Dengue Vaccine Live
Jeneng merek: Dengvaxia
Kelas obat:
Agen Antineoplastik
Panganggone Dengue Vaccine Live
Vaksin dengue urip nduweni kegunaan ing ngisor iki:
Vaksin dengue urip yaiku vaksin sing dituduhake kanggo nyegah penyakit dengue sing disebabake dening virus dengue serotipe 1, 2, 3 lan 4. Vaksin dengue urip disetujoni kanggo digunakake ing wong umur 9 nganti 16 taun kanthi infeksi dengue sadurunge sing dikOnfirmasi laboratorium lan manggon ing wilayah endemik.
Vaksin dengue urip nduweni watesan ing ngisor iki:
Vaksin dengue urip ora disetujoni kanggo digunakake ing individu sing sadurunge ora kena infeksi virus dengue utawa sing informasi iki ora dingerteni. Wong-wong sing sadurunge ora kena infeksi luwih beresiko kena penyakit dengue sing abot nalika divaksinasi lan sabanjure kena virus dengue. Infeksi dengue sadurunge bisa ditaksir liwat rekam medis saka infeksi dengue sing wis dikonfirmasi laboratorium sadurunge utawa liwat tes serologis sadurunge vaksinasi.
Aman lan efektifitas vaksin dengue urip durung ditetepake ing individu sing manggon ing dengue. dhaerah nonendemik kang lelungan menyang dhaerah endemis dengue.
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Carane nggunakake Dengue Vaccine Live
Umum
Vaksin dengue langsung kasedhiya ing wangun dosis lan kekuatan ing ngisor iki:
Suspensi kanggo injeksi (0,5 mL) sing diwenehake minangka bubuk lyophilized kanggo direkonstitusi karo pengencer sing diwenehake.
Dosis
Sampeyan penting panyedhiya label pabrik dikonsultasi kanggo informasi sing luwih rinci babagan dosis lan administrasi obat iki. Ringkesan dosis:
Pasien Anak
Telung dosis (saben 0,5 mL) 6 sasi (ing sasi 0, 6, lan 12).
Pènget
Kontraindikasi
Pènget/PanandhapRisiko Tambah Penyakit Dengue Parah Sawisé Vaksin Dengue Urip ing Wong sing Ora Nate Infèksi Virus Dengue
Ing wong sing durung divaksinasi, infèksi dengue pisanan arang nyebabake penyakit dengue sing abot, dene infeksi dengue kapindho kanthi serotipe sing beda yaiku digandhengake karo tambah risiko penyakit dengue sing abot. Pemberian langsung vaksin dengue marang wong sing durung kena infeksi virus dengue digandhengake karo tambah risiko penyakit dengue sing abot nalika individu sing divaksinasi banjur kena infeksi serotipe virus dengue. Mula, para profesional kesehatan kudu ngevaluasi individu kanggo infeksi dengue sadurunge kanggo ngindhari vaksinasi marang individu sing durung kena infeksi virus dengue.
Infeksi virus dengue sadurunge bisa dievaluasi liwat rekam medis dengue sing wis dikonfirmasi laboratorium sadurunge. infèksi utawa liwat serotest sadurunge vaksinasi.
Ora ana tes sing diresiki FDA sing kasedhiya kanggo nemtokake infeksi dengue sadurunge. Tes non-FDA sing kasedhiya bisa ngasilake asil positif palsu (contone, amarga reaktivitas silang karo flavivirus liyane).
Manajemen Reaksi Alergi Akut
Vaksin dengue urip bisa nyebabake reaksi hipersensitivitas, kalebu anafilaksis. Pangobatan lan pengawasan medis sing cocog kudu disedhiyakake sawise administrasi vaksin dengue langsung.
Batesan Efektivitas Vaksin
Vaksinasi nganggo vaksin dengue bisa uga ora nglindhungi kabeh individu. Disaranake kanggo nerusake langkah-langkah perlindungan pribadi marang gigitan nyamuk sawise vaksinasi.
