Neurotoxicity, manifested as both auditory and vestibular ototoxicity, can occur. The auditory changes are irreversible, are usually bilateral, and may be partial or total. Eighth nerve impairment and nephrotoxicity may develop, primarily in patients having preexisting renal damage and in those with healthy renal function to whom aminoglycosides are administered for longer periods or in higher doses than those recommended. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions. The risk of aminoglycoside-induced hearing loss increases with the degree of exposure to either high peak or high trough serum concentrations. Patients who develop cochlear damage may not have symptoms during therapy to warn them of eighth-nerve toxicity, and partial or total irreversible bilateral deafness may continue to develop after the drug has been discontinued. Keep patients treated with tobramycin injection and other aminoglycosides under close clinical observation because these drugs have an inherent potential for causing ototoxicity.
Rarely, nephrotoxicity may not become apparent until the first few days after cessation of therapy. Aminoglycoside-induced nephrotoxicity usually is reversible. Keep patients treated with tobramycin injection and other aminoglycosides under close clinical observation because these drugs have an inherent potential for causing nephrotoxicity.
Closely monitor renal and eighth nerve function in patients with known or suspected renal impairment and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Periodically monitor peak and trough serum concentrations of aminoglycosides during therapy to assure adequate levels and to avoid potentially toxic levels. Prolonged serum concentrations above 12 mcg/mL should be avoided. Rising trough levels (above 2 mcg/mL) may indicate tissue accumulation. Such accumulation, excessive peak concentrations, advanced age, and cumulative dose may contribute to ototoxicity and nephrotoxicity. Examine urine for decreased specific gravity and increased excretion of protein, cells, and casts. Periodically measure serum urea nitrogen (BUN), serum creatinine, and creatinine clearance. When feasible, it is recommended that serial audiograms be obtained in patients old enough to be tested, particularly high-risk patients. Evidence of impairment of renal, vestibular, or auditory function requires discontinuation of the drug or dosage adjustment.
Use tobramycin injection with caution in premature and neonatal infants because of their renal immaturity and the resulting prolongation of serum half-life of the drug.
Avoid concurrent and sequential use of other neurotoxic or nephrotoxic antibiotics, particularly other aminoglycosides (eg, amikacin, streptomycin, neomycin, kanamycin, gentamicin, paromomycin), cephaloridine, viomycin, polymyxin B, colistin, cisplatin, and vancomycin. Other factors that may increase patient risk are advanced age and dehydration.
Do not give aminoglycosides concurrently with potent diuretics, such as ethacrynic acid and furosemide. Some diuretics themselves cause ototoxicity, and intravenously (IV) administered diuretics enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
Aminoglycosides can cause fetal harm when administered to a pregnant woman.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Generic: 10 mg/mL (2 mL); 80 mg/2 mL (2 mL); 1.2 g/30 mL (30 mL)
Solution, Injection [preservative free]:
Generic: 80 mg/2 mL (2 mL); 2 g/50 mL (50 mL)
Solution Reconstituted, Injection:
Generic: 1.2 g (1 ea)
Solution Reconstituted, Injection [preservative free]:
Generic: 1.2 g (1 ea)
Mechanism of Action
Interferes with bacterial protein synthesis by binding to 30S ribosomal subunit, resulting in a defective bacterial cell membrane
Oral: Poorly absorbed
IM: Rapid and complete
Distributes to extracellular fluid, including serum, abscesses, ascitic, pericardial, pleural, synovial, lymphatic, and peritoneal fluids; poor penetration into CSF, eye, bone, prostate; Vd: Higher in neonates than older pediatric and adult patients; also increased in patients with edema, ascites, fluid overload; decreased in patients with dehydration; Systemic:
Neonates: 0.45 ± 0.1 L/kg
Infants: 0.4 ± 0.1 L/kg
Children: 0.35 ± 0.15 L/kg
Adolescents: 0.3 ± 0.1 L/kg
Adults: 0.2 to 0.3 L/kg
Normal renal function: Urine (~90% to 95%) within 24 hours
Time to Peak
Serum: IM: 30 to 60 minutes; IV: ~30 minutes; Note: Distribution may be prolonged after larger doses. One study reported a 1.7-hour distribution period after a 60-minute, high-dose aminoglycoside infusion (Demczar 1997).
