Drug information for MYOZYME

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INJECTABLE; IV (INFUSION)	20MG/KG	Prescription		ALGLUCOSIDASE ALFA	GAA protein, human	GENZYME	125141 2009-01-16 Label 2008-12-24 Letter 2006-06-21 Review 2006-05-02 Letter 2006-04-28 Label

Drug Adverse Effects information for MYOZYME

Role code	Indications	Reaction	# Reports
PS	ANAEMIA	COLON CANCER METASTATIC	1
PS	COLITIS ULCERATIVE	CONVULSION	4
PS	COLITIS ULCERATIVE	SUBDURAL HAEMATOMA	4
PS	DROOLING	RESPIRATORY FAILURE	1
PS	DROOLING	STAPHYLOCOCCAL SEPSIS	1
PS	DROOLING	THERAPEUTIC RESPONSE DECREASED	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	ADRENAL GLAND CANCER METASTATIC	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	AORTIC DISSECTION	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	ARRHYTHMIA	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	ASTHENIA	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	BREAST CANCER METASTATIC	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	CANDIDIASIS	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	CARDIAC ARREST	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	CARDIAC FAILURE	7
PS	GLYCOGEN STORAGE DISEASE TYPE II	CARDIO-RESPIRATORY ARREST	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	CARDIOPULMONARY FAILURE	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	CARDIOVASCULAR DISORDER	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	COLON CANCER METASTATIC	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	CONVULSION	5
PS	GLYCOGEN STORAGE DISEASE TYPE II	DEATH	10
PS	GLYCOGEN STORAGE DISEASE TYPE II	DECUBITUS ULCER	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	DISEASE PROGRESSION	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	DRUG HYPERSENSITIVITY	4
PS	GLYCOGEN STORAGE DISEASE TYPE II	DYSPNOEA	2
PS	GLYCOGEN STORAGE DISEASE TYPE II	ERYTHEMA	4
PS	GLYCOGEN STORAGE DISEASE TYPE II	FLUSHING	4
PS	GLYCOGEN STORAGE DISEASE TYPE II	FOETAL HEART RATE DECELERATION	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	GASTROINTESTINAL HAEMORRHAGE	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	HYPERSENSITIVITY	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	HYPOTHERMIA	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	IRRITABILITY	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	LOW BIRTH WEIGHT BABY	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	MOTOR DYSFUNCTION	2
PS	GLYCOGEN STORAGE DISEASE TYPE II	MUSCULAR WEAKNESS	2
PS	GLYCOGEN STORAGE DISEASE TYPE II	MYOCARDIAL INFARCTION	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	PLACENTAL DISORDER	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	PNEUMONIA ASPIRATION	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	PNEUMOTHORAX	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	PREMATURE BABY	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	PREMATURE RUPTURE OF MEMBRANES	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	PSEUDOMONAS INFECTION	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	PULMONARY HYPERTENSION	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	PYREXIA	2
PS	GLYCOGEN STORAGE DISEASE TYPE II	RESPIRATORY DISORDER	3
PS	GLYCOGEN STORAGE DISEASE TYPE II	RESPIRATORY DISTRESS	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	RESPIRATORY FAILURE	4
PS	GLYCOGEN STORAGE DISEASE TYPE II	SEPSIS	2
PS	GLYCOGEN STORAGE DISEASE TYPE II	SKIN NECROSIS	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	STAPHYLOCOCCAL SEPSIS	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	SUBDURAL HAEMATOMA	4
PS	GLYCOGEN STORAGE DISEASE TYPE II	SUDDEN DEATH	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	THERAPEUTIC RESPONSE DECREASED	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	UPPER RESPIRATORY TRACT INFECTION	1
PS	GLYCOGEN STORAGE DISEASE TYPE II	URINARY TRACT INFECTION	1
PS	HYPERTENSION	COLON CANCER METASTATIC	1
PS	IMMUNOSUPPRESSION	DYSPNOEA	1
PS	IMMUNOSUPPRESSION	PNEUMOTHORAX	1
PS	IMMUNOSUPPRESSION	PYREXIA	1
PS	INFECTION	DYSPNOEA	1
PS	INFECTION	PNEUMOTHORAX	1
PS	INFECTION	PYREXIA	1
PS	NAUSEA	COLON CANCER METASTATIC	1
PS	OSTEOPOROSIS	COLON CANCER METASTATIC	1
PS	PREMEDICATION	CONVULSION	2
PS	PREMEDICATION	GASTROINTESTINAL HAEMORRHAGE	2
PS	PREMEDICATION	IRRITABILITY	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	CARDIAC FAILURE	5
PS	PRODUCT USED FOR UNKNOWN INDICATION	CARDIOPULMONARY FAILURE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	CARDIOVASCULAR DISORDER	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	COLON CANCER METASTATIC	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	CONVULSION	23
PS	PRODUCT USED FOR UNKNOWN INDICATION	DISEASE PROGRESSION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	GASTROINTESTINAL HAEMORRHAGE	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	IRRITABILITY	9
PS	PRODUCT USED FOR UNKNOWN INDICATION	PULMONARY HYPERTENSION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	SUBDURAL HAEMATOMA	14
SS	COLITIS ULCERATIVE	CONVULSION	16
SS	COLITIS ULCERATIVE	SUBDURAL HAEMATOMA	16
SS	DROOLING	RESPIRATORY FAILURE	1
SS	DROOLING	STAPHYLOCOCCAL SEPSIS	1
SS	DROOLING	THERAPEUTIC RESPONSE DECREASED	1
SS	GLYCOGEN STORAGE DISEASE TYPE II	CONVULSION	16
SS	GLYCOGEN STORAGE DISEASE TYPE II	RESPIRATORY FAILURE	1
SS	GLYCOGEN STORAGE DISEASE TYPE II	STAPHYLOCOCCAL SEPSIS	1
SS	GLYCOGEN STORAGE DISEASE TYPE II	SUBDURAL HAEMATOMA	16
SS	GLYCOGEN STORAGE DISEASE TYPE II	THERAPEUTIC RESPONSE DECREASED	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	CONVULSION	56
SS	PRODUCT USED FOR UNKNOWN INDICATION	SUBDURAL HAEMATOMA	56
C	GLYCOGEN STORAGE DISEASE TYPE II	ALANINE AMINOTRANSFERASE INCREASED	1
C	GLYCOGEN STORAGE DISEASE TYPE II	ASPARTATE AMINOTRANSFERASE INCREASED	1
C	GLYCOGEN STORAGE DISEASE TYPE II	CHEST X-RAY ABNORMAL	1
C	GLYCOGEN STORAGE DISEASE TYPE II	HEADACHE	1
C	GLYCOGEN STORAGE DISEASE TYPE II	PNEUMONIA	1
C	GLYCOGEN STORAGE DISEASE TYPE II	PYREXIA	1
C	GLYCOGEN STORAGE DISEASE TYPE II	RED BLOOD CELL SEDIMENTATION RATE INCREASED	1

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