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Zinacef 750 mg 1’s powder for injection (vial)




The instruction
for medical use

of Zinatsef® medicine

the Trade name
of Zinatsef®

the International unlicensed

name Tsefuroksim Lekarstvennaya a form
Powder for preparation of solution for injections, 750 mg

One bottle contains
active agent – tsefuroksy sodium of 789 mg, is equivalent to a tsefuroksim of 750 mg.

The description
Powder from white till cream 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 Absorption At properties in oil administration of the drug Cmax of a tsefuroksim is reached in 30-45 minutes after an injection.
makes Communication with proteins of plasma from 33% to 50% (depending on a measurement method).
The concentration of a tsefuroksim exceeding the minimum overwhelming concentration for the majority of microorganisms are present at a bone tissue, synovial and intraocular liquids.
Tsefuroksim gets through a blood-brain barrier at inflammation of meningeal covers.
Tsefuroksim is not metabolized and removed by means of the renal mechanism by glomerular filtration and canalicular secretion.
Elimination half-life of a tsefuroksim after parenteral administration makes about 70 minutes.
At newborn children in the first weeks of life the elimination half-life of a tsefuroksim can be 3-5 times more long, than at adults.
Within 24 hours after parenteral administration tsefuroksy almost completely (85 – 90%) the most part of drug is removed with urine in not changed look, and – within the first 6 hours.
At competitive purpose of a probenetsid the removal of a tsefuroksim slows down that leads to increase in its level in plasma serum.
Serumal levels of a tsefuroksim decrease at dialysis.
The pharmacodynamics
of Zinatsef® belongs to tsefalosporinovy antibiotics of the II generation. Зинацеф® has bactericidal activity concerning a wide range of activators, including the strains producing β-lactamazu.
Зинацеф® ampicillin – and amoksitsillinustoychivy strains is active in the relation.
Bactericidal effect of the drug Zinatsef® is connected with suppression of synthesis of a cell wall of bacteria as a result of linking with the main proteins targets.
The prevalence of the acquired resistance depends on a geographical location and time, and for some types can be very high. It is recommended to address local data on resistance of strains, especially in case of treatment of heavy infections.
Зинацеф® it is active concerning the following microorganisms:

(*) it was shown clinical effektivnostv the course of clinical trials

the Majority of sensitive strains

Gram-positive aerobes:
Streptococcus pyogenes *
Beta-hemolytic streptococci

Gram-negative aerobes:
Haemophilus influenzae including ampicillin – resistant strains *
Haemophilus parainfluenzae *
Moraxella catarrhalis *
Neisseria gonorrhea * including the strains which are producing and not producing
Neisseria meningitidis Shigella spp penicillinase.

Gram-positive anaerobe bacterias:
Peptostreptococcus spp.
Propionibacterium spp.

Borrelia burgdorferi *

Microorganisms with possible resistance

Gram-positive aerobes:
Staphylococcus spp. including S. aureus (only Methicillinum – sensitive isolates) *
Streptococcus pneumoniae *
Viridans group streptococcus

Gram-negative aerobes:

Bordetella pertussis Citrobacter spp. not including
C. freundii Enterobacter spp. not including E. aerogenes and
E. cloacae Escherichia coli *
Klebsiella spp. including K. pneumoniae *

Proteus mirabilis Proteus spp. not including P. penneri and

P. vulgaris Providencia spp. Salmonella spp.

Gram-positive anaerobe bacterias:
Clostridium spp. not including C. difficile

Gram-negative anaerobe bacterias:
Bacteroides spp. not including
B. fragilis Fusobacterium spp.

Resistant microorganisms

Gram-positive aerobes:
Enterococcus spp. including E. faecalis and E.
faecium Listeria monocytogenes

Gram-negative aerobes:
Acinetobacter spp.

Burkholderia cepacia Campylobacter spp.

Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Morganella morganii Proteus penneri Proteus vulgaris Pseudomonas spp. including

P. aeruginosa Serratia spp. Stenotrophomonas maltophilia

Gram-positive anaerobe bacterias:
Clostridium difficile

Gram-negative anaerobe bacterias:

Other Bacteroides fragilis:

Chlamydia species Mycoplasma species Legionella species

Treatment of the infectious diseases caused by bacteria, sensitive to a tsefuroksim, or until definition of the infectious agent. The sensitivity to a tsefuroksim varies depending on a geographical location and time in this connection it is recommended to address whenever possible local data on sensitivity of microorganisms to antibiotics.
– infections of upper and lower airways (including acute and chronic bronchitis, bacterial pneumonia, abscess of lungs, postoperative infectious diseases of bodies of a thorax)
– infections of an ear, a throat, a nose (including sinusitis, tonsillitis, pharyngitis, average otitis)
– infections of urinary tract (including acute and chronic pyelonephritis, cystitis, a symptomless bacteriuria)
– infections of skin and soft tissues (including cellulitis, erysipelatous inflammation and wound fevers)
– infections of bones and joints (including osteomyelitis and septic arthritis)
– infections in gynecology and obstetrics (including inflammatory diseases of bodies of a small pelvis)
– gonorrhea (in particular at impossibility of use of penicillin)
– a septicaemia
– meningitis
– peritonitis
– prevention of infectious complications at abdominal organs surgeries, a small pelvis, at orthopedic operations, heart surgeries, lungs, a gullet and vessels in the presence of the increased risk of developing infections.
In most cases the drug Zinatsef® is used as monotherapy, but also can be applied in combination with aminoglikozidny antibiotics or in a combination with metronidazole, especially to prevention of infections at a large intestine surgeries and in gynecology.
In case of need the drug Zinatsef® can be used before transition to the Zinnat® drug treatment in the form of suspension or tablets at therapy of pneumonia and exacerbation of chronic bronchitis.

The route of administration and doses
Drug is intended for intramuscular or intravenous administration.
The general recommendations
Intramusculary or intravenously 750 mg 3 times a day.
In more hard cases the drug is administered intravenously in a dose of 1.5 g 3 times a day. If necessary the drug Zinatsef® can be administered each 6 hours, and the daily dose can make from 3 to 6 g. In some infections the prescribing of the drug Zinatsef® in a dose of 750 mg or 1.5 g 2 times a day (intramusculary or intravenously) with the subsequent administration of drug of Zinnat® inside is effective.
Children and babies
of 30-100 mg/kg/days for 3-4 receptions. For the majority of infections the optimum dose makes 60 mg/kg/days.
30-100 mg/kg/days in 2-3 receptions.
of 1.5 g once (two doses on 750 mg intramusculary in different injection points, for example, in both gluteuses).
of Drug can be applied as monotherapy to treatment of the bacterial meningitis caused by sensitive strains.
Adults: To 3 g there are intravenously each 8 hours.
Children and babies: 150-250 mg/kg/days intravenously for 3-4 receptions.
Newborns: 100 mg/kg/days intravenously.
Prevention of postoperative complications
At abdominal organs surgeries, a basin and orthopedic interventions, the drug Zinatsef® in a dose of 1.5 g is administered intravenously during introduction anesthesia. In 8 and 16 hours after operation in addition it can be entered intramusculary 750 mg of the drug Zinatsef®. At heart surgeries, lungs, a gullet and vessels during introduction anesthesia the drug Zinatsef® is administered intravenously in a dose of 1.5 g, and then, within 24-48 hours, on 750 mg 3 times a day intramusculary.
At full replacement of a joint 1.5 g of the powder Zinatsef® it is possible to mix with a polymer package methyl – methacrylate cement before addition of liquid monomer.
Step therapy
Duration of parenteral and oral administration of drug is defined by weight of an infection and the clinical status of the patient.
Pneumonia: 1.5 2-3 times a day (intravenously or intramusculary) within 48-72 hours with the subsequent prescribing of the drug Zinnat® for intake in a dose of 500 mg 2 times a day within 7-10 days.
Exacerbation of chronic bronchitis: 750 mg Зинацефа® 2-3 times a day (intravenously or intramusculary) within 48-72 hours with the subsequent prescribing of drug Зиннат® 500 of mg 2 times a day within 5-10 days.
The renal failure
Tsefuroksim is removed by means of renal metabolism.
In a renal failure the dose decline of Zinatsefa® is recommended that is reflected in the table. However, there is no need to reduce a standard dose of drug (750 mg-1.5 of 3 times a day) at patients with clearance of creatinine higher than 20 ml/min.
Dose adjustment of the drug Zinatsef® in a renal failure at adults