Syncope
Syncope (pingsan) bisa kedadeyan sawise, utawa malah sadurunge, vaksinasi karo vaksin dengue urip minangka respon psikogenik kanggo injeksi nganggo jarum. Prosedur kudu ditindakake kanggo nyegah ciloko tiba lan kanggo ngatur reaksi syncopal.
Populasi Tertentu
KandhutanAna registri pajanan meteng sing ngawasi asil meteng ing wanita sing kena vaksin dengue nalika meteng. Wanita sing nampa vaksin dengue urip nalika meteng dianjurake kanggo hubungi langsung, utawa hubungi profesional kesehatan, Sanofi Pasteur Inc. ing 1-800-822-2463 (1-800-VACCINE) kanggo ndhaftar utawa njupuk informasi babagan pendaptaran.
Ringkesan Resiko: Kabeh meteng duwe risiko cacat lair, mundhut, utawa akibat sing ora becik. Ing populasi umum AS, kira-kira risiko latar mburi cacat lair utama lan keguguran ing kandhutan sing diakoni sacara klinis yaiku 2% nganti 4% lan 15% nganti 20%, masing-masing.
Ora ana studi khusus babagan vaksin dengue urip ditindakake ing antarane wanita ngandhut. Sawetara kasus pajanan sing ora disengaja nalika meteng dilaporake sajrone studi klinis. Kasil kandhutan sing ora sah sing terisolasi (umpamane, lair mati, pati intrauterine, aborsi spontan, ovum blighted) wis diamati kanggo meteng sing katon iki, kanthi frekuensi lan sifat sing padha ing individu sing divaksinasi dibandhingake karo klompok kontrol, lan kanthi faktor risiko sing diidentifikasi kanggo kabeh kasus. Data sing kasedhiya ing wanita ngandhut ora cukup kanggo nemtokake efek vaksin dengue urip marang meteng, perkembangan embrio-janin, babaran lan perkembangan postnatal.
Ing rong studi toksisitas perkembangan, efek vaksin dengue urip ing embrio. -pembangunan janin lan postnatal dievaluasi ing terwelu lan tikus sing ngandhut. Sinau toksisitas perkembangan ditindakake ing terwelu wadon sing diwenehi dosis infèksius kultur sel 5 log1050% (CCID50) vaksin dengue urip (dosis manungsa lengkap saka 4,5 log10 nganti 6,0 log10 CCID50) kanthi injeksi intravena sadurunge kawin lan nalika ngandhut. Panliten kasebut nuduhake ora ana bukti mbebayani kanggo janin amarga vaksin dengue urip. Ing panaliten liyane, tikus wadon diwenehi dosis siji 5 log10 CCID50, 6,5 log10 CCID50 (kira-kira 3 kali dosis manungsa paling dhuwur) utawa 8 log10 CCID50 (kira-kira 100 kali dosis manungsa paling dhuwur) vaksin dengue kanthi injeksi intravena nalika ngandhut. . Toksisitas janin diamati ing dosis beracun ibu.
Pertimbangan Klinis: Wanita ngandhut luwih beresiko ngalami komplikasi sing ana gandhengane karo infeksi dengue dibandhingake karo wanita sing ora ngandhut. Wanita ngandhut sing kena infeksi dengue bisa uga duwe risiko luwih gedhe kanggo asil meteng sing ora becik, kalebu kelahiran prematur lan nglairake. Transmisi vertikal virus dengue saka ibu sing nandhang viremia nalika nglairake bayi wis dilaporake.
Viremia vaksin bisa kedadeyan 7 nganti 14 dina sawise vaksinasi kanthi durasi <7 dina. Potensi penularan virus vaksin saka ibu marang bayi ora dingerteni.
Data Kewan: Ing rong studi toksisitas perkembangan, efek vaksin dengue urip ing perkembangan embrio-janin lan postnatal dievaluasi ing terwelu sing ngandhut lan Tikus.
