Announcement of the State Drug Administration on revising the instructions of the amendment

Announcement of the State Drug Administration on revising the instructions of the amendment

(2022 No. 72)

According to the results of adverse drug reactions, in order to further ensure the safety of public medication, the State Drug Administration decided to have a hydroxyeyl starch injection (including hydroxyethyls (including hydroxyethyls, 20 sodium chloride injections, hydroxye ethyl starch 40 sodium chloride injection , Hydrocarbonium hydroxyl ethyl starch 40 injection, hydroxye ethyl starch 200/0.5 sodium chloride injection, hypertonic hydroxye ethyl starch 200/0.5 sodium chloride injection, hydroxyeyl starch 130/0.4 chlorine chlorine chlorine chlorine Sodium injection, hydroxyeyl starch 130/0.4 electrolyte injection) The content of the instruction manual is uniformly revised. The relevant matters are announced as follows:

I. The listing permits of the above drugs shall, in accordance with the relevant provisions of the "Administrative Measures for the Registration of Drugs", in accordance with the relevant provisions of the Drug Registration Management, in accordance with the requirements of the instructions (see attachments) in accordance with the instructions (see attachments) in accordance with the hydroxye ethyl starch injection instructions (see attachments) Drug review centers or provincial drug supervision and administration departments will be recorded.

If the revised content involves drug labels, it should be revised together. The instructions and other contents of the label should be consistent with the original approval content. Drugs produced from the date of filing shall not continue to use the original drug instructions. The holder of the drug listing permit shall be replaced by the drug manual and label of the factory within 9 months after the filing.

2. The holder of the drug listing permit shall conduct in -depth research on the mechanism of new adverse reactions, take effective measures to do a good job of publicity and training of drug use and safety issues, and guide physicians and pharmacists to use medicine reasonably.

3. Clinicians and pharmacists should carefully read the amendments to the above -mentioned drug manuals. When choosing a medication, they should conduct full benefit/risk analysis based on the new revision instructions.

Fourth, patients should read the drug instructions carefully before taking the medicine. If the prescription medicine is used, the medicine should be strictly obeyed.

V. Provincial pharmaceutical supervision and management department shall urge the drug listing license holders of the above drugs in the administrative area to make the corresponding instructions and labels and instruction replacement in accordance with the requirements, and severely investigate and punish illegal and illegal acts in accordance with the law.

Special announcement.

Attachment: 1. Hydroxyeyl starch 20 sodium chloride injection, hydroxye ethyl starch 40 sodium chloride injection, hypertonic sodium hydroxye ethyl starch 40 injection solution, hydroxy ethyl starch 200/0.5 sodium chloride injection Line, hyperlove hydroxye ethyl starch 200/0.5 sodium chloride injection, hydroxye ethyl starch 130/0.4 sodium chloride injection instruction manual safety content revision requirements

2. Hydroxyeyl starch 130/0.4 electrolyte injection instructions Safety content revision requirements

State Drug Administration

September 2, 2022

appendix:

1. Hydroxyeyl starch 20 sodium chloride injection, hydroxye ethyl starch 40 sodium chloride injection solution, hypertonic sodium hydroxyl ethyl starch 40 injection solution, hydroxye ethyl starch 200/0.5 sodium chloride injection, and sodium chloride injection,, sodium chloride injection,, Hydroxyl ethyl starch 200/0.5 sodium chloride injection, hydroxye ethyl starch 130/0.4 sodium chloride injection instruction manual safety content revision requirements

2. Hydroxyeyl starch 130/0.4 electrolyte injection instructions Safety content revision requirements

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