Regulatory Affairs teams, quality assurance specialists, and healthcare professionals need to be aware of a critical quality issue associated with the needles of Arixtra prefilled syringes. This issue, announced by Swissmedic, impacts the safety and efficacy of the product.
Introduction | Details of the Issue | Who is Affected? | Regulatory Implications | FAQ | Conclusion | Disclaimer
Arixtra: Background
Arixtra (generic name: Fondaparinux Sodium) is a synthetic anticoagulant medication that prevents and treats deep vein thrombosis, which may lead to pulmonary embolism.
Identification of the Issue
According to Swissmedic, the quality issue with the prefilled syringes involves problems with the needles, which may affect the safe administration of the drug.
Details of the Issue
- The issue specifically concerns the needles of the prefilled syringes, which may not be suitable for safe administration.
- This has serious implications for patients who are prescribed this medication to prevent deep vein thrombosis and pulmonary embolism.
Who is Affected?
Regulatory Implications
Frequently Asked Questions
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Q: What is the problem with the Arixtra prefilled syringes?
A: The issue specifically concerns the needles of the prefilled syringes, which may not be suitable for safe administration.
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Q: Who is affected by the problem with the prefilled syringe needles of Arixtra?
A: Parties affected by the quality issue include patients, healthcare professionals, and Regulatory Affairs teams.
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Q: What are the regulatory implications of the quality issue?
A: The quality issue has serious implications for the safety and efficacy of Arixtra (fondaparinux sodium) prefilled syringes.
Conclusion
Based on Swissmedic’s announcement, Regulatory Affairs teams and healthcare professionals should be aware of the critical quality issue associated with Arixtra prefilled syringe needles.
Disclaimer
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