Drug information for NAGLAZYME
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
INJECTABLE; INJECTION
5MG/5ML
Prescription
GALSULFASE
galsulfase
BIOMARIN
125117
2011-05-05 Letter
2011-05-05 Letter
2011-05-05 Letter
2011-04-29 Label
2011-04-29 Label
2011-04-29 Label
2005-09-13 Review
2005-06-07 Letter
2005-06-07 Label
Drug Adverse Effects information for NAGLAZYME
Role code
Indications
Reaction
# Reports
PS
MUCOPOLYSACCHARIDOSIS VI
ACUTE RESPIRATORY DISTRESS SYNDROME
2
PS
MUCOPOLYSACCHARIDOSIS VI
ANAPHYLACTIC SHOCK
1
PS
MUCOPOLYSACCHARIDOSIS VI
ASCITES
1
PS
MUCOPOLYSACCHARIDOSIS VI
ASTHMA
1
PS
MUCOPOLYSACCHARIDOSIS VI
ATLANTOAXIAL INSTABILITY
1
PS
MUCOPOLYSACCHARIDOSIS VI
BLADDER DISORDER
1
PS
MUCOPOLYSACCHARIDOSIS VI
BRAIN INJURY
2
PS
MUCOPOLYSACCHARIDOSIS VI
BRONCHOPNEUMONIA
2
PS
MUCOPOLYSACCHARIDOSIS VI
BRONCHOSPASM
1
PS
MUCOPOLYSACCHARIDOSIS VI
CARDIAC FAILURE
2
PS
MUCOPOLYSACCHARIDOSIS VI
CARDIAC FAILURE CHRONIC
1
PS
MUCOPOLYSACCHARIDOSIS VI
CARDIO-RESPIRATORY ARREST
1
PS
MUCOPOLYSACCHARIDOSIS VI
CARDIOPULMONARY FAILURE
1
PS
MUCOPOLYSACCHARIDOSIS VI
CATHETER CULTURE POSITIVE
1
PS
MUCOPOLYSACCHARIDOSIS VI
CERVICAL CORD COMPRESSION
2
PS
MUCOPOLYSACCHARIDOSIS VI
CERVICAL SPINAL STENOSIS
1
PS
MUCOPOLYSACCHARIDOSIS VI
CONDITION AGGRAVATED
1
PS
MUCOPOLYSACCHARIDOSIS VI
CONGESTIVE CARDIOMYOPATHY
1
PS
MUCOPOLYSACCHARIDOSIS VI
DEATH
3
PS
MUCOPOLYSACCHARIDOSIS VI
DYSPNOEA
1
PS
MUCOPOLYSACCHARIDOSIS VI
EAR INFECTION
1
PS
MUCOPOLYSACCHARIDOSIS VI
GAIT DISTURBANCE
1
PS
MUCOPOLYSACCHARIDOSIS VI
HYPERSENSITIVITY
1
PS
MUCOPOLYSACCHARIDOSIS VI
HYPERTENSION
1
PS
MUCOPOLYSACCHARIDOSIS VI
HYPERTONIA
1
PS
MUCOPOLYSACCHARIDOSIS VI
HYPOAESTHESIA
1
PS
MUCOPOLYSACCHARIDOSIS VI
HYPOKINESIA
1
PS
MUCOPOLYSACCHARIDOSIS VI
HYPOTONIA
2
PS
MUCOPOLYSACCHARIDOSIS VI
INFECTION
1
PS
MUCOPOLYSACCHARIDOSIS VI
LIVER INJURY
1
PS
MUCOPOLYSACCHARIDOSIS VI
MULTI-ORGAN FAILURE
1
PS
MUCOPOLYSACCHARIDOSIS VI
MUSCLE SPASTICITY
1
PS
MUCOPOLYSACCHARIDOSIS VI
MUSCULAR WEAKNESS
1
PS
MUCOPOLYSACCHARIDOSIS VI
NASOPHARYNGITIS
1
PS
MUCOPOLYSACCHARIDOSIS VI
NECK PAIN
1
PS
MUCOPOLYSACCHARIDOSIS VI
ODONTOGENIC CYST
1
PS
MUCOPOLYSACCHARIDOSIS VI
OXYGEN SATURATION DECREASED
2
PS
MUCOPOLYSACCHARIDOSIS VI
PNEUMONIA
10
PS
MUCOPOLYSACCHARIDOSIS VI
PRODUCT QUALITY ISSUE
2
PS
MUCOPOLYSACCHARIDOSIS VI
PULMONARY HYPERTENSION
2
PS
MUCOPOLYSACCHARIDOSIS VI
PULMONARY OEDEMA
1
PS
MUCOPOLYSACCHARIDOSIS VI
PYRAMIDAL TRACT SYNDROME
1
PS
MUCOPOLYSACCHARIDOSIS VI
RENAL DISORDER
1
PS
MUCOPOLYSACCHARIDOSIS VI
SINUSITIS
1
PS
MUCOPOLYSACCHARIDOSIS VI
SLEEP APNOEA SYNDROME
2
PS
MUCOPOLYSACCHARIDOSIS VI
SPINAL CORD COMPRESSION
9
PS
MUCOPOLYSACCHARIDOSIS VI
TACHYCARDIA
1
PS
MUCOPOLYSACCHARIDOSIS VI
TONSILLECTOMY
1
PS
MUCOPOLYSACCHARIDOSIS VI
TOOTH DISORDER
1
PS
