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Meropenem

Medically reviewed on Feb 15, 2019

Pronunciation

(mer oh PEN em)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Intravenous:

Merrem: 500 mg (1 ea [DSC]); 1 g (1 ea [DSC])

Generic: 500 mg (1 ea); 1 g (1 ea); 1 g/50 mL in NaCl 0.9% (1 ea); 500 mg/50 mL in NaCl 0.9% (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

Merrem: 500 mg (1 ea); 1 g (1 ea) [pyrogen free]

Generic: 500 mg (1 ea [DSC]); 1 g (1 ea [DSC])

Brand Names: U.S.

  • Merrem

Pharmacologic Category

  • Antibiotic, Carbapenem

Pharmacology

Inhibits bacterial cell wall synthesis by binding to several of the penicillin-binding proteins, which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis; bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested

Distribution

Penetrates into most tissues and body fluids including urinary tract, peritoneal fluid, bone, bile, lung, bronchial mucosa, muscle tissue, heart valves (Craig 1997), and CSF (CSF penetration: Neonates and Infants ≤3 months: 70%)

Vd:

Neonates and Infants ≤3 months: Median: ~0.47 L/kg (Smith 2011)

Children: 0.3-0.4 L/kg (Blumer 1995)

Adults: 15 to 20 L

Metabolism

Hepatic; hydrolysis of beta-lactam bond to open beta-lactam form (inactive) (Craig, 1997)

Excretion

Urine (~70% as unchanged drug; ~28% inactive metabolite); feces (2%)

Clearance: Neonates and Infants ≤3 months: 0.12 L/hour/kg (Smith 2011); Infants and Children: 0.26-0.37 L/hour/kg (Blumer 1995)

Time to Peak

Tissue: ~1 hour following infusion except in bile, lung, and muscle; CSF: 2 to 3 hours with inflamed meninges

Half-Life Elimination

Neonates and Infants ≤3 months: Median: 2.7 hours; range: 1.6- 3.8 hours (Smith 2011)

Infants and Children 3 months to 2 years: 1.5 hours

Children 2-12 years and Adults: 1 hour

Protein Binding

~2%

Special Populations: Renal Function Impairment

Clearance correlates with CrCl in patients with renal impairment.

Special Populations: Elderly

Reduction in plasma clearance correlates with age-associated reduction in creatinine clearance (CrCl) (Craig 1997)

Use: Labeled Indications

Meningitis, bacterial: Treatment of bacterial meningitis in pediatric patients 3 months and older caused by Haemophilus influenzae, Neisseria meningitidis, and penicillin-susceptible isolates of Streptococcus pneumoniae.

Skin and skin structure infections, complicated: Treatment of complicated skin and skin structure infections in adults and pediatric patients 3 months and older caused by Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.

Intra-abdominal infections: Treatment of complicated appendicitis and peritonitis in adult and pediatric patients caused by viridans group streptococci, E. coli, Klebsiella pneumoniae, P. aeruginosa, B. fragilis, B. thetaiotaomicron, and Peptostreptococcus species.

Off Label Uses

Catheter-related blood stream infections

Based on the Infectious Disease Society of America (IDSA) Diagnosis and Management of Intravascular Catheter-Related Infection guidelines, meropenem given for catheter-related blood stream infections is effective and recommended in the management of this condition.

Cystic fibrosis, pulmonary exacerbation

Data from several randomized trials in patients with cystic fibrosis and infection with Pseudomonas aeruginosa treated with meropenem (with and without the use of tobramycin) supports the use of meropenem in the treatment of this condition [Blumer 2005], [Byrne 1995], [Latzin 2008]. Clinical experience also suggests the use of meropenem for pulmonary exacerbation in patients with cystic fibrosis [Chmiel 2014], [Zobell 2012]. Additional trials may be necessary to further define the role of meropenem in this condition.

Febrile neutropenia

Based on the Infectious Disease Society of America (IDSA) Clinical Practice Guideline for the Use of Antimicrobial Agents in Neutropenic Patients with Cancer: 2010 Update, meropenem given for febrile neutropenia is effective and recommended in the management of this condition.

