Active substanceCefepimCefepim
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  • Dosage form: & nbsp
    Powder for the preparation of solution for intravenous and intramuscular injection.
    Composition:
    COMPOSITION*

    Active substance: 500 mg or 1000 mg of cefepime in the form of cefepime hydrochloride monohydrate 594.5 mg or 1189.1 mg.

    Excipients: L-arginine 362.5 mg or 725.0 mg.

    * - Packaging is done taking into account a 5% rebate, which is necessary to ensure full recovery of the claimed dosage. In this case, the recoverable amount of cefepime from one vial is 500 and 1000 mg, respectively.
    Description:Powder from white to white with a yellowish tinge.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.E.01   Cefepim

    Pharmacodynamics:Cefepim is a wide-spectrum cephalosporin antibiotic. Cefepim suppresses the synthesis of proteins of the cell wall of bacteria, has a broad spectrum of bactericidal action against various Gram-positive and Gram-negative bacteria,including most strains resistant to aminoglycosides or cephalosporin antibiotics of the third generation, such as ceftazidime. Cefepim highly resistant to hydrolysis by most beta-lactamases, it has a low affinity for beta- lactamases and rapidly penetrates into cells of gram-negative bacteria. It is proved that cefepime has a very high affinity for penicillin-binding protein (PSB) type 3, a high affinity for PSB type 2 and moderate affinity for PSA types 1a and 16. Cefepim has bactericidal action against a wide range of bacteria. MAXIPIM® is active against the following microorganisms:

    Gram-positive aerobes:

    Staphylococcus aureus (including strains producing beta-lactamase); Staphylococcus epidermidis (including strains producing beta-lactamase); other strains Staphylococcus spp., including Staphylococcus hominis, Staphylococcus saprophyticus; Streptococcus pyogenes (group streptococci A); Streptococcus agalactiae (Streptococcus group B);

    Streptococcus pneumoniae (including strains with medium resistance to penicillin - a minimum inhibitory concentration of 0.1 to 1 μg / ml); other beta-hemolytic Streptococcus spp. (groups C, G, F), Streptococcus bovis (Group D), Streptococcus spp. groups Viridans.

    NOTE: Most strains of enterococci, for example, Enterococcus faecalis, and staphylococci resistant to methicillin, are resistant to the action of most cephalosporin antibiotics, including cefepime.

    Gram-negative aerobes:

    Acinetobacter calcoaceticus (sub-stems anitratus, Iwofif); Aeromonas hydrophila; Capnocytophaga spp.;

    Citrobacter spp., including Citrobacter diversus, Citrobacterfreundii, Campylobacter jejuni;

    Enterobacter spp., including Enterobacter cloacae, Enterobacter aerogenes, Enterobacter

    sakazakii;

    Escherichia coli;

    Gardnerella vaginalis;

    Haemophilus ducreyi;

    Haemophilus influenzae (including strains producing beta-lactamase); Haemophilus parainfluenzas, Hafnia alvei;

    Klebsiella spp. including Klebsiella pneumoniae, Klebsiella oxytoca, Klebsiella ozaenae; Legionella spp.; Morganella morganii;

    Moraxella catarrhalis (Branhamella catarrhalis) (including strains producing beta-lactamases);

    Neisseria gonorrhoeae (including strains producing beta-lactamase); Neisseria meningitidis;

    Pantoea agglomerans (before famous as Enterobacter agglomerans); Proteus spp. including Proteus mirabilis, Proteus vulgaris; Providencia spp. including Providencia rettgeri, Providencia stuartii;

    Pseudomonas spp. including Pseudomonas aeruginosa, Pseudomonas putida, Pseudomonas stutzer;

    Salmonella spp .;

    Serratia including Serratia marcescens, Serratia liquefaciens; Shigella spp .; Yersinia enterocolitica;


    NOTE: Cefepim inactive at respect of many strains Stenotrophomonas maltophilia, before known as Xanthomonas maltophilia and Pseudomonas maltophilia).

    Anaerobes:

    Bacteroides spp .; Clostridium perfringens; Fusobacterium spp .; Mobiluncus spp .; Peptostreptococcus spp .;

    Prevotella melaninogenica (famous as Bacteroides melaninogenicus); Veillonella spp.


    NOTE: Cefepim inactive at respect Bacteroides fragilis and Clostridium difficile.

    Pharmacokinetics:
    Mean concentrations of cefepime in the blood plasma of adult healthy men at different times after a single intravenous administration for 30 minutes to 12 hours and a maximum concentration (Cmax) are shown in the table below.