MUCOPOLYSACCHARIDOSIS VI
TOOTH EXTRACTION
1
PS
MUCOPOLYSACCHARIDOSIS VI
TRACHEAL OEDEMA
1
PS
MUCOPOLYSACCHARIDOSIS VI
TRACHEOMALACIA
1
PS
MUCOPOLYSACCHARIDOSIS VI
UPPER RESPIRATORY TRACT INFECTION
1
PS
MUCOPOLYSACCHARIDOSIS VI
VENOUS INSUFFICIENCY
1
PS
PREMEDICATION
ASCITES
3
PS
PREMEDICATION
BRAIN INJURY
2
PS
PREMEDICATION
CARDIAC FAILURE CHRONIC
3
PS
PREMEDICATION
CONDITION AGGRAVATED
3
PS
PREMEDICATION
CONGESTIVE CARDIOMYOPATHY
3
PS
PREMEDICATION
HYPERTONIA
3
PS
PREMEDICATION
LIVER INJURY
3
PS
PREMEDICATION
MULTI-ORGAN FAILURE
3
PS
PREMEDICATION
PNEUMONIA
5
PS
PREMEDICATION
PULMONARY OEDEMA
3
PS
PREMEDICATION
RENAL DISORDER
3
PS
PREMEDICATION
SPINAL CORD COMPRESSION
3
PS
PREMEDICATION
VENOUS INSUFFICIENCY
3
PS
PRODUCT USED FOR UNKNOWN INDICATION
EAR INFECTION
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
PNEUMONIA
18
PS
PRODUCT USED FOR UNKNOWN INDICATION
SINUSITIS
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
SPINAL CORD COMPRESSION
6
PS
PRODUCT USED FOR UNKNOWN INDICATION
TRACHEAL OBSTRUCTION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
UPPER RESPIRATORY TRACT INFECTION
2
PS
PYREXIA
EAR INFECTION
1
PS
PYREXIA
SINUSITIS
1
PS
PYREXIA
UPPER RESPIRATORY TRACT INFECTION
1
SS
MUCOPOLYSACCHARIDOSIS VI
ASCITES
2
SS
MUCOPOLYSACCHARIDOSIS VI
ATLANTOAXIAL INSTABILITY
4
SS
MUCOPOLYSACCHARIDOSIS VI
BLADDER DISORDER
4
SS
MUCOPOLYSACCHARIDOSIS VI
BRONCHOSPASM
4
SS
MUCOPOLYSACCHARIDOSIS VI
CARDIAC FAILURE CHRONIC
2
SS
MUCOPOLYSACCHARIDOSIS VI
CONDITION AGGRAVATED
2
SS
MUCOPOLYSACCHARIDOSIS VI
CONGESTIVE CARDIOMYOPATHY
2
SS
MUCOPOLYSACCHARIDOSIS VI
GAIT DISTURBANCE
4
SS
MUCOPOLYSACCHARIDOSIS VI
HYPERTONIA
2
SS
MUCOPOLYSACCHARIDOSIS VI
HYPOKINESIA
4
SS
MUCOPOLYSACCHARIDOSIS VI
HYPOTONIA
4
SS
MUCOPOLYSACCHARIDOSIS VI
LIVER INJURY
2
SS
MUCOPOLYSACCHARIDOSIS VI
MULTI-ORGAN FAILURE
2
SS
MUCOPOLYSACCHARIDOSIS VI
MUSCLE SPASTICITY
4
SS
MUCOPOLYSACCHARIDOSIS VI
MUSCULAR WEAKNESS
4
SS
MUCOPOLYSACCHARIDOSIS VI
OXYGEN SATURATION DECREASED
4
SS
MUCOPOLYSACCHARIDOSIS VI
PNEUMONIA
1
SS
MUCOPOLYSACCHARIDOSIS VI
PULMONARY OEDEMA
2
SS
MUCOPOLYSACCHARIDOSIS VI
PYRAMIDAL TRACT SYNDROME
4
SS
MUCOPOLYSACCHARIDOSIS VI
RENAL DISORDER
2
SS
MUCOPOLYSACCHARIDOSIS VI
SLEEP APNOEA SYNDROME
4
SS
MUCOPOLYSACCHARIDOSIS VI
SPINAL CORD COMPRESSION
4
SS
MUCOPOLYSACCHARIDOSIS VI
VENOUS INSUFFICIENCY
2
SS
PREMEDICATION
ASCITES
6
SS
PREMEDICATION
CARDIAC FAILURE CHRONIC
6
SS
PREMEDICATION
CONDITION AGGRAVATED
6
SS
PREMEDICATION
CONGESTIVE CARDIOMYOPATHY
6
SS
PREMEDICATION
HYPERTONIA
6
SS
PREMEDICATION
LIVER INJURY
6
SS
PREMEDICATION
MULTI-ORGAN FAILURE
6
SS
PREMEDICATION
PULMONARY OEDEMA
6
SS
PREMEDICATION
RENAL DISORDER
6
SS
PREMEDICATION
VENOUS INSUFFICIENCY
6
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