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

    Each vial contains:

    Active substance: ceftriaxone sodium, corresponding to 1 g of ceftriaxone.

    Description:The powder is almost white or white with a yellowish hue of color.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.D.04   Ceftriaxone

    Pharmacodynamics:Tertsef® is a third generation generic cephalosporin antibiotic for parenteral administration. Bactericidal activity is due to the suppression of bacterial cell wall synthesis. It is characterized by resistance to the action of most beta-lactamases of gram-negative and gram-positive microorganisms. It is active against the following microorganisms: Gram-positive aerobes - Staphylococcus aureus (including strains producing penicillinase), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus spp.the Viridans group; Gram-negative aerobes - Acinetobacter calcoaceticus, Borrelia burgdorferi, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae (including strains forming penicillinase), Haemophilus parainfluenzae, Klebsiella spp. (including Klebsiella pneumoniae), Moraxella catarrhalis, (including penicillinase-producing strains), Morganella morganii, Neisseria gonorrhoeae (including strains forming penicillinase), Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Serratia spp. (including Serratia marcescens); individual strains of Pseudomonas aeruginosa are also sensitive; anaerobes - Bacteroides fragilis, Clostridium spp. (except Clostridium difficile), Peptostreptococcus spp. Has in vitro activity against most strains of the following microorganisms, although the clinical significance of this is unknown: Citrobacter diversus, Citrobacter freundii, Providencia spp. (including Providencia rettgeri), Salmonella spp., including Salmonella typhi, Shigella spp .; Streptococcus agalactiae, Bacteroides bivius, Bacteroides melaninogenicus. Methicillin-resistant staphylococci are resistant to cephalosporins, incl. to ceftriaxone, many Streptococcus strains of group D and enterococci, incl. Enterococcus faecalis, also resistant to ceftriaxone.
    Pharmacokinetics:
    After a dose of 1-2 g for more than 24 hours, the concentrations of ceftriaxone exceed the values ​​of the minimum inhibitory concentration for most pathogens in more than 60 different tissues (including lungs, heart, bile ducts, liver, glands, middle ear, nasal mucosa , bones) and in many tissue fluids (including cerebrospinal fluid, pleural fluid, as well as in prostate and synovial fluid).
    Absorption
    With intramuscular (IM) administration ceftriaxone is well absorbed from the injection site and reaches high concentrations in the blood serum. Bioavailability of ceftriaxone is 100%. The maximum concentration in plasma (about 80 mg / l) is achieved 2-3 hours after the injection.
    Distribution
    Ceftriaxone penetrates well into various tissues and body fluids, and also through the placental barrier and in low concentrations is found in breast milk. The average volume of distribution in healthy adults is 0.13 l / kg. Ceftriaxone reversibly binds to albumin. And the degree of binding decreases with increasing concentration, decreasing, for example, from 95% at plasma concentrations below 100 mg / l to 85% with plasma concentrations of ceftriaxone
    300 mg / l.

    Serum levels

    After intravenous (iv) infusion of 1 g of ceftriaxone for 30 minutes, its serum concentration immediately after administration was 123.2 μg / ml and 94.81, 57.8, 20.2 and 4.6 μg / ml , respectively, after 1.5; 4, 12 and 24 hours after the start of the infusion.

    After intramuscular injection of 1 g of ceftriaxone, the serum concentration is 79.2 μg / ml after 1.5 hours and 58.2, 35.5 and 7.8 μg / ml, respectively, at 4, 12 and 24 hours after administration.

    In newborns and in children with inflammation of the meninges ceftriaxone penetrates into the cerebrospinal fluid. In cerebrospinal fluid, the maximum concentration reaches 18 mg / l after iv injection of ceftriaxone in a dose of 50-100 mg / kg body weight for 4 hours. After administration of ceftriaxone at a dose of 50 mg / kg of body weight in adult patients with meningitis, its therapeutic concentrations are maintained for 2-24 hours. Metabolism

    Ceftriaxone is not subject to systemic metabolism, but under the influence of intestinal

    flora, it turns into an inactive metabolite.

