{"id":176,"date":"2025-07-07T11:04:05","date_gmt":"2025-07-07T04:04:05","guid":{"rendered":"https:\/\/pythonsonline.com\/index.php\/2025\/07\/07\/sandoz-mengenang-cefazolin-karena-kesalahan-pengemasan-membuka-fasilitas-biosimilar-di-slovenia\/"},"modified":"2025-07-07T11:04:05","modified_gmt":"2025-07-07T04:04:05","slug":"sandoz-mengenang-cefazolin-karena-kesalahan-pengemasan-membuka-fasilitas-biosimilar-di-slovenia","status":"publish","type":"post","link":"https:\/\/pythonsonline.com\/index.php\/2025\/07\/07\/sandoz-mengenang-cefazolin-karena-kesalahan-pengemasan-membuka-fasilitas-biosimilar-di-slovenia\/","title":{"rendered":"Sandoz mengenang cefazolin karena kesalahan pengemasan, membuka fasilitas biosimilar di Slovenia"},"content":{"rendered":"<div>\n<div class=\"\">\n<div style=\"width:30%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:\" class=\" figure\">\n<div id=\"image-caption\" class=\"text-gray-500 italic\">\n<div class=\"blockText_blockContent__TbCXh\">\n<p class=\"pb-2\">Tabung Uji Laboratorium Sains, Peralatan Laboratorium | Kredit Gambar: \u00a9 miliarphotos.com &#8211; \u00a9 miliarphotos.com &#8211; stock.adobe.com<\/p>\n<\/div>\n<\/div>\n<div class=\"hidden top-(-100%) block w-(1px) transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden\"><img decoding=\"async\" class=\"m-auto absolute inset-0 max-w-(0%) max-h-(0%) border-(3px) border-solid border-white shadow-(0px_0px_8px_rgba(0,0,0,0.3)) box-border transition ease-in-out duration-500\" src=\"https:\/\/cdn.sanity.io\/images\/0vv8moc6\/pharmtech\/d7bb9e4fb00f33d39d294c4a3df62069aa2aaee9-1280x720.jpg?fit=crop&amp;auto=format\"\/><\/div>\n<\/div>\n<\/div>\n<p class=\"pb-2\">FDA yang diumumkan pada tanggal 27 Juni 2025, bahwa Sandoz, Inc. secara sukarela mengingat satu lot cefazolin untuk injeksi, USP, 1 gram per botol setelah pelanggan mengeluh bahwa empat kalium penisilin untuk injeksi, USP, 20 juta unit botol) tidak benar termasuk dalam karton Cefazolin untuk cetak vial. Sementara perusahaan menyatakan belum menerima laporan tentang efek samping yang terkait dengan penarikan, mereka memang menerima satu keluhan tentang produk yang salah yang diberikan kepada pasien.<\/p>\n<article class=\"float-none w-auto my-4 p-4 bg-(#eee) md:clear-both md:float-right md:w-(40%) md:p-4 md:mt-0 md:mb-4 md:ml-4\">\n<div>\n<h3 class=\"text-xl mb-3 font-medium\">Kunci takeaways<\/h3>\n<div class=\"blockText_blockContent__TbCXh\">\n<ul class=\"my-2\">\n<li class=\"list-disc ml-8\">Empat botol kalium penisilin g untuk injeksi, USP salah dimasukkan dalam banyak cefazolin untuk injeksi, USP.<\/li>\n<li class=\"list-disc ml-8\">Kedua antibiotik memiliki indikasi yang berbeda. Menggunakan kalium penisilin untuk injeksi, USP alih -alih cefazolin untuk injeksi, USP bisa mengancam jiwa.<\/li>\n<li class=\"list-disc ml-8\">Fasilitas baru Sandoz di Slovenia akan menghasilkan produk yang dapat disuntikkan untuk biosimilar yang ada dan yang akan datang.<\/li>\n<li class=\"list-disc ml-8\">Fasilitas baru ini merupakan bagian dari investasi $ 1,1 miliar yang telah direncanakan perusahaan hingga 2029.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/article>\n<p class=\"pb-2\">Nomor lot yang terkena dampak adalah PG4360, nomor Vial National Drug Code (NDC) 0781-3451-70, dengan tanggal kedaluwarsa 2027-Nov (1). Lot diproduksi oleh Sandoz GmbH dan didistribusikan oleh Sandoz Inc. Botol yang salah termasuk memiliki vial NDC 0781-6136-94 dan tanggal kedaluwarsa 2027-nov.<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\">Dua antibiotik memiliki indikasi yang berbeda<\/h2>\n<p class=\"pb-2\">Cefazolin untuk injeksi USP diindikasikan untuk pengobatan dan\/atau pencegahan infeksi bakteri di berbagai bagian tubuh pada orang dewasa, orang tua, dan anak -anak (1). Penicillin G potassium for injection treats certain serious infections, such as septicemia, skin infections, and wound infections, and can be used to treat diphtheria, community-acquired pneumonia, peritonitis, meningitis\/brain abscesses, osteomyelitis, infections of the genital tract, anthrax, tetanus, gas gangrene, listeriosis, pasteurellosis, rat bite fever, fusospirochetes, actinomycosis, komplikasi pada gonore dan sifilis, dan lyme. Ini harus digunakan untuk hanya mengobati atau mencegah infeksi yang disebabkan oleh bakteri yang rentan untuk mengurangi kemungkinan bakteri yang resistan terhadap obat berkembang.