    Mean concentrations of cefepime in plasma (μg / ml) after intravenous administration

    The dose of cefepime

    0.5 h

    1h

    2h

    4h

    8h

    12 h

    FROMm(μg / ml)

    500 mg IV

    38,2

    21,6

    11,6

    5,0

    1,4

    0,2

    39,1±3,5

    1 g of IV

    78,7

    44,5

    24,3

    10,5

    2,4

    0,6

    81,7+5,1

    2 g IV

    163,1

    85,8

    44,8

    19,2

    3,9

    1,1

    163,9+25,3


    After intramuscular injection cefepime absorbed completely.
    Cmax and the time to reach the maximum concentration (Tmax) after a single intramuscular injection are shown in the table below.
    Mean concentrations of cefepime in plasma (μg / ml) after intramuscular injection

    The dose of cefepime

    0.5 h

    1 h

    2h

    4h

    8h

    12 h

    FROMm(μg / ml)

    TmOh

    (h)

    500 mg IM

    8,2

    12,5

    12,0

    6,9

    1,9

    0,7

    13,9+3,4

    1,4±0,9

    1 g IM

    14,8

    25,9

    26,3

    16,0

    4,5

    1,4

    29,6±4,4

    1,6+0,4

    2 g IM

    36,1

    49,9

    51,3

    31,5

    8,7

    2,3

    57,5±9,5

    1,5+0,4


    Therapeutic concentrations of cefepime are found in the following fluids and tissues: urine, bile, peritoneal, bullous fluid, bronchial mucosa, sputum, prostate, appendix and gallbladder. The binding of cefepime to serum proteins is on average 16.4% and does not depend on the concentration of the drug in the blood serum.
    Cefepime is metabolized to N-methylpyrrolidine, which rapidly converts to N-methylpyrrolidine oxide.
    Cefepime is excreted mainly by the kidneys, by glomerular filtration (renal clearance is on average 110 ml / min). In urine, about 85% of
    of the administered dose of unaltered cefepime, less than 1% N-methylpyrrolidine, about 6.8% N-methylpyrrolidine oxide, and about 2.5% cefepime epimer.
    After dosing from 250 mg to 2 g, the half-life of cefepime from the body is about 2 hours on average. The total clearance is an average of 120 ml / min. When intravenously administered to healthy volunteers at a dose of 2 g every 8 hours for 9 days, cumulation of the drug was not observed.
    Patients with impaired renal function
    Half-life from the body with renal failure increases, while there is a linear relationship between total clearance and clearance of creatinine. In case of severe violations of the kidney function requiring dialysis sessions, the half-life period averages 13 hours for hemodialysis and 19 hours for continuous peritoneal dialysis. In case of impaired renal function, a dose adjustment is required.
    Patients with hepatic impairment
    The pharmacokinetics of cefepime in patients with impaired liver function does not change. Dose adjustments for these patients are not required. Patients over 65 years of age
    After a single intravenous injection of 1 g of the drug to healthy volunteers over the age of 65, there was an increase in the area under the concentration-time curve (AUC) and a decrease in renal clearance in comparison with young volunteers.With impaired renal function, older patients require a dose adjustment.
    Children
    Pharmacokinetics of the drug was studied in children aged 2 months to 11 years after a single dose of 50 mg / kg body weight intravenously or intramuscularly, and after repeated administration (every 8-12 hours, for at least 48 hours). After a single intravenous injection, the total clearance and volume of distribution were 3.3 ml / min / kg and 0.3 l / kg, respectively. The half-life from the body averaged 1.7 hours. The excretion of cefepime unchanged by the kidneys was 60.4% of the administered dose, and the renal clearance was an average of 2.0 ml / min / kg. After multiple intravenous administration, the concentration of cefepime in the blood plasma in the equilibrium state, as well as other pharmacokinetic parameters, did not differ from those after a single administration. Age and sex of patients did not significantly affect the overall clearance and volume of distribution, taking into account the correction for body weight.
    After intramuscular administration, the maximum concentration of cefepime in plasma in the equilibrium state averaged 68 μg / ml and was attained on average 0.75 hours.8 hours after intramuscular administration cefepime concentrations in the blood plasma averaged 6 μg / ml. Absolute bioavailability of cefepime after intramuscular injection averaged 82%.

