Trough-ceftriaxone 1’s 1g powder for solution for injection
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The instruction for medical use of TRO-TsEFTRIAKS medicine the Trade name of Tro-Tseftriaks the International unlicensed name Tseftriakson Lekarstvennaya a form Powder for preparation of solution for injections of 1 g Structure 1 bottle contains active agent – tseftriakson (in the form of a tseftriakson of sodium) 1000.0 mg the Description From white till yellowish orange color crystal powder. Pharmacotherapeutic group Beta laktamnye antibacterial drugs other. Cephalosporins of the third generation. Tseftriakson. The ATX J01DD04 code the Pharmacological Pharmacokinetics Pharmacokinetics properties of a tseftriakson has nonlinear character. All key pharmacokinetic parameters based on the general concentration of drug except for elimination half-life, depend on a dose. The maximum concentration in plasma after single intramuscular introduction of 1 g of drug makes about 81 mg/l and is reached within 2-3 hours after introduction. The areas under a curve concentration in plasma – time after intravenous and intramuscular administration are identical. It means that the bioavailability of a tseftriakson after intramuscular introduction is 100%. The volume of distribution of a tseftriakson is 7-12 l. After introduction in a dose of 1-2 g tseftriakson well gets into fabrics and liquids of an organism. Within more than 24 hours of its concentration much more exceed the minimum overwhelming concentration for the majority of causative agents of infections more than in 60 fabrics and liquids (including in lungs, heart, bilious ways, a liver, tonsils, a middle ear and mucous a nose, bones and also spinal, pleural and synovial liquids and a secret of a prostate). After intravenous use tseftriakson quickly gets into cerebrospinal fluid where bactericidal concentration concerning sensitive microorganisms remain within 24 hours. Tseftriakson reversibly contacts albumine, and extent of binding decreases with concentration growth, decreasing, for example, from 95% at concentration in plasma less than 100 mg/l to 85% at concentration of 300 mg/l. Thanks to smaller concentration of albumine in an intercellular lymph, the share of a free tseftriakson in it is higher, than in plasma. Tseftriakson gets through the inflamed meninx at children, including newborns. In 24 hours after intravenous administration in doses of 50-100 mg/kg of body weight (to newborns and babies, respectively) concentration of a tseftriakson in cerebrospinal fluid exceed 1.4 mg/l. The maximum concentration in cerebrospinal fluid is reached approximately in 4 hours after intravenous administration and makes, on average, 18 mg/l. In bacterial meningitis the average concentration of a tseftriakson in cerebrospinal fluid makes 17% of concentration in plasma, in aseptic meningitis – 4%. At adult patients with meningitis in 2-24 hours, after introduction of a dose of 50 mg/kg of body weight, concentration of a tseftriakson in cerebrospinal fluid many times over exceed the minimum overwhelming concentration for the most widespread causative agents of meningitis. Tseftriakson passes through a placental barrier and in small concentration gets to breast milk. Tseftriakson is not exposed to system metabolism, and turns into inactive metabolites under the influence of intestinal microflora. The general plasma clearance of a tseftriakson is 10-22 ml/min. The renal clearance equals 5-12 ml/min. of 50-60% of a tseftriakson 40-50% are removed in not changed view with urine, and – in not changed view with bile. Elimination half-life of a tseftriakson makes about 8 hours at adults. The pharmacokinetics at special groups of patients At patients with a renal failure or a liver pharmacokinetics of a tseftriakson changes slightly, only small increase in elimination half-life is noted. If only function of kidneys is broken, removal with bile increases if only function of a liver is broken, removal through kidneys increases. Patients are more senior than 75 years At persons 75 years elimination half-life of a tseftriakson, on average, in two or three times more, than at adults of young age are more senior. Children At newborn children okolo70 the % of a dose is removed through kidneys. Babies in the first 8 days have lives, on average, in two or three times more, than at