokinetics:
At intake absorption is high. Bioavailability is 45%, half-life – 4 hour. The drug is excreted in the urine in unchanged form (95% of the dose administered intravenously).
The rate and extent of absorption pidotimoda greatly reduced by simultaneous administration with food. Bioavailability after oral administration with food is reduced to 50%, the maximum serum concentration reached at 2 hours later compared with the fasting state.
Pharmacokinetic studies involving elderly patients showed no differences from the pharmacokinetics in adults.
The drug is completely excreted in the urine, elimination half-life is increased in patients with renal insufficiency. Nevertheless, even with severe renal failure (creatinine content in the blood plasma of 5 mg / dL) pidotimoda half-life does not exceed 8-9 hours. Since the patients taking the drug every 12 hours or 24 hours, the risk of accumulation in renal failure absent.
Studies in hepatic failure is not carried out, since the drug is almost completely excreted in the urine unchanged.
Pregnancy and breast-feeding
Pregnancy:
Previous applications pidotimoda pregnant absent or limited (less than 300 pregnancy outcomes). Studies in animals did not reveal any direct or indirect adverse effects on reproductive function.
It is advisable to avoid the use of the drug Imunoriks in the first trimester of pregnancy.
Lactation:
No allocation pidotimoda data or its metabolites in breast milk. Women are advised to stop breastfeeding during treatment in order to avoid exposure to the active substance on the child.
Conditions of supply of pharmacies
On prescription.
side effects
Few adverse events were reported in the reports of the clinical trials (stomach pain, burning sensation in the stomach) were comparable to adverse events in the placebo in double-blind clinical trials; apparently, these effects have been associated with concomitant antibiotic therapy.
During the post-registration application reported following undesirable effects, which the frequency determined correspondingly to the following: very often (> 1/10), often (> 1/100, but
special instructions
Effects on ability to driving and other mechanisms:
Does not affect.
Storage conditions
Store at a temperature not higher than 30 ° C. Keep out of the reach of children!.
Dosing and Administration
Inside.
Because food affects the absorption Imunoriks drug, it should be taken without meals.
adults:
Acute phase: 800 mg (vial 2), 2 times a day for 2 hours before or 2 hours after eating for 2 weeks; Further maintenance therapy of 800 mg (2 vials) 1 times a day for 60 days.
Prevention: 800 mg (2 vials) 1 times a day for 2 hours before or 2 hours after a meal for 60 days.
Children over 3 years:
Acute phase: 400 mg (1 vial) 2 times a day for 2 hours before or 2 hours after eating for 2 weeks; Further maintenance therapy of 400 mg (1 bottle) 1 times a day for 60 days.
Prevention: 400 mg (1 bottle) 1 times a day for 2 hours before or 2 hours after a meal for 60 days.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist