A1-Proteinase Inhibitor
Kelas obat: Agen Antineoplastik , Agen Antineoplastik
Panganggone A1-Proteinase Inhibitor
Kekurangan Inhibitor α1-Proteinase bawaan
Terapi panggantos ing pasien kanthi defisiensi inhibitor α1-proteinase kongenital (uga disebut α1-antitrypsin) lan emfisema sing katon sacara klinis.
Ora dituduhake minangka terapi kanggo pasien sing nandhang penyakit paru-paru sing kekurangan inhibitor α1-proteinase kongenital durung ditetepake.
American Thoracic Society lan European Respiratory Society (ATS/ERS) nyatakake yen terapi inhibitor α1-proteinase ora entuk manfaat, lan ora dianjurake kanggo pasien sing duwe penyakit ati sing gegandhengan karo α1-proteinase. .
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Carane nggunakake A1-Proteinase Inhibitor
Administrasi
IV Administrasi
Diwenehake kanthi infus IV.
Administrasi infus IV Zemaira liwat jalur IV nggunakake set administrasi sing ngemot filter inline (ukuran pori 5 µm).
Monitor tingkat infus lan status klinis (contone, tandha vital , reaksi sing gegandhengan karo infus) pasien terus-terusan sajrone infus.
Ngatur kanthi ati-ati; tusukan percutaneous kanthi jarum sing terkontaminasi getih bisa nularake agen infèksius. (Deleng Resiko Agen Transmisi ing Preparasi sing asale saka Plasma miturut Ati-ati.)
RekonstitusiBotol saka inhibitor α1-proteinase lyophilized lan pengencer kudu ing suhu kamar sadurunge rekonstitusi.
Rekonstitusi vial saka inhibitor α1-proteinase lyophilized karo banyu steril sing diwenehake pabrikan kanggo injeksi tanpa pengawet. Nggunakake jarum utawa piranti transfer sing diwenehake, tambahake volume sing cocog saka pengencer sing diwenehake menyang vial sing ngemot inhibitor α1-proteinase. (Waca Tabel 1.) Swirl vial alon-alon kanggo mesthekake pembubaran; ora goyang.
Jumlah kira-kira (mg utawa g) inhibitor α1-proteinase sing aktif sacara fungsional.
Banyu steril sing disedhiyakake pabrikan kanggo injeksi tanpa pengawet.
Tabel 1. Rekonstitusi Preparat Inhibitor α1-ProteinasePreparasi Inhibitor α1-Proteinase
Kekuwatan Dosis sing Dilabeli ing Vial
Volume Pengencer
Aralast
500 mg
25 mL
Aralast
1 g
p>50 mL
Prolastin
500 mg
20 mL
Prolastin
1 g
40 mL
Zemaira
1 g
20 mL p>
Solusi asil saka Aralast, Prolastin, utawa Zemaira ngemot ora kurang saka (NLT) 16 mg, NLT 20 mg, utawa kira-kira 50 mg inhibitor α1-proteinase saben mL.
Kanggo administrasi dosis gedhe, sawetara vial sing wis dikonstitusi bisa dikumpulake ing wadhah infus IV sing kosong lan steril (umpamane, tas IV kosong utawa botol kaca) nggunakake teknik aseptik.
Mbusak solusi Aralast lan Prolastin sing dikonstitusi saka vial nggunakake jarum panyaring sing diwenehake dening pabrikan.
Solusi sing dikonstitusi ora ngandhut pengawet; administrasi ing 3 jam sawise reconstitution.
Sembarang solusi sing ora digunakake kudu dibuwang; mbuang peralatan administrasi sesuai karo prosedur limbah biohazard.
Tingkat AdministrasiAdministrasi Aralast ing tingkat infus ≤0,08 mL/kg saben menit.
Administrasi Zemaira kanthi tingkat infus kira-kira 0,08 mL/kg saben menit.