Neonates: ≤1,200 g: 11 hours; >1,200 g: 2 to 9 hours
Infants: 4 ± 1 hour
Children: 2 ± 1 hour
Adolescents: 1.5 ± 1 hour
Adults: IV: 2 to 3 hours; directly dependent upon glomerular filtration rate
Adults with impaired renal function: 5 to 70 hours
Use in Specific Populations
Special Populations: Renal Function Impairment
Clearance is decreased in renal impairment.
Use: Labeled Indications
Treatment of documented or suspected infections caused by susceptible gram-negative bacilli, including Pseudomonas aeruginosa.
Hypersensitivity to tobramycin, other aminoglycosides, or any component of the formulation
Dosage and Administration
Note: Individualization is critical because of the narrow therapeutic index.
In underweight and nonobese patients, use of total body weight (TBW) instead of ideal body weight for determining the initial mg/kg/dose is widely accepted (Nicolau 1995). Ideal body weight (IBW) also may be used to determine doses for patients who are neither underweight nor obese (Gilbert 2009).
Initial and periodic plasma drug levels (eg, peak and trough with conventional dosing, post dose level at a prespecified time with extended-interval dosing) should be determined, particularly in critically-ill patients with serious infections or in disease states known to significantly alter aminoglycoside pharmacokinetics (eg, cystic fibrosis, burns, or major surgery).
Severe life-threatening infections: IM, IV:
Conventional: 1 to 2.5 mg/kg/dose every 8 to 12 hours; to ensure adequate peak concentrations early in therapy, higher initial dosage may be considered in selected patients when extracellular water is increased (edema, septic shock, postsurgical, and/or trauma)
Once-daily: 4 to 7 mg/kg/dose once daily; some clinicians recommend this approach for all patients with normal renal function; this dose is at least as efficacious with similar, if not less, toxicity than conventional dosing.
Brucellosis: IM, IV: 240 mg (IM) daily or 5 mg/kg (IV) daily for 7 days; either regimen recommended in combination with doxycycline
Cerebrospinal fluid (CSF) shunt infection (adjunct to systemic therapy): Intraventricular (use a preservative-free preparation) (off-label route): 5 to 20 mg/day; some experts recommend adjusting dosage and administration interval based on CSF tobramycin concentrations (goal: 10 to 20 times MIC of causative organism) (IDSA [Tunkel 2017]; data are limited (Smetana 2018). When intraventricular tobramycin is administered via a ventricular drain, clamp drain for 15 to 60 minutes after administration (allows solution to equilibrate in CSF) (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]). Note: Intraventricular administration is generally reserved for use in patients who fail parenteral therapy despite removal of CSF shunt or when CSF shunt cannot be removed (Baddour 2018).
Cholangitis: IM, IV: 4 to 6 mg/kg once daily with ampicillin
Diverticulitis, complicated: IM, IV: 1.5 to 2 mg/kg every 8 hours (with ampicillin and metronidazole)
Meningitis, bacterial due to Pseudomonas aeruginosa: IV: 5 mg/kg/day in divided doses every 8 hours (administered with other antimicrobials) (IDSA [Tunkel 2004]; IDSA [Tunkel 2017])
Pelvic inflammatory disease: IM, IV: Loading dose: 2 mg/kg, then 1.5 mg/kg every 8 hours or 4.5 mg/kg once daily
Plague (Yersinia pestis): IM, IV: Treatment: 5 mg/kg/day, followed by postexposure prophylaxis with doxycycline
Pneumonia, hospital-acquired or ventilator-associated: IV: 5 to 7 mg/kg/day once daily for 7 days; may consider shorter or longer duration depending on rate of clinical improvement. When used as empiric therapy, use in combination with an agent active against S. aureus and an additional antipseudomonal agent. Note: Aminoglycosides are not recommended as monotherapy in patients with hospital-acquired or ventilator-associated pneumonia due to P. aeruginosa (Kalil 2016).
Prophylaxis against endocarditis (dental, oral, upper respiratory procedures, GI/GU procedures): IM, IV: 1.5 mg/kg with ampicillin (50 mg/kg) 30 minutes prior to procedure. Note: AHA guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis no longer recommended by the AHA.
