This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Betadine (Povidone-Iodine Ophthalmic) 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 (67)
Life Threatening Events (2)
Disability (1)
Reports by Reaction Type
Toxic Anterior Segment Syndrome (37),
Medication Error (20),
Endophthalmitis (8),
Post Procedural Complication (7),
Drug Hypersensitivity (7),
Rash Maculo-Papular (4),
Anaphylactic Shock (3),
Visual Acuity Reduced (3),
Rash Erythematous (3),
Pruritus (2),
Injury Corneal (2),
Laryngeal Oedema (2)
Below are a few examples of reports where side effects / adverse reactions may be related to Betadine (Povidone-Iodine Ophthalmic). For a complete list or a specific selection of reports, please use the links above.
Possible Betadine side effects in 60 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23
Patient: 60 year old male
Reactions: Toxic Skin Eruption
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betadine
Dosage: 2 l, 1x/day
Start date: 2012-07-21
End date: 2012-07-26
Betadine
Dosage: 1 l, 1x/day
Administration route: Topical
Indication: Wound Treatment
Start date: 2012-07-20
End date: 2012-07-20
Fluconazole
Dosage: 400 mg, 1x/day
Start date: 2012-07-20
End date: 2012-07-25
Imovane
Dosage: 7.5 mg, 1x/day - 1df daily
Administration route: Oral
Start date: 2012-07-22
End date: 2012-07-25
Possible Betadine side effects in 33 year old female
Reported by a physician from United States on 2012-08-23
Patient: 33 year old female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Betadine
Dosage: unk
Epinephrine
Dosage: unk
Potassium Penicillin G
Dosage: unk
Possible Betadine side effects in male
Reported by a physician from France on 2012-08-09
Patient: male
Reactions: Anaphylactic Shock
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betadine
Dosage: once/sngle administration
Start date: 2011-11-28
End date: 2011-11-28
Cefazolin
Dosage: once/sngle administration
Indication: Antibiotic Prophylaxis
Start date: 2011-11-28
End date: 2011-11-28
Chirocaine
Dosage: once/sngle administration
Indication: Local Anaesthesia
Start date: 2011-11-28
End date: 2011-11-28
Midazolam HCL
Dosage: once/sngle administration
Indication: Anaesthesia
Start date: 2011-11-28
End date: 2011-11-28
Xylocaine
Dosage: once/sngle administration
Indication: Local Anaesthesia
Start date: 2011-11-28
End date: 2011-11-28
Other drugs received by patient: Xanax
Possible Betadine side effects in 23 year old female
Reported by a physician from France on 2012-08-06
Patient: 23 year old female
Reactions: Ventricular Tachycardia, Anaphylactic Shock, Laryngeal Oedema, Cardiac Arrest
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betadine
Carbocaine
Indication: Anaesthesia
Start date: 2012-05-30
End date: 2012-05-30
Cefazolin
Indication: Prophylaxis
Start date: 2012-05-30
End date: 2012-05-30
Midazolam HCL
Start date: 2012-05-30
End date: 2012-05-30
Naropin
Indication: Anaesthesia
Start date: 2012-05-30
End date: 2012-05-30
Sufentanil Citrate
Dosage: 5, once/single administration
Start date: 2012-05-30
End date: 2012-05-30
Other drugs received by patient: Birth Control Pill
Possible Betadine side effects in male
Reported by a physician from Australia on 2012-08-03
Patient: male
Reactions: Eye Irritation, Foreign Body Sensation in Eyes, Ocular Discomfort, Iodine Allergy, Injury Corneal
Drug(s) suspected as cause:
Betadine
Indication: Product Used FOR Unknown Indication
Lucentis
Indication: AGE-Related Macular Degeneration
Start date: 2011-10-01
Lucentis
Start date: 2012-07-03
Possible Betadine side effects in female
Reported by a physician from United States on 2012-08-02
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Betadine
Dosage: unk
Hydrochlorothiazde TAB
Dosage: unk
Lisinopril
Dosage: unk
Lyrica
Dosage: unk
Prednisone
Dosage: unk
Zestril
Dosage: unk
Possible Betadine side effects in male
Reported by a consumer/non-health professional from Australia on 2012-07-13
Patient: male
Reactions: Eye Irritation, Foreign Body Sensation in Eyes, Ocular Discomfort, Iodine Allergy, Injury Corneal
Drug(s) suspected as cause:
Betadine
Indication: Product Used FOR Unknown Indication
Lucentis
Indication: AGE-Related Macular Degeneration
Start date: 2011-10-01
Lucentis
Start date: 2012-07-06
Possible Betadine side effects in male
Reported by a physician from France on 2012-07-13
Patient: male
Reactions: Rash Maculo-Papular, Dermatitis Exfoliative, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betadine
Indication: Cataract Operation
Start date: 2012-06-07
End date: 2012-06-07
Carbocaine
Dosage: 0.4 grams/ 20 ml
Indication: Cataract Operation
Start date: 2012-06-07
End date: 2012-06-07
Dexamethasone
Indication: Cataract Operation
Start date: 2012-06-07
End date: 2012-06-07
Diamox
Indication: Cataract Operation
Start date: 2012-06-07
End date: 2012-06-07
Diclofenac
Indication: Cataract Operation
Start date: 2012-06-07
End date: 2012-06-07
Levofloxacin
Administration route: Oral
Indication: Cataract Operation
Start date: 2012-06-06
End date: 2012-06-07
Phenylephrine HCL
Indication: Cataract Operation
Start date: 2012-06-07
End date: 2012-06-07
Tropicamide
Indication: Cataract Operation
Start date: 2012-06-07
End date: 2012-06-07
Other drugs received by patient: Desloratadine; Spiriva; Digoxin; Levothyroxine Sodium; Furosemide; Allopurinol; Humera; Symbicort; Ramipril; Amlodipine Besylate; Bricanyl; Fenofibrate; Aspirin; Amiodarone HCL
