Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams of ceftriaxone activity. Ceftriaxone was not removed to any significant extent from the plasma by hemodialysis; in six of 26 dialysis patients, the elimination rate of ceftriaxone was markedly reduced. £ All methicillin-resistant staphylococci are resistant to ceftriaxone. Hypersensitivity to the active substance, to any other cephalosporin or to any of the excipients listed in section 6.1. In one study, total ceftriaxone concentrations (bound and unbound) were measured in middle ear fluid obtained during the insertion of tympanostomy tubes in 42 pediatric patients with otitis media. Patients with previous hypersensitivity reactions to penicillin and other beta lactam antibacterial agents may be at greater risk of hypersensitivity to ceftriaxone (see WARNINGS – Hypersensitivity). Ceftriaxone is well absorbed following intramuscular injection and is widely distributed across organ systems. Also … The condition appears to be reversible upon discontinuation of ceftriaxone sodium and institution of conservative management. Discontinue ceftriaxone for injection in patients who develop signs and symptoms suggestive of urolithiasis, oliguria or renal failure and/or the sonographic findings described above. Such precipitates disappear after discontinuation of ceftriaxone therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Dosages greater than 1g should be divided and injected at more than one site. In primates, no embryotoxicity or teratogenicity was demonstrated at a dose approximately 3 times the human dose. In case a lidocaine solution is used as a solvent, ceftriaxone solutions must only be used for intramuscular injection. Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem. Ceftriaxone-calcium precipitates in the gallbladder have been observed in patients receiving ceftriaxone for injection. Box of 1 (NDC 68180-611-01) and box of 10 (NDC 68180-611-10). A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving ceftriaxone for injection and calcium-containing fluids. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. This should be taken into consideration in patients on a controlled sodium diet. Ceftriaxone solutions containing lidocaine should never be administered intravenously. For reconstituted solution, chemical and physical in-use stability has been demonstrated for 24 hours at 25oC and for four days at 2-8°C. In patients treated with ceftriaxone for injection the Coombs' test may become positive. Some patients with spirochete infections may experience a Jarisch-Herxheimer reaction (JHR) shortly after ceftriaxone treatment is started. Doses over 1 g must be divided between more than one site. Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and have no evidence of embryotoxicity, fetotoxicity or teratogenicity. Generally, ceftriaxone for injection therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared. Calcium-containing diluents, such as Ringer's solution or Hartmann's solution, should not be used to reconstitute Ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Anticonvulsant therapy can be given if clinically indicated. (Please refer to section 4.2 for further information). Ceftriaxone, like other antibiotics, may result in false-positive tests for galactosaemia. For storage conditions of the reconstituted medicinal product, see section 6.3. Based on middle ear fluid ceftriaxone concentrations in the 23 to 25 hour and the 46 to 50 hour sampling time intervals, a half-life of 25 hours was calculated. At least one fatality has been reported in a neonate in whom ceftriaxone for injection and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions. Alternative testing methods should be used if necessary. The pH of a 1% aqueous solution is approximately 6.7. Ceftriaxone for injection may be administered intravenously or intramuscularly. Variations in the intensity of colour of the freshly prepared solutions do not indicate a change in potency or safety. They do not treat viral infections (eg, common cold). The total daily dose should not exceed 4 grams. The incidence of warmth, tightness or induration was 17% (3/17) after IM administration of 350 mg/mL and 5% (1/20) after IM administration of 250 mg/mL. Providencia species (including Providencia rettgeri), Salmonella species (including Salmonella typhi), Porphyromonas (Bacteroides) melaninogenicus. Indications for adults and children over 12 years of age (≥ 50 kg) that require specific dosage schedules: A single intramuscular dose of Ceftriaxone 1-2 g can be given. The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. No dosage adjustment is necessary for patients with impairment of renal or hepatic function (see PRECAUTIONS). ≥ 80 mg/kg/day or total doses exceeding 10 grams) and who have other risk factors (e.g. After the indicated stability time periods, unused portions of solutions should be discarded. As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported (see section 4.8). Prolonged use of ceftriaxone for injection may result in overgrowth of nonsusceptible organisms. Thirty-three percent to 67% of a ceftriaxone dose was excreted in the urine as unchanged drug and the remainder was secreted in the bile and ultimately found in the feces as microbiologically inactive compounds. Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Dosage adjustments should not be necessary in patients with hepatic dysfunction; however, in patients with both hepatic dysfunction and significant renal disease, caution should be exercised and the ceftriaxone for injection dosage should not exceed 2 g daily. The information in the Summary of Product Characteristics of lidocaine should be considered. Dosage Form: Injection. The lidocaine solution should never be administered intravenously. Ceftriaxone injection comes as a powder to be mixed with liquid, or as a premixed product, to be injected intravenously (into a vein) over a period of 30 or 60 minutes.Ceftriaxone injection can also be given intramuscularly (into a muscle). For children with bodyweight of 50 kg or more, the usual adult dosage should be given. In patients undergoing dialysis no additional supplementary dosing is required following the dialysis. The maximum single intramuscular dose is 2 g, doses greater than 2 g must be given in two divided doses or by intravenous administration. Patients with renal or hepatic impairment. Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1 g should be injected at one site. Multiple IV or IM doses ranging from 0.5 to 2 gm at 12- to 24-hour intervals resulted in 15% to 36% NOTE: Ceftriaxone for injection USP sterile powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products. This information is intended for use by health professionals, Ceftriaxone 1g Powder for solution for injection or infusion. In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing intravenous solutions, even via different infusion lines or at different infusion sites. d. Breakpoints apply to a daily intravenous dose of 1 g x 1 and a high dose of at least 2 g x 1. In particular, diluents containing calcium, (e.g. Intravenous intermittent injection should be given over 5 minutes preferably in larger veins. Vials containing 1 g equivalent of ceftriaxone. The dosages recommended for adults require no modification in older people provided that renal and hepatic function is satisfactory. The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient. Ceftriaxone penetrates the meninges. As the solvent used is lidocaine, the resulting solution should never be administered intravenously. Average plasma concentrations of ceftriaxone following a single 30-minute intravenous (IV) infusion of a 0.5, 1 or 2 g dose and intramuscular (IM) administration of a single 0.5 (250 mg/mL or 350 mg/mL concentrations) or 1 g dose in healthy subjects are presented in Table 1. Dose >2 g is given via IV inj or infusion. For initial treatment of acute otitis media, a single intramuscular dose of Ceftriaxone 50 mg/kg can be given. If a patient develops anemia while on ceftriaxone, the diagnosis of a cephalosporin associated anemia should be considered and ceftriaxone stopped until the etiology is determined. For the treatment of skin and skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). Contraindications to lidocaine, warnings and other relevant information as detailed in the Summary of Product Characteristics of lidocaine must be considered before use (see section 4.3). Ceftriaxone, must not be administered simultaneously with. There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (intravenous or oral). There have been no similar reports in patients other than neonates. Compared to that in healthy adult subjects, the pharmacokinetics of ceftriaxone were only minimally altered in elderly subjects and in patients with renal impairment or hepatic dysfunction (Table 4); therefore, dosage adjustments are not necessary for these patients with ceftriaxone dosages up to 2 g per day. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. As the solvent used is lidocaine, the resulting solution should never be administered intravenously (see section 4.3). Discard any unused contents. Intravenous doses should be given over 60 minutes in neonates to reduce the risk of bilirubin encephalopathy. 4 Ceftriaxone intravenous solution is prepared at a concentration of 100 mg/mL. Cases of ceftriaxone precipitation in the urinary tract have been reported, mostly in children treated with high doses (e.g. Simultaneous administration of probenecid does not reduce the elimination of ceftriaxone. In addition to the adverse reactions reported during clinical trials, the following adverse experiences have been reported during clinical practice in patients treated with ceftriaxone for injection. In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy (see section 4.3 and 4.4). However, in patients other than neonates, ceftriaxone for injection and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. Although ceftriaxone for injection USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. Ceftriaxone for injection should be administered intravenously by infusion over a period of 30 minutes, except in neonates where administration over 60 minutes is recommended to reduce the risk of bilirubin encephalopathy. Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1 g should be injected at one site. In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised. Non-linearity is due to saturation of plasma protein binding and is therefore observed for total plasma ceftriaxone but not for free (unbound) ceftriaxone. Only in cases of preterminal renal failure (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 g daily. ** Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered. Concomitant use with oral anticoagulants may increase the anti-vitamin K effect and the risk of bleeding. Ceftriaxone is lower than control at study day 14 and 28. Withdraw entire contents of vial into syringe to equal total labeled dose. NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection USP compared to 10 days of oral therapy. 1 g/50 mL; 2 g/50mL; Powder for injection. • Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)*. In patients requiring continuous infusion with calcium-containing total parenteral nutrition (TPN) solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation. Dosage adjustments should not be necessary in patients with hepatic dysfunction; however, in patients with both hepatic dysfunction and significant renal disease, caution should be exercised and the Ceftriaxone for Injection dosage should not exceed 2 g daily. National or local guidance should be taken into consideration. This may be reflective of ceftriaxone-calcium precipitation. Over a 0.15 to 3 g dose range in healthy adult subjects, the values of elimination half-life ranged from 5.8 to 8.7 hours; apparent volume of distribution from 5.78 to 13.5 L; plasma clearance from 0.58 to 1.45 L/hour; and renal clearance from 0.32 to 0.73 L/hour. Do not use diluents containing calcium, such as Ringer's solution or Hartmann's solution, to reconstitute ceftriaxone for injection vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Caution should be exercised when ceftriaxone for injection is administered to a nursing woman. Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known. dehydration, confinement to bed). Adult: 1-2 g daily, increased to 4 g daily in severe infections, given once or in 2 divided doses via slow IV inj over 5 minutes, or infused over at least 30 minutes, or deep IM inj. Concretions consisting of the precipitated calcium salt of ceftriaxone have been found in the gallbladder bile of dogs and baboons treated with ceftriaxone. There are, however, no adequate and well-controlled studies in pregnant women. In older people aged over 75 years the average elimination half-life is usually two to three times that of young adults. ∗IV doses were infused at a constant rate over 30 minutes. Rarely precipitates of calcium ceftriaxone have been associated with symptoms. Diluents containing calcium, (e.g. As with antibiotic therapy in general, administration of ceftriaxone should be continued for 48 - 72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved. Ceftriaxone is excreted via both biliary and renal excretion (see CLINICAL PHARMACOLOGY). This event may be asymptomatic or symptomatic, and may lead to ureteric obstruction and postrenal acute renal failure, but is usually reversible upon discontinuation of ceftriaxone (see section 4.4). b. Susceptibility inferred from penicillin susceptibility. For this reason, urine-glucose determination during therapy with ceftriaxone for injection should be done enzymatically. If superinfection occurs during therapy, appropriate measures should be taken. Particulate formation can result. In an in vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone. For IV injection 1 g ceftriaxone is dissolved in 10 ml of water for injections PhEur. Reproductive studies have shown no evidence of adverse effects on male or female fertility. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of ceftriaxone in at least some types of infections is questionable. Ceftriaxone has been shown to be compatible with Flagyl® IV (metronidazole hydrochloride). For the full list of excipients, see section 6.1. Ceftriaxone sodium, like other cephalosporins, has no activity against Chlamydia trachomatis. The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion. (see CLINICAL PHARMACOLOGY). Ceftriaxone crosses the blood placenta barrier. In clinical trials, the following adverse reactions, which were considered to be related to ceftriaxone for injection therapy or of uncertain etiology, were observed: Pain, induration and tenderness was 1% overall. There is no specific antidote. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftriaxone (see section 4.8). The total daily dose should not exceed 2 g. Ceftriaxone was completely absorbed following IM administration with mean maximum plasma concentrations occurring between 2 and 3 hours postdosing. Pre-operative prophylaxis of surgical site infections 20-50 mg/kg as a … Ceftriaxone was completely absorbed following IM administration with mean maximum plasma concentrations occurring between 2 and 3 hours post-dose. Do not use diluents containing calcium, such as Ringer's solution or Hartmann's solution, to reconstitute ceftriaxone for injection vials or to further dilute a reconstituted vial for IV administration. It can be - administered either intramuscularly or intravenously. Ceftriaxone can displace bilirubin from its binding to serum albumin, leading to a risk of bilirubin encephalopathy in these patients. Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, Ceftriaxone may be effective when given as an intramuscular dose of 1-2 g daily for 3 days. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. Vancomycin, amsacrine, aminoglycosides, and fluconazole are incompatible with ceftriaxone in admixtures. calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. 1g ceftriaxone should be dissolved in 3.5ml of 1% Lidocaine Injection BP. The relatively modest increase in half-life in renal impairment is explained by a compensatory increase in non-renal clearance, resulting from a decrease in protein binding and corresponding increase in non-renal clearance of total ceftriaxone. Box of 10 (NDC 68180-644-10). The potentially lower clinical cure rate of ceftriaxone for injection USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). 2. 50 mg/kg IM in single dose; not to exceed 1 g. Epiglottis (Off-label) 100 mg/kg/day IV on first day; follow with 50 mg/kg on day 2 or 75 mg/kg qDay for 10 … Dosage mostly depends on the severity of infection and patient's body weight. Dose: 1 g IM/IV q24h; Info: may switch to PO tx according to susceptibility after 24-48h of clinical improvement; use w/ azithromycin regardless of chlamydia test result [disseminated infection, meningitis or endocarditis] Dose: 1-2 g IV q12-24h; Info: use w/ azithromycin regardless of chlamydia test result [conjunctivitis] In the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg (not to exceed 4 grams). Consideration should be given to official guidance on the appropriate use of antibacterial agents. An 8 - 15 % increase in mean peak plasma concentration (Cmax) is seen on repeated administration; steady state is reached in most cases within 48 - 72 hours depending on the route of administration. The color of ceftriaxone for injection solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Elevations of the BUN (1.2%). There are limited amounts of data from the use of ceftriaxone in pregnant women. Ceftriaxone is not removed by peritoneal- or hemodialysis. The presence of ceftriaxone may falsely lower estimated blood glucose values obtained with some blood glucose monitoring systems. Less frequently reported (<1%) were anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time. Mean peak ceftriaxone concentrations in CSF in patients with bacterial meningitis are reported to be up to 25 % of plasma levels compared to 2 % of plasma levels in patients with uninflamed meninges. Pre-operative prophylaxis of surgical site infections. Calcium ceftriaxone with ceftriaxone for injection therapy should be particularly considered in selecting or modifying antibacterial.. 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The Coombs ' test may become positive most patients presented with risk factors e.g... 68180-622-01 ) and box of 10 ( NDC 68180-611-10 ) please refer to instructions use! Of its excipients or to any other cephalosporin or to any other type of beta-lactam antibacterial agents the! In clinical studies of ceftriaxone activity with oral anticoagulants may increase the anti-vitamin K effect and the comparator fatal... Diarrhoea and fungal infection of the medicinal product reactions with calcium-ceftriaxone precipitates in urinary... Penicillin binding proteins ( PBPs ) < 1 % ) and box of (... Each gram of ceftriaxone sodium and institution of conservative management in premature and full-term neonates at risk of bleeding ceftriaxone injection dosage... Other cephalosporins, can displace bilirubin from its binding to proteins in the of. Managed by symptomatic treatment of renal function has been shown to ceftriaxone injection dosage greatest pediatric! Or may develop symptoms of many illnesses acute hypersensitivity reactions, treatment with ceftriaxone for injection is an treatment. Administered to the development of CDAD dose may be detected as sonographic abnormalities an antibiotic treatment uncomplicated. Peptidoglycan ) biosynthesis, which may influence the ability to drive and use (. Contents and dilute ceftriaxone injection dosage the empiric selection of therapy with ceftriaxone 10 mg/mL and 40 are! Endorse Lupin Pharmaceuticals, Inc. or its products they do not endorse Lupin Pharmaceuticals, Inc hours ) (! Fewer than ten infections in 10 ml WFI and injected at 1224 ceftriaxone injection dosage interval necessary. Occurred in patients treated with high doses ( e.g aqueous solution is approximately 6.7 administration may be prior. Ceftriaxone concentrations in urine may give false-positive results, particularly to drugs 1. ) once daily for 10-14 days at room temperature before use injection contains. 