Tularemia: IM, IV: 5 mg/kg/day divided every 8 hours for 1 to 2 weeks
Urinary tract infection, complicated (including pyelonephritis) (alternative agent): Outpatients: IM, IV: 5 mg/kg once, followed by 5 to 14 days of appropriate oral therapy. Note: Alternative parenteral agent when fluoroquinolones or beta-lactams cannot be used due to allergy, intolerance, unmodifiable drug interactions, or resistance (Hooton 2018).
Dosage should be based on an estimate of ideal body weight.
IM, IV: 1.5 to 5 mg/kg/day in 1 to 2 divided doses
IV: Once daily or extended interval: 5 to 7 mg/kg/dose given every 24, 36, or 48 hours based on creatinine clearance
Note: Dosage should be based on an estimate of ideal body weight. In morbidly obese children, adolescents, and adults, dosage requirement may best be estimated using a dosing weight of IBW + 0.4 (TBW - IBW). Dosage should be individualized based upon serum concentration monitoring. Initial and periodic plasma drug concentrations (eg, peak and trough with conventional dosing, post dose level at a prespecified time with extended-interval dosing) should be determined, particularly in critically ill patients with serious infections or in disease states known to significantly alter aminoglycoside pharmacokinetics (eg, cystic fibrosis, burns, or major surgery). Some dosing based on gentamicin studies:
General dosing, susceptible infection:
Conventional dosing: Infants, Children, and Adolescents: IM, IV: 6 to 7.5 mg/kg/day divided every 6 to 8 hours; individualize dosing based on patient-specific clinical parameters (Red Book [AAP 2015])
Extended-interval dosing: Limited data available:
Weight-directed: Infants, Children, and Adolescents: IV: 4.5 to 7.5 mg/kg/dose every 24 hours (Contopoulos-Ioannidis 2004; Red Book [AAP 2015])
Age-directed: Based on data from 114 patients, the following has been suggested (McDade 2010):
Infants ≥3 months and Children <2 years: IV: 9.5 mg/kg/dose every 24 hours
Children 2 to <8 years: IV: 8.5 mg/kg/dose every 24 hours
Children ≥8 years and Adolescents: IV: 7 mg/kg/dose every 24 hours
Cystic fibrosis, pulmonary infection: Infants, Children, and Adolescents:
Conventional dosing: IM, IV: 3.3 mg/kg/dose every 8 hours (Flume 2009)
Extended-interval dosing: IV: Initial: 10 to 12 mg/kg/dose every 24 hours (Flume 2009; Smyth 2005; Van Meter 2009); Note: The CF Foundation recommends extended-interval dosing as preferred over conventional dosing.
Endocarditis, treatment: Children and Adolescents: IV: 3 to 6 mg/kg/day divided every 8 hours; use in combination with other antibiotics dependent upon organism and source of infection (ie, valve-type) (AHA [Baltimore 2015])
Intra-abdominal infection, complicated: Infants, Children, and Adolescents: IV: 3 to 7.5 mg/kg/day divided every 8 to 24 hours (Solomkin 2010)
Meningitis (Tunkel 2004):
Infants and Children: IV: 7.5 mg/kg/day divided every 8 hours
Adolescents: IV: 5 mg/kg/day divided every 8 hours
VP-shunt infection, ventriculitis: Limited data available: Infants, Children, and Adolescents: Intraventricular/intrathecal (use a preservative-free preparation): 5 to 20 mg/day
Peritonitis (CAPD) (Warady 2012): Limited data available: Infants, Children, and Adolescents: Intraperitoneal: Continuous: Loading dose: 8 mg per liter of dialysate; maintenance dose: 4 mg per liter
Urinary tract infection:
Traditional dosing: Infants and Children 2 to 24 months: IV: 5 mg/kg/day divided every 8 hours (AAP 2011)
Extended-interval dosing: Limited data available: Based on data from 179 patients, the following age-directed dosing has been suggested (Carapetis 2001):
Infants and Children <5 years: IV: 7.5 mg/kg/dose every 24 hours
Children 5 to 10 years: IV: 6 mg/kg/dose every 24 hours
Children >10 years and Adolescents: IV: 4.5 mg/kg/dose every 24 hours
In moderate obesity (TBW/IBW ≥1.25) or greater, (eg, morbid obesity [TBW/IBW >2]), initial dosage requirement may be estimated using a dosing weight of IBW + 0.4 (TBW - IBW) (Traynor 1995).