<\/p>\n<p class=\"pb-2\">Menurut siaran pers FDA (1), kedua antibiotik memiliki indikasi yang berbeda meskipun menjadi bagian dari kelompok antibiotik beta-laktam yang sama dan memiliki populasi pasien yang tumpang tindih. Regimen dosis untuk masing -masing mungkin juga berbeda.<\/p>\n<p class=\"pb-2\">Pemberian injeksi kalium penisilin g alih-alih injeksi cefazolin mungkin memiliki konsekuensi yang mengancam jiwa yang mencakup kurangnya kemanjuran yang mengakibatkan pengobatan infeksi parah yang kurang optimal, resistensi antibiotik, reaksi alergi, interaksi obat, dan aritmia jantung yang disebabkan oleh kalium tinggi.<\/p>\n<p class=\"pb-2\">Sandoz meminta pelanggan untuk mengembalikan produk yang ditarik, yang dikirim untuk memilih pedagang grosir untuk distribusi nasional. Perusahaan merekomendasikan penyedia berhenti menggunakan produk segera. Efek samping dapat dilaporkan ke FDA melalui program pelaporan efek samping MedWatch -nya.<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\">Fasilitas Biosimilars Baru<\/h2>\n<p class=\"pb-2\">Dalam berita Sandoz lainnya, perusahaan tersebut memecah fasilitas baru di Slovenia pada bulan Juli yang akan menghasilkan produk suntik untuk biosimilar yang ada dan yang akan datang. Proyek ini menambahkan $ 440 juta untuk investasi $ 1,1 miliar yang telah direncanakan perusahaan hingga 2029.<\/p>\n<p class=\"pb-2\">&#8220;Biosimilar adalah segmen paling cepat dari pipa kami karena kebutuhan pasien dan sistem perawatan kesehatan untuk obat-obatan kritis ini terus tumbuh dengan cepat,&#8221; Richard Saynor, kepala eksekutif Sandoz, mengatakan dalam siaran pers (2). \u201cSebagai pemimpin global di lapangan, kami berinvestasi untuk memenuhi permintaan pasien yang berkembang pesat. Dengan komitmen lebih dari US $ 1,1 miliar, kami bangga memperluas kapasitas manufaktur biosimilar kami di Eropa sebagai investor asing langsung Slovenia. Ini adalah langkah besar lainnya yang akan memposisikan Sandoz yang unik untuk mengkapitalisasi biosimilaries yang belum pernah ada di depan Sandoz.<\/p>\n<p class=\"pb-2\">&#8220;Investasi kami dalam bidang bioman di jantung Eropa menandai tonggak penting lainnya dalam membangun jaringan manufaktur independen kami sendiri &#8211; yang meningkatkan kontrol, ketahanan, dan kelincahan kami di seluruh rantai pasokan global,&#8221; Glenn Gerecke, kepala manufaktur dan petugas pasokan di Sandoz, mengatakan dalam rilisnya. \u201cKami mengakui nilai strategis yang dibawa Slovenia bagi kami sebagai perusahaan: kumpulan bakat yang sangat terampil dalam ilmu pengetahuan alam dan teknik; lokasi sentral dengan infrastruktur logistik kelas dunia; produksi kompetitif biaya; dan lingkungan yang stabil dan berbasis inovasi yang terkait erat dengan akademia dan penelitian.&#8221;<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\">Referensi<\/h2>\n<ol class=\"my-2\">\n<li class=\"list-decimal ml-8\">FDA. Sandoz Inc. mengeluarkan penarikan kembali secara nasional secara nasional dari satu lot cefazolin untuk suntikan karena kesalahan pengemasan produk. Siaran pers. 27 Juni 2025. Https:\/\/www.fda.gov\/safety\/recalls-market-withdrawals-safety-alerts\/sandoz-inc-issues-voluntary-nationwide-recall-oe-lot-cefazolin-injection-product-pendamping<\/li>\n<li class=\"list-decimal ml-8\">Sandoz. Sandoz lebih lanjut menegaskan kepemimpinan dalam biosimilars, memecah dasar fasilitas Slovenia baru untuk memperluas hub biosimilar Eropa dan jangkauan pasar global. Siaran pers. 1 Juli 2025. Https:\/\/www.sandoz.com\/sandoz-further-asserts-leadership-biosimilars-break-ground-new-lovenia-facility-expand-uropean\/<\/li>\n<\/ol>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Tabung Uji Laboratorium Sains, Peralatan Laboratorium | Kredit Gambar: \u00a9 miliarphotos.com &#8211; \u00a9 miliarphotos.com &#8211; stock.adobe.com FDA yang diumumkan pada tanggal 27 Juni 2025, bahwa Sandoz, Inc. secara sukarela mengingat satu lot cefazolin untuk injeksi, USP, 1 gram per botol setelah pelanggan mengeluh bahwa empat kalium penisilin untuk injeksi, USP, 20 juta unit botol) tidak [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":165,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-176","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.9 - 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