adults. The pharmacodynamics Bactericidal activity of a tseftriakson is caused by suppression of synthesis of cellular membranes. In vitro tseftriakson possesses a broad spectrum of activity concerning gram-negative and gram-positive microorganisms. Vysokoustoychiv to the majority β-лактамаз (as penicillinases, and tsefalosporinaz), developed by gram-positive and gram-negative bacteria. Tseftriakson is usually active concerning the following microorganisms: Gram-positive aerobes: Staphylococcus aureus (metitsillinochuvstvitelny), Staphylococci coagulase-negative, Streptococcus pyogenes (ß – hemolytic, groups A), Streptococcus agalactiae (ß – hemolytic, groups B), ß – hemolytic streptococci (groups And, C), Streptococcus viridans, Streptococcus pneumoniae. Note. Metitsillinoustoychivye Staphylococcus spp. rezistentna to cephalosporins, including to a tseftriakson. As a rule, Enterococcus faecalis, Enterococcus faecium and Listeria monocytogenes are also steady. Gram-negative aerobes: Acinetobacter lwoffi, Acinetobacter anitratus (mainly, A. baumanii) *, Aeromonas hydrophila, Alcaligenes faecalis, Alcaligenes odorans, alkaligenopodobny bacteria, Borrelia burgdorferi, Capnocytophaga spp., Citrobacter diversus (including C. amalonaticus), Citrobacter freundii *, Escherichia coli, Enterobacter aerogenes *, Enterobacter cloacae *, Enterobacter spp. (other) *, Haemophilus ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Hafnia alvei, Klebsiella oxytoca, Klebsiella pneumoniae **, Moraxella catarrhalis (before Branhamella catarrhalis), Moraxella osloensis, Moraxella spp. (other), Morganella morganii, Neisseria gonorrhea, Neisseria meningitidis, Pasteurella multocida, Plesiomonas shigelloides, Proteus mirabilis, Proteus penneri *, Proteus vulgaris *, Pseudomonas fluorescens *, Pseudomonas spp. (other) *, Providentia rettgeri *, Providentia spp. (other), Salmonella typhi, Salmonella spp. (netifoidny), Serratia marcescens *, Serratia spp. (other) *, Shigella spp., Vibrio spp., Yersinia enterocolitica, Yersinia spp. Other. * Some isolates of these types are resistant to a tseftriakson, mainly, owing to education laktamaz, coded by chromosomes. ** Some isolates of these types are steady owing to formation of a number plazmido-mediated laktamaz. Note. Many strains of the above-stated microorganisms polyresistant to other antibiotics, such as aminopenicillin and ureidopenicillin, cephalosporins of the first and second generation and aminoglycosides, are sensitive to a tseftriakson. Treponema pallidum is sensitive to a tseftriakson of in vitro and in experiments on animals. Clinical trials show what tseftriakson has good efficiency concerning primary and secondary syphilis. Behind very small exceptions, clinical P. aeruginosa isolates are resistant to a tseftriakson. Anaerobe bacterias: Bacteroides spp. (zhelchechuvstvitelny) *, Clostridium spp. (except for C. difficile), Fusobacterium nucleatum, Fusobacterium spp. (other), Gaffkia anaerobica (before Peptococcus), Peptostreptococcus spp. * Some isolates of these types are resistant to a tseftriakson because of education β-лактамаз. Note. Many strains of the β-lactamazoforming Bacteroides spp. (in particular, B. fragilis) are steady. Also Clostridium difficile is steady. The indications of the Infection caused by activators, sensitive to the drug Tro-Tseftriaks: sepsis meningitis a disseminate disease of Lyme (early and late stages of a disease) of of an infection of abdominal organs (peritonitis, infections of biliary tract and digestive tract) of an infection of bones, joints, soft tissues, skins, wound fevers of of an infection at patients with the weakened immunity of of an infection of kidneys and urinary tract of of respiratory infection, especially pneumonia, infections of ENT organs (including acute average otitis) genital infections, including gonorrhea preoperative prevention of infectious complications. Route of administration and doses Standard dosage Intravenously, intramusculary. Adults and children are more senior than 12 years: on 1-2 g once a day (each 24 hours). In hard cases or in infections which causative agents have only moderate sensitivity to a tseftriakson it is possible to increase a daily dose to 4 g. Duration of treatment depends on a course of the disease. As well as always at antibiotic treatment, administration of the drug Tro-Tseftriaks should