ICumberland Pharmaceuticals Inc., inkampani ekhethekile eyenza imithi, namuhla imemezele ukuthi i-US Food and Drug Administration (FDA) igunyaze ukulebula okunwetshiwe kwe-Caldolor®, ukwakheka okulethwe ngomjovo we-ibuprofen, manje okuhlanganisa ukusetshenziswa ekuphathweni kwangaphambi kokusebenza.
Ilebula esanda kugunyazwa i-FDA ihlanganisa ulwazi olumayelana nezinkomba nokusetshenziswa komkhiqizo, isibalo esifanele seziguli, imiphumela yocwaningo lomtholampilo, imiphumela engemihle engaba khona, imininingwane yokuphepha kwesiguli, kanye nemiyalelo yokusetshenziswa kwabesifazane abakhulelwe, izingane nezinye izakhamuzi.
Ukusekela lokhu kusetshenziswa okwandisiwe kweCaldlor, ucwaningo lwezinhlungu zokuhlinzwa zamathambo zaqinisekisa ukunciphisa ubuhlungu obukhulu lapho umkhiqizo uphathwa njalo ngamahora ayisithupha (uqale ngaphambi kokuhlinzwa) nge-morphine eyengeziwe etholakalayo ngesisekelo esidingekayo. Isamba seziguli eziyi-185 zahlelwa ngokungahleliwe futhi zelashwa nge-Caldlor® 800 mg noma i-placebo elawulwa njalo emahoreni ayisithupha (iqalwe ngaphambi kokuhlinzwa) kanye ne-morphine ehlinzekwa ngokwesisekelo esidingekayo.
Ukusebenza kahle kuboniswe njengokunciphisa ngokwezibalo okukhulu kokuqina kobuhlungu ngaphezu kwamahora angu-24 ngemva kokuhlinzwa ezigulini eziphathwe nge-Callor® uma kuqhathaniswa nalabo abathola i-placebo.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- Supporting this expanded use of Caldolor, a study of orthopedic surgical pain confirmed the significant pain reduction when the product was administered every six hours (started pre-operatively) with supplemental morphine available on an as needed basis.
- A total of 185 patients were randomized and treated with either Caldolor® 800 mg or placebo administered every six hours (started pre-operatively) and morphine provided on an as needed basis.
- Ukusebenza kahle kuboniswe njengokunciphisa ngokwezibalo okukhulu kokuqina kobuhlungu ngaphezu kwamahora angu-24 ngemva kokuhlinzwa ezigulini eziphathwe nge-Callor® uma kuqhathaniswa nalabo abathola i-placebo.