Solution for injection: Dilute in 50-100 mL NS or D5W for IV infusion.
IM: May be administered IM by withdrawing the appropriate dose directly from a vial or by using a prefilled syringe. The pharmacy bulk package and tobramycin in sodium chloride 0.9% is not intended for IM administration.
IV: Administer by intermittent infusion over 20 to 60 minutes; higher doses are generally administered over 60 minutes (Aminimanizani 2002; Demczar 1997). Flush line with saline before and after administration.
Intraventricular (off-label route): Use preservative-free preparations only. When administered through a ventricular drain, clamp drain for 15 to 60 minutes before opening the drain to allow tobramycin solution to equilibrate in the CSF (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]).
May require supplementation of calcium, magnesium, potassium.
Stable at room temperature both as the clear, colorless solution and as the dry powder. Reconstituted solutions remain stable for 24 hours at room temperature and 96 hours when refrigerated.
Amphotericin B: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Arbekacin: May enhance the nephrotoxic effect of Aminoglycosides. Arbekacin may enhance the ototoxic effect of Aminoglycosides. Monitor therapy
Ataluren: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, an increased risk of nephrotoxicity may occur with the concomitant use of ataluren and aminoglycosides. Avoid combination
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Bisphosphonate Derivatives: Aminoglycosides may enhance the hypocalcemic effect of Bisphosphonate Derivatives. Monitor therapy
Botulinum Toxin-Containing Products: Aminoglycosides may enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Monitor therapy
Capreomycin: May enhance the neuromuscular-blocking effect of Aminoglycosides. Monitor therapy
CARBOplatin: Aminoglycosides may enhance the ototoxic effect of CARBOplatin. Especially with higher doses of carboplatin. Monitor therapy
Cefazedone: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cephalosporins (2nd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cephalosporins (3rd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cephalosporins (4th Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cephalothin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cephradine: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination
CISplatin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Colistimethate: Aminoglycosides may enhance the nephrotoxic effect of Colistimethate. Aminoglycosides may enhance the neuromuscular-blocking effect of Colistimethate. Consider therapy modification
CycloSPORINE (Systemic): Aminoglycosides may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Monitor therapy
Distigmine: Aminoglycosides may diminish the therapeutic effect of Distigmine. Monitor therapy
Foscarnet: May enhance the nephrotoxic effect of Aminoglycosides. Avoid combination
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Loop Diuretics: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, nephrotoxicity and ototoxicity. Monitor therapy
Mannitol (Systemic): May enhance the nephrotoxic effect of Aminoglycosides. Avoid combination
Mecamylamine: Aminoglycosides may enhance the neuromuscular-blocking effect of Mecamylamine. Avoid combination
Methoxyflurane: Aminoglycosides may enhance the nephrotoxic effect of Methoxyflurane. Avoid combination
Neuromuscular-Blocking Agents: Aminoglycosides may enhance the respiratory depressant effect of Neuromuscular-Blocking Agents. Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May decrease the excretion of Aminoglycosides. Data only in premature infants. Monitor therapy
Oxatomide: May enhance the ototoxic effect of Aminoglycosides. Monitor therapy
Penicillins: May decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Exceptions: Amoxicillin; Ampicillin; Bacampicillin; Cloxacillin; Dicloxacillin; Nafcillin; Oxacillin; Penicillin G (Parenteral/Aqueous); Penicillin G Benzathine; Penicillin G Procaine; Penicillin V Benzathine; Penicillin V Potassium. Consider therapy modification
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification
Tenofovir Products: Aminoglycosides may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification
Vancomycin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro, leading to a potential underestimation of aminoglycoside serum concentration.
Frequency not defined.
