Drug information for ELAPRASE

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; IV (INFUSION)	6MG/3ML	Prescription		IDURSULFASE	Iduronate Sulfatase	SHIRE	125151 2007-11-13 Label 2007-11-08 Letter 2006-10-05 Letter 2006-09-26 Review

Drug Adverse Effects information for ELAPRASE

Role code	Indications	Reaction	# Reports
PS	LOCAL ANAESTHESIA	ANAPHYLACTIC REACTION	1
PS	LOCAL ANAESTHESIA	CHILLS	1
PS	LOCAL ANAESTHESIA	COUGH	1
PS	LOCAL ANAESTHESIA	CYANOSIS	1
PS	LOCAL ANAESTHESIA	DYSPNOEA	1
PS	LOCAL ANAESTHESIA	FLUSHING	1
PS	LOCAL ANAESTHESIA	HYPERSENSITIVITY	1
PS	LOCAL ANAESTHESIA	LIP OEDEMA	1
PS	LOCAL ANAESTHESIA	RESPIRATORY DISTRESS	1
PS	LOCAL ANAESTHESIA	RETCHING	1
PS	LOCAL ANAESTHESIA	TONGUE OEDEMA	1
PS	LOCAL ANAESTHESIA	TREMOR	1
PS	MUCOPOLYSACCHARIDOSIS II	ANAPHYLACTIC REACTION	1
PS	MUCOPOLYSACCHARIDOSIS II	ASPIRATION	1
PS	MUCOPOLYSACCHARIDOSIS II	ASTHMA	1
PS	MUCOPOLYSACCHARIDOSIS II	BLOOD IMMUNOGLOBULIN G INCREASED	1
PS	MUCOPOLYSACCHARIDOSIS II	BRONCHITIS	1
PS	MUCOPOLYSACCHARIDOSIS II	CARDIO-RESPIRATORY ARREST	1
PS	MUCOPOLYSACCHARIDOSIS II	CARDIO-RESPIRATORY DISTRESS	1
PS	MUCOPOLYSACCHARIDOSIS II	CEREBROVASCULAR ACCIDENT	1
PS	MUCOPOLYSACCHARIDOSIS II	CHILLS	1
PS	MUCOPOLYSACCHARIDOSIS II	COUGH	2
PS	MUCOPOLYSACCHARIDOSIS II	CYANOSIS	1
PS	MUCOPOLYSACCHARIDOSIS II	DEATH	4
PS	MUCOPOLYSACCHARIDOSIS II	DEVICE RELATED INFECTION	2
PS	MUCOPOLYSACCHARIDOSIS II	DRUG HYPERSENSITIVITY	1
PS	MUCOPOLYSACCHARIDOSIS II	DYSPHONIA	2
PS	MUCOPOLYSACCHARIDOSIS II	DYSPNOEA	3
PS	MUCOPOLYSACCHARIDOSIS II	FEBRILE CONVULSION	1
PS	MUCOPOLYSACCHARIDOSIS II	FLUSHING	3
PS	MUCOPOLYSACCHARIDOSIS II	GENERALISED ERYTHEMA	2
PS	MUCOPOLYSACCHARIDOSIS II	HISTIOCYTOSIS	1
PS	MUCOPOLYSACCHARIDOSIS II	HYPERSENSITIVITY	1
PS	MUCOPOLYSACCHARIDOSIS II	HYPOAESTHESIA	1
PS	MUCOPOLYSACCHARIDOSIS II	IMPLANT SITE EFFUSION	1
PS	MUCOPOLYSACCHARIDOSIS II	INFUSION RELATED REACTION	6
PS	MUCOPOLYSACCHARIDOSIS II	INFUSION SITE EXTRAVASATION	1
PS	MUCOPOLYSACCHARIDOSIS II	JOINT SWELLING	1
PS	MUCOPOLYSACCHARIDOSIS II	LIP OEDEMA	1
PS	MUCOPOLYSACCHARIDOSIS II	LIP SWELLING	2
PS	MUCOPOLYSACCHARIDOSIS II	MALAISE	1
PS	MUCOPOLYSACCHARIDOSIS II	OROPHARYNGEAL PAIN	2
PS	MUCOPOLYSACCHARIDOSIS II	OSTEOMYELITIS	1
PS	MUCOPOLYSACCHARIDOSIS II	OXYGEN SATURATION DECREASED	2
PS	MUCOPOLYSACCHARIDOSIS II	PARAESTHESIA	1
PS	MUCOPOLYSACCHARIDOSIS II	PNEUMONIA	2
PS	MUCOPOLYSACCHARIDOSIS II	PNEUMONIA ASPIRATION	1
PS	MUCOPOLYSACCHARIDOSIS II	PRODUCTIVE COUGH	1
PS	MUCOPOLYSACCHARIDOSIS II	PRURITUS	2
PS	MUCOPOLYSACCHARIDOSIS II	PYREXIA	1
PS	MUCOPOLYSACCHARIDOSIS II	RASH	4
