Active substanceCefepimCefepim
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  • Dosage form: & nbsppowder for solution for intravenous and intramuscular administration
    Composition:

    The substance is a sterile mixture of cefepime hydrochloride monohydrate and L-arginine:

    active substance:

    cefepime

    - 0.5 g

    -1.0 g

    (as cefepime hydrochloride monohydrate)

    - 0.5945 g

    -1.1890 g

    auxiliary substance:

    L-arginine

    - 0.3972 g

    - 0.7943 g

    Description:Powder from white to light yellow color.
    Pharmacotherapeutic group:Antibiotic-cephalosporin
    ATX: & nbsp

    J.01.D.E.01   Cefepim

    Pharmacodynamics:

    Cefepime is a wide-spectrum cephalosporin antibiotic.

    Cefepime inhibits the synthesis of cell wall proteins 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 PSB types 1a and 1b.

    Cefepime has a bactericidal effect against a wide range of bacteria and 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 staphylococcus, resistant to methylene, are resistant to the action of most cephalosporin antibiotics, including cefepime.

    Gram-negative aerobes:

    Acinetobacter calcoaceticus (sub-stems anitratus, Iwofii);

    Aeromonas hydrophila;

    Capnocytophaga spp .;

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

    Enterobacter spp., including Enterobacter cloacae, Enterobacter aerogenes, Enterobacter sakazakii;

    Escherichia coli;

    Gardnerella vaginalis;

    Haemophilus ducreyi;

    Haemophilus influenza (including strains producing beta-lactamase); Haemophilus parainfluenzae; Hafnia alvei;

    Klebsiella spp., including Klebsiella pneumoniae, Klebsiella oxytoca, Klebsiella ozaenae;

    Legionella spp .;

    Morganella morganii;

    Moraxella catarrhalis (Branhamella catarrhalis) (including strains, beta-producing-lactamase);

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

    Pantoea agglomerans (formerly known 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 stutzeri;

    Salmonella spp .;

    Serratia, including Serratia marcescens, Serratia liquefaciens;

    Shigella spp .;

    Yersinia enterocolitica.

    Note: Cefepime is inactive for many strains Stenotrophomonas maltophilia (formerly known as Xanthomonas maltophilia and Pseudomonas maltophilia).

    Anaerobes:

    Bacteroides spp .;

    Clostridium perfringens;

    Fusobacterium spp .;

    Mobiluncus spp .;

    Peptostreptococcus spp .;

    Prevotella melaninogenica (known as Bacteroides melaninogenicus);

    Veillonella spp.

    Note: Cefepime is inactive with respect to Bacteroides fragilis and Clostridium difficile.

    Pharmacokinetics:

    Average concentrations of cefepime in the blood plasma of adult healthy men at different times after a single intravenous injection 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

    1 h

    2 hours

    4 hours

    8 h

    12 h

    FROMmOh (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.

    FROMmax and time to reach the maximum concentration in the blood plasma (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

    2 hours

    4h

    8 h

    12 h

    FROMmOh (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 and bullous fluids, 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. Cefepim metabolized in Nmethylpyrrolidine, which rapidly converts into an oxide Nmethylpyrrolidine.

    Cefepime is excreted mainly by the kidneys, by glomerular filtration (renal clearance is on average 110 ml / min). In urine, approximately 85% of the administered dose of unchanged cefepime is found, less than 1% Nmethylpyrrolidine, 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. With intravenous administration of the drug 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 serious violations of 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, healthy volunteers over 65 years of age had 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 in an unchanged form by the kidneys was 60.4% of the administered dose, and renal clearance - 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%.

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

    Time (hours) after administration

    Concentration in plasma (μg / ml) **

    Concentration in the CSF (μg / ml) **

    Concentration ratio in CSF / 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. Concentration in plasma and CSF was 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:

    - Infections of the lower respiratory tract, including bronchitis and pneumonia;

    - 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 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 cefepime or Larginine, as well as the antibiotic cephalosporin group, penicillins or other beta-lactam antibiotics;

    - children age up to 2 months.

    Carefully:Diseases of the gastrointestinal tract (including history), especially colitis, renal impairment (creatinine clearance less than 50 mL / min).
    Pregnancy and lactation:

    Due to the fact that adequate and well-controlled clinical studies in pregnant women have not been conducted, the use during pregnancy is possible only in those cases where the intended benefits to the mother outweighs the potential risk to the fetus.

    If you need to use the drug during breastfeeding, you should decide whether to stop breastfeeding, because cefepime is found in breast milk.