Central nervous system: Confusion, disorientation, dizziness, headache, lethargy, vertigo
Dermatologic: Exfoliative dermatitis, pruritus, skin rash, urticaria
Endocrine & metabolic: Decreased serum calcium, decreased serum magnesium, decreased serum potassium, decreased serum sodium, increased lactate dehydrogenase, increased nonprotein nitrogen
Gastrointestinal: Diarrhea, nausea, vomiting
Genitourinary: Casts in urine, oliguria, proteinuria
Hematologic & oncologic: Anemia, eosinophilia, granulocytopenia, leukocytosis, leukopenia, thrombocytopenia
Hepatic: Increased serum ALT, increased serum AST, increased serum bilirubin
Local: Pain at injection site
Otic: Auditory ototoxicity, hearing loss, tinnitus, vestibular ototoxicity
Renal: Increased blood urea nitrogen, increased serum creatinine
<1%, postmarketing, and/or case reports: Anaphylaxis, Clostridioides (formerly Clostridium) difficile-associated diarrhea, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
Concerns related to adverse effects:
- Nephrotoxicity: [US Boxed Warning]: May cause nephrotoxicity; usual risk factors include pre-existing renal impairment, concomitant nephrotoxic medications, advanced age, and dehydration. Discontinue treatment if signs of nephrotoxicity occur; renal damage is usually reversible.
- Neuromuscular blockade and respiratory paralysis: May cause neuromuscular blockade, respiratory failure, and prolonged respiratory paralysis, especially when given soon after anesthesia or muscle relaxants.
- Neurotoxicity: [US Boxed Warning]: May cause neurotoxicity; usual risk factors include pre-existing renal impairment, concomitant neuro-/nephrotoxic medications, advanced age, and dehydration. Ototoxicity is proportional to the amount of drug given and the duration of treatment. Tinnitus or vertigo may be indications of vestibular injury and impending bilateral irreversible damage. Tinnitus and/or hearing loss have also been reported. Discontinue treatment if signs of ototoxicity occur.
- Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
- Hearing impairment: Use with caution in patients with pre-existing vertigo, tinnitus, or hearing loss.
- Hypocalcemia: Use with caution in patients with hypocalcemia.
- Neuromuscular disorders: Use with caution in patients with neuromuscular disorders, including myasthenia gravis and Parkinson disease.
- Renal impairment: Use with caution in patients with pre-existing renal insufficiency; dosage modification required during systemic therapy.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
- Pregnancy: [US Boxed Warnings]: Aminoglycosides may cause fetal harm if administered to a pregnant woman.
Dosage form specific issues:
- Sulfite: Solution for injection may contain sodium metabisulfate; use caution in patients with sulfite allergy.
- Long-term use: Systemic therapy is not intended for long-term therapy due to toxic hazards associated with extended administration.
Urinalysis, urine output, BUN, serum creatinine, peak and trough plasma tobramycin levels. Levels are typically obtained after the third dose in conventional dosing. Be alert to ototoxicity; hearing should be tested before and during treatment
Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro. This may be clinically-significant for certain penicillin (ticarcillin, piperacillin, carbenicillin) and aminoglycoside (gentamicin, tobramycin) combination therapy in patients with significant renal impairment. Close monitoring of aminoglycoside levels is warranted.
Tobramycin crosses the placenta.
[US Boxed Warning]: Aminoglycosides may cause fetal harm if administered to a pregnant woman. There are several reports of total irreversible bilateral congenital deafness in children whose mothers received another aminoglycoside (streptomycin) during pregnancy. Although serious side effects to the fetus/infant have not been reported following maternal use of all aminoglycosides, a potential for harm exists.
Due to pregnancy-induced physiologic changes, some pharmacokinetic parameters of tobramycin may be altered (Bourget 1991). Tobramycin injection may be used for the management of cystic fibrosis in pregnant patients with Pseudomonas aeruginosa (inhalation is preferred unless risk of infection is great) (Edenborough 2008) and as an alternative antibiotic for prophylactic use prior to cesarean delivery (Bratzler 2013).
What is this drug used for?
- It is used to treat bacterial infections.
Frequently reported side effects of this drug
- Injection site pain
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain.
- Electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting.
- Passing out
- Sore throat
- Muscle weakness
- Burning or numbness feeling
- Noise or ringing in the ears
- Trouble hearing
- Hearing loss
- Severe loss of strength and energy
- Clostridioides (formerly Clostridium) (C. diff)-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools.
- Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes.
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
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