    Concentrations of the drug in cerebrospinal fluid (CSF) and in blood plasma in children with bacterial meningitis

    Time watch)

    Concentration

    Concentration

    Attitude

    after

    in plasma

    in the CSF

    concentrations in the CSF

    introduction of

    (μg / ml) **

    (μg / ml) **

    / blood plasma **

    0,5

    67,1 ±51,2

    5,7 ±0,14

    0,12 ±0,14

    1

    44,1 ±7,8

    4,3 ± 1,5

    0,10 ±0,04

    2

    23,9 ±12,9

    3,6 ±2,0

    0,17 ±0,09

    4

    11,7 ±15,7

    4,2 ±1,1

    0,87 ±0,56

    8

    4,9 ±5,9

    3,3 ±2,8

    1,02 ±0,64


    ** patient age: 3.1 months - 12 years, average age: 3 years. The dose of the drug is 50 mg / kg of body weight with intravenous administration for 5 to 20 minutes every 8 hours. Concentrations in plasma and CSF were determined at the end of the administration on the 2nd or 3rd day of treatment with the drug.
    Indications:
    Infectious-inflammatory diseases caused by microorganisms sensitive to cefepime, in adults:

    - Lower respiratory tract infections, including pneumonia and bronchitis

    - Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated

    - Infections of the skin and soft tissues

    - Abdominal infections, including peritonitis and biliary tract infections

    - Gynecological infections

    - Septicemia

    - Febrile neutropenia

    Prevention of possible infections in the conduct of cavitary surgery.

    Infectious and inflammatory diseases caused by microorganisms sensitive to cefepime, in children:

    - Pneumonia

    - Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated

    - Infections of the skin and soft tissues

    - Septicemia

    - Febrile neutropenia

    - Bacterial meningitis
    Contraindications:
    - Hypersensitivity to any component of the drug, as well as cephalosporin, penicillin and other beta-lactam antibiotics

    - Children up to 2 months
    Carefully:Diseases of the gastrointestinal tract in history (especially colitis), renal failure (creatinine clearance less than 50 ml / min).
    Pregnancy and lactation:Adequate and controlled clinical studies in pregnant women have not been conducted. In pregnancy, the drug should be used only if the intended benefit to the mother exceeds the potential risk to the fetus. Cefepim is found in breast milk in very low concentrations. During the period of breastfeeding, the drug should be used only if the intended benefit to the mother exceeds the potential risk to the child.
    Dosing and Administration:

    Intravenously (intravenously) or intramuscularly (in / m). The dose and route of administration depend on the sensitivity of the pathogens, the severity of the infection, the state of kidney function and the general condition of the patient.

    Intravenous administration It is recommended for patients with severe or life-threatening infections, especially when there is a risk of septic shock.

    Preparation solution for intravenous administration

    The drug is dissolved in 5 or 10 ml of sterile water for injection, 5% solution of dextrose and 0.9% solution of sodium chloride for injection, as indicated in the table below, and injected within 3-5 minutes either directly into the vein or into the system for intravenous administration, through which a compatible solution for intravenous administration enters the patient's body.

    Preparation of a solution for intravenous infusion

    PThe prepared solution (see above) is transferred to an infusion vessel with other compatible solutions for

    intravenous infusions (see below) and administered for at least 30 minutes.

    Scope

    Approx.

    Near

    solution

    are

    the

    for

    th

    concentrate

    dilution

    amount

    action

    I

    received

    cefepime

    (ml)

    of the

    (mg / ml)

    solution

    (ml)

    Intravenously

    no

    introduction:

    500

    5

    5,7

    90

    mg / bottle

    1 g / bottle

    10

    11,4

    90

    Drug solutions with a concentration of 1-40 mg / ml are compatible with the following parenteral solutions: 0.9% solution of sodium chloride for injection; 5% or 10% dextrose solution for injection; 1/6 M sodium lactate for injection, 5% dextrose solution and 0.9% sodium chloride for injection; Ringer's lactate solution.

    Intramuscular administration: dose up to 1 g (volume <3.1 ml) can be administered as a single injection. The maximum dose (2 g / 6.2 mL) should be given as two injections at different locations.

    Preparation of a solution for intramuscular injection

    The drug is dissolved in sterile water for injection, 5% dextrose solution or 0.9% solution of sodium chloride for injection, bacteriostatic water for injection with parabens or benzyl alcohol, 0.5% or 1% lidocaine solution, as indicated in the table below.