    Excretion

    At a dose in the range of 0.15 to 3 g, the half-life (T1 / 2) values ​​are 6-9 hours, the total plasma clearance is 0.6-1.4 l / h, the renal clearance is 0.3-0.7 l / h. 50-60% of ceftriaxone is excreted by the kidneys unchanged, the rest is excreted with bile through the intestine in the form of inactive metabolites. Ceftriaxone accumulates in the urine. Concentrations in the urine are 5-10 times higher than those in the blood plasma.

    Ceftriaxone is not excreted by dialysis. This applies to both hemodialysis and peritoneal dialysis. Kidney excretion occurs through glomerular filtration, tubular secretion is absent. In connection with this, there is no increase in the concentration of ceftriaxone in the serum with simultaneous application of probenecid, including in high doses (1-2 g).

    Nonlinearity

    The pharmacokinetics of ceftriaxone with respect to dose is non-linear. This nonlinearity is explained by the dependence of the concentration of ceftriaxone on the degree of binding to blood plasma proteins.

    With the exception of T1 / 2, all other pharmacokinetic parameters are dose-dependent. Repeated doses of 0.5-2 g lead to the accumulation of ceftriaxone by 15-36%

    compared with the values ​​when taking a single dose.

    Special patient groups

    Patients elderly (over 75 years)

    In this group of patients, T1 / 2 ceftriaxone is increased approximately 2-3 times compared to young patients.

    Pharmacokinetics in special clinical cases

    In the first week of life, 80% of the dose is excreted by the kidneys; In the first month of life, this value approaches that of adult patients. In newborns in the first 8 days of life, the mean T1 / 2 values ​​are 2-3 times higher than in adults.

    Patients with impaired renal and / or liver function

    In patients with impaired renal function, excretion of the drug with bile increases and, conversely, if the liver function is impaired, kidney excretion is enhanced. T1 / 2 ceftriaxone from plasma in this group of patients is slightly increased.In patients with impaired function of the kidneys and liver, an increase is possible T1/2. In the case of renal failure, the terminal phase of T1 / 2 is more prolonged and may have values ​​up to 14 hours.

    Indications:
    Infectious-inflammatory diseases caused by microorganisms sensitive to ceftriaxone:

    - infections of the abdominal cavity (peritonitis, inflammatory diseases of the gastrointestinal tract (GIT), bile ducts, including cholangitis, empyema of the gallbladder),

    - infection of the pelvic organs,

    - infections of the lower respiratory tract (including pneumonia, lung abscess, pleural empyema),

    - acute otitis media,

    - infection of bones and joints, skin and soft tissues (including infected wounds and burns),

    - urinary tract infections (complicated and uncomplicated),

    - uncomplicated gonorrhea,

    - bacterial meningitis,

    - bacterial septicemia,

    - Lyme disease.

    Prevention of postoperative infections.

    Infectious diseases in persons with weakened immunity.
    Contraindications:
    - Hypersensitivity to ceftriaxone (including other cephalosporins, penicillins, carbapenems).

    - Hyperbilirubinemia in newborns; Newborns, who showed intravenous administration of calcium-containing solutions.

    - In / m administration is contraindicated in children younger than 2 years (when used as a solvent lidocaine).
    Carefully:Ulcerative colitis, simultaneous violations of the liver and kidneys; enteritis or colitis associated with the use of antibacterial drugs; premature babies.
    Pregnancy and lactation:
    Tercef® can be used during pregnancy if the expected benefit to the mother exceeds the potential harm to the fetus.
    In low concentrations ceftriaxone is excreted in breast milk. Care should be taken during breastfeeding during treatment with the drug.
    Intramuscular injection
    In / m administration of ceftriaxone and lidocaine is contraindicated during pregnancy and during lactation.
    Dosing and Administration:
    Tercef® is injected deep into the / m or IV / (drip, jet).
    Tercef® can be used after the preparation of the solution according to the recommendations presented below.
    The dose and method of administration should be determined depending on the severity and location of the infection, the sensitivity of the pathogen, as well as the age and condition of the patient.
    In / in the injection should be administered for at least 2-4 minutes.A dose of more than 50 mg / kg of body weight should be slowly injected for at least 30 minutes. In / m administration, as a rule, is contraindicated in children up to 2 years (when used as a solvent lidocaine).
    For the / m introduction, follow the instructions given below.

