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According to the results of adverse drug reaction assessment, in order to further protect the safety of public drug use, the State Medical Products Administration decided to uniformly revise
the instructions of liver hydrolyzed peptide injections (including liver hydrolyzed peptide injection and liver hydrolyzed peptides for injection).
The relevant matters are hereby announced as follows:
1.
The MAHs of the above-mentioned drugs shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, report to the Drug Evaluation Center of the State Medical Products Administration or the provincial drug regulatory department for the record before January 27, 2023 in accordance with the requirements for the revision of the
instructions for liver hydrolyzed peptide injections (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 instructions
.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
2.
Drug marketing authorization holders shall conduct in-depth research on the mechanism of occurrence of new adverse reactions, take effective measures to publicize and train on drug use and safety issues, and guide physicians and pharmacists in rational drug use
.
3.
Clinicians and pharmacists should carefully read the revised content of the above drug instructions, 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 medication, and should strictly follow the doctor's advice when using prescription drugs
.
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 in 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: Liver hydrolyzed peptide injection manual revision requirements
NMPA
October 28, 2022
annex
Liver hydrolyzed peptide injection instructions revision requirements
1.
A warning should be added, which reads as follows
Adverse reactions of this product include anaphylactic shock, which should be used in medical institutions with rescue conditions, and allergic reactions or other serious adverse reactions after medication must be stopped immediately and treated
in time 。
2.
The following content should be included under [Adverse Reactions].
Post-marketing surveillance data show that the following adverse reactions/events can be seen in this product:
1.
Systemic reactions: hypersensitivity, anaphylactic shock, chills, fever, hyperthermia, fatigue;
2.
Skin and subcutaneous tissue: itching, rash (urticaria, maculopapular rash, erythematous rash, etc.
), flushing;
3.
Gastrointestinal system: nausea, vomiting, abdominal pain, diarrhea, abdominal discomfort;
4.
Respiratory system: chest tightness, dyspnea, shortness of breath;
5.
Cardiovascular system: palpitations, palpitations, hypotension;
6.
Nervous system: dizziness, headache, tremor, impaired consciousness;
7.
Drug site reaction: phlebitis, pain, redness, swelling, itching
at the injection site.
3.
The following content should be included under [Precautions].
1.
Adverse reactions of this product include anaphylactic shock, which should be used in medical institutions with rescue conditions, and allergic reactions or other serious adverse reactions after medication must be stopped immediately and treated
in time.
2.
This product should be used immediately, administered separately, and contraindicated to be mixed with
other drugs.
If it is really necessary to combine other drugs, the interval with this product should be carefully considered, and the infusion pipeline must be rinsed
with an appropriate amount of dilution between the two drugs.
3.
The patient's medication history and allergy history should be carefully asked before medication
.
Strengthen monitoring during medication and closely observe the medication reaction, especially for the first 30 minutes
.
If abnormalities are found, the drug is immediately discontinued, and active treatment measures are adopted to treat the patient
.
4.
Lack of relevant research data, not recommended for
pregnant women.
5.
At present, there is no systematic research data on the application of this product in children, and it is not recommended for
children.
6.
It has been reported in the literature that this product is stored with sodium p-aminosalicylate and dexamethasone for injection
Contraindicated
in matching.
(Note: If the safety content of the original approval specification is more comprehensive or stricter than the content required by this amendment, the original approval content
shall be retained.
) If other contents of the specification are inconsistent with the above revision requirements, they shall be revised
together.
）
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