Smallpox Vaccine Live
Jeneng merek: ACAM2000
Kelas obat:
Agen Antineoplastik
Panganggone Smallpox Vaccine Live
Vaksin cacar urip nduweni kegunaan ing ngisor iki:
Vaksin cacar urip dituduhake kanggo imunisasi aktif marang penyakit cacar ing individu sing ditemtokake duwe risiko dhuwur kanggo infeksi cacar.
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Carane nggunakake Smallpox Vaccine Live
Umum
Vaksin cacar urip (ACAM2000) kasedhiya ing wangun dosis lan kekuatan ing ngisor iki:
Vial dosis kaping pirang-pirang sing ngemot vaksin lyophilized lan vial sing ngemot pengencer. Sawise rekonstitusi karo pengencer kaya sing diarahake dening pabrikan, saben vial vaksin nyedhiyakake kira-kira 100 dosis; saben dosis 0,0025 mL ngemot 2,5 x 105 nganti 12,5 x 105 unit pembentuk plak (PFU) virus vaccinia.
Dosis
Iku penting < b>supaya labeling pabrikan dikonsultasi kanggo informasi sing luwih rinci babagan dosis lan administrasi obat iki. Ringkesan dosis:
Dewasa
Dosis lan AdministrasiPènget
Kontraindikasi
Pènget / PancegahanKomplikasi lan Kematian Vaksinasi Serius
Vaksin cacar urip (ACAM2000) ngandhut virus vaccinia sing kompeten replikasi. Wong sing duwe risiko paling gedhe ngalami komplikasi serius sawise nampa vaksin cacar sing kompeten replikasi asring sing paling beresiko mati amarga cacar, lan risiko komplikasi vaksinasi sing serius kudu ditimbang karo risiko infeksi cacar sing bisa fatal. p>
Komplikasi serius sing bisa kedadeyan sawise vaksinasi primer utawa vaksinasi ulang kanthi vaksin cacar urip sing kompeten replikasi kalebu miokarditis lan/utawa perikarditis, ensefalitis, encephalomyelitis, encephalopathy, vaccinia progresif (vaccinia necrosum), vaksinasi umum, infeksi kulit vaksin sing abot, erythema multiforme major (kalebu sindrom Stevens-Johnson), vaksinasi eksim, lan wuta. Komplikasi kasebut arang banget nyebabake cacat abot, sekuele neurologis permanen, lan pati. Pati janin bisa kedadeyan yen vaksin cacar urip sing kompeten kanggo replikasi diwenehake marang wanita ngandhut (pirsani Pregnancy under Cautions).
Adhedhasar uji klinis ACAM2000, gejala sing dicurigai miokarditis utawa perikarditis (kayata nyeri dada, mundhak. troponin/enzim jantung, utawa kelainan ECG) dumadi ing 5,7 saben 1000 vaksinasi primer (95% CI: 1,9-13,3). Temuan iki kalebu kasus miokarditis simtomatik utawa asimtomatik akut utawa perikarditis utawa loro-lorone.
Sacara historis, pati sawise vaksinasi karo virus vaccinia urip iku kedadeyan langka; kira-kira 1 pati saben yuta vaksinasi primer lan 1 pati saben 4 yuta vaksinasi ulang wis kedadeyan sawise vaksinasi karo virus vaksinasi urip. Pati paling asring minangka akibat saka kematian jantung dadakan, ensefalitis postvaccinial, vaccinia progresif, utawa vaccinatum eksim. Pati uga wis kacarita ing kontak sing ora divaksinasi sing ora disengaja kena infeksi dening individu sing wis divaksinasi.
