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Flagyl (Metronidazole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Flagyl (Metronidazole) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (352)
Death (27)
Life Threatening Events (11)
Disability (12)

Reports by Reaction Type

Drug Hypersensitivity (39)Nausea (23)Vomiting (20)Diarrhoea (17)Abdominal Pain (15)Urticaria (15)Confusional State (14)Pyrexia (14)NO Adverse Event (14)Clostridium Difficile Colitis (13)Headache (13)Erythema (13)

Below are a few examples of reports where side effects / adverse reactions may be related to Flagyl (Metronidazole). For a complete list or a specific selection of reports, please use the links above.

Possible Flagyl side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-27

Patient:

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Betamethasone Valerate
    Dosage: unk
    Start date: 2012-04-10
    End date: 2012-05-07

Flagyl
    Dosage: 1000 mg, unk
    Administration route: Oral
    Indication: Pseudomembranous Colitis
    Start date: 2012-04-03
    End date: 2012-04-04

Flagyl
    Dosage: 1000 unk, unk
    Administration route: Oral
    Start date: 2012-04-29
    End date: 2012-05-12

Vancomycin HCL
    Dosage: 1 mg, unk
    Start date: 2012-04-16
    End date: 2012-04-29

Zyvox
    Dosage: 1200 mg, unk
    Start date: 2012-05-02
    End date: 2012-05-15

Other drugs received by patient: Dorner; Aldactone; Dorner; Lebenin; Olopatadine HCL; Plavix; Pydoxal; Clobetasol Propionate; Hirudoid; Aspara K; Yunasupin; Vancomycin HCL; Gentamicin Sulfate; Nizoral; Hirudoid; Prednisolone; Plavix; Lebenin; Aspara K; Trichlormethiazide; Myser (Difluprednate); Myser (Difluprednate); Methylprednisolone Sodium Succinate



Possible Flagyl side effects in female

Reported by a physician from France on 2012-08-27

Patient: female

Reactions: Drug Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flagyl
    Administration route: Oral
    Indication: Oral Candidiasis
    Start date: 2011-08-13
    End date: 2011-08-29

Lasix
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-17

Propylthiouracil
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-18
    End date: 2011-08-22

Rocephin
    Indication: Bronchitis
    Start date: 2011-08-11
    End date: 2011-08-22

Rovamycine
    Indication: Bronchitis
    Start date: 2011-08-11

Roxithromycine
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2011-08-16
    End date: 2011-08-23

Other drugs received by patient: Potassium Chloride; Potassium Chloride; Transipeg (France)



Possible Flagyl side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male

Reactions: Pain in Extremity

Drug(s) suspected as cause:
Flagyl



Possible Flagyl side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient: male

Reactions: Intestinal Ischaemia, Abdominal Pain, Abdominal Distension, Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-02

Acetaminophen
    Indication: Product Used FOR Unknown Indication

Arixtra
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06
    End date: 2012-03-01

Arixtra
    Start date: 2012-01-27
    End date: 2012-03-01

Atarax
    Dosage: evening
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Chlorpromazine HCL
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-27

Codeine
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-03-01

Flagyl
    Indication: Product Used FOR Unknown Indication

Imodium
    Start date: 2012-02-02

Imodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06
    End date: 2012-03-01

Nexium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Quetiapine Fumarate
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-02-06

Quetiapine Fumarate
    Administration route: Oral
    Start date: 2012-03-06

Rocephin
    Indication: Product Used FOR Unknown Indication

Sandostatin
    Dosage: 1 in the morning and 1 in the evening
    Start date: 2012-03-01
    End date: 2012-03-01

Sandostatin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-03-01

Spasfon
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-02

Tranxene
    Dosage: in the evening
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Tranxene
    Start date: 2012-01-27
    End date: 2012-03-01



Possible Flagyl side effects in 53 year old female

Reported by a physician from United States on 2012-08-22

Patient: 53 year old female

Reactions: Abdominal Pain, Diarrhoea, Pouchitis, Gastric Disorder, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flagyl
    Dosage: unk
    Indication: Pouchitis
    Start date: 2012-05-01
    End date: 2012-05-01

Humira
    Dosage: 40 mg/0.8 ml
    Indication: Crohn's Disease
    Start date: 2010-01-01

Other drugs received by patient: Esomeprazole; Vincodin



Possible Flagyl side effects in 59 year old female

Reported by a physician from United States on 2012-08-22

Patient: 59 year old female

Reactions: Toxic Encephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flagyl



Possible Flagyl side effects in 71 year old

Reported by a physician from United States on 2012-08-21

Patient: 71 year old

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Allopurinol
    Dosage: unk

Flagyl
    Dosage: unk

Keflex
    Dosage: unk



Possible Flagyl side effects in 77 year old female

Reported by a pharmacist from United States on 2012-08-21

Patient: 77 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Neuropathy Peripheral