    Adults and children over 12 years of age with a body weight >50 kg

    The average daily dose is 1-2 g of ceftriaxone once a day (every 24 hours). In severe cases or infections, the causative agents of which have only moderate sensitivity to ceftriaxone, the daily dose can be increased to 4 g.

    Newborns (up to 2 weeks)

    20-50 mg / kg body weight IV once a day (with an interval of 24 hours). With heavy

    the daily dose should not exceed 50 mg / kg.

    For infants, see section Special instructions.

    When determining the dose, no distinction should be made between full-term and

    premature babies.

    In newborns, the duration of IV infusion should be at least 60 minutes, in order

    To prevent the displacement of bilirubin from serum albumin, thereby

    reducing the risk of developing bilirubin encephalopathy.

    Children (the first 15 days of life up to 12 years) with a body weight of <50 kg

    20-80 mg / kg of body weight once a day (with an interval of 24 hours).

    In severe infections, the daily dose should not exceed 80 mg / kg, except for the treatment of meningitis.

    Children with a body weight of 50 kg or more are prescribed doses intended for adults.

    Elderly patients

    Older patients are not required to adjust the dose.

    Special recommendations for dosing

    Meningitis

    Treatment begins with the introduction of 100 mg / kg once a day, the daily dose should not exceed 4 g. After identifying the pathogen and determining its sensitivity, the dose can be reduced accordingly. The best results for meningococcal meningitis were achieved with a duration of treatment for 4 days, with meningitis caused by Haemophilus influenzae - 6 days, Streptococcus pneumoniae - 7 days.

    For newborns (up to 2 weeks), the dose should not exceed 50 mg / kg / day.

    When Lyme disease Adults and children are prescribed in a dose of 50 mg / kg (maximum

    daily dose - 2 g), once a day for 14 days.

    When uncomplicated gonorrhea (caused by penicillinase-producing and penicillinase-forming strains), Tertsef® is administered once a day at a dose of 250 mg.

    Prevention of postoperative infections

    It should be used 1-2 g of the drug Tertsef® once for 30-90 minutes before the beginning of surgical intervention in / m or / in.In operations on the colon and rectum, the simultaneous (but separate) administration of the Tertsef® preparation and one of the 5-nitroimidazoles, for example, ornidazole, was well established.

    Renal insufficiency

    In patients with impaired renal function there is no need to reduce the dose, if the function liver remains normal. Only in cases of severe renal failure, with creatinine clearance <10 ml / min, the daily dose should not exceed 2 g in adult patients.

    Liver failure

    In patients with hepatic dysfunction there is no need to reduce the dose, if the function kidneys remains normal.

    When combination of severe renal and hepatic insufficiency should regularly monitor the concentration of ceftriaxone in the plasma and, if necessary, adjust its dose (see sections Special instructions and pharmacokinetics).

    Hemodialysis or peritoneal dialysis

    Because the ceftriaxone to a small extent dialyzed, patients on dialysis, additional administration of the drug after the dialysis session is not required, however, it is necessary to monitor the concentration of ceftriaxone in the serum for possible dose adjustment, since the rate of excretion of the drug in these patients may be reduced.

    In patients on long-term outpatient peritoneal dialysis (CAPD), ceftriaxone can be administered intravenously or in the case of development of infections associated with the administration of CAPD, ceftriaxone can be added directly to the dialysate (for example, 1 -2 g of ceftriaxone is added to the first portions of the dialysate on the day of treatment).

    Duration of treatment

    The duration of treatment with Tertsef® depends on the course of the disease, it should be continued for at least 2-3 days after the disappearance of the clinical symptoms of the disease or after a negative result of the microbiological examination. Recommendations for dosing should be observed for specific indications.

    Method of solution preparation

    Despite the fact that the prepared solutions retain their physical and chemical stability for 24 hours at a temperature of 2-8 ° C, it is better to use freshly prepared solutions immediately after preparation. Do not use calcium-containing solutions (such as Ringer and Hartmann) to dilute the preparation because of the possibility of precipitation.The formation of calcium ceftriaxone precipitate is also possible by mixing ceftriaxone with calcium-containing solutions in one infusion line.

    For this reason ceftriaxone and calcium-containing solutions should not be mixed or administered simultaneously (see section Special instructions).

    If there is no history of allergic reactions, make a scarification skin test with the drug solution. In the presence of allergic reactions in the anamnesis, first make a skin test and, if it has a negative result, proceed to the scarification sample. The result of the samples is read after 30 minutes. Intramuscular injections of Tertsef® without lidocaine are painful. When using lidocaine as a solvent, it is necessary to make a test for hypersensitivity to it.

    Do not administer intravenous solutions of Tertsef® with lidocaine! After a / m injection, it is recommended to always pull the syringe plunger (no blood should appear) to make sure that the blood vessel is not damaged.

    Cooking method

    For intravenous injection 1 g or 2 g of Tertsef® is dissolved in 3.6 ml or 7.2 ml of a 1% solution of lidocaine (concentration of ceftriaxone 250 mg / ml), respectively. Beforehand, the sensitivity of the patient to lidocaine should be determined.In / m injections of solutions in water for injections are painful. If necessary, solutions with higher dilution may be administered. The injection is injected deep into the gluteus muscle. It is recommended to inject no more than 1 g of the drug into one buttock. Solutions of the drug Tercef® with lidocaine, prepared for the / m introduction, do not inject IV!

    For direct intravenous injection 1 g or 2 g of Tertsef® is dissolved in 9.6 ml or 19.2 ml of sterile water for injection (ceftriaxone concentration 100 mg / ml), respectively. The duration of the injection is 2-4 minutes.

    For short-term intravenous infusion 1 g and 2 g of Tertsef® are also dissolved for direct intravenous injection and diluted to a concentration of ceftriaxone 10 mg / ml in 90 ml and 180 ml of solvent, respectively. The following solvents are used for the preparation of infusion: water for injection, 0.9% sodium chloride solution, 5%, 10% dextrose (glucose) solution, 5% levulose solution. The duration of the infusion is 30 minutes.

    Solutions of Tercef® should not be mixed or added to solutions containing other antibiotics or other solvents, with the exception of those listed above, because of possible incompatibility.

    Side effects:

    Adverse reactions are classified as follows depending on their frequency: very frequent (>1/10), frequent (>1/100, <1/10), infrequent (>1/1000, <1/100), rare (>1/10000, <1/1000), very rare (<1/10000), the frequency is unknown (single messages).

    From the side of the blood and lymphatic system

    Rare - eosinophilia, leukopenia, granulocytopenia.

    Very rare - agranulocytosis (<500 / mm3), preferably after 10 days of treatment and after a total dose of more than 20 g of ceftriaxone; violations of coagulation, thrombocytopenia, a slight elongation of prothrombin time, anemia (including hemolytic anemia).

    Frequency unknown - thrombocytosis.

    From the nervous system

    Infrequent - headache, nonsystemic dizziness, dizziness.

    Frequency unknown - a violation of taste.

    From the gastrointestinal tract

    Infrequent - stomatitis, glossitis, anorexia, nausea, vomiting, abdominal pain, diarrhea. These adverse reactions are usually mild and often occur during or after treatment.

