Drug information for KALBITOR

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; INJECTION	10MG/ML	Prescription		ECALLANTIDE	ecallantide	DYAX CORP.	125277 2012-04-27 Letter 2011-09-13 Letter 2011-07-08 Other 2011-05-17 Letter 2010-02-14 Review 2010-02-14 Summary Review 2009-12-08 Letter 2009-12-02 Label 2009-12-02 Other 2009-12-02 Medication Guide

Drug Adverse Effects information for KALBITOR

Role code	Indications	Reaction	# Reports
PS	ANGIOEDEMA	DIALYSIS	1
PS	ANGIOEDEMA	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	1
PS	ANGIOEDEMA	GENERAL PHYSICAL HEALTH DETERIORATION	1
PS	HEREDITARY ANGIOEDEMA	ALCOHOL POISONING	1
PS	HEREDITARY ANGIOEDEMA	BLOOD PRESSURE DECREASED	2
PS	HEREDITARY ANGIOEDEMA	COUGH	1
PS	HEREDITARY ANGIOEDEMA	DEVICE RELATED SEPSIS	1
PS	HEREDITARY ANGIOEDEMA	DRUG EFFECT DELAYED	1
PS	HEREDITARY ANGIOEDEMA	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	4
PS	HEREDITARY ANGIOEDEMA	ERYTHEMA	2
PS	HEREDITARY ANGIOEDEMA	FORMICATION	1
PS	HEREDITARY ANGIOEDEMA	HEART RATE INCREASED	2
PS	HEREDITARY ANGIOEDEMA	HEREDITARY ANGIOEDEMA	2
PS	HEREDITARY ANGIOEDEMA	HYPERSENSITIVITY	2
PS	HEREDITARY ANGIOEDEMA	HYPERTENSION	1
PS	HEREDITARY ANGIOEDEMA	LARGE CELL LUNG CANCER METASTATIC	2
PS	HEREDITARY ANGIOEDEMA	NASAL CONGESTION	1
PS	HEREDITARY ANGIOEDEMA	OEDEMA	4
PS	HEREDITARY ANGIOEDEMA	PNEUMONIA	2
PS	HEREDITARY ANGIOEDEMA	PNEUMONIA ASPIRATION	2
PS	HEREDITARY ANGIOEDEMA	PRURITUS	1
PS	HEREDITARY ANGIOEDEMA	ROAD TRAFFIC ACCIDENT	1
PS	HEREDITARY ANGIOEDEMA	URTICARIA	1
PS	HYPERTENSION	HEREDITARY ANGIOEDEMA	1
PS	HYPERTENSION	PNEUMONIA	1
PS	HYPERTENSION	PNEUMONIA ASPIRATION	1
PS	LOCALISED OEDEMA	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	2
PS	LOCALISED OEDEMA	OEDEMA	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	COUGH	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	DEVICE RELATED SEPSIS	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	DRUG EFFECT DELAYED	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	8
PS	PRODUCT USED FOR UNKNOWN INDICATION	HEREDITARY ANGIOEDEMA	6
PS	PRODUCT USED FOR UNKNOWN INDICATION	HYPERTENSION	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	NASAL CONGESTION	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	OEDEMA	8
PS	PRODUCT USED FOR UNKNOWN INDICATION	PNEUMONIA	6
PS	PRODUCT USED FOR UNKNOWN INDICATION	PNEUMONIA ASPIRATION	6
SS	ANGIOEDEMA	DIALYSIS	1
SS	ANGIOEDEMA	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	1
SS	ANGIOEDEMA	GENERAL PHYSICAL HEALTH DETERIORATION	1
SS	HEREDITARY ANGIOEDEMA	COUGH	2
SS	HEREDITARY ANGIOEDEMA	DEVICE RELATED SEPSIS	2
SS	HEREDITARY ANGIOEDEMA	DRUG EFFECT DELAYED	2
SS	HEREDITARY ANGIOEDEMA	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	8
SS	HEREDITARY ANGIOEDEMA	HYPERTENSION	2
SS	HEREDITARY ANGIOEDEMA	NASAL CONGESTION	2
SS	HEREDITARY ANGIOEDEMA	OEDEMA	8
SS	LOCALISED OEDEMA	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	4
SS	LOCALISED OEDEMA	OEDEMA	4
SS	PRODUCT USED FOR UNKNOWN INDICATION	COUGH	18
SS	PRODUCT USED FOR UNKNOWN INDICATION	DEVICE RELATED SEPSIS	18
SS	PRODUCT USED FOR UNKNOWN INDICATION	DRUG EFFECT DELAYED	18
SS	PRODUCT USED FOR UNKNOWN INDICATION	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	16
SS	PRODUCT USED FOR UNKNOWN INDICATION	HYPERTENSION	18
SS	PRODUCT USED FOR UNKNOWN INDICATION	NASAL CONGESTION	18
SS	PRODUCT USED FOR UNKNOWN INDICATION	OEDEMA	16
C	HEREDITARY ANGIOEDEMA	ABDOMINAL MASS	1
C	HEREDITARY ANGIOEDEMA	ABDOMINAL PAIN UPPER	1
C	HEREDITARY ANGIOEDEMA	BRADYCARDIA	1
C	HEREDITARY ANGIOEDEMA	GASTRIC CYST	1
C	HEREDITARY ANGIOEDEMA	HEREDITARY ANGIOEDEMA	1
C	PROPHYLAXIS	ABDOMINAL MASS	1
C	PROPHYLAXIS	ABDOMINAL PAIN UPPER	1
C	PROPHYLAXIS	BRADYCARDIA	1
C	PROPHYLAXIS	GASTRIC CYST	1
C	PROPHYLAXIS	HEREDITARY ANGIOEDEMA	1

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