-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
According to the results of the assessment of adverse drug reactions, in order to further protect the safety of public medication, the State Medical Products Administration decided to uniformly revise
the contents of the instructions for resorcinol injection (including resorcinol injection and resorcinol for injection).
The relevant matters are hereby announced as follows:
1.
The marketing authorization holders of the above-mentioned drugs shall report to the Center for Drug Evaluation of the State Medical Products Administration or the provincial drug administration department for the record
before February 8, 2023 in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and in accordance with the revised requirements of the instructions for resorcinol injection (see annex).
Where the revised content involves drug labels, they shall be revised together, and the instructions and other contents of the label shall be consistent
with the original approved content.
Drugs produced on the date of filing shall not continue to use the original drug insert.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
2.
Drug MAHs shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to do a good job in publicizing and training on drug use and safety issues, and guide physicians and pharmacists in rational drug
use.
3.
Clinicians and pharmacists should carefully read the revised contents of the above drug inserts, and when selecting drugs, they should conduct a full benefit/risk analysis
according to the newly revised instructions.
4.
Patients should carefully read the drug instructions before taking drugs, and if they use prescription drugs, they should strictly follow the doctor's advice
.
5.
The provincial-level drug regulatory departments shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job of revising the corresponding instructions and replacing labels and instructions as required, and strictly investigate and deal with
violations of laws and regulations in accordance with law.
This is hereby announced
.
Attachment: Resorcinol injection specification revision requirements
State Food and Drug Administration
November 8, 2022
annex
Resorcinol injection specification revision requirements
1.
[Adverse reactions] should include the following
The following adverse reactions/events (these adverse reactions/events are derived from spontaneous reports where sample sizes cannot be determined, making it difficult to accurately estimate their frequency) with postmarketing monitoring of resorcinol injections:
Skin and its appendage lesions: rash (such as urticaria, erythematous rash, maculopapular rash, etc.
), itching, hyperhidrosis;
Systemic damage: chills, fever, chills, fatigue, pallor;
Gastrointestinal damage: nausea, vomiting, dry mouth, abdominal pain, bloating, diarrhea;
Respiratory damage: chest tightness, dyspnea, shortness of breath, cough;
Neurological impairment: dizziness, headache, numbness, tremors, convulsions;
Damage to the cardiovascular system: palpitations, increased blood pressure, cyanosis;
Immune disorders and infections: anaphylactic reactions, anaphylactoid reactions, anaphylactic shock;
Other: phlebitis, pain at the injection site, itching at the injection site, blurred vision, dysuria, urinary retention
.
II.
[Precautions] should include the following
Post-marketing monitoring of this product has anaphylactic shock case reports, it is recommended to use in medical institutions with rescue conditions, before medication should carefully ask the patient about the drug history and allergy history, pay attention to observation during the medication, once there are rash, itching, dyspnea, blood pressure drop and other symptoms and signs, should be immediately discontinued and timely treatment
.
(Note: If the safety content of the original approval manual is more comprehensive or stricter than the requirements of this revision, the original approval content
should be retained.
) If other contents of the manual are inconsistent with the above revision requirements, they shall be revised
together.
）
={"common":{"bdSnsKey":{},"bdText":"","bdMini":"1","bdMiniList":false,"bdPic":"","bdStyle":"0","bdSize":"32"},"share":{},"image":{"viewList":[" weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"],"viewText":"share:","viewSize":"24"},"selectShare":{" bdContainerClass":null,"bdSelectMiniList":["weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"]}}; with(document)0[(getElementsByTagName('head')[0]|| body). 