    Scope

    Near

    Near

    solution

    the

    the

    for

    amount

    concentrate

    dilution

    received

    action

    I (ml)

    th

    cefepime

    solution

    (mg / ml)

    (ml)

    Inside

    muscular

    introduction:

    500

    1,5

    2,2

    230

    mg / bottle

    1 g / bottle

    3.0

    4,4

    230

    Storage of solutions for intravenous and intramuscular administration:

    The prepared solutions of the preparation for intramuscular and intravenous administration are stable for 24 hours at room temperature or 7 days when stored in a refrigerator (2-8 ° C).Like all solutions for parenteral use, before administration The prepared solutions of the preparation should be checked for the absence of visible mechanical inclusions. Otherwise, it is forbidden to use the prepared solution. When stored, the powder and the prepared solution may darken, which does not affect the activity and quality of the preparation.

    Dosing regimens of cefepime depending on the disease, body weight and age of the patient

    The dose for children should not exceed the maximum recommended dose for adults (2 g IV, every 8 hours). The experience of intramuscular administration of the drug to children is limited.

    Adults and children weighing more than 40 kg with normal kidney function

    Urinary infections

    500 mg -

    every 12

    paths, light and

    1 g

    hours

    medium gravity:

    in / in or in / m

    Other infections,

    1 g IV or

    every 12

    light and medium

    w / m

    hours

    severity:

    Severe infections:

    2 g IV

    every 12 hours

    Very heavy and

    2 g IV

    every 8

    life-threatening

    hours

    infection:

    The usual duration of treatment is 7-10 days; severe infections may require longer treatment. In the case of treatment of febrile neutropenia, the usual duration of treatment is 7 days or untildisappearance of neutropenia.

    Prevention of infections with surgical operations

    60 minutes prior to the beginning of the surgical operation, 2 g of the drug are administered intravenously in the form of infusion, for 30 minutes. Immediately after the end of the infusion, the patient is administered 500 mg of metronidazole intravenously. A solution of metronidazole is prepared according to the instructions for its use. Due to the pharmaceutical

    the incompatibility of metronidazole and cefepime should not be confused in a single vessel. Infusion system before the introduction of metronidazole should be washed. During prolonged (more than 12 hours) surgical operations 12 hours after the first dose, repeated administration of cefepime in the same dose is recommended with the subsequent administration of metronidazole.

    Children from 2 months with a body weight of up to 40 kg

    For urinary tract infections, skin and soft tissue infections, pneumonia, the recommended dose is 50 mg / kg every 12 hours for 10 days. In case of severe infections - every 8 hours.

    Patients with febrile neutropenia, septicemia, bacterial meningitis should be administered 50 mg / kg every 8 hours for 7-10 days.

    Patients with impaired renal function

    Patients with impaired renal function require adjustment of the dosage of cefepime to compensate for the reduced rate of excretion in the urine. The dosage regimen depends on the degree of impaired renal function, the severity of infection and the sensitivity of microorganisms. With weak or moderate disturbances of kidney function, the initial dose of the drug is the same as with normal kidney function.

    Recommended maintenance doses of cefepime depending on the creatinine clearance are presented in the table below. The creatinine clearance for men is calculated from the serum creatinine concentration using the following formula:

    Body weight (kg) х (140 - age)

    Creatinine clearance = ----------------------------------------------- ------

    (ml / min) 72 x serum creatinine (mg / dL)

    The creatinine clearance for women is calculated by the same formula using the factor 0.85.

    Clearance

    creatinine (ml / min)

    Recommended maintenance doses

    (Usual dose, dose adjustment is not required)

    2 grams each

    2 grams each

    1 g each

    500 mg each

    >50

    e

    e

    e

    e

    8h

    12 h

    12 h

    12 h

    30-50

    2 grams

    2 grams

    1 g

    500 mg

    every

    every

    every

    every

    e

    e

    e

    e

    12 h

    24 h

    24 h

    24 h

    11-29

    2 grams

    1 g

    500 mg

    500 mg

    every

    every

    every

    every

    e

    e

    e

    e

    24 h

    24 h

    24 h

    24 h

    <10

    1 g

    500 mg

    250 mg

    250 mg

    every

    every

    every

    every

    e 24

    e

    e

    e

    h

    24 h

    24 h

    24 h

    Patients

    on

    hemodialysis

    s *

    500 mg

    500 mg

    500 mg

    500 mg

    every

    every

    every

    every

    e

    e

    e

    e

    24 h

    24 h

    24 h

    24 h

    * For patients on hemodialysis, a dose reduction

    of the drug: 1 g on the first day of treatment and then 500 mg per day for all infections, with the exception of febrile neutropenia, where the dose is 1 g per day. In the days of dialysis, the drug should be administered after the end of dialysis. If possible, the drug should be administered at the same time every day.

