Fibrinogen (Human)
Jeneng merek: RiaSTAP
Kelas obat:
Agen Antineoplastik
Panganggone Fibrinogen (Human)
Episode Pendarahan Akut
Digunakake kanggo ngontrol episode pendarahan akut ing pasien kanthi kekurangan fibrinogen kongenital (yaiku afibrinogenemia [ora ana utawa konsentrasi fibrinogen plasma sing sithik banget], hypofibrinogenemia [konsentrasi fibrinogen plasma sing suda]); ditetepake minangka obat yatim piatu dening FDA kanggo digunakake ing kondisi iki.
Ora dituduhake ing pasien karo dysfibrinogenemia (ana fibrinogen ora normal utawa disfungsional).
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Carane nggunakake Fibrinogen (Human)
Umum
Monitor tingkat fibrinogen. Tingkat target yaiku 100 mg / dL; njaga tingkat iki nganti hemostasis dipikolehi.
Saben vial siji-sijine ngandhut antara 900–1300 mg fibrinogen (manungsa). Potensi fibrinogen sing nyata kanggo saben lot dituduhake ing label vial.
Administrasi
Administrasi IV
Administrasi kanthi injeksi IV alon nggunakake garis khusus. p> Reconstitution
Reconstitute vial karo 50 ml banyu steril kanggo injeksi. Alon-alon swirl nganti bubuk lyophilized rampung larut. Aja goyangake vial. Solusi sing dikonstitusi kudu ora ana warna lan bening nganti rada opal lan kudu dipriksa kanthi visual kanggo partikel; Mbuwang solusi yen mendhung utawa yen ana partikel.
Tingkat administrasiTingkat maksimal yaiku 5 ml / menit.
Dosis
Dosis individu adhedhasar tingkat pendarahan , asil tes laboratorium, lan kondisi klinis pasien.
Dosis dituduhake ing mg fibrinogen lan adhedhasar bobot. Administrasi 70 mg/kg fibrinogen (manungsa) nambah konsentrasi fibrinogen ing plasma kira-kira 120 mg/dL ing studi farmakokinetik ing 14 pasien.
Pasien Anak
Episode Perdarahan Akut IVNalika tingkat fibrinogen dhasar dikenal, gunakake rumus ing ngisor iki:
Target tingkat fibrinogen (mg/dL) - tingkat fibrinogen sing diukur (mg/dL) / 1,7 (mg/dL saben mg/kg bobot awak) = mg fibrinogen/bobot awak (ing kg)
Yen tingkat fibrinogen awal ora dingerteni, dosis sing disaranake yaiku 70 mg/kg.
Dewasa
Episode Pendarahan Akut IVNalika tingkat fibrinogen dhasar dikenal, gunakake rumus ing ngisor iki:
Target tingkat fibrinogen (mg/dL) - tingkat fibrinogen sing diukur (mg/dL) / 1,7 (mg/dL saben mg/kg bobot awak) = mg fibrinogen/bobot awak (ing kg)
Yen tingkat fibrinogen awal ora dingerteni, dosis sing disaranake yaiku 70 mg/kg.
Populasi Khusus
Ora ana rekomendasi dosis populasi khusus ing wektu iki.
Pènget
Kontraindikasi
Pènget/PanandhapPènget
Reaksi Sensitivitas
Reaksi alergi lan/utawa hipersensitivitas bisa kedadeyan. Ngawasi kanthi rapet kanggo manifestasi hipersensitivitas (contone, gatal-gatal, urtikaria umum, sesak dada, wheezing, hipotensi, anafilaksis). Langsung mandhegake obat kasebut lan menehi perawatan sing cocog yen ana hipersensitivitas.
Trombosis
Acara thromboembolic (contone, MI, emboli paru, DVT, trombosis arteri) bisa kedadeyan. Timbang keuntungan obat kasebut nglawan risiko trombosis. Monitor trombosis.
Risiko Agen Tular ing Preparasi sing asale saka Plasma
Potensi kendaraan kanggo transmisi virus manungsa (contone, HIV, virus hepatitis B [HBV], virus hepatitis C [HCV]) lan agen infèksi liyane.
Skrining donor sing luwih apik lan prosedur ngilangi/ngurangi virus wis suda, nanging ora bisa ngilangi risiko panularan patogen kanthi preparat sing asale saka plasma. Kemungkinan isih ana kanggo transmisi penyakit. Laporake manawa ana infeksi sing dicurigai menyang pabrikan ing 866-915-6958.
Populasi Spesifik
KandhutanKategori C.
LaktasiOra diteliti ing wanita sing nyusoni kanthi kekurangan fibrinogen kongenital.
Panggunaan PediatrikDievaluasi ing jumlah bocah sing winates. ≤16 taun.
Panggunaan GeriatrikPengalaman ing umur ≥65 taun ora cukup kanggo nemtokake manawa wong diwasa geriatrik nanggapi beda karo wong diwasa sing luwih enom.
Efek Umum sing Saru
Demam, sirah.
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