    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 of a solution for intravenous administration

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

    Preparation of a solution for intravenous infusion

    The 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.

    Volume of dilution solution (ml)

    The approximate volume of the solution obtained (ml)

    The approximate concentration of cefepime (mg / ml)

    Intravenous introduction:

    500 mg / bottle

    5

    5,7

    90

    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.

    Intramuscular injection: the dose 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 in different places.

    Preparation of solution for intramuscular injection

    The preparation is dissolved in sterile water for injection, 5% dextrose solution or 0.9% solution of sodium chloride for injection, 0.5% or 1% lidocaine solution, as indicated in the table below.

    Volume of dilution solution (ml)

    The approximate volume of the solution obtained (ml)

    The approximate concentration of cefepime (mg / ml)

    Intramuscular introduction:

    500 mg / bottle

    1,5

    2,2

    230

    1 g / bottle

    3,0

    4,4

    230

    Storage of solutions for intravenous and intramuscular administration

    Only freshly prepared solution is used.

    As with all solutions for parenteral administration, before preparation, 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.

    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 tract infections of mild and moderate severity:

    500 mg - 1 g IV or IM

    every 12 hours

    Other infections of mild to moderate severity:

    1 g IV or IM

    every 12 hours

    Severe infections:

    2 g IV

    every 12 hours

    Very serious and life-threatening infections:

    2 g IV

    every 8 hours

    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 until neutropenia disappears.

    Prevention of infections during 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.application. Due to the pharmaceutical incompatibility of metronidazole and cefepime, they should not be mixed 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 is recommended in the same dose 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, according to the following formula:

    Creatinine clearance (ml / min) = Body weight (kg) x (140 - age) / [72 x serum creatinine (mg / dL)]

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

    Creatinine clearance (ml / min)

    Recommended maintenance doses

    (Usual dose, dose adjustment is not required)

    >60

    2 grams

    every 8 hours

    2 grams

    every 12 hours

    1 g

    every 12 hours

    500 mg

    every 12 hours

    30-60

    2 grams

    every 12 hours

    2 grams

    every 24 hours

    1 g

    every 24 hours

    500 mg

    every 24 hours

    11-29

    2 grams

    every 24 hours

    1 g

    every 24 hours

    500 mg

    every 24 hours

    500 mg

    every 24 hours

    ≤11

    1 g

    every 24 hours

    500 mg

    every 24 hours

    250 mg

    every 24 hours

    250 mg

    every 24 hours

    With continuous ambulatory peritoneal dialysis

    2 grams

    every 48 hours

    2 grams

    every 48 hours

    1 g

    every 48 hours

    500 mg

    every 48 hours

    Patients on hemodialysis *

    500 mg

    every 24 hours

    500 mg

    every 24 hours

    500 mg

    every 24 hours

    500 mg

    every 24 hours

    * For patients on hemodialysis, it is recommended: 1 g on the first day of treatment and then at 500 mg every 24 hours for all infections, except for ferile neutropenia, where the dose is 1 g every 24 hours.In days of hemodialysis, the drug should be administered at the end of hemodialysis. 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.

    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:

    Creatinine clearance (ml / min / 1.732) = 0.55 x height (cm) / serum creatinine (mg / dl)

    or

    Creatinine clearance (ml / min / 1.732) = [0.52 x height (cm) / serum creatinine (mg / dl)] - 3.6.

    Patients with impaired hepatic function

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

    Side effects:

    The most frequent 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 - increased activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, anemia, eosinophilia, increased prothrombin time or partial thromboplastin time; infrequently - increased blood urea nitrogen, serum creatinine, thrombocytopenia, leukopenia and neutropenia; frequency unknown - aplastic anemia, hemolytic anemia, agranulocytosis.

    Post-registration experience: encephalopathy (impaired consciousness, including confusion, hallucinations, stupor and coma), myoclonus, seizures and anonzodorozhny epileptic status. Despite the fact that most cases were observed in patients with renal failure who received cefepime in doses higher than recommended, in some cases, neurotoxicity was noted in patients who underwent dose adjustment depending on the degree of renal failure.

    Overdose:

    Symptoms (often occur in patients with chronic renal failure): convulsions, encephalopathy,accompanied by hallucinations, impaired consciousness, stupor, coma, myoclonia, epileptiform attacks, neuromuscular excitement.

    Treatment: should stop the introduction of the drug and conduct symptomatic therapy. The use of hemodialysis accelerates the removal of cefepime from the body.

