Statements (55)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:pharmaceuticals
|
| gptkbp:approves |
gptkb:2011
|
| gptkbp:brand |
gptkb:Makena
|
| gptkbp:category |
Category B
|
| gptkbp:clinical_trial |
Phase III
conducted in multiple countries reduced risk of complications conducted in Australia conducted in Asia conducted in Canada conducted in Europe conducted in the United States improved neonatal outcomes shown to reduce preterm birth rates |
| gptkbp:clinical_use |
given to women with a history of preterm birth
|
| gptkbp:condition |
premature birth
preterm labor |
| gptkbp:contraindication |
allergy to hydroxyprogesterone
|
| gptkbp:dosage_form |
solution for injection
|
| gptkbp:effective_date |
FDA approved
|
| gptkbp:formulation |
oil-based solution
|
| gptkbp:frequency |
once a week
|
| gptkbp:generic_availability |
no generic available
|
| https://www.w3.org/2000/01/rdf-schema#label |
Makena
|
| gptkbp:ingredients |
gptkb:hydroxyprogesterone_caproate
|
| gptkbp:invention |
patented
|
| gptkbp:manufacturer |
gptkb:AMAG_Pharmaceuticals
|
| gptkbp:marketed_as |
gptkb:Makena
|
| gptkbp:mechanism_of_action |
progestin hormone
|
| gptkbp:packaging |
single-dose vial
|
| gptkbp:patient_education |
importance of adherence to treatment
informed about potential side effects monitoring for signs of complications |
| gptkbp:patient_population |
pregnant women at risk of preterm delivery
|
| gptkbp:price |
varies by pharmacy
|
| gptkbp:provides_guidance_on |
ACOG guidelines recommend use
|
| gptkbp:regulatory_compliance |
approved by FDA
approved by EMA |
| gptkbp:related_products |
gptkb:17-alpha-hydroxyprogesterone
progesterone |
| gptkbp:research |
studies on long-term effects
studies on safety profile studies on efficacy in multiple pregnancies |
| gptkbp:route_of_administration |
intramuscular injection
|
| gptkbp:side_effect |
headache
nausea hypertension injection site reactions gestational diabetes thromboembolic disorders |
| gptkbp:storage |
store at room temperature
|
| gptkbp:type_of_insurance |
may be covered by insurance
|
| gptkbp:used_for |
prevention of preterm birth
|
| gptkbp:bfsParent |
gptkb:South_Maui
|
| gptkbp:bfsLayer |
6
|