    With hemodialysis within 3 hours, approximately 68% of the administered dose is removed from the body.

    With continuous ambulatory peritoneal dialysis drug can be used in the initial recommended doses of 500 mg, 1 g or 2 g, depending on the severity of the infection, with intervals between administrations - 48 hours.

    Children with impaired renal function

    Children with impaired renal function are recommended to reduce the dose or increase the interval between administrations, as indicated in the table above. Creatinine clearance is calculated by the following formulas:

    0.55 x height (cm)

    Creatinine clearance = ----------------------------------------------- --------------

    (ml / min / 1.732) serum creatinine (mg / dl)

    or

    0.52 x height (cm)

    Creatinine clearance = ----------------------------------------------- - - 3.6

    (ml / min / 1.732) serum creatinine (mg / dl)

    Patsieita with a violation of liver function

    Dose adjustments for patients with impaired liver function are not required.

    Side effects:

    The most common side effects are from the gastrointestinal tract and allergic reactions. The following are side effects of organs and systems according to their frequency: very frequent (>10%); frequent (>1% and <10%); infrequent (>0.1% and <1%); rare (>0.01% and <0.1%); the frequency is unknown (there is no data on the incidence of this side effect).

    Infections: infrequently - candidiasis of the oral mucosa, vaginal infections; rarely - candidiasis

    Allergic reactions: often - rashes on the skin; infrequently - erythema, urticaria, itching; rarely anaphylactic reactions; frequency unknown - anaphylactic shock, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome

    From the central nervous system: infrequently - a headache; rarely - convulsions, paresthesia, dysgesia, dizziness; frequency unknown - confusion, short-term loss of consciousness, hallucinations, coma, stupor, encephalopathy, myoclonic cramps

    From the side of the vessels: rarely - vasodilation; frequency unknown - bleeding

    On the part of the respiratory system: rarely shortness of breath

    From the gastrointestinal tract: often - diarrhea, infrequently - nausea, vomiting, colitis (including pseudomembranous colitis); rarely - abdominal pain, constipation; frequency is unknown - digestive disorders.

    From the urinary system: frequency unknown - renal failure, toxic nephropathy

    General reactions and reactions at the site of administration: often - phlebitis at the injection site, pain at the injection site, infrequently - fever and inflammation at the injection site; rarely - chills Other: rarely - genital itching, change in taste, vaginitis, erythema, false positive Coombs test without hemolysis.

    Changes in laboratory indicators: often - increasing the activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, anemia, eosinophilia, prolonged prothrombin time or the partial thromboplastin time and infrequently -increasing blood urea nitrogen, serum creatinine, thrombocytopenia, leukopenia and neutropenia; frequency unknown - aplastic anemia, hemolytic anemia, agranulocytosis.

    Overdose:Symptoms: encephalopathy (confusion, hallucinations, stupor, coma), myoclonic seizures, increased neuromuscular excitability. In cases of significant excess of recommended doses, especially in patients with impaired renal function, hemodialysis is indicated.
    Interaction:
    The solution preparation of pharmaceutically incompatible with solutions of metronidazole, vancomycin, gentamicin, tobramycin sulfate, netilmicin sulfate, so they can not be mixed. However, with the simultaneous administration of cefepime and these antibiotics, each of them can be administered separately.

    Data on the compatibility of solutions of cefepime and other medications, as well as their stability, are given in the table below.