Data babagan kedadeyan kedadeyan ala ing antarane personel militer AS lan responden pisanan sipil sing divaksinasi karo vaksin cacar sing kasedhiya sadurunge sing ngemot replikasi- virus vaccinia sing kompeten (yaiku, galur Kesehatan Dewan Kesehatan Kota New York; Dryvax) sajrone program vaksinasi sing diwiwiti ing Desember 2002 ditampilake ing Tabel 1. Insiden kedadeyan ala sing bisa dicegah (vaksinatum eksim, transmisi kontak, lan autoinokulasi) sing dilapurake ing program kasebut yaiku luwih murah dibandhingake karo data sing diklumpukake ing taun 1960-an nalika vaksinasi cacar rutin dianjurake ing populasi AS; prabédan iki bisa uga amarga prosedur screening vaksinasi sing luwih apik lan panggunaan rutin bandage protèktif ing situs inokulasi. Myocarditis lan pericarditis ora umum dilapurake sawise vaksinasi cacar ing taun 1960-an, nanging muncul minangka acara sing luwih kerep adhedhasar pengawasan sing luwih aktif ing program militer lan sipil.
Program Departemen Pertahanan wiwit Januari 2005 (n) = 730.580): 71% vaksinasi utami; 89% lanang; umur rata-rata 28,5 taun.
Program Departemen Kesehatan lan Layanan Manungsa wiwit Januari 2004 (n = 40.422): 36% vaksinasi primer; 36% lanang; umur rata-rata 47,1 taun.
Tabel 1. Insiden Kedadean Saru Serius sing Dilaporake karo Vaksin Cacar Live (Dryvax) ing taun 2002–2005Kedadeyan sing ora becik
N
Kejadian saben yuta
N
Kedadeyan saben yuta
Miokarditis/perikarditis
86
117,71
21
519,52
Ensefalitis pasca-vaksin
1
1.37
1
24.74
Vaksinatum Eksim
0
0,00
0
0,00
Vaksinia umum
43
58,86
3
74.22
Vaksinia progresif
0
0.00
>0
0,00
Vaksinia janin
0
0,00
0
0.00
Transmisi kontak
52
71.18
0
0,00
Inokulasi otomatis (non-okular)
62
84,86
>20
494.78
Vaksin okular
16
21.90
3
74.22
Kedadeyan Kardiovaskular
Ing uji klinis sing nglibatake 2983 wong sing nampa vaksin cacar urip (ACAM2000) lan 868 wong sing nampa vaksin cacar sing kasedhiya sadurunge (Dryvax), 10 kasus sing dicurigai miokarditis (7 saka 2983 panampa ACAM2000 [0,2%] lan 3 saka 868 panampa Dryvax [0,3%]) diidentifikasi. Wektu rata-rata kanggo wiwitan miokarditis lan/utawa perikarditis sing dicurigai sawise vaksinasi yaiku 11 dina (kisaran: 9-20 dina). Kabeh wong sing ngalami penyakit jantung iki naif kanggo vaccinia. Saka 10 kasus kasebut, 2 dirawat ing rumah sakit; ora ana sing isih 8 mbutuhake rawat inap utawa perawatan karo obat. Saka 10 kasus, 8 subklinis lan mung dideteksi dening kelainan ECG kanthi utawa tanpa elevasi sing gegandhengan karo troponin jantung I. Kasus kasebut ditanggulangi kanthi 9 sasi, kajaba siji wanita ing grup Dryvax sing duwe fraksi ejeksi ventrikel kiwa sing ora normal. ing ECG.
Perkiraan paling apik kanggo risiko miokarditis lan perikarditis ing panampa vaksin cacar urip sing kompeten replikasi asale saka uji klinis fase 3 sing mbandhingake ACAM2000 lan Dryvax ing ngendi ana pemantauan aktif kanggo potensial miokarditis lan perikarditis . Ing antarane vaksin sing naif marang vaccinia, 8 kasus sing dicurigai miokarditis lan perikarditis diidentifikasi ing loro klompok vaksin kasebut, kanthi tingkat insiden total 6,9 saben 1000 vaksin (8 saka 1162). Tingkat kanggo grup ACAM2000 yaiku 5.7 (95% CI: 1.9-13.3) saben 1000 vaksin (5 saka 873 vaksin) lan tarif kanggo grup Dryvax yaiku 10.4 (95% CI: 2.1-30.0) saben 1000 vaksin (1000 vaksin). saka 289 vaksin). Ora ana kasus miokarditis lan/utawa perikarditis sing diidentifikasi ing taun 1819 wong sing wis divaksinasi sadurunge. Asil jangka panjang miokarditis lan perikarditis sawise vaksinasi vaksin cacar urip saiki ora dingerteni.