Drug(s) suspected as cause:
Flagyl

Other drugs received by patient: Amlodipine



Possible Flagyl side effects in 7 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 7 year old male, weighing 27.7 kg (60.9 pounds)

Reactions: Clostridial Infection

Drug(s) suspected as cause:
Flagyl



Possible Flagyl side effects in female

Reported by a physician from France on 2012-08-20

Patient: female

Reactions: Dysaesthesia, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flagyl
    Administration route: Oral
    Indication: Mastoiditis
    Start date: 2012-06-19
    End date: 2012-07-26

Ofloxacin
    Dosage: auricular drops 1.5mg/0.5ml
    Administration route: Oral
    Indication: Mastoiditis
    Start date: 2012-06-19

Rocephin
    Indication: Mastoiditis
    Start date: 2012-06-19

Other drugs received by patient: Antalgic; Previscan



Possible Flagyl side effects in 71 year old

Reported by a physician from United States on 2012-08-20

Patient: 71 year old

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Allopurinol
    Dosage: unk

Flagyl
    Dosage: unk

Keflex
    Dosage: unk



Possible Flagyl side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-20

Patient: male

Reactions: Abdominal Pain, Intestinal Ischaemia, Abdominal Distension, Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Indication: Product Used FOR Unknown Indication

Acetaminophen
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-02

Arixtra
    Start date: 2012-03-06
    End date: 2012-03-01

Arixtra
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-27
    End date: 2012-03-01

Atarax
    Dosage: evening
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Chlorpromazine HCL
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-27

Codeine
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-03-01

Flagyl
    Indication: Product Used FOR Unknown Indication

Imodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06
    End date: 2012-03-01

Imodium
    Start date: 2012-02-02

Nexium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Quetiapine Fumarate
    Administration route: Oral
    Start date: 2012-02-06

Quetiapine Fumarate
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-03-06

Rocephin
    Indication: Product Used FOR Unknown Indication

Sandostatin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-03-01

Sandostatin
    Dosage: 1 in the morning and 1 in the evening
    Start date: 2012-03-01
    End date: 2012-03-01

Spasfon
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-02

Tranxene
    Dosage: in the evening
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Tranxene
    Start date: 2012-01-27
    End date: 2012-03-01



Possible Flagyl side effects in 29 year old male

Reported by a physician from Singapore on 2012-08-13

Patient: 29 year old male

Reactions: Angioedema, Anaphylactic Reaction, Urticaria, Hypotension

Drug(s) suspected as cause:
Acyclovir
    Indication: Product Used FOR Unknown Indication

Ceftriaxone
    Indication: Product Used FOR Unknown Indication

Flagyl
    Indication: Product Used FOR Unknown Indication

Toradol
    Indication: Product Used FOR Unknown Indication



Possible Flagyl side effects in

Reported by a physician from Japan on 2012-08-13

Patient:

Reactions: Platelet Count Decreased, Erythema Multiforme

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Betamethasone
    Dosage: unk mg, unk
    Start date: 2012-04-10
    End date: 2012-05-07

Flagyl
    Dosage: 1000 mg, unk
    Start date: 2012-04-29
    End date: 2012-05-12

Flagyl
    Dosage: 1000 mg, unk
    Administration route: Oral
    Indication: Pseudomembranous Colitis
    Start date: 2012-04-03
    End date: 2012-04-04

Vancomycin Hydrochloride
    Dosage: 1 g, unk
    Start date: 2012-04-16
    End date: 2012-04-29

Zyvox
    Dosage: 1200 mg, unk

Other drugs received by patient: Lebenin; Yunasupin; Gentamicin Sulfate; Dorner; Lebenin; Pydoxal; Nizoral; Methylprednisolone Sodium Succinate; Targocid; Dorner; Myser (Difluprednate); Olopatadine HCL; Prednisolone; Nicoranta; Plavix; Trichlormethiazide; Vancomycin Hydrochloride; Aspara K; Myser (Difluprednate); Plavix; Aldactone; Aspara K



Possible Flagyl side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from Singapore on 2012-08-09

Patient: 64 year old male

Reactions: Periorbital Oedema

Drug(s) suspected as cause:
Flagyl
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication

Vibramycin
    Dosage: (df)
    Indication: Product Used FOR Unknown Indication



Possible Flagyl side effects in 51 year old female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 51 year old female, weighing 68.5 kg (150.7 pounds)

Reactions: Drug Hypersensitivity, Urticaria

Drug(s) suspected as cause:
Flagyl
    Dosage: 500 mg, 3x/day for 3 days
    Indication: Skin Infection
    Start date: 2012-04-30
    End date: 2012-05-01

