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Glycogen storage disease type II / Hepatology / Alglucosidase alfa / Hypersensitivity / Anaphylaxis / Medicine / Health / Allergology


HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LUMIZYME safely and effectively. See full prescribing information for LUMIZYME. LUMIZYME® (alglucosidase alfa), fo
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Document Date: 2014-08-04 14:23:48


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City

Reference / /

Company

IgG / Genzyme Corporation / /

Event

FDA Phase / /

IndustryTerm

reconstituted and diluted alglucosidase alfa solution / cardiopulmonary resuscitation equipment / reconstituted alglucosidase alfa solution / reconstituted and diluted solution / healthcare professional / /

MedicalCondition

Life-threatening anaphylactic reactions / anaphylactic shock / Erythema Vomiting Rigors Pallor Cyanosis Agitation Tremor / GAA deficiency / chest pain / headache / experienced hypersensitivity / ventricular extrasystoles / recurrent hypersensitivity / nausea / anaphylaxis / muscle weakness / hyperhidrosis / If anaphylaxis / tremor / severe hypersensitivity / Cardiac Arrhythmia / fatigue / bradycardia / tachycardia / hypersensitivity / anaphylactic reactions / diarrhea / restlessness / membranous glomerulonephritis / cardiac arrest / pruritus / Infantile-onset Pompe disease / back pain / Pompe disease / wheezing / hypotension / severe inflammatory arthropathy / cardiac hypertrophy / hypertension / Clinical Trials Adverse Reaction Rash / OF ANAPHYLAXIS / bronchospasm / proteinuria / nephrotic syndrome / flushing / disease / respiratory tract irritation / Sudden Cardiac Death / dyspnea / infantileonset Pompe disease / late-onset Pompe disease / Carcinogenesis / Life-threatening anaphylaxis / apnea / erythema / Nephrotic syndrome / vomiting / Placebo-Treated Patients Adverse Reaction Hyperhidrosis Urticaria Anaphylaxis Chest Discomfort Muscle Twitching Myalgia Flushing / Wolff Parkinson-White syndrome / urticaria / angioedema / acute underlying respiratory illness / livedo reticularis / rigors / still experienced hypersensitivity / delayed-onset hypersensitivity / Additional hypersensitivity / supraventricular tachycardia / deficiency / dizziness / cough / rash / paresthesia / respiratory distress / /

MedicalTreatment

cardiopulmonary resuscitation / intravenous infusion / massage / enzyme replacement therapy / catheter / resuscitation / /

Organization

Central Venous Catheter Placement Administration / DOSAGE AND ADMINISTRATION / FDA / /

Person

Wolff Parkinson-White / /

/

Position

General / General Anesthesia / Major / representative / /

Product

DOSAGE FORMS AND STRENGTHS For injection / Sodium Chloride / Sterile Water for Injection / For injection / epinephrine / for / /

Technology

antibodies / Pharmacokinetics / Pharmacodynamics / /

URL

www.fda.gov/medwatch / /

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