Acara jantung iskemik, kalebu fatalitas, wis dilaporake sawise vaksinasi cacar; hubungane acara kasebut, yen ana, kanggo vaksinasi durung ditetepake. Kajaba iku, kasus non-iskemik, kardiomiopati dilatasi wis dilapurake sawise vaksinasi cacar; hubungane kasus iki kanggo vaksinasi cacar ora dingerteni.
Ana uga tambah risiko efek salabetipun sawise vaksinasi karo vaksin cacar urip ing individu karo penyakit jantung dikenal, kalebu sing didiagnosis sadurunge infark miokard, angina, congestive gagal jantung, kardiomiopati, nyeri dada utawa sesak ambegan kanthi aktivitas, stroke utawa serangan iskemik transien, utawa kondisi jantung liyane. Kajaba iku, risiko efek samping bisa uga tambah ing wong sing wis didiagnosis 3 utawa luwih saka faktor risiko penyakit koroner iskemik ing ngisor iki: tekanan darah tinggi, kolesterol getih dhuwur, diabetes mellitus utawa gula darah tinggi, relatif tingkat pertama (contone. , ibu, bapak, adhine, adhine) sing duwe penyakit jantung sadurunge umur 50 taun, utawa riwayat ngrokok.
Komplikasi lan Buta Okular
Infeksi mata sing ora disengaja (vaksinia okular) sawise vaksinasi karo vaksin cacar urip sing kompeten replikasi bisa nyebabake komplikasi okular kalebu keratitis, jaringan parut kornea lan wuta. Pasien sing nggunakake obat tetes mata kortikosteroid bisa uga ngalami risiko komplikasi okular.
Gangguan Kurang Kekebalan Bawaan utawa Diperoleh
Infeksi lokal utawa sistemik sing abot karo vaksinia (vaksinia progresif) bisa kedadeyan sawise vaksinasi karo vaksin cacar sing kompeten replikasi manggon ing individu sing sistem kekebalan lemah, kalebu sing duwe leukemia, limfoma, transplantasi organ, keganasan umum, HIV/AIDS, utawa kurang imun seluler utawa humoral, lan sing nampa terapi radiasi utawa perawatan karo antimetabolit, agen alkilasi, kortikosteroid dosis dhuwur (luwih saka 10 mg prednison saben dina utawa padha kanggo 2 minggu utawa luwih suwe), utawa obat imunomodulator liyane. Vaksin cacar urip wis contraindicated ing individu karo immunodeficiency abot (ndeleng Contraindications ing Cautions). Vaksin sing duwe kontak cedhak sing duwe kondisi kasebut bisa uga duwe risiko tambah amarga virus vaccinia urip bisa ditularake banjur ditularake saka vaksin menyang kontak cedhak kasebut.
Riwayat utawa Anane Eksim lan Kahanan Kulit Liyane
Individu sing nandhang eksim kanthi deskripsi apa wae, kayata dermatitis atopik, neurodermatitis, lan kondisi eksim liyane, tanpa preduli saka keruwetan kondisi kasebut, lan individu sing duwe riwayat kahanan kasebut ing sawayah-wayah kepungkur, ana risiko luwih dhuwur kanggo ngembangake vaksinasi eksim sawise vaksinasi karo vaksin cacar sing kompeten kanthi replikasi. Kontak cedhak sing duwe kondisi eczematous bisa uga duwe risiko tambah amarga virus vaccinia urip bisa ditularake lan banjur ditularake saka vaksin menyang kontak cedhak kasebut.
