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1.
Chinese Journal of Medical Instrumentation ; (6): 446-449, 2021.
Article in Chinese | WPRIM | ID: wpr-888643

ABSTRACT

The lung is an important organ in systemic toxicity test of medical devices and is significant in safety evaluation. Based on the authors' understanding of medical devices, this study provides a brief analysis of the lung examination and common problems in systemic toxicity, so as to provide references for the pre-clinical safety evaluation of medical devices. It should be noted that a reasonable risk assessment should be made after comprehensive assessment for specific medical device products.


Subject(s)
Humans , Equipment Safety , Lung , Risk Assessment
2.
China Pharmacy ; (12): 4152-4154,4155, 2016.
Article in Chinese | WPRIM | ID: wpr-605463

ABSTRACT

OBJECTIVE:To guide rational use of Heamocoagulase agkistrodon for injection,and to provide reference for phar-maceutical care. METHODS:Treatment methods and outcome of 9 cases of allergic shock induced by Heamocoagulase agkistrodon for injection were retrieved from CNKI and VIP database during 2009-2015,and then analyzed statistically,based on one case of allergic shock induced by Heamocoagulase agkistrodon for injection in the Affiliated Hospital of Zhunyi Medical College. RE-SULTS:10 pationts with allergic shock induced by Heamocoagulase agkistrodon for injection mainly used the drug for hemostasis before and after surgery,heavy menstrual bleeding,etc.,with dose of 1 or 2 U. Route of administration included intravenous injec-tion and intravenous dripping. Allergic shock often occurred within 30 min after medication. CONCLUSIONS:The use of Heamoco-agulase agkistrodon for injection in some patients belongs to off-label drug use,and route of administration is different from that stated in package inserts. Allergic shock induced by Heamocoagulase agkistrodon for injection occurs rapidly;the drug should be used strictly according to package inserts and authoritative literatures;emergency plan should be developed before medication in or-der to guarantee the safety of drug use.

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