    The end of cefepime

    Name / concentration of another drug in the mixture

    Infusion solution

    Stability period

    With room. temperature, light

    Fridge

    40 mg / ml

    Amicacin 6 mg / ml

    0,9% sodium chloride or 5% dextrose

    24 h

    7 days

    40 mg / ml

    Ampicillin 1 mg / ml

    5% dextrose

    8h

    8h

    40 mg / ml

    Ampicillin 10 mg / ml

    5% dextrose

    2h

    8h

    40 mg / ml

    Ampicillin 1 mg / ml

    0.9% sodium chloride

    24 h

    48 h

    40 mg / ml

    Ampicillin 10 mg / ml

    0.9% sodium chloride

    8h

    48 h

    4 mg / ml

    Ampicillin 40 mg / ml

    0.9% sodium chloride

    8h

    8h

    4-40 mg / ml

    Clindamycin 0.25-6 mg / ml

    0,9% sodium chloride or 5% dextrose

    24 h

    7 days

    4 mg / ml

    Heparin 10-50 units / ml

    0,9% sodium chloride or 5% dextrose

    24 h

    7 days

    4 mg / ml

    Potassium chloride 10-40 meq / l

    0,9% sodium chloride or 5% dextrose

    24 h

    7 days

    4 mg / ml

    Theophylline 0.8 mg / ml

    5% dextrose

    24 h

    7 days

    Special instructions:
    In the presence of factors that can cause a violation of kidney function, correction of the dose of cefepime is required in order to compensate for the reduced rate of excretion of the drug with urine. The dosage regimen depends on the degree of renal failure, the severity of infection and the sensitivity of microorganisms. With weak or moderate disturbances of kidney function, the initial dose of the drug is the same as with normal kidney function. The risk of developing toxic reactions is especially increased in elderly patients with impaired renal function.
    As with other representatives of this class, cases of encephalopathy (usually reversible) in patients with cefepime (confusion, hallucinations, stupor, coma, stupor), myoclonus convulsions (including an unimportant epileptic status) and / or renal failure.Most cases were observed in patients with impaired renal function, who were given doses higher than those recommended. Usually, the symptoms of neurotoxicity disappeared after the interruption of treatment and / or after hemodialysis, but sometimes they ended in a fatal outcome. In patients with impaired renal function or in the presence of other factors that may lead to a delay in the excretion of cefepime, its dose should be adjusted.
    Before the beginning of treatment, it should be established that the patient has an anamnesis of allergic reactions to cefepime, other cephalosporin antibiotics, penicillins and other beta-lactam antibiotics, as well as other forms of allergy. When developing an allergic reaction, discontinue drug treatment and take appropriate measures. With the development of a severe allergic reaction (for example, anaphylactic reaction), epinephrine and other maintenance therapy may be required directly during the administration of the drug.
    When appointing empirical treatment, it is necessary to take into account the data on the acquired resistance of microorganisms-pathogens.Stability of microorganisms can change with time and geographical location. To identify the microorganism-pathogen and determine sensitivity to cefepime, appropriate tests should be carried out. Cefepim can be used in the form of monotherapy even before the identification of the microorganism-pathogen, since it has a wide spectrum of antibacterial action against gram-positive and gram-negative microorganisms. At the risk of mixed aerobic / anaerobic infection (especially when microflora insensitive to cefepime may be present) treatment with the drug cefepime in combination with a drug acting on anaerobes, can begin before identification of the pathogen.
    After identifying the pathogen and determining the sensitivity to antibiotics, treatment should be carried out in accordance with the test results.
    As with other antibiotics, drug treatment cefepime can lead to colonization of insensitive microflora. With the development of superinfections during treatment, appropriate measures must be taken.
    Clostridium difficile-associated diarrhea
    With the use of virtually all broad-spectrum antibiotics, the occurrence of diarrhea associated with Clostridium difficile (CDAD-Clostridium difficile-associated diarrhea) may occur, which can occur in both mild and severe, even lethal outcomes.
    If diarrhea occurs during treatment with the drug, it is necessary to confirm the diagnosis of CDAD. Care should be taken to monitor the patient for development of CDAD, since cases of its occurrence more than two months after stopping the use of antibiotics were recorded. If CDAD is suspected or confirmed, antibiotics should be discontinued, except for those that are prescribed to suppress Clostridium difficile.

    Effect on the ability to drive transp. cf. and fur:The study of the effect of the drug on the ability to concentrate attention was not carried out, however, given the potential for side effects from the central nervous system, one should refrain from driving and working with dangerous mechanisms during drug treatment.
    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular injection of 500 mg and 1000 mg.


    Packaging:For 500 mg or 1000 mg of active substance in a transparent glass bottle type I, sealed with bromobutyl stopper and aluminum cap flip off. 1 bottle with instructions for use in a pack of cardboard.
    Storage conditions:In the dark place at a temperature of 15 to 30 ° C. KEEP OUT OF THE REACH OF CHILDREN!
    Shelf life:
    3 years.
    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015873 / 01
    The owner of the registration certificate:Bristol-Myers Squibb CompanyBristol-Myers Squibb Company USA
    Manufacturer: & nbsp
    Representation: & nbspBRISTOL-Majers SKVIBB, LLCBRISTOL-Majers SKVIBB, LLCRussia
    Information update date: & nbsp22.10.2015
    Illustrated instructions
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