    Very rare - pseudomembranous colitis (see section Special instructions).

    From the urinary system

    Infrequent - oliguria, increased serum creatinine.

    Rare - formation of precipitates in the kidneys (reversible after cessation of ceftriaxone treatment).

    Frequency unknown - hematuria.

    Infectious complications

    Rare - candidiasis, superinfection.

    Frequency unknown - vaginitis.

    Common violations and local reactions

    Frequent - phlebitis after intravenous administration. Its appearance can be minimized if the drug is administered slowly for at least 2-4 minutes. Pain in the injection site.

    With rapid on / in the introduction of possible reactions of intolerance, such as a feeling of heat and nausea. This can be avoided with slow intravenous administration (within 2-4 minutes).

    Pain and compaction of tissues at the site of administration is noted and after the / m administration.

    Rare - fever, chills.

    Frequency unknown - increased sweating, "hot flashes" of blood to the face.

    Immune system disorders

    Frequent - skin allergic reactions (dermatitis, urticaria, exanthema), itching, swelling of the skin and joints.

    Rare - severe acute hypersensitivity reactions, up to anaphylactic shock; Lyell's syndrome, Stevens-Johnson syndrome, erythema multiforme.

    Frequency unknown allergic pneumonitis.

    Disturbances from the liver and bile ducts

    Very Frequent - symptomatic precipitation of calcium salts of ceftriaxone in the gallbladder, reversible cholelithiasis.

    Frequent - increase in the concentration of "liver" enzymes (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase).

    Rare - pancreatitis (possibly caused by obstruction of the bile ducts).

    Frequency unknown - jaundice, hyperbilirubinemia.

    Disturbances from the respiratory system

    Frequency not known - bronchospasm, nosebleeds.

    From the muscular system

    Frequency unknown - convulsions.

    From the heart

    Frequency unknown - a feeling of palpitations.

    Overdose:No cases of an overdose with Tertsef® were reported. Possible development of the following symptoms: nausea, vomiting, diarrhea.
    Treatment: symptomatic. Hemodialysis and peritoneal dialysis are not effective. There is no specific antidote.
    Interaction:

    Diuretics

    With the simultaneous use of ceftriaxone with diuretics of function disorders kidney is not observed.

    Aminoglycosides

    There are no reports of an increased risk of oto- and nephrotoxicity with the simultaneous use of cephalosporins and aminoglycosides.These drugs should be administered separately to avoid physico-chemical incompatibility. Bacteriostatic antibiotics, such as chloramphenicol and tetracycline, can reduce the activity of ceftriaxone, especially in acute infections, accompanied by rapid proliferation of microorganisms. Therefore, simultaneous use of ceftriaxone and bacteriostatic antibiotics is not recommended.

    Probenecid

    Probenecid does not affect the excretion of ceftriaxone.

    Oral contraceptives

    Ceftriaxone may reduce the effectiveness of hormonal contraceptives. Therefore, the use of additional non-hormonal contraceptive measures during its use and within a month after discontinuation of treatment is recommended.

    Disulfide-like effect

    Does not contain N-methylthiothetrazole group, therefore, when interacting with ethanol, it does not lead to the development of disulfiram-like reactions characteristic of some cephalosporins.

    Pharmaceutical incompatibility

    Pharmaceutically incompatible with solutions containing calcium (including Hartman and Ringer's solution), as well as with amsacrine, vancomycin, fluconazole and aminoglycosides.

    Special instructions:Tercef® is used with the proven sensitivity of pathogenic microorganisms, which is determined by diffusion or dilution, using standard nutrient media.