Gynecologic and pelvis infection

Data from randomized trials support the use of meropenem in the treatment of gynecologic and pelvic infections (eg, endometritis, pelvic cellulitis, pelvic inflammatory disease, salpingitis) [Hemsell 1997], [Maggioni 1998]. Additional trials may be necessary to further define the role of meropenem in this condition.

Melioidosis (Burkholderia pseudomallei)

Melioidosis is a worldwide subtropic and tropic bacterial disease due to contact with Burkholderia pseudomallei contaminated water or soil [Lipsitz 2012]. Data from a limited number of patients treated with meropenem (case series of 63 patients in a single institution) suggest that meropenem may be beneficial for the treatment of this condition [Cheng 2004].

A DHHS Workshop on Treatment of and Postexposure Prophylaxis for Burkholderia pseudomallei and B. mallei infection also supports the use of meropenem as a second-line agent for initial treatment of melioidosis [Lipsitz 2012]. Additional data may be necessary to further define the role of meropenem for the treatment of melioidosis.

Pneumonia, hospital-acquired or ventilator-associated

Based on the Infectious Diseases Society of America and the American Thoracic Society (IDSA/ATS) guidelines for management of adults with hospital-acquired and ventilator-associated pneumonia, meropenem given for the empiric treatment of hospital-acquired or ventilator-associated pneumonia, alone or in combination with other antimicrobials (dependent on patient factors), is an effective and recommended treatment option in the management of this condition.

Prosthetic joint infection

Based on the Infectious Diseases Society of America (IDSA) Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guideline, meropenem given for prosthetic joint infection is effective and recommended in the management of this condition.

Skin and soft tissue necrotizing infections

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), meropenem, in combination with an agent effective against methicillin resistant S. aureus (MRSA) (eg, vancomycin, linezolid, daptomycin), is an effective and recommended empiric treatment for polymicrobial (mixed) necrotizing infections of the skin, fascia, and muscle.

Surgical site Infection

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), meropenem is an effective and recommended option for treatment of surgical site infections occurring after intestinal or genitourinary tract surgery. Systemic antibacterials are not routinely indicated for surgical site infections, but may be beneficial (in conjunction with suture removal plus incision and drainage) in patients with significant systemic response (eg, temperature >38.5ºC, heart rate >110 beats per minute, erythema/induration extending >5 cm from incision, WBC >12,000/mm3).

Urinary tract infection, complicated (including pyelonephritis)

Data from a multicenter, randomized, parallel-group study support the use of meropenem in the treatment of complicated urinary tract infections [Cox 1995]. Clinical experience also suggests the utility of meropenem in the treatment of complicated urinary tract infections, although use should be reserved for critically ill patients or patients with risk factor(s) for multidrug-resistant (MDR) pathogens, including extended-spectrum beta-lactamase (ESBL)-producing organisms [Hooton 2018].

Contraindications

Hypersensitivity to meropenem, other drugs in the same class, or any component of the formulation; patients who have experienced anaphylactic reactions to beta-lactams

Dosing: Adult

Usual dosage range: IV: 1.5 to 6 g daily divided every 8 hours

Extended infusion method (off-label dosing): IV: 0.5 to 2 g over 3 hours every 8 hours (Crandon 2011; Dandekar 2003). Note: Dosing used at some centers and is based on pharmacokinetic/pharmacodynamic modeling and not clinical efficacy data. Meropenem stability (admixed with NS at a concentration of 20 mg/mL) at room temperature for >1 hour or under refrigeration for >15 hours is not supported by the manufacturer. Data exist supporting stability (admixed with NS at a concentration of 20 mg/mL) at room temperature for ≤4 hours and under refrigeration ≤24 hours (Patel 1997).