Possible Betadine side effects in 71 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 71 year old male, weighing 82.1 kg (180.6 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: opthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in 69 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 69 year old male, weighing 99.8 kg (219.5 pounds)
Reactions: Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: ophthalmic
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Possible Betadine side effects in 77 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 77 year old female, weighing 50.3 kg (110.8 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in 45 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 45 year old male, weighing 69.9 kg (153.7 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in 68 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 68 year old female, weighing 61.2 kg (134.7 pounds)
Reactions: Post Procedural Complication, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in 80 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 80 year old male, weighing 171.6 kg (377.5 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in 89 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 89 year old male, weighing 73.0 kg (160.7 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 61 year old female, weighing 82.1 kg (180.6 pounds)
Reactions: Post Procedural Complication, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Possible Betadine side effects in 23 year old female
Reported by a physician from France on 2012-07-02
Patient: 23 year old female
Reactions: Ventricular Tachycardia, Anaphylactic Shock, Laryngeal Oedema, Cardiac Arrest
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Betadine
Start date: 2012-05-30
Carbocaine
Indication: Anaesthesia
Start date: 2012-05-30
End date: 2012-05-30
Cefazolin
Indication: Prophylaxis
Start date: 2012-05-30
End date: 2012-05-30
Midazolam HCL
Start date: 2012-05-30
End date: 2012-05-30
Naropin
Indication: Anaesthesia
Start date: 2012-05-30
End date: 2012-05-30
Sufentanil Citrate
Start date: 2012-05-30
End date: 2012-05-30
Other drugs received by patient: Birth Control Pill
Possible Betadine side effects in
Reported by a consumer/non-health professional from United States on 2012-06-27
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Bactrim
Dosage: unk
Betadine
Dosage: unk
Demerol
Dosage: unk
Doxycycline Hyclate
Dosage: unk
E-Mycin
Dosage: unk
Potassium Penicillin G
Dosage: unk
Possible Betadine side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-25
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Betadine
Dosage: unk
Hydrochlorothiazide
Dosage: unk
Lisinopril
Dosage: unk
Lyrica
Dosage: unk
Prednisone
Dosage: unk
Zestril
Dosage: unk
Possible Betadine side effects in 71 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20
Patient: 71 year old male, weighing 82.1 kg (180.6 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20
Patient: 61 year old female, weighing 82.1 kg (180.6 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in 77 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20
Patient: 77 year old female, weighing 50.3 kg (110.8 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: (opthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in 69 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20
Patient: 69 year old male, weighing 99.8 kg (219.5 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: ophthalmic
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: ophthalmic
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Possible Betadine side effects in 80 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20
Patient: 80 year old male, weighing 171.6 kg (377.5 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: (opthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in 68 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20
Patient: 68 year old female, weighing 61.2 kg (134.7 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in 89 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20
Patient: 89 year old male, weighing 73.0 kg (160.7 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: (ophthalmic)
Administration route: Oral
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Possible Betadine side effects in 45 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20
Patient: 45 year old male, weighing 69.9 kg (153.7 pounds)
Reactions: Medication Error, Toxic Anterior Segment Syndrome
Drug(s) suspected as cause:
Betadine
Dosage: ophthalmic
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: intraocular
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
BSS
Dosage: (intraocular)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Nevanac
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Vigamox
Dosage: (ophthalmic)
Indication: Intraocular Lens Implant
Start date: 2012-05-15
End date: 2012-05-15
Other drugs received by patient: Epinephrine
Possible Betadine side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient:
Reactions: Endophthalmitis
Drug(s) suspected as cause:
Betadine
Possible Betadine side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-14
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Betadine
Dosage: unk
Epinephrine
Dosage: unk
Potassium Penicillin G
Dosage: unk
Possible Betadine side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient: male
Reactions: Endophthalmitis
Drug(s) suspected as cause:
Betadine
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