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Topamax (Topiramate) - Cleft LIP and Palate - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Cleft LIP and Palate (47)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Topamax (Topiramate) where reactions include cleft lip and palate. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 47   Next >>

Possible Topamax side effects in female

Reported by a lawyer from United States on 2012-08-24

Patient: female

Reactions: Speech Disorder, Cleft LIP and Palate, Foetal Growth Restriction, Foetal Heart Rate Abnormal, Otitis Media Chronic, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydroxyzine
    Indication: Foetal Exposure During Pregnancy

Zoloft
    Indication: Foetal Exposure During Pregnancy

Trazodone Hydrochloride
    Indication: Foetal Exposure During Pregnancy

Ibuprofen
    Indication: Foetal Exposure During Pregnancy

Fentanyl
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Colace
    Indication: Foetal Exposure During Pregnancy

Bupivacaine HCL
    Indication: Foetal Exposure During Pregnancy

Ibuprofen

Terbutaline
    Indication: Foetal Exposure During Pregnancy

Oxytocin
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Mirtazapine
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Multi-Vitamins; Metformin HCL; Risedronate Sodium; Folic Acid; Ferrous Sulfate TAB



Possible Topamax side effects in female

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

Patient: female

Reactions: Cleft LIP and Palate, Cardiac Murmur, Nose Deformity, Developmental Delay, Hypertelorism of Orbit, Emotional Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamictal
    Indication: Foetal Exposure During Pregnancy

Misoprostol
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Acetaminophen

Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Phenobarbital TAB
    Indication: Foetal Exposure During Pregnancy

Loratadine
    Indication: Foetal Exposure During Pregnancy

Butorphanol Tartrate
    Indication: Foetal Exposure During Pregnancy

Nasonex
    Indication: Foetal Exposure During Pregnancy

Prevacid
    Indication: Foetal Exposure During Pregnancy

Promethazine HCL
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Multi-Vitamins; Ferrous Gluconate



Possible Topamax side effects in

Reported by a lawyer from United States on 2012-08-10

Patient:

Reactions: Atrial Septal Defect, Cleft LIP and Palate, Patent Ductus Arteriosus

Drug(s) suspected as cause:
Topamax



Possible Topamax side effects in male

Reported by a lawyer from United States on 2012-08-09

Patient: male

Reactions: Cleft LIP and Palate, Cataract, Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax

Other drugs received by patient: Multi-Vitamins



Possible Topamax side effects in female

Reported by a lawyer from United States on 2012-07-30

Patient: female

Reactions: Cleft LIP and Palate, Hyperbilirubinaemia, Hydronephrosis, Premature Baby, Hyperkalaemia, Otitis Media Chronic, Small FOR Dates Baby, Autism Spectrum Disorder, Heart Disease Congenital

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neurontin
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Phenobarbital TAB
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Vitamin



Possible Topamax side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: female

Reactions: Cleft LIP and Palate, Maternal Drugs Affecting Foetus, Amniotic Band Syndrome, Premature Baby, Anophthalmos, Bicuspid Aortic Valve, Cryptophthalmos, Tongue Disorder, Heart Disease Congenital, Microphthalmos, Optic Nerve Hypoplasia, Pterygium Colli

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Midrin
    Indication: Foetal Exposure During Pregnancy

Topamax

Migquin
    Indication: Foetal Exposure During Pregnancy
    Start date: 2005-10-24

Topamax
    Indication: Foetal Exposure During Pregnancy

Topamax
    Start date: 2005-10-21

Nitrofurantoin
    Indication: Foetal Exposure During Pregnancy
    Start date: 2005-11-29

Topamax



Possible Topamax side effects in female

Reported by a lawyer from United States on 2012-07-26

Patient: female

Reactions: Cleft LIP and Palate, Hydronephrosis, Hyperbilirubinaemia, Autism Spectrum Disorder, Small FOR Dates Baby, Hyperkalaemia, Premature Baby, Heart Disease Congenital

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Phenobarbital TAB
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Neurontin
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Vitamin