Flagyl
    Dosage: 500 mg, daily from 4th day
    Start date: 2012-05-01
    End date: 2012-05-03



Possible Flagyl side effects in 72 year old female

Reported by a physician from France on 2012-08-08

Patient: 72 year old female, weighing 56.0 kg (123.2 pounds)

Reactions: Vascular Purpura

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atacand
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-06-03

Esidrix
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-06-03

Flagyl
    Administration route: Oral
    Start date: 2012-04-01

Nexium
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-06-03

Other drugs received by patient: Sectral; Plavix; Acetaminophen



Possible Flagyl side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-07

Patient: 58 year old female

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flagyl
    Dosage: unk
    Administration route: Oral
    Indication: Candidiasis
    Start date: 2012-07-18
    End date: 2012-07-19

Fluconazole
    Dosage: 200 mg, daily
    Administration route: Oral
    Indication: Candidiasis
    Start date: 2012-07-18
    End date: 2012-07-19

Rocephin
    Dosage: unk
    Administration route: Oral
    Indication: Infection
    Start date: 2012-03-29
    End date: 2012-07-19

Other drugs received by patient: Lasix; Cyclosporine



Possible Flagyl side effects in 84 year old

Reported by a physician from United States on 2012-08-07

Patient: 84 year old

Reactions: Nausea, Drug Intolerance, Drug Hypersensitivity

Drug(s) suspected as cause:
Codeine Sulfate
    Dosage: unk

Flagyl
    Dosage: unk



Possible Flagyl side effects in 84 year old

Reported by a physician from United States on 2012-08-06

Patient: 84 year old

Reactions: Nausea, Drug Hypersensitivity

Drug(s) suspected as cause:
Codeine Sulfate
    Dosage: unk

Flagyl
    Dosage: unk



Possible Flagyl side effects in 72 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-06

Patient: 72 year old female

Reactions: Vascular Purpura, Staphylococcal Infection, Pleurisy, Purulence, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atacand
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-01
    End date: 2012-06-03

Esidrix
    Dosage: (df oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-01
    End date: 2012-06-03

Flagyl
    Dosage: (500 mg tid oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-01

Nexium
    Dosage: (20 mg, daily oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-01
    End date: 2012-07-03

Other drugs received by patient: Plavix; Sectral; Acetaminophen



Possible Flagyl side effects in 71 year old

Reported by a physician from United States on 2012-08-06

Patient: 71 year old

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Allopurinol
    Dosage: unk

Flagyl
    Dosage: unk

Keflex
    Dosage: unk



Possible Flagyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female, weighing 69.9 kg (153.8 pounds)

Reactions: Flushing, Nausea, Feeling Hot, Rash Papular, Bacterial Infection, Skin Burning Sensation, Vaginal Infection, Paraesthesia

Drug(s) suspected as cause:
Flagyl
    Indication: Vaginal Infection
    Start date: 2012-03-01
    End date: 2012-04-01

Flagyl
    Indication: Bacterial Infection

Niaspan
    Indication: Blood Cholesterol Increased
    Start date: 2012-03-01

Other drugs received by patient: Zetia



Possible Flagyl side effects in 69 year old female

Reported by a individual with unspecified qualification from France on 2012-08-03

Patient: 69 year old female

Reactions: Incorrect Route of Drug Administration

Drug(s) suspected as cause:
Flagyl



Possible Flagyl side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-02

Patient:

Reactions: NO Adverse Event, Atrioventricular Block Complete, Sepsis, Platelet Count Decreased, Cardiogenic Shock, Erythema Multiforme, Myocardial Infarction, Toxic Skin Eruption

Drug(s) suspected as cause:
Betamethasone Valerate
    Dosage: unk
    Start date: 2012-04-10
    End date: 2012-05-07

Flagyl
    Dosage: 1000 mg, unk
    Administration route: Oral
    Indication: Pseudomembranous Colitis
    Start date: 2012-04-03
    End date: 2012-04-04

Flagyl
    Dosage: 1000 unk, unk
    Administration route: Oral
    Start date: 2012-04-29
    End date: 2012-05-12

Vancomycin Hydrochloride
    Dosage: 1 mg, unk
    Start date: 2012-04-16
    End date: 2012-04-29

Zyvox
    Dosage: 1200 mg, unk
    Start date: 2012-05-02
    End date: 2012-05-15

Other drugs received by patient: Plavix; Lebenin; Yunasupin; Hirudoid; Aldactone; Aspara K; Nizoral; Hirudoid; Prednisolone; Dorner; Trichlormethiazide; Olopatadine HCL; Methylprednisolone Sodium Succinate; Clobetasol Propionate; Plavix; Dorner; Lebenin; Aspara K; Myser (Difluprednate); Pydoxal; Gentamicin Sulfate; Vancomycin Hydrochloride; Myser (Difluprednate)