Administrasi Prolastin kanthi tingkat infus ≥0,08 mL/kg saben menit.
Yen efek salabetipun kedaden, ngurangi tingkat infus utawa sementara interrupted infus nganti kawujudan suda. Infus banjur bisa diterusake maneh ing tingkat sing ditrima dening pasien.
Dosis
Dosis inhibitor α1-proteinase ing mg dituduhake ing syarat-syarat inhibitor α1-proteinase aktif fungsional, sing ditemtokake dening neutrofil manungsa (Zemaira) utawa pankreas babi (Aralast, Prolastin. aktivitas inhibitor elastase.
Jumlah mg inhibitor α1-proteinase sing aktif sacara fungsional dituduhake ing label saben vial.
Aktivitas spesifik inhibitor α1-proteinase fungsional ing Aralast, Prolastin, utawa Zemaira yaiku NLT 0,55, NLT 0,35, utawa NLT 0,7 mg, saben mg protein.
Dewasa
Defisiensi Inhibitor α1-Proteinase Bawaan IV60 mg/kg kanthi infus IV sapisan saben minggu.
Pènget
Kontraindikasi
Pènget/PanandhapPènget
Resiko Agen Tular ing Preparasi sing asalé saka Plasma
Potensi kendaraan kanggo transmisi virus manungsa (yaiku, hepatitis A [HAV] utawa virus C [HCV]; HIV-1 utawa HIV-2; parvovirus B19) utawa agen infèksius liyane.
Senajan prosedur sing ketat (contone, screening donor plasma, aplikasi sawetara langkah penghapusan / pengurangan virus) kanggo nyegah panularan agen infèksius, risiko penularan isih tetep.
Risiko infeksi virus kudu ditimbang karo keuntungan saka terapi inhibitor α1-proteinase.
Kabeh infèksi sing dianggep bisa ditularaké déning prodhuk inhibitor α1-proteinase kudu dilaporake menyang pabrikan sing cocog.
Risiko Penyakit Creutzfeldt-JakobBisa nggawa risiko nularake agen penyebab penyakit Creutzfeldt-Jakob (CJD), sanajan transmisi liwat getih manungsa, komponen getih, utawa turunan plasma (kalebu inhibitor α1-proteinase) durung didokumentasikake. CJD minangka penyakit degeneratif sing langka, nanging bisa nyebabake fatal saka CNS sing ana hubungane karo agen sing bisa ditularake sing kurang dimangerteni. remot banget.
Reaksi Sensitivitas
Reaksi HipersensitivitasReaksi hipersensitivitas sing serius (contone, reaksi anafilaksis utawa anafilaktoid).
Yen reaksi hipersensitivitas akut (umpamane, gatal-gatal, urtikaria umum, sesak dada, dyspnea, wheezing, semaput, hipotensi, anafilaksis), langsung mandheg lan miwiti terapi sing cocog kaya sing dituduhake (umpamane, epinefrin, kortikosteroid). , pangopènan saluran napas sing nyukupi, oksigen).
Pancegahan Umum
Ekspansi Volume PlasmaEkspansi sementara volume plasma bisa kedadeyan sajrone infus; kanthi ati-ati kanggo pasien sing duwe risiko kakehan sirkulasi.
Populasi Spesifik
KandhutanKategori C.
LaktasiOra dingerteni manawa inhibitor α1-proteinase disebarake menyang susu. Disaranake ati-ati yen inhibitor α1-proteinase digunakake.
Panggunaan PediatrikKaamanan lan khasiat durung ditetepake.
Gangguan HepatikPanganggone ora dianjurake kanggo pasien sing nandhang penyakit ati sing ana gandhengane karo kekurangan inhibitor α1-proteinase.
Efek Sabar sing Umum
Sakit sirah, ngantuk, demam telat, pusing, pusing, asthenia, nyeri situs injeksi, paresthesia, pruritus.
Disclaimer
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