Vaksin karo kelainan kulit akut, kronis, utawa eksfoliatif aktif liyane ( contone, kobong, impetigo, varicella zoster, acne vulgaris kanthi lesi mbukak, penyakit Darier, psoriasis, dermatitis seborrheic, eritroderma, dermatitis pustular) utawa kontak kluwarga sing duwe kelainan kulit bisa uga duwe risiko luwih dhuwur kanggo vaksinasi eksim.
Hipersensitivitas kanggo Vaksin utawa Komponen
Vaksin cacar urip ngandhut jumlah neomycin lan polymyxin B. Individu sing alergi marang komponen kasebut bisa uga duwe risiko sing luwih dhuwur kanggo efek samping sawise vaksinasi.
Manajemen Komplikasi Vaksinasi Cacar
Pusat Kontrol lan Nyegah Penyakit (CDC) AS bisa mbantu dokter ing diagnosis lan manajemen pasien sing dicurigai ngalami komplikasi vaksinasi (cacar). Vaccinia immune globulin (VIG) dituduhake kanggo perawatan komplikasi tartamtu sawise vaksinasi karo vaksin cacar urip sing kompeten replikasi. Yen VIG lan/utawa antivirus dibutuhake utawa informasi tambahan dibutuhake, dokter kudu ngubungi pusat operasi darurat CDC ing 770-488-7100.
Nyegah Panularan Virus Live Vaccinia
Langkah sing paling penting kanggo nyegah autoinokulasi sing ora disengaja lan transmisi kontak sawise vaksinasi karo vaksin cacar urip sing kompeten replikasi yaiku ngumbah tangan kanthi lengkap sawise ngganti bandage utawa sawise liyane. kontak karo situs vaksinasi.
Individu sing rentan kanggo efek salabetipun virus vaccinia (yaiku, sing nandhang penyakit jantung, penyakit mata, negara immunodeficiency [kalebu infeksi HIV], eksim, wanita ngandhut, bayi) kudu diidentifikasi. lan langkah-langkah kudu ditindakake kanggo ngindhari kontak antarane individu kasebut lan wong-wong sing wis nampa vaksin cacar sing kompeten replikasi urip lan duwe lesi vaksinasi aktif.
Petugas kesehatan sing bubar divaksinasi kudu ngindhari kontak karo pasien, utamane sing duwe immunodeficiencies, nganti scab ing situs vaksinasi wis kapisah saka kulit. Nanging, yen kontak terus karo pasien ora bisa dihindari, buruh kesehatan sing wis divaksinasi kudu mesthekake yen situs vaksinasi ditutupi kanthi apik lan ngetutake teknik cuci tangan sing apik. Ing setelan iki, klamben sing luwih occlusive bisa digunakake. Sandhangan poliuretan semipermeabel minangka penghalang efektif kanggo ngeculake vaccinia. Nanging, exudate bisa nglumpukake ing ngisor klamben, lan kudu ati-ati kanggo nyegah panyebaran virus nalika ganti ganti. Kajaba iku, akumulasi cairan ing ngisor klamben bisa nambah maserasi kulit ing situs vaksinasi. Akumulasi exudate bisa dikurangi kanthi nutupi situs vaksinasi kanthi gauze garing, banjur nglebokake klamben ing gauze. Klamben kudu diganti saben 1-3 dina.
Sumbangan Darah lan Organ
Sumbangan getih lan organ kudu dihindari paling sethithik 30 dina sawisé vaksinasi nganggo vaksin cacar sing kompeten réplikasi.
Interferensi Tes Laboratorium
Vaksin cacar urip (ACAM2000) bisa nyebabake tes positif palsu kanggo sifilis. Asil tes reagin plasma cepet (RPR) positif kudu dikonfirmasi nggunakake tes sing luwih spesifik, kayata tes antibodi treponemal fluoresensi (FTA).
