Statements (60)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
pharmaceutical drug
|
| gptkbp:activeDuring |
gptkb:parathyroid_hormone
|
| gptkbp:administrativeDivision |
daily
|
| gptkbp:availableFormats |
vial
pre-filled syringe |
| gptkbp:clinicalTrials |
gptkb:Canada
gptkb:United_States gptkb:OPKO_Health,_Inc. Europe Phase 3 monitored for safety published in medical journals informed consent required included in treatment protocols improved calcium levels reduced symptoms of hypoparathyroidism screened for eligibility |
| gptkbp:community_service |
available
safety and efficacy quality of life measures |
| gptkbp:contraindication |
allergic reactions
hypercalcemia hypocalcemia |
| gptkbp:date |
FDA_approved
|
| gptkbp:developedBy |
gptkb:OPKO_Health,_Inc.
|
| gptkbp:dosageForm |
injection
|
| gptkbp:drugInterdiction |
none reported
available_on_FDA_website |
| gptkbp:formulation |
injectable solution
|
| gptkbp:hasPopulation |
children
adults |
| gptkbp:healthcare |
provided by healthcare professionals
important for efficacy |
| https://www.w3.org/2000/01/rdf-schema#label |
OPKO 2300
|
| gptkbp:is_monitored_by |
kidney function
bone density calcium levels |
| gptkbp:lastProduced |
2021
|
| gptkbp:mandates |
hypoparathyroidism treatment
|
| gptkbp:manufacturer |
gptkb:OPKO_Health,_Inc.
|
| gptkbp:marketedAs |
gptkb:Canada
gptkb:European_Union gptkb:United_States brand name |
| gptkbp:offers |
varies by region
|
| gptkbp:patentAssignee |
gptkb:OPKO_Health,_Inc.
|
| gptkbp:regulatoryCompliance |
EMA_approved
|
| gptkbp:research |
provided_by_OPKO_Health,_Inc.
|
| gptkbp:researchFocus |
endocrinology
metabolic disorders |
| gptkbp:researchInterest |
with academic institutions
with healthcare organizations |
| gptkbp:route |
subcutaneous injection
|
| gptkbp:shelfLife |
24 months
|
| gptkbp:sideEffect |
headache
nausea injection site reactions |
| gptkbp:storage |
refrigerated
|
| gptkbp:triggerType |
replaces parathyroid hormone
|
| gptkbp:usedFor |
treatment of hypoparathyroidism
|