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Index of reports
> Cases with Factor Viii Inhibition (25)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Refacto (Antihemophilic Factor) where reactions include factor viii inhibition. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Refacto side effects in 5 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-11
Patient: 5 year old male, weighing 17.5 kg (38.5 pounds)
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in 5 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-05
Patient: 5 year old male, weighing 17.5 kg (38.5 pounds)
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in 13 month old male
Reported by a physician from France on 2012-05-17
Patient: 13 month old male, weighing 11.5 kg (25.3 pounds)
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in 1 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-08
Patient: 1 year old male, weighing 13.0 kg (28.6 pounds)
Reactions: Haemorrhage, Injury, Factor Viii Inhibition
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Refacto
Dosage: 500 iu once weekly
Indication: Factor Viii Deficiency
Start date: 2011-04-01
End date: 2011-11-09
Refacto
Indication: Prophylaxis
Possible Refacto side effects in 20 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-16
Patient: 20 year old male
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Indication: Surgery
Refacto
Dosage: as needed
Indication: Haemorrhage
Refacto
Indication: Haemophilia
Possible Refacto side effects in 1 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-19
Patient: 1 year old male, weighing 13.0 kg (28.6 pounds)
Reactions: Haemorrhage, Injury, Factor Viii Inhibition
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Refacto
Dosage: 500 iu once weekly
Indication: Factor Viii Deficiency
Start date: 2011-04-01
End date: 2011-11-09
Refacto
Indication: Prophylaxis
Possible Refacto side effects in 5 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-13
Patient: 5 year old male
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-07
Patient:
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-06
Patient: male
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-06
Patient: male
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-06
Patient: male
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in 1 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-02-16
Patient: 1 year old male, weighing 13.0 kg (28.6 pounds)
Reactions: Haemorrhage, Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Dosage: 500 iu once weekly
Indication: Factor Viii Deficiency
Start date: 2011-04-01
End date: 2011-11-09
Refacto
Dosage: 750-1000 iu, 2x/week
Indication: Prophylaxis
Start date: 2011-11-09
Possible Refacto side effects in 9 year old male
Reported by a physician from United Kingdom on 2012-02-06
Patient: 9 year old male, weighing 45.0 kg (99.0 pounds)
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in 14 month old male
Reported by a physician from United Kingdom on 2012-02-01
Patient: 14 month old male
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Dosage: 3 doses (unknown units and frequency)
Start date: 2011-06-01
Refacto
Dosage: recurrent treatments (unknown units and frequencies)
Refacto
Dosage: 1 dose (unknown units and frequency)
Indication: Factor Viii Deficiency
Start date: 2011-05-01
Possible Refacto side effects in 1 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-01-26
Patient: 1 year old male, weighing 13.0 kg (28.6 pounds)
Reactions: Haemorrhage, Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Dosage: 500 iu once weekly
Indication: Factor Viii Deficiency
Start date: 2011-04-01
Refacto
Indication: Prophylaxis
Possible Refacto side effects in 1 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-01-17
Patient: 1 year old male
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Dosage: 500 iu once weekly
Indication: Factor Viii Deficiency
Refacto
Indication: Prophylaxis
Possible Refacto side effects in 2 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-01-05
Patient: 2 year old male
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Dosage: 500 iu once weekly
Indication: Factor Viii Deficiency
Refacto
Indication: Prophylaxis
Possible Refacto side effects in 5 month old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-12-15
Patient: 5 month old male, weighing 7.6 kg (16.7 pounds)
Reactions: Hypersensitivity, Hydrocephalus, Factor Viii Inhibition
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Refacto
Dosage: continuous infusion starting 5u/kg/hr up to 12u/kg/hr
Indication: Cerebral Haemorrhage
Start date: 2011-08-14
End date: 2011-08-26
Refacto
Dosage: 3 x bolus - 250units
Indication: Central Venous Catheterisation
Start date: 2011-08-26
End date: 2011-08-26
Refacto
Dosage: 500 units + 250 units - on demand
Indication: Factor Viii Deficiency
Start date: 2011-08-14
End date: 2011-08-14
Refacto
Dosage: infusion; 90 units/kg/hr
Indication: Injury
Start date: 2011-08-26
Other drugs received by patient: Moviprep; Paracetamol; Heparin; Phenytoin; Lactulose; Heparin; Clotrimazole
Possible Refacto side effects in male
Reported by a physician from France on 2011-12-09
Patient: male
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in 5 month old male
Reported by a physician from United Kingdom on 2011-12-07
Patient: 5 month old male, weighing 7.6 kg (16.7 pounds)
Reactions: Hypersensitivity, Factor Viii Inhibition
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Refacto
Dosage: unk
Start date: 2011-08-26
End date: 2011-08-29
Refacto
Dosage: continuous infusion up to 62.5 units
Indication: Cerebral Haemorrhage
Start date: 2011-08-14
End date: 2011-08-25
Refacto
Dosage: unk
Indication: Central Venous Catheterisation
Start date: 2011-08-25
End date: 2011-08-26
Other drugs received by patient: Clotrimazole; Phenytoin; Paracetamol; Moviprep; Heparin; Lactulose; Heparin
Possible Refacto side effects in 6 month old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-12-05
Patient: 6 month old male, weighing 7.6 kg (16.7 pounds)
Reactions: Hypersensitivity, Factor Viii Inhibition
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Refacto
Dosage: unk
Indication: Central Venous Catheterisation
Start date: 2011-08-25
End date: 2011-08-26
Refacto
Dosage: continuous infusion up to 62.5 units
Indication: Cerebral Haemorrhage
Start date: 2011-08-14
End date: 2011-08-25
Refacto
Dosage: unk
Start date: 2011-08-26
End date: 2011-08-28
Other drugs received by patient: Paracetamol; Moviprep; Phenytoin; Lactulose; Clotrimazole
Possible Refacto side effects in 6 month old male
Reported by a physician from United Kingdom on 2011-11-29
Patient: 6 month old male
Reactions: Hypersensitivity, Factor Viii Inhibition
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Refacto
Dosage: unk
Indication: Central Venous Catheterisation
Start date: 2011-08-25
End date: 2011-08-26
Refacto
Dosage: unk
Indication: Cerebral Haemorrhage
Start date: 2011-08-14
End date: 2011-08-25
Refacto
Dosage: unk
Start date: 2011-08-26
End date: 2011-08-28
Possible Refacto side effects in 14 month old male
Reported by a physician from United Kingdom on 2011-11-16
Patient: 14 month old male
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-06
Patient: male
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Possible Refacto side effects in 31 year old male
Reported by a physician from France on 2011-10-04
Patient: 31 year old male, weighing 78.0 kg (171.6 pounds)
Reactions: Factor Viii Inhibition
Drug(s) suspected as cause:
Refacto
Dosage: 3000 iu every twelve hours for ten days
Refacto
Dosage: 3000 iu, 1x/day
End date: 2010-12-29
Refacto
Dosage: unk
Refacto
Dosage: 400 iu, 2x/day, just before surgery
Indication: Factor Viii Deficiency
Start date: 2010-12-17
Refacto
Dosage: 3000 iu every eight hours for 24 hours after surgery
Indication: Intervertebral Disc Protrusion
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