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Zinnat 250 mg / 5 ml 100 ml granules for oral suspension

$39.40

4f3a619a9114

Description

The instruction for medical use of Zinnat Torgovoye medicine a name Zinnat Mezhdunarodnoye the unlicensed name Tsefuroksim Lekarstvennaya the Granule form for preparation of suspension for intake, 250 mg / 5мл Structure of 5 ml of suspension contain active agent – the tsefuroksima aksetit 300.0 mg (corresponds to a tsefuroksim of 250 mg), excipients: stearic acid, sucrose, Tutti Frutti fragrance, potassium to atsesulfa, aspartame, K30 povidone, pitch xanthane. Description of the Granule of white or almost white color. At cultivation, water forms suspension from white till light yellow color with a characteristic fruit smell. Pharmacotherapeutic group Antibacterial drugs for system use. Beta laktamnye antibacterial drugs other. Cephalosporins of the second generation. Tsefuroksim. The ATX J01DC02 code tsefuroksy aksetit the Pharmacological Pharmacokinetics Absorption Later properties of intake is soaked up from digestive tract and quickly hydrolyzed in a mucous membrane of intestines and blood with release of a tsefuroksim in a system blood stream. Optimum absorption is reached at intake of suspension together with food. At intake of suspension the speed of absorption (Cmax) of a tsefuroksim of an aksetil is lower, than at reception of tablets by which (Cmax) is defined in 2.4 hours owing to what the maximum concentration decreases, time of its achievement increases and the system bioavailability decreases (by 4-17%). Distribution makes Extent of linking of a tsefuroksim with proteins of blood plasma from 33% to 50%, depending on a route of administration. Metabolism Tsefuroksim is not metabolized in an organism. Removal Elimination half-life of a tsefuroksim makes 1-1.5 hours. Tsefuroksim is allocated with kidneys in an invariable look by glomerular filtration and canalicular secretion. Competitive purpose of a probenitsid increases AUC indicator by 50%. A renal failure the Pharmacokinetics of a tsefuroksim was not investigated at patients with various degree of renal dysfunction. Elimination half-life of a tsefuroksim increases with depression of function of kidneys that is the main management for selection of a dose at such patients. At the patients who are on a hemodialysis, at least 60% of the general dose of a tsefuroksim are present at an organism at the time of the beginning of dialysis which is removed within 4 hours of the procedure of dialysis. Thus, such patients need purpose of an additional dose of a tsefuroksim on completion of the procedure of a hemodialysis. A pharmacodynamics of Zinnat® – a tsefalosporinovy antibiotic of the II generation. Possesses a broad spectrum of activity. It is resistant to action of the majority β-лактамаз therefore ampicillin – resistant or amoxicillin – resistant strains is active in the relation. Works bakteritsidno, breaks synthesis of a cell wall of bacteria as a result of linking with the main proteins targets. The resistance of strains depends on a geographical location and time. Use local data on resistance for treatment of heavy infections. Tsefuroksim is effective concerning the following microorganisms Gram-positive aerobic bacteria: Staphylococcus aureus (Methicillinum – sensitive isolates) * Streptococcus pyogenes Streptococcus agalactiae Gram-negative aerobic bacteria: Borrelia burgdorferi Spirochete Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis Microorganisms with a possible rezistentost to a tsefuroksim Gram-positive aerobic bacteria: Streptococcus pneumoniae Gram-negative aerobic bacteria: Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Proteus spp., (not including P. Vulgaris) Providencia spp. Gram-positive anaerobic bacteria: Peptostreptococcus spp. Propionibacterium spp. Gram-negative anaerobic bacteria: Fusobacterium spp. Bacteroides spp. Gram-positive aerobic bacteria are resistant to a tsefuroksim: Enterococcus faecalis Enterococcus faecium Gram-negative aerobic bacteria: Acinetobacter spp. Campylobacter spp. Morganella morganii Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens Gram-negative anaerobic bacteria: Bacteroides fragilis Other Chlamydia spp. Mycoplasma spp. Legionella spp. * All Methicillinum – steady bacteria of