GMPc Vietnam JSC
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Yêu cầu ngừng sử dụng thuốc kháng sinh Tarcefoksym sau 2 ca tử vong

20/07/2016 | 3136 | Tin tức Tổng hợp

Giám đốc Sở Y tế Hà Nội Nguyễn Khắc Hiền vừa yêu cầu thủ trưởng các cơ sở y tế trên địa bàn, Công ty TNHH một thành viên Dược phẩm Trung ương I, các cơ sở kinh doanh và sử dụng thuốc trên địa bàn ngừng mua, sử dụng, cung cấp thuốc Tarcefoksym.

Thuốc Tarcefoksym (hoạt chất Cefotaxim 1g) là loại thuốc kháng sinh chỉ định điều trị các bệnh nhiễm khuẩn đường niệu-sinh dục; viêm mô tế bào, chốc lở, nhọt, áp-xe; viêm tai giữa, viêm xoang, viêm phổi, viêm phế quản; viêm ruột, lỵ trực khuẩn; điều trị viêm màng não; nhiễm khuẩn huyết, bệnh lậu; dự phòng nhiễm khuẩn trong phẫu thuật.
 
Trước đó, Cục Quản lý Dược, Bộ Y tế đã thông báo tạm ngừng việc mua, bán và sử dụng trên toàn quốc đối với thuốc Tarcefoksym dạng bào chế bột pha tiêm (hoạt chất Cefotaxim 1g/lọ), SĐK VN-18105-14 và VN-6089-08, do Công ty Tarchomin Pharmaceutical Works Polfa S.A của Ba Lan sản xuất và đăng ký.
 
Cục Quản lý Dược dẫn báo cáo của Trung tâm Quốc gia về thông tin thuốc và theo dõi phản ứng có hại của thuốc cho biết, chỉ trong 4 tháng đầu năm 2016 đã ghi nhận 300 trường hợp có phản ứng có hại nghi ngờ liên quan đến hoạt chất Cefotaxim.
 
Trong đó thuốc Tarcefoksym (hoạt chất Cefotaxim 1g), SĐK VN-18105-14 của Công ty Tarchomin Pharmaceutical được báo cáo với tỷ lệ phản ứng có hại cao nhất lên tới 13,4%. Nhiều nhất là 2 lô số 1101015 và 1081115 với 4 báo cáo cho mỗi lô, trong đó mỗi lô có 1 trường hợp tử vong.
 
Cục Quản lý Dược yêu cầu Viện Kiểm nghiệm thuốc Trung ương và Viện Kiểm nghiệm thuốc TP.HCM khẩn trương lấy mẫu và kiểm tra chất lượng thuốc Tarcefoksym trong 2 lô nói trên để báo cáo về Cục.
 
Tuyết Mai (TTXVN)

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  • GMPc Vietnam JSC
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  • Home
  • About Us
    • Summary information
    • Key Personnel
  • Services
    • WHO GMP Pharmaceutical facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • EU GMP Pharmaceutical Factory
      • Feasibility study report
      • Design detailed construction drawings
      • QM documentation – Validation
      • GMP application and product dossier application
      • Project management - Construction supervision
    • CGMP, ISO 22716-certified cosmetics facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • CGMP ASEAN Training and Guidance
      • Preparation of CGMP ASEAN/ ISO 22716 registration dossier
      • CGMP ASEAN Re-evaluation consultation
    • Health-supplement facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • HS GMP Training and Guidance
      • Preparation HS GMP registration dossier
      • HS GMP - Re-evaluation consultation
    • Eligibility For Cosmetic Manufacturing
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • Pharmaceutical distribution center
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • GSP warehouses
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Veterinary Pharmaceutical Facilities
      • Project Feasibility Study
      • Technology and Equipment consultation
      • Detail Construction and MEP Drawing
      • Project management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • GMP, GLP, GSP training
      • Basis knowledge
      • Intensive Training
    • Other GPs’s consultation
      • GLP inspection laboratories
      • GDP distribution systems
      • GPP pharmacy
      • WHO GACP medicinal materials
    • Register and Announce
      • Announcement of Imported Cosmetic
    • Dairy Factory
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
  • Jobs
  • Contact
 
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