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Medical Network, March 24 News On March 23, the State Food and Drug Administration issued the "Announcement on Revising the Instructions for Fluoroquinolones for Systemic Use (No.
44 of 2021)", [Adverse Reactions] and [Attention] Matters] and [Medications for the Elderly] have been revised.
Among them, [Adverse Reaction] increases the risk of aortic aneurysm and aortic dissection.
44 of 2021)", [Adverse Reactions] and [Attention] Matters] and [Medications for the Elderly] have been revised.
Among them, [Adverse Reaction] increases the risk of aortic aneurysm and aortic dissection.
annex
Revised requirements for the package insert of fluoroquinolones for systemic use
1.
General requirements for manual revision
General requirements for manual revision
1.
This revision of the manual is only for systemic fluoroquinolone drugs (oral preparations and injection preparations), and the specific revision opinions are applicable to each specific category of systemic fluoroquinolone drugs.
This revision of the manual is only for systemic fluoroquinolone drugs (oral preparations and injection preparations), and the specific revision opinions are applicable to each specific category of systemic fluoroquinolone drugs.
2.
This revision of the instructions for systemic fluoroquinolone drugs (oral preparations and injection preparations) is mainly aimed at the three parts of [ Adverse Reactions ], [Precautions], and [Medications for the Elderly], and the following principles should be followed: If the relevant content approved by the State Drug Administration is more stringent and comprehensive, the instructions should be revised in accordance with this revision.
The relevant content approved by the State Drug Administration shall not be deleted in principle.
If the original approved content is more comprehensive or stricter than this revision, the original approved content should be retained.
This revision of the instructions for systemic fluoroquinolone drugs (oral preparations and injection preparations) is mainly aimed at the three parts of [ Adverse Reactions ], [Precautions], and [Medications for the Elderly], and the following principles should be followed: If the relevant content approved by the State Drug Administration is more stringent and comprehensive, the instructions should be revised in accordance with this revision.
The relevant content approved by the State Drug Administration shall not be deleted in principle.
If the original approved content is more comprehensive or stricter than this revision, the original approved content should be retained.
2.
The following content should be added under [Adverse Reaction]
The following content should be added under [Adverse Reaction]
1.
Serious and other important adverse reactions
Serious and other important adverse reactions
Risk of aortic aneurysm and aortic dissection
3.
Add the following content under [Notes]
Add the following content under [Notes]
Risk of aortic aneurysm and aortic dissection
Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
The reason for the increased risk has not yet been determined.
For patients who are known to have aortic aneurysms or a high-risk aortic aneurysm, use XXXX only if no other antibacterial treatment is available.
The reason for the increased risk has not yet been determined.
For patients who are known to have aortic aneurysms or a high-risk aortic aneurysm, use XXXX only if no other antibacterial treatment is available.
4.
Add the following content under [Medications for the Elderly]:
Add the following content under [Medications for the Elderly]:
Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
(See 【Notes】).
(See 【Notes】).
(Note: If the other contents of the manual are inconsistent with the above revision requirements, they should be revised together.
)
)
Medical Network, March 24 News On March 23, the State Food and Drug Administration issued the "Announcement on Revising the Instructions for Fluoroquinolones for Systemic Use (No.
44 of 2021)", [Adverse Reactions] and [Attention] Matters] and [Medications for the Elderly] have been revised.
Among them, [Adverse Reaction] increases the risk of aortic aneurysm and aortic dissection.
44 of 2021)", [Adverse Reactions] and [Attention] Matters] and [Medications for the Elderly] have been revised.
Among them, [Adverse Reaction] increases the risk of aortic aneurysm and aortic dissection.
annex
Revised requirements for the package insert of fluoroquinolones for systemic use
1.
General requirements for manual revision
General requirements for manual revision
1.
This revision of the manual is only for systemic fluoroquinolone drugs (oral preparations and injection preparations), and the specific revision opinions are applicable to each specific category of systemic fluoroquinolone drugs.
This revision of the manual is only for systemic fluoroquinolone drugs (oral preparations and injection preparations), and the specific revision opinions are applicable to each specific category of systemic fluoroquinolone drugs.
2.
This revision of the instructions for systemic fluoroquinolone drugs (oral preparations and injection preparations) is mainly aimed at the three parts of [ Adverse Reactions ], [Precautions], and [Medications for the Elderly], and the following principles should be followed: If the relevant content approved by the State Drug Administration is more stringent and comprehensive, the instructions should be revised in accordance with this revision.
The relevant content approved by the State Drug Administration shall not be deleted in principle.
If the original approved content is more comprehensive or stricter than this revision, the original approved content should be retained.