Possible Topamax side effects in male

Reported by a lawyer from United States on 2012-07-12

Patient: male

Reactions: Cleft LIP and Palate, Cerebral Palsy, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Plagiocephaly, Feeding Disorder, Hydrocele, Duane's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Oxycontin
    Indication: Foetal Exposure During Pregnancy

Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Ultram
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Feldene
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Folic Acid; Fish OIL



Possible Topamax side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05

Patient: female

Reactions: Cleft LIP and Palate, Foetal Growth Restriction, Speech Disorder, Otitis Media Chronic, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydroxyzine
    Indication: Foetal Exposure During Pregnancy

Zoloft
    Indication: Foetal Exposure During Pregnancy

Trazodone HCL
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Mirtazapine
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Risedronate Sodium; Folic Acid; Metformin HCL



Possible Topamax side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: female

Reactions: Cleft LIP and Palate, Hydronephrosis, Hyperbilirubinaemia, Autism Spectrum Disorder, Small FOR Dates Baby, Hyperkalaemia, Premature Baby, Heart Disease Congenital

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neurontin
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Phenobarbital TAB
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Vitamin



Possible Topamax side effects in male

Reported by a lawyer from United States on 2012-06-29

Patient: male

Reactions: Cleft LIP and Palate, Pneumonia, Cataract

Drug(s) suspected as cause:
Topamax

Other drugs received by patient: Multi-Vitamins



Possible Topamax side effects in male

Reported by a lawyer from United States on 2012-06-22

Patient: male

Reactions: Cleft LIP and Palate, Otitis Media Chronic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax

Other drugs received by patient: Folic Acid; Multi-Vitamins



Possible Topamax side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: male

Reactions: Cerebral Palsy, Cleft LIP and Palate, Maternal Drugs Affecting Foetus, Ear Infection, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Plagiocephaly, Dacryostenosis Congenital, Hypermetropia, Feeding Disorder, Hydrocele, Duane's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxycontin
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Feldene
    Indication: Foetal Exposure During Pregnancy

Acetaminophen

Ultram
    Indication: Foetal Exposure During Pregnancy

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Leucovorin Calcium; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Fish OIL



Possible Topamax side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14

Patient: male

Reactions: Cleft LIP and Palate, Torticollis, Craniosynostosis, Lacrimal Disorder, Developmental Delay, Feeding Disorder, Duane's Syndrome, Hydrocele

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Acetaminophen

Feldene
    Indication: Foetal Exposure During Pregnancy

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Ultram
    Indication: Foetal Exposure During Pregnancy

Oxycontin
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Leucovorin Calcium; Fish OIL; Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP



Possible Topamax side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-11

Patient: female

Reactions: Asthma, Retinopathy of Prematurity, Congenital Central Nervous System Anomaly, Meningitis Neonatal, Strabismus, Pharyngotonsillitis, Developmental Delay, Intraventricular Haemorrhage Neonatal, Patent Ductus Arteriosus, Emotional Disorder, Gastrooesophageal Reflux Disease, Cleft LIP and Palate, Apgar Score LOW, Premature Baby, Malocclusion, Abnormal Behaviour, Bronchopulmonary Dysplasia, Nasal Septum Deviation, Lung Disorder, Sepsis, Enlarged Clitoris, Attention Deficit / Hyperactivity Disorder, Sleep Apnoea Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax
    Indication: Foetal Exposure During Pregnancy
    Start date: 2001-01-01
    End date: 2007-01-01

Prometrium
    Indication: Foetal Exposure During Pregnancy

Nifedipine
    Indication: Foetal Exposure During Pregnancy

Terbutaline
    Indication: Foetal Exposure During Pregnancy

Lithium Carbonate
    Indication: Foetal Exposure During Pregnancy

Clindamycin
    Indication: Foetal Exposure During Pregnancy

Lexapro
    Indication: Foetal Exposure During Pregnancy

Zithromax
    Indication: Foetal Exposure During Pregnancy

Betamethasone
    Indication: Foetal Exposure During Pregnancy

Ampicillin
    Indication: Foetal Exposure During Pregnancy



Possible Topamax side effects in male

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

Patient: male

Reactions: Cleft LIP and Palate, Pneumonia, Cataract, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Topamax

Other drugs received by patient: Multi-Vitamins



Possible Topamax side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-07

Patient: male

Reactions: Cleft LIP and Palate, Otitis Media Chronic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax

Other drugs received by patient: Multi-Vitamins; Folic Acid



Possible Topamax side effects in male

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

Patient: male

Reactions: Cleft LIP and Palate, Craniosynostosis, Developmental Delay, Torticollis, Feeding Disorder, Hydrocele, Duane's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Feldene
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Oxycodone / Acetaminophen
    Indication: Foetal Exposure During Pregnancy

Acetaminophen

Selective Serotonin Reuptake Inhibitor
    Indication: Foetal Exposure During Pregnancy

Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Oxycontin
    Indication: Foetal Exposure During Pregnancy

Vicodin
    Indication: Foetal Exposure During Pregnancy

Ultram
    Indication: Foetal Exposure During Pregnancy

Soma
    Indication: Foetal Exposure During Pregnancy

Nystatin
    Indication: Foetal Exposure During Pregnancy

Effexor
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP; Folic Acid; Fish OIL



Possible Topamax side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-04

Patient: male

Reactions: Cleft LIP and Palate, Craniosynostosis, Developmental Delay, Duane's Syndrome

Drug(s) suspected as cause:
Topamax
    Indication: Foetal Exposure During Pregnancy

Crestor
    Indication: Foetal Exposure During Pregnancy

Ovcon-35
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP



Possible Topamax side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04

Patient: male

Reactions: Anxiety, Cleft LIP and Palate, Post-Traumatic Stress Disorder, Communication Disorder, Congenital Anomaly, Chronic Sinusitis, Depression, Attention Deficit / Hyperactivity Disorder

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Topamax
    Indication: Foetal Exposure During Pregnancy

Clonazepam
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Citalopram Hydrobromide



Possible Topamax side effects in

Reported by a lawyer from United States on 2012-04-25

Patient:

Reactions: Cleft LIP and Palate, Craniosynostosis

Drug(s) suspected as cause:
Topamax



Possible Topamax side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-25

Patient: male

Reactions: Cleft LIP and Palate, Anxiety, Post-Traumatic Stress Disorder, Communication Disorder, Congenital Anomaly, Chronic Sinusitis, Depression, Attention Deficit / Hyperactivity Disorder

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Topamax
    Indication: Foetal Exposure During Pregnancy

Clonazepam
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Citalopram Hydrobromide



Possible Topamax side effects in female

Reported by a physician from United States on 2012-04-19

Patient: female

Reactions: Cleft LIP and Palate, Maternal Drugs Affecting Foetus, Premature Baby, Cryptophthalmos, Tongue Disorder, Heart Disease Congenital, Microphthalmos, Congenital Tongue Anomaly, Pterygium Colli, Optic Nerve Hypoplasia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax
    Indication: Foetal Exposure During Pregnancy

Topamax
    Start date: 2005-10-21

Migquin
    Indication: Foetal Exposure During Pregnancy
    Start date: 2005-10-24

Topamax

Topamax

Midrin
    Indication: Foetal Exposure During Pregnancy

Nitrofurantoin
    Indication: Foetal Exposure During Pregnancy
    Start date: 2005-11-29



Possible Topamax side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-13

Patient: male

Reactions: Weight Decreased, Cleft LIP and Palate, Atrial Septal Defect, Maternal Drugs Affecting Foetus, Chronic Fatigue Syndrome, Urine Output Decreased, Ventricular Septal Defect, Respiratory Distress, Cystic Fibrosis, Vitamin D Decreased, Patent Ductus Arteriosus, Emotional Disorder, Feeding Disorder Neonatal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax



Possible Topamax side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-12

Patient: female

Reactions: Asthma, Retinopathy of Prematurity, Congenital Central Nervous System Anomaly, Meningitis Neonatal, Strabismus, Pharyngotonsillitis, Developmental Delay, Intraventricular Haemorrhage Neonatal, Patent Ductus Arteriosus, Emotional Disorder, Gastrooesophageal Reflux Disease, Cleft LIP and Palate, Apgar Score LOW, Premature Baby, Abnormal Behaviour, Malocclusion, Bronchopulmonary Dysplasia, Nasal Septum Deviation, Lung Disorder, Sepsis, Enlarged Clitoris, Sleep Apnoea Syndrome, Attention Deficit / Hyperactivity Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zithromax
    Indication: Foetal Exposure During Pregnancy

