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Aksetin 750 mg 10s powder for solution for injection and inf.




The instruction for medical use of Aksetin Torgovoye medicine nazvaniyeaksetin the International unlicensed name Tsefuroksim Lekarstvennaya a form Powder for preparation of solution for injections and infusions of 750 mg and 1.5 g Structure One bottle contains active agent – tsefuroksy sodium (it is equivalent to a tsefuroksim) – 750 mg and 1500 mg the Description Powder from white till light-yellow color. Pharmacotherapeutic group Antibacterial drugs for system use. Beta laktamnye antibacterial drugs, other. Cephalosporins of the second generation. Tsefuroksim. The ATX J01DC02 code the Pharmacological Pharmacokinetics Later properties of intramuscular introduction in a dose of 750 mg the maximum concentration of a tsefuroksim in blood plasma is reached in 45-60 min. and makes about 27 mkg/ml. At intravenous administration of 750 mg and 1.5 g of a tsefuroksim in 15 min. the levels are equal in plasma to 50 and 100 mkg/ml respectively, therapeutic concentration remains 5 and 8 h respectively. Elimination half-life at intravenous and intramuscular administration makes about 80 min. (at newborns can be 3-5 times higher). Contacts proteins of plasma for 50%. About 80% of a dose are removed by kidneys during 8 h in not changed look (high concentration in urine is created), in 24 h is removed completely: 50% by canalicular secretion, 50% by glomerular filtration. Therapeutic concentration are created in pleural and synovial liquids, bile, a phlegm, a bone tissue, cerebrospinal fluid (at inflammation of a meninx), a myocardium, skin and soft tissues. Passes through a placenta and in breast milk. A pharmacodynamics Aksetin – a tsefalosporinovy antibiotic of the II generation for parenteral use. Works bakteritsidno, breaks synthesis of a cell wall of microorganisms. Possesses a broad spectrum of activity. It is resistant to action of the majority beta laktamaz. It is highly active concerning Staphylococcus aureus, including the strains resistant to penicillin (except for the rare strains resistant to Methicillinum), Staphylococcus epidermidis, Haemophilus influenzae, Klebsiella spp., Enterobacter spp., Streptococcus pyogenes, Escherichia coli, Streptococcus mitis (viridans group), Clostridium spp., Proteus mirabilis, Proteus rettgeri, Salmonella typhi, S. typhimurium, and other types of Salmonella spp., Shigella spp., Neisseria spp. (including the strains of N. gonorrhoeae producing beta lactamazu) and Bordetella pertusis. Drug is also moderately active concerning strains of Proteus Vulgaris, Proteus morganii. The majority of strains of Bacteroides fragilis are insensitive to drug. It is inactive concerning Pseudomonas, Campilobacter, Acinobacter calcoaceticus, the majority of strains of Serratia, Clostridium difficile. Indications the Infectious and inflammatory diseases caused by activators, sensitive to drug, including – pharyngitis, sinusitis, tonsillitis – acute and chronic bronchitis, a bronchoectatic disease, bacterial pneumonia, lung abscess – post-operational infections of bodies of a thorax – a panniculitis, erysipelatous inflammation, a wound fever of skin and soft tissues – septic arthritis, osteomyelitis – an asymptomatic bacteriuria, cystitis, acute and chronic pyelonephritis, – a septicaemia – meningitis – peritonitis – infections of bodies of a small pelvis and an abdominal cavity – prevention of emergence of infectious complications at operations on bodies of a thorax, abdominal cavity, a basin, joints the Route of administration and doses administer the Drug intramusculary and intravenously. Intramuscular introduction. Add 3 ml of water for injections to 750 mg of drug and carefully stir up before receiving an opaque suspension. For intravenous jet administration of 750 mg of drug dissolve in not less than 9 ml of water for injections. As solvent it is possible to use also isotonic solution of sodium of chloride or 5% glucose solution. Enter slowly within 3-5 minutes. To adults and children with body weight more than 40 kg, in oil or in/in appoint 0.75-1.5 g 3 times a day. If necessary the interval between injections can be reduced till six