Statements (60)
Predicate | Object |
---|---|
gptkbp:instance_of |
gptkb:Biology
|
gptkbp:administered_by |
intravenous infusion
|
gptkbp:approves |
gptkb:2006
gptkb:FDA |
gptkbp:availability |
prescription only
|
gptkbp:clinical_trial |
gptkb:Shire_Pharmaceuticals
multiple countries improved quality of life Phase III reduced symptoms safety profile established efficacy demonstrated improved enzyme levels |
gptkbp:clinical_use |
long-term treatment
|
gptkbp:condition |
lysosomal storage disorders
|
gptkbp:contraindication |
active infections
severe allergic reactions severe liver disease severe kidney disease hypersensitivity to idursulfase |
gptkbp:dosage_form |
gptkb:Software_Solutions
|
gptkbp:duration |
lifelong
|
gptkbp:financial_support |
available
|
https://www.w3.org/2000/01/rdf-schema#label |
Elaprase
|
gptkbp:ingredients |
gptkb:idursulfase
|
gptkbp:is_monitored_by |
regular check-ups
|
gptkbp:manufacturer |
gptkb:Shire_Pharmaceuticals
|
gptkbp:marketed_as |
gptkb:Elaprase
|
gptkbp:mechanism_of_action |
replaces deficient enzyme
|
gptkbp:patient_education |
provided by manufacturer
|
gptkbp:patient_population |
pediatric and adult patients
|
gptkbp:price |
high
|
gptkbp:project |
commercialized
|
gptkbp:regulatory_compliance |
approved
|
gptkbp:research_focus |
genetic disorders
long-term outcomes pediatric treatments enzyme replacement therapies lysosomal storage diseases |
gptkbp:route_of_administration |
IV
|
gptkbp:service_frequency |
weekly
|
gptkbp:shelf_life |
24 months
|
gptkbp:side_effect |
fatigue
headache muscle pain nausea fever vomiting urticaria rash joint pain chills anaphylaxis infusion reactions hypersensitivity reactions |
gptkbp:storage |
refrigerated
|
gptkbp:targets |
gptkb:Mucopolysaccharidosis_II
|
gptkbp:used_for |
gptkb:Hunter_syndrome
|
gptkbp:bfsParent |
gptkb:Shire_plc
|
gptkbp:bfsLayer |
5
|