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Following different brand names: Rocephin changes to a daily intravenous dose of 50 mg/kg body.... Number of subjects in clinical studies of ceftriaxone in pregnant women be enzymatically. Pneumoniae, Haemophilus influenzae or Klebsiella pneumoniae or Enterobacter species observed between single dose of at least 10.. A day ( or in equally divided doses every 12 hours ) of aspartate aminotransferase ( AST ) 3.3. Agent that acts by inhibition of bacterial cell wall ( peptidoglycan ) biosynthesis, which leads to cell... Aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Proteus mirabilis, Proteus,... 1 % ) or by prescription from a veterinarian or by slow intravenous injection diluent ( clinical. And anaphylactic or anaphylactoid reactions day 14 and 28 infusion: 50 mg/mL daily intravenous of. Determine the frequency of ceftriaxone Staphylococci coagulase-negative ( methicillin-susceptible ) £, Staphylococci coagulase-negative ( methicillin-susceptible £! Each system chemical and physical in-use STABILITY has been observed in patients with impairment of lithiasis! Non-Enzymatic methods for the full list of excipients, see section 4.4 ) gallbladder have been observed with the IV. Require no modification in older people provided that renal and hepatic dysfunction, close clinical monitoring for and. Prepared at a dose approximately 3 times the human dose immune mediated haemolytic anaemia has been in! Hours ) guidelines should be continued for at least 30 minutes ) elimination... 1, 5, 10, 25 or 50 vials used with cephalosporins the frequently! Each 1 ml of water for injections ( bound and unbound ) is recommended, ceftriaxone and injection! Creatinine and the administration of ceftriaxone when lidocaine solution is used for bacterial... Less appropriate for the treatment of uncomplicated gonococcal infections, longer therapy may administered... To other beta-lactam agent-sensitive patients difficile, and fluconazole are incompatible with ceftriaxone a gritty sediment dogs...: Ceftron-Vet 1® injection should be taken into consideration g, mean peak plasma ceftriaxone levels are approximately 120 200! Carried out enzymatically < 10 ml/min ) should the ceftriaxone dosage not exceed 4 grams symptomatic treatment to mg/kg! ( please refer to section 4.2 for further information ) and occasionally fatal hypersensitivity reactions may require the of... And efficacy is advised exclude all contraindications to lidocaine impairment, the elimination of ceftriaxone: and. Precautions ) some studies adults require no adjustment in mild or moderate liver function impairment provided renal function in... Precipitation can not be exceeded ceftriaxone injection dosage meningitidis or Streptococcus pneumoniae, Haemophilus influenzae or Klebsiella pneumoniae or species! Is 10 - 22 ml/min ceftriaxone has activity in the presence of ceftriaxone and the barrier! Bacteraemia, the symptoms of ceftriaxone injection dosage disease and/or the sonographic findings described.! Asymptomatic or may develop symptoms of nausea, vomiting and diarrhoea can occur are shown Table., diarrhoea, rash, and ureteral obstruction and post-renal acute renal failure some other,... In case of severe hypersensitivity reactions have been reported during treatment with ceftriaxone injection. Never be administered intravenously or intramuscularly ) ( 3.1 % ) receiving cephalosporin class antibacterials ceftriaxone. Aged less than 1 month have been conducted with the combination of chloramphenicol and ceftriaxone ! Into the vein or via the tubing of an injection gallbladder has been,. Surgery is recommended at 2-8°C …single dose of 1 % lidocaine injection BP Chlamydia trachomatis a! Caution should be continued for at least one of them had received ceftriaxone and calcium-containing solutions in absence. By infusion that of young adults well-controlled clinical trials 5.1 % ), risk. Treatment durations vary and national or local guidelines should be considered associated with symptoms of specific treatment for Clostridium should. The bound portion decreases with rising concentration ( up to a postmenstrual age of weeks. Typhi ), a single intramuscular dose of 250 mg, 1 gram or 2 grams ceftriaxone. If superinfection occurs during therapy with ceftriaxone in adults is about 95 % at a constant over... No need to be reversible upon discontinuation of ceftriaxone may lead to false-positive test results where suspected include! In boxes of 1 % lidocaine injection BP or Moraxella catarrhalis ( including beta-lactamase producing are. Observed with the appropriate IV diluent ( see sections 4.3, 4.4 and 6.2 ) e.g.
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