Indication-specific dosing:

Meningitis, bacterial (community-acquired or health care associated): As a component of empiric therapy or pathogen-specific therapy (eg, Acinetobacter baumannii, P. aeruginosa, extended spectrum beta-lactamase-producing gram-negative bacilli; alternative agent for other Enterobacteriaceae, Listeria monocytogenes, Neisseria meningitidis, and S. pneumoniae): IV: 2 g every 8 hours; for empiric therapy, use in combination with vancomycin (IDSA [Tunkel 2004]; IDSA [Tunkel 2017])

Catheter-related bloodstream infections (off-label use): IV: 1 g every 8 hours (Mermel 2009)

Cholangitis, intra-abdominal infections, complicated: IV: 1 g every 8 hours. Note: 2010 IDSA guidelines recommend treatment duration of 4 to 7 days (provided source controlled). Not recommended for mild-to-moderate, community-acquired intra-abdominal infections due to risk of toxicity and the development of resistant organisms (Solomkin 2010).

Cystic fibrosis, pulmonary exacerbation (off-label use): IV: 2 g every 8 hours (Chmiel 2014)

Febrile neutropenia (off-label use): IV: 1 g every 8 hours (Ohata 2011; Paul 2010)

Gynecologic and pelvic infections (off-label use): IV: 500 mg every 8 hours (Hemsell 1997; Maggioni 1998)

Melioidosis (Burkholderia pseudomallei) (off-label use): IV: Initial treatment (intensive-phase): 1 g every 8 hours (Cheng 2004; Inglis 2006; Lipsitz 2012). Note: Meropenem is an alternative treatment to ceftazidime for melioidosis; continued treatment with oral antibiotics is recommended after intensive-phase is completed (Lipsitz 2012).

Pneumonia (hospital-acquired, healthcare-associated, or ventilator-associated) (off-label use): IV: 1 g every 8 hours (ATS/IDSA 2005)

Prosthetic joint infection, Pseudomonas aeruginosa (off-label use): IV: 1 g every 8 hours for 4 to 6 weeks (consider addition of aminoglycoside) (IDSA [Osmon 2013])

Skin and skin structure infections, complicated: IV:

Pseudomonas aeruginosa-suspected or confirmed: 1 g every 8 hours

Pseudomonas aeruginosa not suspected: 500 mg every 8 hours

Skin and soft tissue necrotizing infections (off-label use): IV: 1 g every 8 hours in combination with an agent effective against MRSA (eg, vancomycin, linezolid, daptomycin) for empiric therapy of polymicrobial (mixed) infections. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014]).

Surgical site infection (intestinal or genitourinary tract surgery) (off-label use): IV: 1 g every 8 hours (IDSA [Stevens 2014])

Urinary tract infection, complicated (including pyelonephritis) (off-label use): IV: 1 g every 8 hours for 10 to 14 days; when used for empiric therapy, use alone or in combination with other appropriate agents. Note: Reserved for critically ill patients or for patients with risk factor(s) for MDR pathogens, including ESBL-producing organisms (Hooton 2018).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

General dosing, susceptible infection (non-CNS): Infants, Children, and Adolescents: IV: 20 mg/kg/dose every 8 hours; maximum dose: 1,000 mg/dose (Bradley 2017)

Cystic fibrosis, pulmonary exacerbation: Limited data available: Infants, Children, and Adolescents: IV: 40 mg/kg/dose every 8 hours; maximum dose: 2,000 mg/dose (Zobell 2012)

Febrile neutropenia, empiric treatment: Limited data available: Infants, Children, and Adolescents: IV: 20 mg/kg/dose every 8 hours; maximum dose: 1,000 mg/dose (Bradley 2017; Lehrnbecher 2017)

Intra-abdominal infection, complicated: Note: IDSA guidelines recommend treatment duration of 4 to 7 days (Solomkin 2010)

Infants 1 to <3 months:

GA <32 weeks: IV: 20 mg/kg/dose every 8 hours

GA ≥32 weeks: IV: 30 mg/kg/dose every 8 hours

Infants ≥3 months, Children, and Adolescents: IV: 20 mg/kg/dose every 8 hours; maximum dose: 1,000 mg/dose

Meningitis: Infants (Limited data available <3 months of age), Children, and Adolescents: IV: 40 mg/kg/dose every 8 hours; maximum dose: 2,000 mg/dose (Bradley 2017); duration of therapy dependent upon pathogen: N. meningitidis, H. influenza: 7 days; S. pneumoniae: 10 to 14 days; aerobic gram-negative bacilli: 21 days (Tunkel 2004)