be continued the patient within at least 48-72 hours after normalization of temperature and confirmation of an eradikation of the activator. Usually the course of treatment makes 4-14 days, at the complicated infections more long introduction can be required. The course of treatment in the infections caused by Streptococcus pyogenes has to make not less than 10 days. Patients with an abnormal liver function have no need to reduce a dose on condition of absence of heavy renal failures. Patients with a renal failure have no need to reduce a dose on condition of absence of tyazhelyy abnormal liver functions. The daily dose of the drug Tro-Tseftriaks should not exceed 2 g only in cases of a renal failure with clearance of creatinine less than 10 ml/min. At a combination of a heavy renal and liver failure it is regularly necessary to define concentration of a tseftriakson in plasma and if necessary to adjust its dose. The patient who is on dialysis, additional administration of drug after dialysis is not required. It is necessary to control, however, concentration of a tseftriakson in serum regarding possible dose adjustment as clearance rate at these patients can decrease. Children Newborns, babies and children are younger than 12 years When prescribing the drug Tro-Tseftriaks once a day it is recommended to adhere to the following modes of dosing: newborns (up to 14 days) – 20-50 mg/kg of body weight once a day, the daily dose should not exceed 50 mg/kg of body weight, – newborns, babies and children of younger age (from 15 days to 12 years): 20-80 mg/kg of body weight once a day, – to children with body weight over 50 kg appoint doses for adults. Aged up to 41 weeks inclusive (totally gestational and chronological age) use of a tseftriakson is contraindicated to premature children. Tro-Tseftriaks it is contraindicated to newborns (≤28 days) who already appoints or supposes intravenous treatment kaltsiysoderzhashchy solutions, including long kaltsiysoderzhashchy infusions, for example, at parenteral nutrition because of risk of formation of precipitated calcium superphosphates of calcic salts of a tseftriakson. Babies and children aged up to 12 years or should enter intravenous doses into 50 mg/kg by drop infusion above within not less than 30 minutes. Newborns should carry out intravenous administration within 60 minutes to reduce potential risk of developing bilirubinovy encephalopathy. Meningitis In bacterial meningitis at babies and children of younger age treatment begin with a dose 100 mg/kg (but no more than 4 g) 1 time a day. After identification of the activator and determination of its sensitivity the dose can be reduced respectively. The best results in a spotted fever were achieved lasting treatment of 4 days, in the meningitis caused by Haemophilus influenzae – 6 days, Streptococcus pneumoniae – 7 days. Lyme’s disease of 50 mg/kg (the highest daily dose – 2 g) to adults and children once a day within 14 days. Acute average otitis At treatment of acute average otitis at children is recommended single intramuscular introduction in a dose of 50 mg/kg (but no more than 1 g). Single intramuscular introduction in a dose of 1-2 g is recommended to adults. According to limited data, in hard cases or at inefficiency of the previous therapy, the drug Tro-Tseftriaks can be effective at intramuscular introduction in a dose of 1-2 g a day within 3 days. The gonorrhea (caused penitsillinazoobrazuyushchy and penitsillinazo – not forming strains) Single intramuscular introduction of 250 mg of the drug Tro-Tseftriaks. Prevention of postoperative infections Depending on degree of infectious risk is entered by 1-2 g of the drug Tro-Tseftriaks once in 30-90 min. prior to operation. At operations on thick and a rectum well proved simultaneous administration of the drug Tro-Tseftriaks and one of 5 nitroimidazoles, for example, of an ornidazol. Introduction Solution has to be used right after preparation. For an intramuscular injection of 500 mg of the drug Tro-Tseftriaks dissolve in 2 ml, and 1 g – in 3.5 ml of 1% of solution of lidocaine and enter deeply into rather big muscle (buttock). It is recommended to enter no more than 1 g into the same muscle. The solution CONTAINING LIDOCAINE CAN not be ENTERED INTRAVENOUSLY! For an intravenous injection dissolve 250 mg or 500 mg of the drug Tro-Tseftriaks in 5 ml, and 1 g – in 10 ml of sterile water for injections, enter intravenously slowly within 5 minutes, it is preferable in a large vein. Intravenous infusion has to last not less than 30 minutes. For preparation of solution part 2 g of the drug Tro-Tseftriaks in 40 ml of one of the following infusion solutions which are not containing calcium ions: 0.9% solution of sodium of chloride, 0.45% chloride sodium solution + 2.5% solution of a dextrose, 5% solution of a dextrose, 10% solution of a dextrose, 6% dextran solution in 5% solution of a dextrose, 6-10% hydroxyethylstarch solution, water for injections. Solutions of the drug Tro-Tseftriaks cannot be mixed or added to the solutions containing other antimicrobial drugs or other solvents except for listed above, because of possible incompatibility. It is impossible to use for preparation of solutions of the drug Tro-Tseftriaks for intravenous administration and their subsequent cultivation solvents, calciferous, such as Ringera solution or Hartman’s solution, because of possible formation of precipitated calcium superphosphates. Formation of precipitated calcium superphosphates of calcic salts of a tseftriakson can happen also at mixture of the drug Tro-Tseftriaks and kaltsiysoderzhashchy solutions when using one venous access. It is impossible to use Tro-Tseftriaks along with kaltsiysoderzhashchy solutions for intravenous administration, including with long infusions of kaltsiysoderzhashchy solutions, for example, at parenteral nutrition with use of the Y-connector. For all groups of patients, except newborns, perhaps consecutive administration of the drug Tro-Tseftriaks and kaltsiysoderzhashchy solutions at careful washing of infusional systems between injections by compatible liquid. Solutions of the drug Tro-Tseftriaks cannot be mixed or added to the solutions containing other antimicrobial drugs or other solvents because of possible incompatibility. Side effects by the Most frequent undesirable reactions registered against the background of therapy tseftriaksony in clinical trials are an eosinophilia, a leukopenia, thrombocytopenia, diarrhea, rash and increase in activity of liver enzymes. For the description of frequency of undesirable reactions the following classification is used: very frequent (≥1/10), frequent (≥1/100 and & lt, 1/10), infrequent (≥1/1000 and & lt, 1/100), rare (≥1/10000 and & lt, 1/1000) and very rare (& lt, 1/10000), including isolated cases. Undesirable reactions are grouped according to classes of systems of bodies of the medical dictionary for standard and legal activity of MedDRA. Infectious and parasitic diseases: infrequently – mycoses of genitals, it is rare – pseudomembranous colitis. Disturbances from the system of blood and lymphatic system: often – an eosinophilia, a leukopenia, thrombocytopenia, infrequently – a granulocytopenia, anemia, a coagulopathy. Disturbances from nervous system: infrequently – a headache and dizziness. Disturbances from the respiratory system, bodies of a thorax and mediastinum: seldom – a bronchospasm. Disturbances from digestive tract: often – diarrhea, not properly executed chair, infrequently – nausea, vomiting. Disturbances from a liver and biliary tract: often – increase in activity of liver enzymes (aspartate aminotransferase (nuclear heating plant), alaninaminotranspherase (ALT), the alkaline phosphatase (AP)). Disturbances from skin and hypodermic fabrics: often – rash, infrequently – an itching, it is rare – krapivn
and. Disturbances from kidneys and urinary tract: seldom – a hamaturia, a glucosuria. It is general disorders and disturbances in the injection site: infrequently – phlebitis, pain in the injection site, fervescence, is rare – hypostases, a fever. Influence on results of laboratory and tool researches: infrequently – increase in concentration of creatinine in blood. Post-registration observation the by-effects observed at use of a tseftriakson in the post-registration period are described Below. Determination of frequencies of the observed by-effects and also their bonds with use of drug of a tseftriakson, is not always possible as it is impossible to establish the exact size of population of patients. Disturbances from digestive tract: pancreatitis, stomatitis, glossitis, disturbance of taste. Disturbances from the system of blood and lymphatic system: thrombocytosis, increase in a