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Zinnat 10s 500 mg coated tablets

$41.00

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Description

The instruction for medical use

of Zinnat® medicine

the Trade name
of Zinnat®

the International unlicensed

name Tsefuroksim Lekarstvennaya
the Tablet form, coated, 500 mg

Structure
One tablet contains
active agent – the tsefuroksima aksetit 601.44 mg (corresponds to a tsefuroksim) (500.00),
excipients: microcrystalline cellulose, sodium of a kroskarmelloz, type A, sodium lauryl sulfate, the vegetable oil hydrogenated silicon dioxide colloidal anhydrous,
structure of a cover: gipromelloza, propylene glycol, methylparahydroxybenzoate (E218), propilparagidroksibenzoat (E216), Opaspry white M-1-7120J,
Opasprey’s list white: a gipromelloza 5sr or 6sr, the titan dioxide (E171),
Natrium benzoicum, alcohol denatured (74 SHOUTING), the water purified.

The description
of the Tablet of a capsulovidny form, coated, white or whitish color, with a biconvex surface, with the marking GX EG2 on the one hand and smooth – with another.

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 reception of tablets after a meal.
After reception of a tsefuroksim together with food its maximum concentration (2.9 mg/l for 125 mg, 4.4 mg/l for 250 mg, 7.7 mg/l for 500 mg and 13.6 mg/l for 1 g) in blood plasma is defined in 2.4 hours.
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
Aerobic gram-positive bacteria:
Streptococcus pyogenes *
Beta-hemolytic streptococci

Aerobic gram-negative bacteria:
Haemophilus influenzae * (including ampicillin – resistant strains)
Haemophilus parainfluenzae *
Moraxella catarrhalis *
Neisseria gonorrhea * (including the strains which are producing and not producing penicillinase)
Anaerobic gram-positive bacteria:
Peptostreptococcus spp.
Propionibacterium spp.

Borrelia burgdorferi spirochetes *
Organisms with a possible rezistentost to a tsefuroksim
Aerobic gram-positive bacteria:
Staphylococcus spp., including S. aureus (only Methicillinum – sensitive isolates) *
Streptococcus pneumoniae *
Aerobic gram-negative bacteria:
Citrobacter spp., not including
C. freundii Enterobacter spp., not including E. aerogenes and
E. cloacae Escherichia coli *
Klebsiella spp., including Klebsiella pneumoniae *

Proteus mirabilis Proteus spp., not including P. penneri and
P. vulgaris Providencia spp.
Anaerobic gram-positive bacteria:
Clostridium spp., not including C. Difficile
Anaerobic gram-negative bacteria:
Bacteroides spp., not including
B. fragilis Fusobacterium spp.

Enterococcus spp., including E. faecalis and

E. faecium Listeria monocytogenes Acinetobacter spp. Burkholderia cepacia Campylobacter spp. Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Morganella morganii Proteus penneri Proteus vulgaris Pseudomonas spp., including
Pseudomonas aeruginosa Serratia spp are resistant to a tsefuroksim.

Stenotrophomonas maltophilia Clostridium difficile Chlamydia species Mycoplasma species Legionella species Bacteroides fragilis
* Clinical performance was not confirmed in clinical trials

Indications
Treatment of the infectious and inflammatory diseases caused by microorganisms, sensitive to drug:
– an upper respiratory tract infection, ENT organs (including acute
average otitis, sinusitis, tonsillitis and pharyngitis)
– lower respiratory tract infections, for example, pneumonia, an acute bronchitis, exacerbation of chronic bronchitis
– an infection of an urinogenital system (including pyelonephritis, cystitis,
an urethritis)
– gonorrhea, an acute uncomplicated gonococcal urethritis, a cervicitis
– infections of skin and soft tissues, for example, a furunculosis, a pyoderma,
impetigo
– Lyme’s disease at an early stage and the subsequent prevention of late
stages of this disease at adults and children is more senior than 12 years
the Sensitivity of strains can vary depending on a geographical location and time. Use whenever possible local data on sensitivity of microorganisms.

The route of administration and doses
averages Duration of use of drug 7 days (from 5 to 10 days). For optimum absorption the drug should be taken after a meal.
Adult

Heavy lower respiratory tract infections or at suspicion of pneumonia

on 500 mg 2 times a day

Lyme’s Disease at adults and children are more senior than 12 years

on 500 mg 2 times a day within 20 days
Step therapy
Duration of therapy depends on disease severity and a clinical condition of the patient.
Pneumonia
of Zinatsef® in a dose of 1.5 g 2-3 times a day (in/in or in oil) within 48-72 hours, and then – Zinnat® in a dose of 500 mg 2 times a day within 7-10 days.
Exacerbation of chronic bronchitis
of Zinatsef® in a dose of 750 mg 2-3 times a day (in/in or in oil) within 48-72 hours, and then – Zinnat® in a dose of 500 mg 2 times a day within 5-10 days.
Children
of the Tablet Zinnat® it is impossible to break therefore children up to 18 years are recommended to use drug in the form of suspension or tablets of 125 mg or 250 mg (the exception – treatment of a disease of Lyme at children is more senior than 12 years).
The renal failure
Tsefuroksim is removed mainly by kidneys. At patients with a renal failure the dose decline for excretion correction 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

Standard individual dose

during the procedure of a hemodialysis

2 – 4

Additional single individual at the end of the procedure of dialysis

Side effects
Side reactions on tsefuroksy are usually passing each 48 hours and have an easy course.
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)

of the Contraindication
– hypersensitivity to antibiotics of group of cephalosporins,
penicillin and Carbapenums or to any component of drug
– children’s and teenage age up to 18 years (the exception – treatment of a disease of Lyme at children is more senior than 12 years)
With care:
– the first trimester of pregnancy

Medicinal interactions
Drugs which reduce acidity of gastric juice can reduce 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 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 with hypersensitivity to antibiotics of a petsitsillinovy row and other beta lactamelements in the anamnesis.
As well as in a case with other antibiotics, at long-term treatment prerparaty the strengthened growth of steady microorganisms (Candida, Enterococci, Clostridium difficile) is possible that it can demand the treatment termination.
At 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.
At the Zinnat® drug treatment of a disease of Lyme Yarisha-Gersgeymer’s reaction is sometimes noted. 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. At step therapy time of switching to oral therapy is defined by weight of an infection, a clinical condition of patients and sensitivity of the activator. In the absence of clinical improvement for 72 h the parenteral therapy should be continued. Study the instruction for use of the drug Zinatsef in case of its appointment.
Pregnancy and the period of a lactation
Use in II and III trimesters of pregnancy, and also in the period of a lactation perhaps in cases when the expected advantage of therapy for mother exceeds potential risk for a fruit.
The lactation
Tsefuroksim gets into breast milk in this connection use of drug when feeding has to be considered with care.
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: disturbance from central nervous system which are shown by excitement, spasms.
Treatment: carry out symptomatic therapy. Зиннат® it is removed at a hemodialysis or peritoneal dialysis.

Form of release and packing
of the Tablet, coated, 500 mg.
On 10 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1 blister strip packaging together with the instruction for medical 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 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/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 Ltd. Glakso Vellk Opereyshens, Great Britain
(Glaxo Wellcome House, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom)

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of Predstavitelstvo GlaksoSmitKlyayn Export Ltd in
Kazakhstan 050059, Almaty, Furmanov St., 273
Phone number: +7 701 9908566, +7 727 258 28 92, +7 727 259 09 96
Fax number: + 7 727 258 28 90
E-mail address:

To Develop kaz.med@gsk.com

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