Vaksin cacar urip (ACAM2000) bisa nyebabake asil negatif palsu sementara kanggo tes kulit tuberkulin (turunan protein dimurnèkaké [PPD]) lan bisa uga mengaruhi tes getih kanggo tuberkolosis. Tes tuberkulin kudu ditundha, yen bisa, sajrone 1 wulan sawise vaksinasi cacar.
Batesan Efektivitas Vaksin
Vaksinasi nganggo vaksin cacar urip bisa uga ora nglindhungi kabeh panampa sawise kena cacar.
Populasi Tertentu
KandhutanVaksin cacar urip (ACAM2000) durung diteliti ing wanita ngandhut. Vaksin virus live vaccinia bisa nyebabake cilaka janin lan pati janin nalika diwenehake marang wanita ngandhut. Infeksi kongenital, utamane kedadeyan sajrone trimester pisanan, wis diamati sawise vaksinasi karo vaksin cacar sing kompeten kanthi replikasi, sanajan risiko kasebut sithik. Vaksinia umum saka jabang bayi, pangiriman awal bayi mati, utawa risiko dhuwur saka kematian perinatal wis dilapurake.
Sawijining setelan sing kudu dianggep vaksinasi kanggo wanita ngandhut yaiku nalika kena infeksi cacar dianggep. kamungkinan. Yen vaksin cacar urip diwenehake marang wong wadon sing lagi ngandhut utawa yen vaksin manggon ing omah sing padha karo utawa duwe kontak cedhak karo wong wadon sing lagi ngandhut, vaksin kasebut kudu dilaporake babagan bebaya potensial kanggo janin. Wanita ngandhut sing kontak cedhak karo vaksin bisa uga tambah risiko amarga virus vaksin urip bisa ditularake lan banjur ditularake menyang kontak sing cedhak.
Penyedhiya kesehatan, departemen kesehatan negara, lan staf kesehatan masyarakat liyane kudu nglaporake menyang Vaksin Cacar Nasional ing Registry Kandhutan kabeh wanita ngandhut sing, wiwit 42 dina sadurunge konsepsi, nampa vaksin cacar sing kompeten replikasi urip utawa wis kontak cedhak karo individu sing nampa vaksin cacar sing kompeten replikasi urip sajrone 28 dina sadurunge. Wanita sipil kudu ngubungi panyedhiya kesehatan utawa departemen kesehatan negara kanggo bantuan ndhaptar ing pendaptaran. Kabeh kasus sipil lan militer kudu dilaporake menyang Departemen Pertahanan AS liwat telpon (619-553-9255), Defense Switched Network (DSN) 553-9255, fax (619-533-7601), utawa e-mail (NHRC). [email protected]).
LaktasiVaksin cacar urip (ACAM2000) durung diteliti ing wanita lactating. Ora dingerteni manawa virus vaksin utawa antibodi disebarake menyang susu manungsa.
Virus vaksin urip bisa ditularake kanthi ora sengaja saka ibu sing nyusoni sing divaksinasi menyang bayine. Bayi duwe risiko dhuwur ngalami komplikasi serius saka vaksinasi cacar live vaccinia.
Panggunaan PediatrikAman lan efektifitas vaksin cacar urip (ACAM2000) durung ditetepake ing kelompok umur wiwit lair nganti umur 16 taun. . Panganggone vaksin ing kabeh kelompok umur pediatrik didhukung dening bukti saka studi sing cukup lan dikontrol kanthi apik ing wong diwasa lan data sajarah tambahan babagan panggunaan vaksin cacar virus vaksin urip ing bocah-bocah.
Sadurunge pemberantasan cacar penyakit, vaksin cacar live vaccinia diterbitake kanthi rutin ing kabeh kelompok umur pediatrik, kalebu neonatus lan bayi, lan efektif kanggo nyegah penyakit cacar. Sajrone wektu kasebut, vaksin virus vaccinia urip sok-sok digandhengake karo komplikasi serius ing bocah-bocah, risiko paling dhuwur yaiku ing bayi sing umure kurang saka 12 sasi.