o’clock, a daily dose of drug – 3.0-6.0 g. To children with body weight less than 40 kg appoint drug in a dose of 30-100 mg/kg/days in 3-4 introductions. For the majority of infections the optimum daily dose makes 60 mg/kg. The newborn (up to 1 month) appoint on 30-100 mg/kg/days in 2-3 introductions. In the first weeks of life the elimination half-life of a tsefuroksim from blood serum of newborns can be in 3-5 times more, than at adults. In gonorrhea drug appoint in a dose 1.5 g once in the form of 1 injection or in the form of 2 injections on 750 mg entered into both buttocks. In meningitis to adults and children with body weight more than 40 kg are appointed on 3 g in/in each 8 h. To children with body weight less than 40 kg appoint 150-250 mg/kg/days in/in in 3-4 introductions. At achievement of optimum therapeutic effect it is possible to reduce a dose of drug to 100 mg/kg/days intravenously. The newborn appoint drug in an initial dose of 100 mg/kg/days intravenously. At achievement of optimum therapeutic effect it is possible to reduce a dose to 50 mg/kg/days intravenously. Pneumonia: 1.5 2-3 times a day (intravenously or intramusculary) within 48-72 hours with the subsequent purpose of a tsefuroksim in tablets in a dose of 500 mg 2 times a day within 7-10 days. Exacerbation of chronic bronchitis: 750 mg 2-3 times a day (intravenously or intramusculary) within 48-72 hours with the subsequent purpose of a tsefuroksim in tablets in a dose of 500 mg 2 times a day within 5-10 days. Duration of every period (parenteral therapy and intake) is defined by weight of an infection and the general condition of the patient. For prevention of infectious complications at operations on bodies of chest and belly cavities, a basin, joints: the drug is administered in/in in an average dose of 1.5 g during introduction anesthesia. If necessary additional administrations of drug in oil in a dose of 750 mg in 8 and 16 h are possible. The patient with renal failures at clearance of creatinine of 10-20 ml/min. 2 times/days recommend to administer the drug on 750 mg, at clearance of creatinine less than 10 ml/min. – on 750 mg 1 times/day. Patients have no need to reduce a standard dose of drug (750 mg – 1.5 g 3 times a day) with clearance of creatinine higher than 20 ml/min. The patient who is on a hemodialysis at the end of each procedure enter 750 more mg. At continuous peritoneal dialysis, drug is appointed on 750 mg by 2 times/days. Side effects – nausea, vomiting, spasms and an abdominal pain – ulcerations of a mucous membrane of an oral cavity, oral cavity candidiasis – pseudomembranous colitis, diarrhea – anemia, a leukopenia, an eosinophilia, a neutropenia, an agranulocytosis, thrombocytopenia, hemolytic anemia. – spasms – a renal failure, a dysuria, an itching of a crotch, a vaginitis, increase in level of creatinine and/or nitrogen, urea, decrease in clearance of creatinine – decrease in hearing – tranzitorny increase in activity of hepatic transaminases, alkaline phosphatase in blood plasma, increase in level of bilirubin, positive reaction of Koombs – skin rash, an itching, a small tortoiseshell, fever Extremely seldom – an exudative multiformny erythema (including Stephens-Johnson’s syndrome), a toxic epidermal necrolysis (Lyell’s disease), skin rash (including urtikarny), a skin itching, medicinal fever, a bronchospasm, a serum disease, an acute anaphylaxis – local reactions: morbidity, infiltrate in the place in oil of introduction, at intravenous administration – thrombophlebitis, Contraindication phlebitis – hypersensitivity to a tsefuroksim and another beta laktamnym to antibacterial drugs – bleedings and gastrointestinal diseases in the anamnesis, including nonspecific ulcer colitis Medicinal interactions Tsefuroksim, suppressing indestinal flora, interferes with vitamin K synthesis. Therefore at co-administration with the drugs reducing aggregation of thrombocytes (NPVS, salicylates, Sulfinpyrazonum) the risk of developing bleedings increases. For the same reason at co-administration with anticoagulants strengthening of anticoagulating action is noted. At co-administration with diuretics and potentially nefrotoksichny antibiotics the risk of development of nephrotoxic