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Zinnat 125 mg / 5 ml 50 ml granules for oral suspension

$26.20

2db90ef0f58e

Description

The instruction
for medical use

of Zinnat® medicine

the Trade name
of Zinnat®

the International unlicensed

name Tsefuroksim Lekarstvennaya
the Granule form for preparation of suspension for intake, 125mg/5ml

Structure
of 5 ml of suspension contain
active agent – the tsefuroksima aksetit 150.0 mg (corresponds
to a tsefuroksim of 125 mg),
excipients: stearic acid, sucrose, Tutti Frutti fragrance 51.880/AP 05:51, potassium to atsesulfa, aspartame, K30 povidone, pitch ksantamovy.

The description
of the Granule in the form of grains of irregular shape, various size, but no more than 3 mm, 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
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 together with food.
Adults

the Majority of infections

on 250 mg twice a day

of the Infection of an urinogenital path

on 125 mg 2 times a day

Pyelonephritis

on 250 mg 2 times in day

of the Lower respiratory tract infection easy and moderate severity, for example, bronchitis

on 250 mg 2 times a day

Heavy lower respiratory tract infections or suspicion of pneumonia

on 500 mg 2 times a day

Uncomplicated gonorrhea

a single dose of 1 g

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.
Use in pediatrics
in case of preferable use of the fixed dose, the average dose for the majority of infections makes 125 mg 2 times a day.
At babies and children up to 12 years in acute average otitis or in the presence of other heavy infections it is recommended to appoint drug in a dose of 250 mg twice a day, with the maximum daily dose in 500 mg.
Clinical trials on use of drug for children are younger than 3 months are absent.
At babies and children from 3 months to 12 years 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.
Average otitis and serious infectious diseases at children
of 15 mg/kg of body weight 2 times a day, but no more than 500 mg a day.
The following 2 tables are divided according to age and weight when using a measured spoon (5 ml) for 125 mg / 5 ml or 250 mg / 5 in suspension ml.
Dose from rascheta10 mg/kg, appointed in the majority of infections:

The age

the Approximate weight (kg)

2 times in day (mg)

the Measured spoon (5 ml)

of 125 mg 250 mg

from 3 to 6 months

4 – 6 40 – 60

from 6 months to 2 years

6 – 12 60 –

120 – 1

from 2 to 12 years

from 12 to & gt,

20 125 1

Dose at the rate of 15 mg/kg, is appointed in average otitis and heavy infections:

The age

the Approximate weight (kg)

is 2 times in day (mg)

the Measured spoon (5 ml)
of 125 mg 250 mg

from 3 to 6 months

4 – 6 60 – 90

from 6 months to 2 years

6 – 12 90 – 180 1 – 1

from 2 to 12 years

from 12 to & gt,

20 180 – 250 1 – 2 – 1
The dosing syringe can be used to dosing accuracy at very small children, however, the measured spoon is the most optimum method of drug dosing at the children capable to accept suspension from a spoon.
The renal failure
Tsefuroksim is removed 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

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.
Gain in a volumetric glass 20 ml of water to a tag.
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 2º C to 8º C)
At administration of drug it is possible to 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.

Side effects
Side reactions on tsefuroksy it is usually passing 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 age up to 3 months
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 antibiotiky.
As well as in a case with other antibiotics, at long-term treatment by drug the strengthened growth of insensitive 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.
Patients with diabetes should consider presence of sucrose as a part of suspension.
When prescribing the drug Zinnat® the 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.
Pregnancy and the period of a lactation
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.
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: symptomatic. Зиннат® it is removed at a hemodialysis or peritoneal dialysis.

A form of release and packing
In the bottles from dark glass with a capacity of 100 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 of 0C up to 8 0C no more than 10 days.
To store out of children’s reach!

2 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).
Owner of the registration certificate
Glakso Opereyshens Great Britain Ltd. Glakso Vellk Opereyshens, Great Britain
(Harmire Road, Barnard Castle, Durham, DL12 8DT, 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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