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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