    Calcium-containing solutions

    There are rare reports of the development of serious adverse reactions, in some cases fatal, in newborns, including premature (in the first 28 days of life) who were injected ceftriaxone and calcium solutions IV. These complications were observed even in the case of the administration of ceftriaxone and calcium solutions at different times, through different infusion lines. In this group of patients precipitation of calcium ceftriaxone salts in the lungs and kidneys was detected, a high risk of sedimentation is associated with a small total circulating blood volume. In addition, T1 / 2 ceftriaxone in this group of patients is larger compared to adult patients (see section Contraindications, Pharmacokinetics and Side effect).

    In patients of any age ceftriaxone can not be mixed or administered simultaneously with solutions containing calcium, including when administered through different infusion lines and when the infusion system is being put in different places.However, patients after the 28th day of life ceftriaxone and solutions containing calcium can be administered sequentially by using various infusion lines, either when the infusion system is placed in different places or after thorough washing of the infusion system with a physiological solution between the infusions to avoid the formation of precipitate. In patients who require prolonged infusion of calcium-containing TPN solutions (solutions for complete parenteral nutrition), physicians can use alternative antibiotic treatment, in which there is no similar risk of precipitate formation. If the use of ceftriaxone is considered necessary in patients who require prolonged parenteral nutrition, TPN solutions and ceftriaxone can be administered simultaneously, but through different infusion lines installed in different locations. An alternative is to stop the introduction of TPN solutions during the infusion of ceftriaxone, taking into account the recommendations for cleaning the infusion lines between the administration of solutions.

    Infection caused by Pseudomonas aeruginosa

    If there is a suspicion of infection caused by Pseudomonas aeruginosa, or when the microorganism is isolated from the crop, its high resistance (> 60%) to ceftriaxone in some regions should be considered.

    In the treatment of infections caused by Pseudomonas aeruginosa, with proven sensitivity to ceftriaxone, a combination with aminoglycosides helps to avoid secondary resistance.

    Hypersensitivity reactions

    Before the beginning of each treatment with Tertsef®, the patient should clarify the history of hypersensitivity reactions to cephalosporins, penicillins and other beta-lactam antibiotics, since it is possible to develop cross-sensitivity hypersensitivity reactions.

    Hypersensitivity reactions to ceftriaxone are more likely to occur in patients with other types of hypersensitivity reactions in the history or in patients with bronchial asthma.

    Allergic reactions of any severity are possible, up to anaphylactic shock.

    It is recommended to closely monitor the patient with allergic reactions in the history after the first injection of the drug, since hypersensitivity reactions develop more rapidly and take place more severely after intravenous administration.Severe acute hypersensitivity reactions and anaphylactic shock require immediate discontinuation of the Tertsef® preparation and all necessary resuscitative measures. In case of development of anaphylactic shock, it is necessary to enter: subcutaneously 0.5-1 mg epinephrine, iv glucocorticosteroid and antihistamines; When bronhospazme enter eufillin and selective beta-adrenomimetiki, appoint oxygen, and if necessary, artificial ventilation of the lungs.

    Correction of dose

    If there is a marked impairment of kidney function in combination with liver failure, a dose reduction is required (see section Method of administration and dose).

    With long-term treatment, it is necessary to regularly monitor the picture of peripheral blood, indicators of the functional state of the liver and kidneys (see section Side effect).

    Secondary Infections

    The use of any antibiotic can lead to an increase in the number of pathogenic microorganisms resistant to the previously used antibacterial drug. It is necessary to closely monitor the appearance of signs of secondary infection caused by such pathogenic microorganisms (including fungal infections).Secondary infections should be treated according to antibiotic therapy standards.

    Pseudomembranous colitis

    The use of Tertsef® can lead to changes in normal intestinal microflora and the development of pseudomembranous colitis. It is necessary to observe patients with diarrhea, appeared during treatment with ceftriaxone or after its application. If severe persistent diarrhea occurs during or after treatment, this may be a sign of the development of pseudomembranous colitis, which can threaten the patient's life. Most often this disease is caused Clostridium difficile. When pseudomembranous colitis is diagnosed, the drug should be discontinued and appropriate therapy initiated: a large amount of fluid, electrolytes, and proteins should be injected and chemotherapeutic agents should be treated with clinically proven efficacy. Means that inhibit the peristalsis of the intestine are contraindicated. Ceftriaxone should be used with caution in patients with diseases of the gastrointestinal tract (especially with colitis) in the anamnesis.