Clearance of creatinine

the Dose of Zinatsefa®

& gt, 20

ml/min. 750 mg-1.5 of 3 times in day

of 10-20

ml/min. 750 mg 2 times a day

& lt, 10

ml/min. 750 mg/days

the Patients who are on a hemodialysis at the end of each session of a hemodialysis need to enter an additional dose of the drug Zinatsef®, equal 750 mg. The dose of 750 mg 2 times a day is recommended to the patients who are in intensive care unit on a continuous hemodialysis with use of the arteriovenous shunt or on high-speed haemo filtration. If haemo filtration with a low speed is used, then doses, as are applied in a renal failure.
IInstruktsiya on preparation of solution for injections
For intramuscular introduction
to Add 3 ml of water for injections to the bottle containing 750 mg of the drug Zinatsef®. It is careful to stir up before formation of opaque suspension.
For intravenous administration
to Add 6 ml of water for injections to the bottle containing 750 mg of the drug Zinatsef®.

Side effects
Side reactions happen very seldom and have passing character.
Undesirable reactions differ on frequency according to the following classification: very often ≥1/10, it is frequent ≥1/100 – & lt, 1/10, infrequently ≥1/1000 – & lt, 1/100, is rare ≥1/10000 – & lt, 1/1000, also lt, 1/10000 is very rare.
– a neutropenia, an eosinophilia
– tranzitorny increase in liver enzymes
– reactions in the place of an injection (pain, thrombophlebitis)
Bol after intramuscular introduction arises at introduction of high doses more often, nevertheless it should not serve as the reason for treatment cancellation.
– a leukopenia, decrease in concentration of hemoglobin, the false positive test of Koombs
– skin rash, a small tortoiseshell, an itching
– digestive tract disorder
– tranzitorny increase in level of bilirubin (especially at patients with the previous liver pathology)
Is rare
– the increased growth of mushrooms of the sort Candida
– thrombocytopenia
– fever of a medicinal etiology
Very seldom
– hemolytic anemia
Cephalosporins belong to the class of antibiotics which are adsorbed on a surface of membranes of erythrocytes and interact with the antibodies directed to this medicinal substance that can lead to false positive reaction of Koombs or hemolytic anemia.
– intestinal nephrite
– an anaphylaxis
– a skin vasculitis
– pseudomembranous colitis
– an exudative multiformny erythema, Stephens-Johnson’s syndrome, a toxic epidermal necrolysis
– increase in level of creatinine, urea nitrogen and decrease in clearance of creatinine

of the Contraindication
– hypersensitivity to active component of drug or other tsefalosporinovy antibiotics

Medicinal interactions
As well as other antibiotics, the drug Zinatsef® can influence indestinal flora, leading to decrease in a resorption of estrogen and decrease in efficiency of oral contraceptives.
The drug Zinatsef® does not influence the tests by definition of a glucosuria based on fermental methods.
Insignificant influence on decrease in indicators of methods of Benedict, Fekhlinga and Klinitest was revealed, nevertheless false positive reactions were not observed.
In case of determination of level of glucose in blood with use of a hexokinase or glyukozoksidaza, patients have to report about what they apply tsefuroksy.
Зинацеф® quantitative definition of creatinine by means of an alkalin of picrate does not influence.
The compatibility of solutions
drug Zinatsef® Solution (5 mg/ml) in 5% or 10% solution of a ksilitol can be kept till 24 o’clock at a temperature not higher than 25 wasps. Зинацеф® it is compatible to the aqueous solutions containing up to 1% of lidocaine of a hydrochloride. The drug Zinatsef® is compatible to the most widely applied infusion solutions. When mixing with the following solutions drug is stable till 24 o’clock at the room temperature:
– 0.9% chloride sodium solution,
– 5% dextrose solution for injections,
– 0.18% solution of sodium of chloride and 4% dextrose solution for injections,
– 5% solution of a dextrose and 0.9% chloride sodium solution,
– 5% solution of a dextrose and 0.45% chloride sodium solution,
– 5% solution of a dextrose and 0.225% chloride sodium solution,
– 10% dextrose solution for injections,
– Ringera solution,
– Ringera solution a lactate,
– lactate sodium M/6 solution
– Hartman’s solution.
Stability of the drug Zinatsef® in 0.9% solution of sodium of chloride and in 5% solution of a dextrose is not broken in the presence of a phosphate sodium hydrocortisone.
With the following solutions the drug Zinatsef® is compatible and stable within 24 hours at the room temperature:
– heparin (10 PIECES/ml and 50 PIECES/ml) in 0.9% chloride sodium solution,
– potassium chloride (10 IEC/l and 40 IEC/l) in 0.9% chloride sodium solution.