Nifedipine
    Indication: Foetal Exposure During Pregnancy

Terbutaline
    Indication: Foetal Exposure During Pregnancy

Betamethasone
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy
    Start date: 2001-01-01
    End date: 2007-01-01

Clindamycin
    Indication: Foetal Exposure During Pregnancy

Ampicillin
    Indication: Foetal Exposure During Pregnancy

Lexapro
    Indication: Foetal Exposure During Pregnancy

Prometrium
    Indication: Foetal Exposure During Pregnancy

Lithium Carbonate
    Indication: Foetal Exposure During Pregnancy



Possible Topamax side effects in female

Reported by a physician from United States on 2012-03-23

Patient: female

Reactions: Cleft LIP and Palate, Cryptophthalmos, Premature Baby, Tongue Disorder, Microphthalmos, Optic Nerve Hypoplasia

Drug(s) suspected as cause:
Topamax

Nitrofurantoin
    Indication: Foetal Exposure During Pregnancy
    Start date: 2005-11-29

Topamax
    Indication: Foetal Exposure During Pregnancy
    Start date: 2005-10-21

Topamax

Midrin
    Indication: Foetal Exposure During Pregnancy

Topamax

Migquin
    Indication: Foetal Exposure During Pregnancy
    Start date: 2005-10-24



Possible Topamax side effects in female

Reported by a lawyer from United States on 2012-03-22

Patient: female

Reactions: Retinopathy of Prematurity, Congenital Central Nervous System Anomaly, Strabismus, Intraventricular Haemorrhage Neonatal, Developmental Delay, Patent Ductus Arteriosus, Emotional Disorder, Gastrooesophageal Reflux Disease, Cleft LIP and Palate, Apgar Score LOW, Premature Baby, Malocclusion, Bronchopulmonary Dysplasia, Nasal Septum Deviation, Lung Disorder, Sepsis, Enlarged Clitoris, Attention Deficit / Hyperactivity Disorder, Sleep Apnoea Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax
    Indication: Foetal Exposure During Pregnancy
    Start date: 2001-01-01
    End date: 2007-01-01

Lithium Carbonate
    Indication: Foetal Exposure During Pregnancy

Terbutaline
    Indication: Foetal Exposure During Pregnancy

Lexapro
    Indication: Foetal Exposure During Pregnancy

Zithromax
    Indication: Foetal Exposure During Pregnancy

Prometrium
    Indication: Foetal Exposure During Pregnancy

Nifedipine
    Indication: Foetal Exposure During Pregnancy

Betamethasone
    Indication: Foetal Exposure During Pregnancy

Clindamycin
    Indication: Foetal Exposure During Pregnancy

Ampicillin
    Indication: Foetal Exposure During Pregnancy



Possible Topamax side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-22

Patient: male, weighing 3.0 kg (6.5 pounds)

Reactions: Cleft LIP and Palate, Weight Decreased, Dysphagia, Deafness Bilateral, Failure To Thrive, Syndactyly, Nose Deformity, Feeding Disorder, Sleep Apnoea Syndrome, Inguinal Hernia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax
    Indication: Foetal Exposure During Pregnancy

Cymbalta
    Indication: Foetal Exposure During Pregnancy

Inderal
    Indication: Foetal Exposure During Pregnancy

Lortab
    Indication: Foetal Exposure During Pregnancy



Possible Topamax side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-20

Patient: male

Reactions: Cleft LIP and Palate, Maternal Drugs Affecting Foetus, Social Avoidant Behaviour, Premature Baby, Micrognathia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax

Other drugs received by patient: Multi-Vitamins; Folic Acid; Iron; Calcium Carbonate



Possible Topamax side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-13

Patient: male

Reactions: Anxiety, Cleft LIP and Palate, Post-Traumatic Stress Disorder, Communication Disorder, Congenital Anomaly, Chronic Sinusitis, Depression, Attention Deficit / Hyperactivity Disorder

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Clonazepam
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Citalopram Hydrobromide



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