Terwelu diwenehi dosis lengkap manungsa [0,5 mL (5 log10 CCID50 / kewan / acara)] vaksin dengue urip kanthi injeksi intravena 30 lan 10 dina sadurunge kawin lan ing Dina 6, 12 lan 27 nalika ngandhut. Ora ana malformasi janin utawa variasi sing gegandhengan karo vaksin lan efek sing ora becik tumrap kesuburan wanita utawa perkembangan preweaning sing dilapurake ing panliten iki. Tikus ngandhut diwenehi dosis siji saka 5 log10 CCID50 (dosis manungsa lengkap saka 4,5 log10 nganti 6,0 log10 CCID50), 6,5 log10 CCID50 (kira-kira 3 kali dosis manungsa paling dhuwur) utawa 8 log10 CCID50 (kira-kira 100 kali dosis manungsa paling dhuwur). ) vaksin dengue urip kanthi injeksi intravena ing dina 6, 9 utawa 12 meteng. Ing dosis 6,5 log10 CCID50 utawa 8 log10 CCID50 vaksin dengue urip, keracunan ibu diamati sing digandhengake karo mundhut postimplantation tambah lan ing dosis 8 log10 CCID50 karo bobot awak janin suda. Pentinge pengamatan iki kanggo manungsa ora dingerteni, utamane nganggep rute administrasi sing beda (rute administrasi manungsa yaiku subkutan) lan tingkat dosis sing ngluwihi dosis manungsa sing dituju. Ora ana malformasi janin sing gegandhengan karo vaksin utawa bukti teratogenesis liyane sing dicathet ing panliten iki.
LaktasiRingkesan Resiko: Data manungsa ora kasedhiya kanggo netepake pengaruh vaksin dengue ing produksi susu, anane ing susu ibu. , utawa efeke marang bocah sing nyusoni. Mupangat pangembangan lan kesehatan saka nyusoni kudu dipikirake bebarengan karo kabutuhan klinis ibu kanggo vaksin dengue urip lan efek negatif sing potensial kanggo bocah sing disusui saka vaksin dengue urip utawa saka kondisi ibu sing ndasari. Kanggo vaksin pencegahan, kondisi sing ndasari yaiku kerentanan kanggo penyakit sing dicegah dening vaksin. Panaliten laktasi ing ngendi tikus wadon diwenehi vaksin dengue dosis siji urip ing dina 14 laktasi ora nuduhake anané vaksin dengue urip ing ASI.
Pertimbangan Klinis: Transmisi vertikal virus dengue, kalebu potensial liwat ASI, wis dilaporake.
Viremia vaksin bisa kedadeyan 7 nganti 14 dina sawise vaksinasi kanthi durasi <7 dina. Potensi penularan virus vaksin saka ibu menyang bayi liwat ASI ora dingerteni.
Data Kewan: Studi toksisitas perkembangan ing ngendi tikus wadon diwenehi injeksi siji 5 log10 CCID50 (dosis manungsa lengkap mulai saka 4.5 log10 nganti 6.0 log10 CCID50), 6.5 log10 CCID50 utawa 8 log10 CCID50 vaksin dengue urip kanthi injeksi intravena ing Dina 14 laktasi ora nuduhake anané vaksin dengue urip ing susu ibu nalika diukur 24 jam sawise administrasi vaksin.
Panggunaan PediatrikAman lan efektifitas vaksin dengue urip ing bocah sing umure luwih enom saka 9 taun durung ditetepake.
Panggunaan GeriatrikAman lan efektifitas vaksin dengue urip ing wong diwasa umur 65 taun. lan luwih lawas durung ditetepake.
Efek Ngaruhi Umum
Reaksi salabetipun sing paling kerep dilapurake preduli saka serostatus dengue sadurunge vaksinasi yaiku sirah (40%), nyeri ing situs injeksi (32%), malaise (25%), asthenia (25%), lan myalgia (29%).
Apa obatan liyane bakal mengaruhi Dengue Vaccine Live
Obat Spesifik
Iku penting panyedhiya label pabrikan dikonsultasi kanggo informasi sing luwih rinci babagan interaksi karo obat iki, kalebu kemungkinan pangaturan dosis. Sorotan interaksi:
Asil tes Tuberculin Purified Protein Derivative (PPD) negatif palsu bisa kedadeyan sajrone 1 wulan sawise vaksinasi nganggo vaksin dengue kanthi langsung.
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