Skin and skin structure infection, complicated:

Manufacturer's labeling: Infants ≥3 months, Children, and Adolescents: IV: 10 mg/kg/dose every 8 hours; maximum dose: 500 mg/dose

Severe or necrotizing infections: Infants, Children, and Adolescents: IV: 20 mg/kg/dose every 8 hours; maximum dose: 1,000 mg/dose (IDSA [Stevens 2014])

Reconstitution

Meropenem infusion vials may be reconstituted with SWFI. The 500 mg vials should be reconstituted with 10 mL, and 1 g vials with 20 mL. May be further diluted to a final concentration ranging from 1 to 20 mg/mL with a compatible solution for infusion. Consult detailed reference/product labeling for compatibility.

Duplex: Unlatch side tab, unfold, remove foil strip from drug chamber. Point set port in downward direction, fold container just below the diluent meniscus, and squeeze the diluent chamber until the seal between the diluent and drug powder opens. Agitate until dissolved.

Administration

IV:

Infants <3 months: Administer as an IV infusion over 30 minutes

Infants ≥3 months, Children, Adolescents, and Adults: Administer IV infusion over 15 to 30 minutes; IV bolus injection (5 to 20 mL) over 3 to 5 minutes

Extended infusion administration (off-label dosing): Adults: Administer over 3 hours (Crandon 2011; Dandekar, 2003). Note: Must consider meropenem’s limited room temperature stability if using extended infusions

Dietary Considerations

Some products may contain sodium.

Storage

Freshly prepared solutions should be used. However, constituted solutions maintain satisfactory potency under the conditions described below. Solutions should not be frozen.

Store intact vials and unactivated Duplex containers at 20°C to 25°C (68°F to 77°F). Unactivated duplex units with foil strip removed from the drug chamber must be protected from light and used within 7 days at room temperature. Once activated, must be used within 1 hour if stored at room temperature or within 15 hours if stored under refrigeration. Do not freeze.

Dry powder should be stored at controlled room temperature 20°C to 25°C (68°F to 77°F).

Injection reconstitution: Stability in vial when constituted (up to 50 mg/mL) with:

SWFI: Stable for up to 3 hours at up to 25°C (77°F) or for up to 13 hours at up to 5°C (41°F).

Infusion admixture (1 to 20 mg/mL): Solution is stable when diluted in NS for 1 hour at up to 25°C (77°F) or 15 hours at up to 5°C (41°F). Solutions constituted with dextrose injection 5% should be used immediately. Note: Meropenem stability (admixed with NS at a concentration of 20 mg/mL) at room temperature for >1 hour or under refrigeration for >15 hours is not supported by the manufacturer. Data exist supporting stability (admixed with NS at a concentration of 20 mg/mL) at room temperature for ≤4 hours and under refrigeration ≤24 hours (Patel, 1997).

Duplex container: Following reconstitution/activation, use within 1 hour if stored at room temperature or 15 hours refrigerated

Drug Interactions

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

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

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Probenecid: May increase the serum concentration of Meropenem. Avoid combination

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

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

Valproate Products: Carbapenems may decrease the serum concentration of Valproate Products. Management: Concurrent use of carbapenem antibiotics with valproic acid is generally not recommended. Alternative antimicrobial agents should be considered, but if a concurrent carbapenem is necessary, consider additional anti-seizure medication. Consider therapy modification

Test Interactions

Positive Coombs' [direct]

Adverse Reactions

1% to 10%:

Cardiovascular: Peripheral vascular disease (>1%), shock (1%), bradycardia (≤1%), cardiac arrest (≤1%), cardiac failure (≤1%), chest pain (≤1%), hypertension (≤1%), hypotension (≤1%), myocardial infarction (≤1%), peripheral edema (≤1%), pulmonary embolism (≤1%), syncope (≤1%), tachycardia (≤1%)

Central nervous system: Headache (2% to 8%), pain (≤5%), agitation (≤1%), anxiety (≤1%), chills (≤1%), confusion (≤1%), delirium (≤1%), depression (≤1%), dizziness (≤1%), drowsiness (≤1%), hallucination (≤1%), insomnia (≤1%), nervousness (≤1%), paresthesia (≤1%), seizure (≤1%)

