-
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
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
According to the results of adverse drug reaction assessment, in order to further protect the safety of public medication, the State Medical Products Administration decided to uniformly revise
the instructions for thymus peptide injection (including thymus peptide for injection, thymus peptide injection and thymus peptide sodium chloride injection).
The relevant matters are hereby announced as follows:
1.
The MAHs of the above-mentioned drugs shall report to the provincial drug regulatory department for the record before April 3, 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
thymus peptide injection instructions (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: Thymus peptide injection instructions revision requirements
1.
Add a black box warning
This product can cause severe allergic reactions (including anaphylactic shock), severe cases can lead to death, it is recommended to use in medical institutions with rescue conditions, before medication should carefully ask the patient drug history and allergy history, the patient should be closely observed during the medication, once allergic reactions or other serious adverse reactions must be stopped immediately and treated
in time.
2.
The following content should be included under [adverse reactions].
The following adverse reactions were reported in post-marketing monitoring (incidence unknown):
Immune system: anaphylaxis, anaphylactic shock
.
Skin and subcutaneous tissues: rash, urticaria, maculopapular rash, erythema, dermatitis, itching, sweating, skin swelling, skin discoloration
.
Systemic and site-of-administration reactions: chest discomfort, chills, fever (hyperthermia), pain, fatigue, edema, injection site pruritus, injection site rash, injection site swelling
.
Respiratory system: cough, shortness of breath, dyspnea, asthma, laryngeal edema
.
Digestive system: nausea, vomiting, abdominal pain, abdominal discomfort, diarrhea, bloating, dry mouth, numbness of the mouth, elevated
liver enzymes.
Cardiovascular system: palpitations, tachycardia, arrhythmias, decreased blood pressure, increased blood pressure, flushing, cyanosis, pallor, phlebitis
.
Neurological and psychiatric reactions: dizziness, headache, hypoesthesia, tremor, confusion, syncope, drowsiness, convulsions, irritability
.
Musculoskeletal: myalgia, back pain, bone pain, arthralgia
.
Other: visual impairment, vertigo, urinary incontinence, loss of appetite
.
3.
The following should be included under [Taboos].
1.
Those who are allergic to this product are banned
.
2.
Pregnant women and lactating women are banned
.
3.
Organ transplanters are banned
.
4.
Patients with hyperthymus or thymic tumor are banned
.
4.
The following content shall be included under [Precautions].
1.
This product can cause severe allergic reactions (including anaphylactic shock), severe cases can lead to death, it is recommended to use in medical institutions with rescue conditions, before medication should carefully ask the patient drug history and allergy history, the patient should be closely observed during the medication, once allergic reactions or other serious adverse reactions must be stopped immediately and treated
in time.
2.
Patients receiving immunosuppressive therapy should use this product
with caution.
5.
The following should be included under [Medication for Pregnant and Lactating Women].
Pregnant and lactating women are banned
.
6.
The following content should be included under [Drugs for the Elderly].
Elderly patients should use this product
with caution.
(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.
）
State Food and Drug Administration
January 4, 2023
={"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). 