    Calcium salt precipitates of efetriacone in the gallbladder After the application of ceftriaxone, usually at doses exceeding the standard recommended doses, ultrasound examination of the gallbladder revealed shadows that were mistaken for stones. They are precipitates of the calcium salt of ceftriaxone, which disappear after the completion or discontinuation of therapy. Such changes rarely give any symptomatology, but in such cases only conservative treatment is recommended. If these phenomena are accompanied by clinical symptoms, then the decision to cancel the drug is left to the discretion of the attending physician.

    Disturbances from the biliary tract can be observed in patients of any age, but more often in newborns and small children, who are usually given a high dose of the drug in terms of body weight. In view of the increased risk of biliary precipitates in children, doses above 80 mg / kg should be avoided, except for the treatment of meningitis. There is no reliable data indicating the formation of gallstones or the development of acute cholecystitis in children after treatment with ceftriaxone. Because these symptoms are temporary and go through with ceftriaxone,no additional therapy is required.

    In patients receiving ceftriaxone, rare cases of pancreatitis, which developed, possibly, as a result of obstruction of the bile ducts are described. Most of these patients already had risk factors for congestion in the bile ducts (previous therapy, severe co-morbidities, completely parenteral nutrition). At the same time, it is impossible to exclude the starting role of precipitate formation in bile ducts under the influence of ceftriaxone.

    Other precautions

    Research in vivo and in vitro showed that, like other cephalosporin antibiotics, ceftriaxone is able to displace bilirubin, associated with serum albumin. Clinical observations of newborns confirmed this information. Therefore, in newborns with hyperbilirubinemia, hypoalbuminuria or acidosis and, especially, in preterm infants, use ceftriaxone Not recommended.

    Cephalosporins tend to absorb on the surface membrane of erythrocytes and to interact with antibodies to the drug,which leads to a false-positive result of the Coombs test and occasionally to mild hemolytic anemia. In this regard, it is possible to cross-react hypersensitivity with penicillins.

    In the treatment of ceftriaxone, false-positive results of the sample for galactosemia, in the determination of glucose in urine (glucosuria is recommended to be determined only by enzyme method).

    When using ceftriaxone, rare cases of prothrombin time change are described. Patients with vitamin K deficiency (impaired synthesis, eating disorder) may need to monitor prothrombin time and prescribe vitamin K (10 mg per week) with an increase in prothrombin time before or during therapy.

    Patients who follow a diet with sodium restriction should take into account that its quantity in the preparation is approximately 70 mg / g. The solutions of the preparation Tertsef®, depending on the concentration, are colored in various shades of yellow color: from light yellow to amber. The color of the solution does not affect the activity, efficacy and tolerability of the preparation.

    Effect on the ability to drive transp. cf. and fur:Given the side effect of ceftriaxone on the nervous system (possibly the occurrence of dizziness, seizures) for the period of treatment should refrain from managing motor transport and complex mechanisms.
    Form release / dosage:Powder for solution for intravenous and intramuscular injection 1 g.
    Packaging:1 g of active substance in colorless glass vials of 30 ml. For 5 bottles together with instructions for use in a pack of cardboard.
    Storage conditions:At a temperature of no higher than 25 ° C. Keep in original packaging! After dissolution, store at a temperature of 2-8 ° C (in the refrigerator) no more than 24 hours. Keep out of the reach of children!
    Shelf life:3 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:P N013582 / 01-2001
    Date of registration:12.12.2011
    The owner of the registration certificate:Aktavis, AOAktavis, AO Iceland
    Manufacturer: & nbsp
    Information update date: & nbsp16.11.2015
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