action increases. Simultaneous oral prescribing of “loopback” diuretics slows down canalicular secretion, reduces renal clearance, increases concentration in plasma and increases T1/2 of a tsefuroksim. Probenetsid reduces canalicular secretion, reduces renal clearance. Pharmaceutical we will combine: with the aqueous solutions containing to 1% of lidocaine of a hydrochloride, 0.9% solution of sodium of chloride, 5 and 10% solution of a dextrose, 0.18% solution of sodium of chloride and 4% solution of a dextrose, 5% solution of a dextrose and 0.9% chloride sodium solution, Ringera solution, Hartman’s solution, lactate sodium solution, heparin (10 PIECES/ml and 50 PIECES/ml) in 0.9% chloride sodium solution. Pharmaceutical it is incompatible: with solutions of aminoglycosides (it is impossible to mix in one syringe), with solution of Natrii hydrocarbonas of 2.74%. Special instructions the Patients who had allergic reactions to penicillin in the anamnesis can have hypersensitivity to tsefalosporinovy antibiotics. During treatment the false positive forward reaction of Koombs and false positive reaction of urine to glucose is possible. At the patients receiving tsefuroksy when determining concentration of glucose in blood it is recommended to use tests with glucose oxydas or a hexokinase. At prolonged use it is recommended to control function of kidneys (especially when using high doses) and to perform prevention of dysbacteriosis. At patients with a renal failure the dose has to be reduced taking into account severity of a renal failure and sensitivity of the activator. After elimination of symptoms of a disease the treatment should be continued during 48-72 h. With care patients should appoint in a renal failure, gastrointestinal diseases (including in the anamnesis), in nonspecific ulcer colitis and also to newborn children (especially premature). At a concomitant use with aminoglycosides and diuretics the risk of emergence of nephrotoxic effects therefore it is necessary to control function of kidneys at use of such combination of drugs, especially at patients of advanced age, with diseases of kidneys and at receiving drug in a high dose increases. At treatment of meningitis by Aksetin at some children the decrease in hearing easy was noted and moderate severity, at the same time in cerebrospinal liquid the positive cultures of Haemophilus influenza in 18-36 hours of therapy were defined. The similar phenomena were noted also at use of other antibiotics, their clinical value is unknown. The possibility of pseudomembranous colitis needs to be meant at patients with the heavy diarrhea which arose in time or after a course of treatment antibiotics. Pregnancy and the period of a lactation Aksetin should be applied with care in the first trimester of pregnancy. Aksetin is allocated with breast milk therefore nursing mothers should show care when prescribing drug. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Should be careful at control of motor transport and moving mechanisms Overdose Symptoms: strengthening of side effects, increase in excitability of a cerebral cortex, spasm. Treatment: symptomatic, hemodialysis, peritoneal dialysis. The form of release and packing, in the number of equivalent 750 mg and 1.5 g of active agent, place Drug in the transparent glass bottles type with an I volume of 15 ml closed by rubber bungs and rolled by aluminum caps. On bottles self-adhesive paste labels. On 10 bottles together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions in original packing in the dry, protected from light place at a temperature not above 25 °C. To store out of children’s reach! A period of storage 2 years not to use drug after expiry date. Prescription status According to the prescription Medokemi Ltd Producer, CYPRUS P. O. Box.51409 CY-3505 Limassol tel.357-25-867600, fax.357-25-560863, the Name and the country of the owner of the registration certificate of Medokemi Ltd, CYPRUS the Name and the country of the Medokemi Ltd organization packer, CYPRUS the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Representative office of Medokemi Ltd Almaty, Mukanov St., 241 office 1B ph. / fax: 313-73-76
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