    Interaction:

    Data on the compatibility of solutions of cefepime and other medications are given in the table below:

    Concentration of cefepime

    Name / concentration of another drug in the mixture

    Infusion solution

    40 mg / ml

    Amicacin 6 mg / ml

    0,9% sodium chloride or 5% dextrose

    40 mg / ml

    Ampicillin 1 mg / ml

    5% dextrose

    40 mg / ml

    Ampicillin 10 mg / ml

    5% dextrose

    40 mg / ml

    Ampicillin 1 mg / ml

    0.9% sodium chloride

    40 mg / ml

    Ampicillin 10 mg / ml

    0.9% sodium chloride

    4 mg / ml

    Ampicillin 40 mg / ml

    0.9% sodium chloride

    4-40 mg / ml

    Clindamycin 0.25-6 mg / ml

    0,9% sodium chloride or 5% dextrose

    4 mg / ml

    Heparin 10-50 units / ml

    0,9% sodium chloride or 5% dextrose

    4 mg / ml

    Potassium chloride 10-40 meq / l

    0,9% sodium chloride or 5% dextrose

    4 mg / ml

    Theophylline 0.8 mg / ml

    5% dextrose

    Diuretics, aminoglycosides, polymyxin B reduce the tubular secretion of cefepime and increase its concentration in the serum, extend the T1/2, increase nephrotoxicity (increasing the risk of nephronecrosis). Cefepim increases the ototoxicity of aminoglycosides.

    Nonsteroidal anti-inflammatory drugs, slowing the excretion of cephalosporins, increase the risk of bleeding. When used simultaneously with bactericidal antibiotics (aminoglycosides), synergism is manifested, with bacteriostatic (macrolides, chloramphenicol, tetracyclines) - antagonism.

    Incompatible with the solution of metronidazole (before the administration of the solution of metronidazole for the prevention of infections during surgical interventions, the infusion system should be rinsed from the solution of cefepime).

    To avoid possible drug interactions with other drugs, cefepime solutions (like most other beta-lactam antibiotics) should not be administered concomitantly with solutions of vancomycin, gentamicin, tobramycin, netilmicin. When prescribing cefepime with the listed drugs, each antibiotic should be administered separately.
    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.

    During post-marketing surveillance have been reported following serious adverse reactions, including life-threatening or lead to death: encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor and coma), myoclonus, seizures, and non-convulsive status epilepticus (see section ". Side effect": Post-registration experience). Most cases were noted in patients with renal insufficiency, who did not undergo dose adjustment. Nevertheless, in some cases, neurotoxicity was noted in patients who underwent dose adjustment depending on the degree of renal failure. In most cases, the symptoms of neurotoxicity were reversible and disappeared after drug withdrawal and / or after hemodialysis.If neurotoxicity is associated with the use of cefepime, consideration should be given to discontinuing cefepime therapy or adjusting the dose in patients with renal insufficiency.

    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 infections (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 almost all broad-spectrum antibiotics, the occurrence of diarrhea associated with Clostridium difficile (CDAD - Clostridium difficile - associated diarrhea), which can occur both in mild form and in severe, up to a lethal outcome.

    If diarrhea occurs during treatment with the drug, it is necessary to confirm the diagnosis CDAD. You should carefully monitor the patient for development CDAD, as cases of its occurrence were registered more than two months after the termination of application of antibiotics. If suspected or confirmed CDAD It is necessary to stop the use of antibiotics, except those that are prescribed for suppression Clostridium difficile.

    Effect on the ability to drive transp. cf. and fur:

    Given the potential for side effects from the nervous system, patients should be careful when driving vehicles and other potentially hazardous activities.

    Form release / dosage:

    Powder for solution for intravenous and intramuscular injection, 0.5 g and 1.0 g.

    Packaging:

    By 0.5 g or 1.0 g of cefepime in bottles of glass (with a capacity of 10 ml), type of FO, FLP-10, 10R or 10Н, ukuporennye rubber stoppers and crimped aluminum caps.

    For 1 or 10 vials, along with instructions for medical use, put in a pack of cardboard.

    For 10 vials, together with instructions for medical use, are placed in a pack of cardboard with a cardboard insert for fixing the vials.

    For hospitals: 50 or 270 bottles, together with an equal number of instructions for medical use, are placed in a box of cardboard.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004131
    Date of registration:08.02.2017
    Expiration Date:08.02.2022
    The owner of the registration certificate:BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus
    Manufacturer: & nbsp
    Representation: & nbspBORISOVSKIY FACTORY OF MEDPREPARATES, OJSCBORISOVSKIY FACTORY OF MEDPREPARATES, OJSC
    Information update date: & nbsp29.03.2017
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