Possible Flagyl side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-02

Patient: 67 year old male

Reactions: Jaundice, Toxoplasmosis, Blood Bilirubin Increased, Gamma-Glutamyltransferase Increased, Cholangitis, Cholestasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Augmentin '500'
    Indication: Superinfection

Augmentin '500'
    Dosage: 1 g, 3x/day
    Administration route: Oral
    Indication: Chronic Sinusitis
    Start date: 2012-05-09
    End date: 2012-05-24

Flagyl
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Chronic Sinusitis
    Start date: 2012-05-09
    End date: 2012-05-24

Flagyl
    Indication: Superinfection

Ibuprofen (Advil)
    Indication: Superinfection

Ibuprofen (Advil)
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Indication: Chronic Sinusitis
    Start date: 2012-05-09
    End date: 2012-05-24



Possible Flagyl side effects in

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient:

Reactions: Contusion, Gastrointestinal Haemorrhage, Hyperkalaemia, Rectal Haemorrhage, Wheezing, Mouth Ulceration, Tongue Ulceration, Tachycardia, Blood PH Decreased, Oesophageal Candidiasis, Oedema Peripheral, Pulmonary Oedema, Thrombocytopenia, Candidiasis, Enterocolitis Haemorrhagic, Anaemia, Atrial Fibrillation, Pancytopenia, Odynophagia, Haemodialysis, Renal Failure, Fungal Infection, Respiratory Failure, Breath Sounds Abnormal, Platelet Count Decreased, Pseudomembranous Colitis, Bone Marrow Toxicity, Laryngeal Ulceration, Herpes Oesophagitis, Leukopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Dificid
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: Clostridium Difficile Colitis
    Start date: 2011-11-05
    End date: 2011-11-01

Flagyl
    Dosage: 500 mg, tid
    Indication: Clostridium Difficile Colitis
    Start date: 2011-11-01
    End date: 2011-11-11

Vancocin Hydrochloride
    Dosage: 200 mg, qid
    Administration route: Oral
    Start date: 2011-11-05
    End date: 2011-11-06

Vancocin Hydrochloride
    Dosage: unk
    Start date: 2011-11-16

Vancocin Hydrochloride
    Dosage: 125 mg, qid
    Administration route: Oral
    Indication: Clostridium Difficile Colitis
    Start date: 2011-11-02
    End date: 2011-11-04

Other drugs received by patient: Afluria; Humalog; Prilosec; Phenergan HCL; Proventil; Atrovent; Solu-Medrol; Oscal 250+d; Vitamin B-12; Advair Diskus 100 / 50; Lasix; Florastor; Protonix; Norco; Atrovent; Rocephin; Novolin R; Zofran; Restoril; Dextrose; Morphine Sulfate; Prednisone; Entocort EC; Celexa



Possible Flagyl side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-31

Patient: female

Reactions: Vomiting, Retinal Haemorrhage, Nausea, Lymphopenia, Scotoma, Fall, Paraesthesia, Hypokalaemia, Acute Polyneuropathy, Balance Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flagyl

Other drugs received by patient: Aspirin; Athymil; Tacrolimus; Cellcept; Prednisone TAB; Rapamune; Lasix; Tranxene; Atorvastatin; Citalopram Hydrobromide



Possible Flagyl side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-31

Patient: male

Reactions: Toxoplasma Serology Positive, Cholangitis, Cholestasis, Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advil
    Dosage: 200 mg qd, oral
    Administration route: Oral
    Indication: Chronic Sinusitis
    Start date: 2012-05-09
    End date: 2012-05-24

Augmentin
    Dosage: 1 g tid oral
    Administration route: Oral
    Indication: Chronic Sinusitis
    Start date: 2012-05-09
    End date: 2012-05-24

Flagyl
    Dosage: 500 mg bid oral
    Administration route: Oral
    Indication: Chronic Sinusitis
    Start date: 2012-05-09
    End date: 2012-05-24



Possible Flagyl side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-31

Patient: female

Reactions: Rhabdomyolysis, Strongyloidiasis, Pyrexia, Headache, Abdominal Pain Upper, Dengue Fever, Arthralgia, Cough

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ceftriaxon
    Dosage: 1 g qd intravenous (not otherwise specified)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-14
    End date: 2012-04-18

Flagyl
    Dosage: 500 mg tid oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-12
    End date: 2012-04-24

Ofloxacin
    Dosage: 200 mg bid intravenous (not otherwise specified)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-14
    End date: 2012-04-18

Tamiflu
    Dosage: 75 mg bid oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Tramadol HCL; Nexium; Lovenox; Doxycycline HCL

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