PS	MUCOPOLYSACCHARIDOSIS II	RASH MACULAR	1
PS	MUCOPOLYSACCHARIDOSIS II	RENAL FAILURE	2
PS	MUCOPOLYSACCHARIDOSIS II	RESPIRATORY DISTRESS	1
PS	MUCOPOLYSACCHARIDOSIS II	RETCHING	1
PS	MUCOPOLYSACCHARIDOSIS II	RHABDOMYOLYSIS	1
PS	MUCOPOLYSACCHARIDOSIS II	SUDDEN DEATH	1
PS	MUCOPOLYSACCHARIDOSIS II	SWELLING FACE	3
PS	MUCOPOLYSACCHARIDOSIS II	SWOLLEN TONGUE	1
PS	MUCOPOLYSACCHARIDOSIS II	TACHYCARDIA	3
PS	MUCOPOLYSACCHARIDOSIS II	TACHYPNOEA	1
PS	MUCOPOLYSACCHARIDOSIS II	TONGUE OEDEMA	1
PS	MUCOPOLYSACCHARIDOSIS II	TREMOR	1
PS	MUCOPOLYSACCHARIDOSIS II	URTICARIA	2
PS	PREMEDICATION	ASPIRATION	1
PS	PREMEDICATION	BLOOD IMMUNOGLOBULIN G INCREASED	7
PS	PREMEDICATION	COUGH	1
PS	PREMEDICATION	DEVICE RELATED INFECTION	2
PS	PREMEDICATION	DRUG HYPERSENSITIVITY	1
PS	PREMEDICATION	DYSPHONIA	14
PS	PREMEDICATION	DYSPNOEA	1
PS	PREMEDICATION	FLUSHING	14
PS	PREMEDICATION	GENERALISED ERYTHEMA	14
PS	PREMEDICATION	HISTIOCYTOSIS	2
PS	PREMEDICATION	INFUSION RELATED REACTION	16
PS	PREMEDICATION	LIP SWELLING	14
PS	PREMEDICATION	OROPHARYNGEAL PAIN	14
PS	PREMEDICATION	OSTEOMYELITIS	2
PS	PREMEDICATION	OXYGEN SATURATION DECREASED	14
PS	PREMEDICATION	RASH	15
PS	PREMEDICATION	SWELLING FACE	14
PS	PREMEDICATION	TACHYCARDIA	14
PS	PREMEDICATION	URTICARIA	14
PS	PRODUCT USED FOR UNKNOWN INDICATION	BLOOD IMMUNOGLOBULIN G INCREASED	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	DYSPHONIA	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	FLUSHING	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	GENERALISED ERYTHEMA	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	INFUSION RELATED REACTION	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	LIP SWELLING	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	OROPHARYNGEAL PAIN	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	OXYGEN SATURATION DECREASED	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	RASH	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	SWELLING FACE	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	TACHYCARDIA	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	URTICARIA	2
PS	SUPPLEMENTATION THERAPY	IMPLANT SITE EFFUSION	1
PS	SUPPLEMENTATION THERAPY	INFUSION RELATED REACTION	1
PS	SUPPLEMENTATION THERAPY	INFUSION SITE EXTRAVASATION	1
SS	MUCOPOLYSACCHARIDOSIS II	HYPOAESTHESIA	4
SS	MUCOPOLYSACCHARIDOSIS II	INFUSION RELATED REACTION	4
SS	MUCOPOLYSACCHARIDOSIS II	PARAESTHESIA	4
SS	MUCOPOLYSACCHARIDOSIS II	PRURITUS	4
SS	MUCOPOLYSACCHARIDOSIS II	RASH	4
SS	MUCOPOLYSACCHARIDOSIS II	SWELLING FACE	4

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