Special instructions
With care patients should appoint drug with anaphylactic reaction to penicillin and others beta laktamnye antibiotics in the anamnesis. 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, patients with diseases of kidneys and at the patients receiving drug in a high dose increases.
At treatment of meningitis the drug Zinatsef® at some children noted decrease in hearing easy and moderate severity, at the same time in cerebrospinal liquid the positive cultures of Haemophilus influenzae in 18-36 hours of therapy were defined. The similar phenomena were noted also at use of other antibiotics, but their clinical value is unknown.
As well as in case of use of other antibiotics, at use of a tsefuroksim the possible excess growth of mushrooms of the sort Candida. Long use of drug can lead to growth of insensitive strains (Enterococci, Clostridium difficile) that can demand the treatment termination.
Pseudomembranous colitis is observed when using a wide range of antibiotics which severity can vary from easy to life-threatening. Therefore, it is very important to mean a possibility of its emergence at patients with the heavy diarrhea which arose in time or after a course of treatment antibiotics. If at the patient the long or considerable diarrhea is observed, spasms in a stomach, treatment has to be cancelled immediately and the patient has to be directed to further inspection.
At step therapy time of transition to oral therapy is defined by weight of an infection, a clinical condition of the patient and sensitivity of the activator. If upon transition to an oral form there does not occur improvement of a state after 72 hours of use, it is necessary to transfer the patient to a parenteral way of introduction of an antibiotic again.
Upon transition to other forms of a tsefuroksim attentively study the instruction for use of drug.
Pregnancy and the period of a lactation
of Embriotoksichesky and teratogenic influence of drug on a fruit is not observed, but, as well as with other drugs, the drug Zinatsef® should be used with care in the first trimester of pregnancy.
Tsefuroksim is allocated with breast milk therefore nursing mothers should show care when prescribing drug.

There Is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms messages.

Symptoms: increase in excitability of a cerebral cortex with development of spasms.
Treatment: symptomatic, hemodialysis, peritoneal dialysis.

The form of release and packing
On 750 mg of drug place in the glass bottles like I or III which are hermetically corked by the traffic jams brombutilovy or butyl laminated by fluoroelastomer, pressed out by caps aluminum with detachable plastic covers.
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions in the place protected from light at a temperature not above 25 °C.
After preparation of solution for injections – 5 hours at a temperature not above 25 °C or 48 hours at a temperature not above 4 °C (in the fridge).
To store out of children’s reach!

Period of storage
2 years.
Not to use after an expiration date.

Prescription status
According to the prescription

the Producer GlaksoSmitKlyayn Manyufacturing S. of the item. And., Italy
Via A. Fleming, 2-37135, Verona

Packer S. GlaksoSmitKlyayn Manyufacturing of the item. And., Italy
Via A. Fleming, 2-37135, Verona

Owner of the registration certificate
S. GlaksoSmitKlyayn of the item. And., Italy
Strada Provinciale Asolana, 90 – 43056, Polo Di Torrile

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 7019908566, +7 727 258 28 92, +7 727 259 09 96
Fax number: + 7 727 258 28 90
E-mail address:

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