tromboplastinovy and prothrombin time, decrease in a prothrombin time, hemolytic anemia. Separate cases of an agranulocytosis are described (& lt, 500 cells / mkl), and most of them developed after 10 days of treatment and use of a cumulative dose of 20 g and more. Disturbances from the immune system: acute anaphylaxis, hypersensitivity. Disturbances from skin and hypodermic fabrics: sharp generalized exanthematous pustulez, separate cases of heavy side reactions (exudative multiformny erythema, Stephens-Johnson’s syndrome, toxic epidermal necrolysis (Lyell’s disease)). Disturbances from nervous system: spasms. Disturbances from an organ of hearing and labyrinth disturbances: vertigo. Infectious and parasitic diseases: superinfections. Also following undesirable reactions are known: formation of precipitated calcium superphosphates of calcic salts of a tseftriakson in a gall bladder with the corresponding symptomatology, bilirubinovy encephalopathy, a hyperbilirubinemia, an oliguria, a vaginitis, the increased sweating, inflows, an allergic pneumonitis, nasal bleeding, jaundice, heart consciousness, a serum disease and also anaphylactic or anaphylactoid reactions. The general disorders and disturbances in the injection site: phlebitis after intravenous administration. It can be avoided, administering the drug slowly within 5 minutes, it is preferable in a large vein. The intramuscular injection without use of lidocaine is painful. Influence on results of laboratory analyses At treatment tseftriaksony at patients false positive results of test of Koombs can be noted. As well as other antibiotics, drug can yield false positive result of test on a galactosemia. False positive results can be received also when determining glucose in urine by not fermental methods therefore during therapy by drug the glucosuria if necessary needs to be determined only by a fermental method. Tseftriakson can cause doubtful decrease in the indicators of a glycemia received by means of some devices of monitoring of content of glucose in blood. If necessary it is necessary to use alternative methods of definition of glucose in blood. Contraindications hypersensitivity to a tseftriakson, other cephalosporins or to any of excipients. heavy reactions of hypersensitivity (for example, anaphylactic reactions) on any other type beta laktamnykh antibacterial drugs (penicillin, monobaktama, karbapenema) in the anamnesis hypersensitivity to solvent – lidocaine the premature newborn to age 41 weeks (totally gestational and chronological age) the full-term newborn (up to 28 days of life): a) in the presence of a hyperbilirubinemia, jaundice, a hypoalbuminemia or acidosis, states at which bilirubin binding disturbance * is possible b) if they need (or can be required) intravenous administration of calcium or calciferous solutions because of risk of formation of precipitated calcium superphosphates of calcic salt of a tseftriakson. * The researches in vitro showed what tseftriakson can force out bilirubin from its communication with seralbumin that increases risk of bilirubinovy encephalopathy at these patients. Before intramuscular introduction of a tseftriakson when as solvent lidocaine is used, it is necessary to consider contraindications for lidocaine (see information in the instruction for medical use of medicine Lidocaine). The solutions of a tseftriakson containing lidocaine should not be entered intravenously. With care Premature children, a renal and/or liver failure, the ulcer colitis, enteritis or colitis connected with use of antibacterial medicines, pregnancy, the lactation period. Medicinal interactions Tseftriakson pharmaceutical is incompatible with amsakriny, Vancomycinum, flukonazoly and aminoglycosides. At simultaneous use of high doses of drug of a tseftriakson and loopback diuretics (for example, furosemide) renal failures were not observed. There are contradictory data on the probability of increase in nephrotoxicity of aminoglycosides at their use with cephalosporins therefore it is necessary to carry out monitoring of renal function and concentration of aminoglycosides to blood. Alcohol intake after introduction of a tseftriakson was not followed by disulfiramopodobny reaction. Tseftriakson does not support N-methylthiotetracindery group which could cause intolerance of ethanol and bleeding that is inherent in some other