S.aureus are resistant to a tsefuroksim. Indications Treatment of the infectious and inflammatory diseases caused by microorganisms, sensitive to drug: – acute streptococcal tonsillitis and pharyngitis – acute bacterial sinusitis – acute average otitis – exacerbation of chronic bronchitis – cystitis – pyelonephritis – the infections of skin and soft tissues (for example, a furunculosis, a pyoderma, impetigo) which are not followed by complications – early stages of a disease of Lyme Neobkhodimo to consider official recommendations about appropriate use of antibacterial substances. The route of administration and doses Is intended for intake. For optimum absorption the drug should be taken together with food. Duration of use of drug averages 7 days (from 5 to 10 days). Adults and children (& gt, 40 kg) Indications Dose Acute tonsillitis and pharyngitis, acute bacterial sinusitis of 250 mg twice a day Acute average otitis 500 twice a day Exacerbation of chronic bronchitis 500 twice a day Cystitis 250 twice a day Pyelonephritis 250 twice a day Infections of skin and soft tissues which are not followed by complications 250 twice a day Treatment of early stages of a disease of Lyme of 500 mg twice a day within 14 days (from 10 to 21 days) Children (& lt, 40 kg) Indications Dose Acute tonsillitis and pharyngitis, acute bacterial sinusitis of 10 mg/kg twice a day at most 125 mg twice a day. Acute otitis of a middle ear of 15 mg/kg twice a day at most on 250 mg twice a day. Exacerbation of chronic bronchitis of 15 mg/kg twice a day at most on 250 mg twice a day. Cystitis of 15 mg/kg twice a day at most on 250 mg twice a day. Pyelonephritis of 15 mg/kg twice a day at most on 250 mg within from 10 to 14 days of the Infection of skin and soft tissues which are not followed by complications of 15 mg/kg twice a day at most on 250 mg twice a day. Treatment of early stages of a disease of Lyme of 15 mg/kg twice a day the maximum on 250 mg twice a day within 14 days (from 10 to 21 days) Is not present experience of use of the drug Zinnat® for children up to 3 months. Aksetit tablets of a tsefuroksim and aksetit granules of a tsefuroksim for suspension for intake not of a bioekvivalentna, they are not interchanged on the basis of a ratio 1mg/1mg. At babies (of 3 months) and children with body weight to 40 kg it is recommended to calculate a drug dose according to the child’s weight at the rate of 10 mg/kg of body weight 2 times a day (for the majority of infections), but no more than 250 mg a day. A dose from rascheta10 mg/kg, appointed in the majority of infections: The age 2 times in day (mg) Volume in ml of 125 mg 250 mg from 3 to 6 months 40 – 60 2,5 – from 6 months to 2 years 60 – 120 2,5-5 – from 2 to 18 years 125 5 2,5 Dose at the rate of 15 mg/kg, is appointed in average otitis and heavy infections: The age 2 times in day (mg) Volume in ml of 125 mg 250 mg from 3 to 6 months 60 – 90 2,5 – from 6 months to 2 years 90 – 180 5-7,5 2,5 from 2 to 18 years 180 – 250 7,5-10 2,5-5 at very small children can be applied To dosing accuracy the dosing syringe, however, the measured spoon is the most optimum method of drug dosing at the children capable to accept suspension from a spoon. A renal failure Safety and efficiency of a tsefuroksim of an aksetil at patients with a renal failure are not established. Tsefuroksim is brought mainly by kidneys. At patients with a renal failure the dose decline for correction of the slowed-down excretion is recommended. The clearance of T1/2 creatinine (hours) the Recommended dose of ≥30 ml/min. 1.4 – 2.4 Correctings of a dose is not required (a standard dose of 125 – 500 mg twice a day) 10-29 ml/min. 4.6 Standard individual dose each 24 hours & lt, 10 ml/min. 16.8 A standard individual dose each 48 hours during the procedure of a hemodialysis 2 – 4 Additional single individual at the end of the procedure of dialysis Preparation of suspension Stir up a bottle several times (within 1 minute). Uncover also a protective membrane. If the membrane was damaged, do not use drug. Gather in a volumetric glass of water to a tag (19 ml for a bottle of 100 ml or 35 ml for a bottle of 200 ml). Pour the measured amount of water in a bottle and close a cover. Turn a bottle and vigorously stir up it (not less than 15 seconds) completely to mix