This revision of the instructions for systemic fluoroquinolone drugs (oral preparations and injection preparations) is mainly aimed at the three parts of [ Adverse Reactions ], [Precautions], and [Medications for the Elderly], and the following principles should be followed: If the relevant content approved by the State Drug Administration is more stringent and comprehensive, the instructions should be revised in accordance with this revision.
The relevant content approved by the State Drug Administration shall not be deleted in principle.
If the original approved content is more comprehensive or stricter than this revision, the original approved content should be retained.
2.
The following content should be added under [Adverse Reaction]
The following content should be added under [Adverse Reaction]
1.
Serious and other important adverse reactions
Serious and other important adverse reactions
Risk of aortic aneurysm and aortic dissection
3.
Add the following content under [Notes]
Add the following content under [Notes]
Risk of aortic aneurysm and aortic dissection
Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
The reason for the increased risk has not yet been determined.
For patients who are known to have aortic aneurysms or a high-risk aortic aneurysm, use XXXX only if no other antibacterial treatment is available.
The reason for the increased risk has not yet been determined.
For patients who are known to have aortic aneurysms or a high-risk aortic aneurysm, use XXXX only if no other antibacterial treatment is available.
4.
Add the following content under [Medications for the Elderly]:
Add the following content under [Medications for the Elderly]:
Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
(See 【Notes】).
(See 【Notes】).
(Note: If the other contents of the manual are inconsistent with the above revision requirements, they should be revised together.
)
)
Medical Network, March 24 News On March 23, the State Food and Drug Administration issued the "Announcement on Revising the Instructions for Fluoroquinolones for Systemic Use (No.
44 of 2021)", [Adverse Reactions] and [Attention] Matters] and [Medications for the Elderly] have been revised.
Among them, [Adverse Reaction] increases the risk of aortic aneurysm and aortic dissection.
44 of 2021)", [Adverse Reactions] and [Attention] Matters] and [Medications for the Elderly] have been revised.
Among them, [Adverse Reaction] increases the risk of aortic aneurysm and aortic dissection.
annex
annex Revised requirements for the package insert of fluoroquinolones for systemic use
Revised requirements for the package insert of fluoroquinolones for systemic use 1.
General requirements for manual revision
1. General requirements for manual revision
General requirements for manual revision
1.
This revision of the manual is only for systemic fluoroquinolone drugs (oral preparations and injection preparations), and the specific revision opinions are applicable to each specific category of systemic fluoroquinolone drugs.
Medicine, medicine, medicineThis revision of the manual is only for systemic fluoroquinolone drugs (oral preparations and injection preparations), and the specific revision opinions are applicable to each specific category of systemic fluoroquinolone drugs.
2.
This revision of the instructions for systemic fluoroquinolone drugs (oral preparations and injection preparations) is mainly aimed at the three parts of [ Adverse Reactions ], [Precautions], and [Medications for the Elderly], and the following principles should be followed: If the relevant content approved by the State Drug Administration is more stringent and comprehensive, the instructions should be revised in accordance with this revision.
The relevant content approved by the State Drug Administration shall not be deleted in principle.
If the original approved content is more comprehensive or stricter than this revision, the original approved content should be retained.
Adverse reactions adverse reactions adverse reactionsThis revision of the instructions for systemic fluoroquinolone drugs (oral preparations and injection preparations) is mainly aimed at the three parts of [ Adverse Reactions ], [Precautions], and [Medications for the Elderly], and the following principles should be followed: If the relevant content approved by the State Drug Administration is more stringent and comprehensive, the instructions should be revised in accordance with this revision.
The relevant content approved by the State Drug Administration shall not be deleted in principle.
If the original approved content is more comprehensive or stricter than this revision, the original approved content should be retained.
2.
The following content should be added under [Adverse Reaction]
2. The following content should be added under [Adverse Reaction]
The following content should be added under [Adverse Reaction]
1.
Serious and other important adverse reactions
Serious and other important adverse reactions
Risk of aortic aneurysm and aortic dissection
3.
Add the following content under [Notes]
3. Add the following content under [Notes]
Add the following content under [Notes]
Risk of aortic aneurysm and aortic dissection
Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
The reason for the increased risk has not yet been determined.
For patients who are known to have aortic aneurysms or a high-risk aortic aneurysm, use XXXX only if no other antibacterial treatment is available.
The reason for the increased risk has not yet been determined.
For patients who are known to have aortic aneurysms or a high-risk aortic aneurysm, use XXXX only if no other antibacterial treatment is available.
4.
Add the following content under [Medications for the Elderly]:
4. Add the following content under [Medications for the Elderly]:
Add the following content under [Medications for the Elderly]:
Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
(See 【Notes】).
(See 【Notes】).
(Note: If the other contents of the manual are inconsistent with the above revision requirements, they should be revised together.
)
)