cephalosporins. Probenetsid does not influence removal of a tseftriakson. Bacteriostatic antibiotics reduce bactericidal effect of a tseftriakson. In vitro was found antagonism between chloramphenicol and tseftriaksony. It is impossible to use solvents, calciferous, such as Ringera solution or Hartman’s solution, at preparation of solutions of a tseftriakson for intravenous administration and their subsequent cultivation because of possible formation of precipitated calcium superphosphates. Formation of precipitated calcium superphosphates of calcic salts of a tseftriakson can happen also at mixture of a tseftriakson and kaltsiysoderzhashchy solutions when using one venous access. It is impossible to use tseftriakson along with kaltsiysoderzhashchy solutions for intravenous administration, including with long infusions of kaltsiysoderzhashchy solutions, for example, at parenteral nutrition with use of the Y-connector. For all groups of patients, except newborns, perhaps consecutive introduction of a tseftriakson and kaltsiysoderzhashchy solutions at careful washing of infusional systems between injections by compatible liquid. For assessment of interaction of a tseftriakson and calcium two researches in vitro are conducted: one with use of blood plasma of the adult, another – plasmas of umbilical blood of the newborn. Various combinations of a tseftriakson with initial concentration to 1 mm (maximum concentration which reaches tseftriakson in vivo at infusional introduction of 2 g of drug within not less than 30 min.) and calcium with initial concentration to 12 mm (48 mg/dl) were analyzed. Decrease in concentration of a tseftriakson in plasma was observed when using calcium in concentration of 6 mm (24 mg/dl) and above for plasma of the adult and in concentration of 4 mm (16 mg/dl) and above for the newborn’s plasma that demonstrates the increased risk of formation of calcic salts of a tseftriakson at newborns. At use of antagonists of vitamin K against the background of therapy tseftriaksony the risk of bleeding increases. It is necessary to control constantly parameters of fibrillation and if necessary to adjust a dose of anticoagulant both in the course, and after the end of therapy by the drug Tro-Tseftriaks. Aminoglycosides: owing to synergism the efficiency concerning gram-negative microorganisms increases, but also the risk from – and nephrotoxicity increases. It is necessary to regulate doses of drugs and in need of the combined treatment to enter them separately into different places and not to mix in one syringe or in one solution because of physical and chemical incompatibility. There are contradictory data on potential increase in nephrotoxicity of aminoglycosides when sharing with cephalosporin. In such cases it is necessary to observe strictly recommended monitoring of concentration of aminoglycosides (and functions of kidneys) in clinical practice. Special instructions As well as at use of other cephalosporins, were registered anaphylactic reactions, including from the death, even in cases when the patient had no allergic reactions in the anamnesis. As well as at use of other cephalosporins, at treatment tseftriaksony development of autoimmune hemolytic anemia is possible. Cases of heavy hemolytic anemia at adults and children, including from the death are registered. At development in the patient who is on treatment tseftriaksony the anemia cannot exclude the diagnosis cephalosporin – the associated anemia and it is necessary to cancel treatment before clarification of the reason. As well as at use of the majority of other antibacterial drugs, at treatment tseftriaksony cases of development of the diarrhea caused by Clostridium difficile (C. difficile), various weight are registered: from slight diarrhea to colitis from the death. Treatment by antibacterial drugs suppresses normal microflora of a large intestine and provokes growth of C. difficile. In turn, C. difficile forms toxins A and B which are factors of pathogenesis of the diarrhea caused by C. difficile. S.’s strains of difficile which are hyper producing toxins are causative agents of infections with high risk of complications and mortality, owing to their possible resistance to antimicrobic therapy, treatment can demand colectomy. It is necessary to remember a possibility of development of the diarrhea caused by C. difficile at all