Vaksin sing duwe kontak cedhak karo bayi (contone, nyusoni ) kudu ngati-ati supaya ora ditularake virus vaccinia urip sing ora sengaja marang bayi.
Panggunaan GeriatrikStudi klinis vaksin cacar urip (ACAM2000) ora kalebu jumlah sing cukup saka individu sing umur 65 taun utawa luwih kanggo nemtokake manawa dheweke nanggapi beda karo wong sing luwih enom. Ora ana data sing diterbitake kanggo ndhukung panggunaan vaksin ing wong geriatri sing umure luwih saka 65 taun.
Efek Samsaya Awon
Informasi babagan safety vaksin cacar urip (ACAM2000) wis ditemokake saka uji klinis sing ngevaluasi vaksin, data sing dikumpulake nalika jaman nalika vaksinasi cacar rutin dianjurake nggunakake sing kasedhiya sadurunge. vaksin vaksinasi sing kompeten replikasi (contone, Dryvax), lan data kedadeyan sing ora becik sing dipikolehi saka program vaksinasi cacar militer lan sipil sajrone taun 2002-2005 sing nggunakake Dryvax.
Kedadeyan sing ora becik sing umum sawise vaksinasi karo vaksin cacar sing kompeten kanthi replikasi langsung kalebu tandha lan gejala situs inokulasi, limfadenitis, lan gejala konstitusional (contone, malaise, lemes, mriyang, myalgia, sirah). Kedadeyan ala iki kurang kerep ing wong sing divaksinasi maneh tinimbang wong sing nampa vaksin sing sepisanan.
Inokulasi sing ora disengaja ing situs liya minangka komplikasi sing paling kerep saka vaksinasi vaksinasi sing kompeten replikasi. Situs sing paling umum yaiku pasuryan, irung, tutuk, lambe, anus, lan alat kelamin.
Ruam kulit sing winates dhewe (contone, urtikaria lan folikulitis) sing ora ana hubungane karo replikasi vaksinia ing kulit bisa kedadeyan sawise vaksinasi. .
Apa obatan liyane bakal mengaruhi Smallpox 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:
Ora ana data sing ngevaluasi administrasi vaksin cacar bebarengan karo vaksin liyane.
Disclaimer
Kabeh upaya wis ditindakake kanggo mesthekake yen informasi sing diwenehake dening Drugslib.com akurat, nganti -tanggal, lan lengkap, nanging ora njamin kanggo efek sing. Informasi obat sing ana ing kene bisa uga sensitif wektu. Informasi Drugslib.com wis diklumpukake kanggo digunakake dening praktisi kesehatan lan konsumen ing Amerika Serikat lan mulane Drugslib.com ora njamin sing nggunakake njaba Amerika Serikat cocok, kajaba khusus dituduhake digunakake. Informasi obat Drugslib.com ora nyetujoni obat, diagnosa pasien utawa menehi rekomendasi terapi. Informasi obat Drugslib.com minangka sumber informasi sing dirancang kanggo mbantu praktisi kesehatan sing dilisensi kanggo ngrawat pasien lan / utawa nglayani konsumen sing ndeleng layanan iki minangka tambahan, lan dudu pengganti, keahlian, katrampilan, kawruh lan pertimbangan babagan perawatan kesehatan. praktisi.
Ora ana bebaya kanggo kombinasi obat utawa obat sing diwenehake kanthi cara apa wae kudu ditafsirake kanggo nuduhake yen obat utawa kombinasi obat kasebut aman, efektif utawa cocok kanggo pasien tartamtu. Drugslib.com ora nanggung tanggung jawab kanggo aspek kesehatan apa wae sing ditindakake kanthi bantuan informasi sing diwenehake Drugslib.com. Informasi sing ana ing kene ora dimaksudake kanggo nyakup kabeh panggunaan, pituduh, pancegahan, bebaya, interaksi obat, reaksi alergi, utawa efek samping. Yen sampeyan duwe pitakon babagan obat sing sampeyan gunakake, takon dhokter, perawat utawa apoteker.
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