Dermatologic: Skin rash (2% to 3%, includes diaper-area moniliasis in infants), pruritus (1%), dermal ulcer (≤1%), diaphoresis (≤1%), urticaria (≤1%)

Endocrine & metabolic: Hypoglycemia (>1%), hypervolemia (≤1%)

Gastrointestinal: Nausea (≤8%), diarrhea (4% to 7%), constipation (1% to 7%), vomiting (≤4%), oral candidiasis (≤2%), gastrointestinal disease (>1%), glossitis (1%), abdominal pain (≤1%), anorexia (≤1%), dyspepsia (≤1%), enlargement of abdomen (≤1%), flatulence (≤1%), intestinal obstruction (≤1%)

Genitourinary: Dysuria (≤1%), pelvic pain (≤1%), urinary incontinence (≤1%), vulvovaginal candidiasis (≤1%)

Hematologic & oncologic: Anemia (≤6%), hypochromic anemia (≤1%)

Hepatic: Cholestatic jaundice (≤1%), hepatic failure (≤1%), jaundice (≤1%)

Infection: Sepsis (2%)

Local: Inflammation at injection site (2%)

Neuromuscular & skeletal: Asthenia (≤1%), back pain (≤1%)

Renal: Renal failure (≤1%)

Respiratory: Pharyngitis (>1%), pneumonia (>1%), apnea (1%), asthma (≤1%), cough (≤1%), dyspnea (≤1%), hypoxia (≤1%), pleural effusion (≤1%), pulmonary edema (≤1%), respiratory tract disease (≤1%)

Miscellaneous: Accidental injury (>1%), fever (≤1%)

Frequency not defined:

Endocrine & metabolic: Hypokalemia, increased lactate dehydrogenase

Genitourinary: Hematuria

Hematologic & oncologic: Decreased hematocrit, decreased hemoglobin, decreased partial thromboplastin time, decreased prothrombin time, decreased white blood cell count, eosinophilia, leukocytosis, quantitative disorders of platelets

Hepatic: Increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, increased serum bilirubin

Renal: Increased blood urea nitrogen, increased serum creatinine

<1%, postmarketing, and/or case reports: Acute generalized exanthematous pustulosis, agranulocytosis, angioedema, Clostridioides (formerly Clostridium) difficile-associated diarrhea, DRESS syndrome, edema at insertion site, epistaxis, erythema multiforme, gastrointestinal hemorrhage, hemolytic anemia, hemoperitoneum, injection site reaction, leukopenia, localized phlebitis, local thrombophlebitis, melena, neutropenia, pain at injection site, positive direct Coombs test, positive indirect Coombs test, Stevens-Johnson syndrome, toxic epidermal necrolysis

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis, have been reported (some without a history of previous allergic reactions to beta-lactams).

• CNS effects: Carbapenems have been associated with CNS adverse effects, including confusional states and seizures (myoclonic); use caution with CNS disorders (eg, brain lesions and history of seizures) and adjust dose in renal impairment to avoid drug accumulation, which may increase seizure risk. Outpatient use may result in paresthesias, seizures, delirium and/or headaches that can impair neuromotor function and alertness; patients should not operate machinery or drive until it is established that meropenem is well tolerated.

• Dermatological effects: Severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, and acute generalized exanthematous pustulosis have occurred; discontinue immediately for severe reactions.

• 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.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required in patients with creatinine clearance ≤50 mL/minute. Increased seizure risk and thrombocytopenia have been reported in patients with renal impairment.

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.

Special populations:

• Elderly: Lower doses (based upon renal function) are often required in the elderly.

Monitoring Parameters

Perform culture and sensitivity testing prior to initiating therapy. Monitor for signs of anaphylaxis during first dose. During prolonged therapy, monitor renal function, liver function, CBC.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Incomplete transplacental transfer of meropenem was found using an ex vivo human perfusion model.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, nausea, vomiting, diarrhea, or constipation. Have patient report immediately to prescriber seizures, muscle rigidity, tremors, abnormal movements, burning or numbness feeling, severe loss of strength and energy, confusion, signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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