patients with diarrhea after antibiotic treatment. Careful collecting the anamnesis since cases of developing of the diarrhea caused by C. difficile later after therapy are noted more than 2 months by antibiotics is necessary. At suspicion or confirmation of the diarrhea caused by C. difficile the cancellation of the current antibiotic treatment difficile which is not directed to S. perhaps will be required. According to clinical indications the corresponding treatment with input of the fluid and electrolytes, proteins, antibiotic treatment concerning S. difficile, surgical treatment has to be appointed. As well as at treatment by other antibacterial drugs, superinfections can develop. At the patients receiving tseftriakson exceptional cases of change of a prothrombin time are described. Control of a prothrombin time can be required by patients with insufficiency of vitamin K (synthesis disturbance, disturbance of food) during therapy and prescribing of vitamin K (10 mg/week) at increase in a prothrombin time prior to the beginning of or during therapy. After use of a tseftriakson, usually in the doses exceeding standard recommended, at ultrasound examination of a gall bladder, shadows which mistakenly took for stones came to light. They represent precipitated calcium superphosphates of calcic salt of a tseftriakson which disappear after end or the termination of therapy tseftriaksony. Similar changes seldom give any symptomatology, but also in such cases only the conservative treatment is recommended. If these phenomena are followed by clinical symptomatology, then the decision on drug withdrawal is left to the discretion of the attending physician. Despite availability of data on formation of intravascular precipitated calcium superphosphates only at newborns at use of a tseftriakson and kaltsiysoderzhashchy infusion solutions or any other kaltsiysoderzhashchy drugs, Tro-Tseftriaks should not mix or appoint children and adult patients along with kaltsiysoderzhashchy infusion solutions, even using various venous accesses. At the patients receiving tseftriakson exceptional cases of the pancreatitis developing perhaps, owing to obstruction of bilious ways are described. Most of these patients had risk factors of stagnation in bilious ways, for example, earlier carried out therapy, a serious illness and completely parenteral nutrition already before. At the same time it is impossible to exclude a starting role, formed under the influence of a tseftriakson, precipitated calcium superphosphates in bilious ways in development of pancreatitis. At long-term treatment it is necessary to carry out complete analysis of blood regularly. Pregnancy and the period of a lactation of Tro-Tseftriaks gets through a placental barrier. Safety of use at pregnancy is not established. Tro-Tseftriaks gets into breast milk. When assigning the feeding women should be careful. There Is no feature of influence on ability to run the vehicle or potentially dangerous mechanisms the data confirming influence of drug on driving of vehicles and work with cars and mechanisms. However during therapy by the drug Tro-Tseftriaks it is necessary to be careful at control of vehicles and work with mechanisms in connection with possibility of dizziness and other undesirable reactions which can affect ability to run vehicles and mechanisms. Overdose Symptoms: nausea, vomiting and diarrhea. Treatment: symptomatic. The hemodialysis and peritoneal dialysis are not effective, there is no specific antidote. A form of release and packing On 1000 mg of a tseftriakson in the bottles from glass corked by rubber bungs of gray color with an aluminum cap of Flipp off. On 1 or 50 bottles with drug together with the approved instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions in the dry place protected from light at a temperature, it is 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 Reyoung Pharmaceutical Co.Ltd., (No. 6, Erlangshan Road, Yiyuan County Zibo, Shandong 256100, China). Reyang Pharmaceutical To., Ltd. (Highway Irlangshan No. 6, Yuan, the city of Zibo, Provintion of Shandong, China – 256100). The owner of the registration certificate of Trodzh Medikal GmbH, 19 Milkhstrasse, 20148 Hamburg, Germany the Address of the organization accepting in the territory of
the Republic Kazakhs Razvernut
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