drug. Turn a bottle in a starting position and once again vigorously stir up. If you are not going to apply suspension at once after cultivation, immediately put a bottle in the fridge (from 2 ºС up to 8 ºС) Pri administration of drug can add cold fruit juice or milk to every portion of suspension. The suspension which is in addition diluted thus should be used immediately. You do not part all volume of suspension with juice or milk at once. The prepared suspension or granules cannot be mixed with hot liquids. Side effects Side reactions on tsefuroksy it is usually passing and have an easy course. The most widespread side reactions are excess growth Candida, an eosinophilia, a headache, dizzinesses, disorders of a GIT and moderate increase in level of liver enzymes. Frequency of occurrence is defined as follows: very often (≥1/10), it is frequent (≥1/100 – & lt, 1/10), infrequently (≥1/1,000 – & lt, 1/100), is rare (≥1/10,000 – & lt, 1/1,000), is very rare (& lt, 1/10,000, including separate cases), it is unknown (frequency cannot be estimated). Often – the strengthened growth of steady microorganisms of the sort Candida – an eosinophilia – a headache, dizziness – gastrointestinal disorders, including diarrhea, nausea, pain in a stomach – temporary increase in activity of enzymes of a liver (ALT, nuclear heating plant, LDG), Infrequently – positive reaction of Koombs, thrombocytopenia, a leukopenia (sometimes pronounced) – skin rash – vomiting Seldom – urticaria, an itching – pseudomembranous colitis Very seldom – hemolytic anemia – fever of a medicinal etiology, a serum disease, an anaphylaxis – jaundice (mainly cholestatic), hepatitis – a polymorphic erythema, Stephens-Johnson’s syndrome, a toxic epidermal necrolysis (exanthematous necrolysis) Is unknown – the excess growth of Clostridium difficile – Yarisha-Gerksgeymer Pri’s reaction the Zinnat® drug treatment of a disease of Lyme is sometimes noted Yarisha-Gerksgeymer’s reaction. This reaction is a direct consequence of bactericidal action of Zinnata® on an infestant – Borrelia burgdorferi spirochete – and is the frequent and usually spontaneously passing treatment consequence. It is necessary to explain to patients that this usual consequence of antibiotic treatment in Lyme’s disease which is not demanding special therapy. The description of separate side reactions Cephalosporins as a class are usually soaked up in a surface of a membrane of erythrocytes and react with the antibodies directed against drug that gives positive antiglobulinovy test (it can interfere with cross matching on compatibility of blood) and in rare instances hemolytic anemia. Contraindications – hypersensitivity to antibiotics of group of cephalosporins, penicillin and Carbapenums or to any component of drug – children’s age up to 3 months With care: – Medicinal interactions Drugs which reduce acidity of gastric juice can reduce the first trimester of pregnancy bioavailability of the drug Zinnat® and minimize effect of acceleration of absorption after meal. As well as other antibiotics, the drug Zinnat® can influence indestinal flora, thereby leading to decrease in a reabsorption of estrogen and decrease in efficiency of the combined oral contraceptives. As when carrying out the ferrotsianidny test the false positive result can be noted, for determination of level of glucose in blood of the patients receiving therapy tsefuroksimy sodium it is recommended to use a glyukozooksidazny or hexokinase technique. Зиннат® does not affect results alkaline pikratnogo a method of determination of level of creatinine. Simultaneous introduction with probenitsidy leads to increase in AUC the drug Zinnat® for 50%. The special instructions Hypersensitivity Drug Zinnat® are appointed with extra care to patients in whose anamnesis there are data on allergic reactions to penicillin or others beta laktamnye antibiotics. As well as in a case with others beta laktamnymi antibiotics did not exclude cases of serious hypersensitivity, sometimes with a lethal outcome. Pri development of the significant manifestations of hypersensitivity tsefuroksimy needs to stop treatment immediately and to immediately take the appropriate emergency measures. Yarisha-Gerksgeymer Pri’s reaction the Zinnat® drug treatment of a disease of Lyme is sometimes noted Yarisha-Gerksgeymer’s reaction. This reaction is a direct consequence of bactericidal action of Zinnata® on an infestant – Borrelia burgdorferi spirochete – and is the frequent and usually spontaneously passing treatment consequence. It is necessary to explain to patients that this usual consequence of antibiotic treatment in Lyme’s disease which is not demanding special therapy. Growth of resistant mikroogranizm As well as in a case with other antibiotics, at long-term treatment by drug is possible the strengthened growth of insensitive microorganisms (Candida, Enterococci, Clostridium difficile) that it can demand the treatment termination. Pri appearance of diarrhea against the background of use of antibiotics, including the drug Zinnat®, it must be kept in mind a possibility of development of pseudomembranous colitis which weight can vary from insignificant to zhizneugrozhayushchy. Thus, it is important to consider the possibility of presence of this pathology at patients with the diarrhea which arose against the background of treatment or after the therapy termination. In the presence at the patient of the long or profound diarrhea or in the presence of abdominal spasms, treatment has to be stopped immediately and the patient has to be directed to a further research. It is also necessary to consider use of special treatment for the purpose of decrease in volume of bacteria of Clostridium difficile. Patients with diabetes should consider presence of sucrose as a part of suspension. Pri prescribing of the drug Zinnat® to patients with phenylketonuria should consider presence of aspartame as a part of drug which can be a phenylalanine source. Use in pediatrics of Experience of treatment of children to 3-month age is not present. Fertility Data on influence of a tsefuroksim on reproductive abilities of people are absent. Researches on animals did not open any influence on reproductive function. Pregnancy of Teratogenic and embriotoksichesky action is not observed, but, as well as in a case with other drugs, drug has to be used with care in early months of pregnancy. Use is possible in cases when the expected advantage of therapy for mother exceeds potential risk for a fruit. The lactation period Tsefuroksim gets into breast milk in this connection, use of drug when feeding has to be considered with care. Use in the period of a lactation is possible in cases when the expected advantage of therapy for mother exceeds potential risk for a fruit. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms As at administration of drug of Zinnat® can arise dizziness cases, it is necessary to be careful at control of vehicles and other mechanisms Overdose Symptoms: disturbances from central nervous system (encephalopathy) which are shown by excitement spasms and can lead to development of a coma. Treatment: carry out symptomatic therapy. Зиннат® it is removed at a hemodialysis or peritoneal dialysis. A form of release and packing the Bottles from dark III glass the volume of 100 or 200 ml soldered by a membrane and corked by the screw-on plastic cover with the device against opening by children of a bottle. On 1 bottle together with a volumetric glass, a measured spoon and the instruction for use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not above 30 °C. To store the prepared suspension in the fridge at a temperature from 2 ºС up to 8 ºС no more than 10 days. To store out of children’s reach! A period of storage of 2 g
yes not to apply after an expiration date Prescription status According to the prescription the Producer Glakso Opereyshens Great Britain Limited, Great Britain (Harmire Road, Barnard Castle, Durham, DL12 8DT, United Kingdom) the Packer Glakso Opereyshens Great Britain Limited, Great Britain (Harmire Road, Barnard Castle, Durham, DL12 8DT, United Kingdom) the Name and the country of the owner of the registration certificate Glakso Opereyshens Great Britain Limited Zinnat is the registered trade mark of GlaksoSmitKlyayn Adres group of companies of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of the products (goods) and responsible for post-registration observation of safety of medicine of Predstavitelstvo kompanii GlaksoSmitKlyayn Export Ltd in Kazakhstan 050059, Almaty, Furmanov St., 273
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