-
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
Source: NMPA: wangxinglai2004
before January 27, 2023.
01 Original text of the notice
According to the results of the 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 warning words and [adverse reactions], [contraindications] and [precautions] in the instructions of astragalus polysaccharides for injection, sodium chloride injection and banlangen injection.
The relevant matters are hereby announced as follows:
1.
The marketing authorization holders of all the above-mentioned drugs shall amend the instructions in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions, and submit them to the provincial drug regulatory authorities for the record
before January 27, 2023.
Where the content of the amendment involves drug labels, it shall be revised together; The instruction manual and other contents of the label shall be consistent
with the original approved content.
Drugs produced from 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 new adverse reactions, take effective measures to publicize and train on drug use and safety issues, and guide physicians, pharmacists and patients 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 promptly urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to complete the revision of the corresponding instructions and the replacement of labels and instructions as required, and strictly investigate and deal with violations of laws and
regulations in accordance with law.
1.
Warnings should be added, which should include:
Adverse reactions of this product include anaphylactic shock, should be used in medical institutions with rescue conditions, users should receive anaphylactic shock rescue training, allergic reactions or other serious adverse reactions after medication must be stopped immediately and timely treatment
.
2.
[Adverse reactions] shall include:
1.
Allergic reaction or anaphylactoid reaction: flushing, chills, fever, rash, itching, dyspnea, palpitations, laryngeal edema, etc.
, with anaphylactic shock case reports
.
2.
Skin and its accessories: rash, itching, erythema, urticaria, sweating, etc
.
3.
Systemic reactions: chest discomfort, chills, fever, pain, fatigue, etc
.
4.
Respiratory system: dyspnea, shortness of breath, cough, etc
.
5.
Gastrointestinal system: nausea, vomiting, abdominal pain, diarrhea, bloating, etc
.
6.
Others: dizziness, headache, eyelid edema, etc
.
3.
The subparagraph [Taboo] shall be added:
Those with a history of allergy or serious adverse reactions to this product and the ingredients contained in it are prohibited
.
4.
[Matters needing attention] shall be added:
1.
Adverse reactions of this product include anaphylactic shock, should be used in medical institutions with rescue conditions, users should receive anaphylactic shock rescue training, allergic reactions or other serious adverse reactions after medication must be stopped immediately and timely treatment
.
2.
Use in strict accordance with the functional indications specified in the drug instructions, and prohibit the use of superfunctional main drugs
.
3.
Strictly control the usage and dosage
.
Use the drug in the
recommended dosage according to the drug label.
No overdose, too fast instillation and long-term continuous medication
.
4.
It is strictly forbidden to mix and match, and the combination of drugs
is cautious.
This product should be used alone, contraindicated to mix with other drugs
.
If it is necessary to combine other drugs, the interval time with this product and drug interactions should be carefully considered, and the infusion pipeline should be flushed with an appropriate amount of dilution to avoid the risk
of mixing this product with other pharmaceutical solutions in the pipeline.
5.
Before taking the drug, the patient's condition, medication history and allergy history
should be carefully inquired.
For special groups such as the elderly and patients who use this product for the first time, it should be used with caution to strengthen clinical drug monitoring
.
6.
Strengthen medication monitoring
.
During medication, the reaction should be closely observed, 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
.
7.
Improper storage of this product may affect the quality of
drugs.
After preparation and during use, this product and drip solution should be carefully checked, and it is found that the drug liquid has turbidity, precipitation, discoloration, crystallization and other changes in drug properties, and the bottle body has air leakage, cracks and other phenomena, it is forbidden to use
.
03 Lampflower sodium chloride injection manual revision requirements 1, should be added warning, the content should be added: 1.
Adverse reactions of this product including anaphylactic shock, should be used in medical institutions with rescue conditions, users should receive anaphylactic shock rescue training, Allergic reactions or other serious adverse reactions after medication must be stopped immediately and treated
in time.
2.
Patients with acute stage or bleeding tendency of cerebral hemorrhage are banned
.
2.
[Adverse reactions] items should include: 1.
Allergic reaction or anaphylactoid reaction: flushing, chills, fever, rash, itching, dyspnea, palpitations, laryngeal edema, anaphylactic shock, etc
.
2.
Skin and its accessories: rash, itching, erythema, urticaria, sweating, etc
.
3.
Systemic reactions: chest discomfort, chest tightness, chills, fatigue, fever, pain, etc
.
4.
Nervous system: dizziness, headache, tremor, etc
.
5.
Cardiovascular system: palpitations, arrhythmias, etc
.
6.
Gastrointestinal system: nausea, vomiting, abdominal discomfort, etc
.
7.
Respiratory system: dyspnea, shortness of breath, etc
.
8.
Others: increased or decreased blood pressure, phlebitis, injection site reactions, etc
.
3.
[Contraindications] items shall include: 1.
Those who are allergic to this product or preparations containing lampflower and the excipients listed in the ingredients or have a history of serious adverse reactions are prohibited
.
2.
Newborns, infants and young children are banned
.
3.
Patients with acute stage or bleeding tendency of cerebral hemorrhage are banned
.
4.
Pregnant women are banned
.
(The corresponding content under [pregnant and lactating women] is deleted) IV.
[Precautions] items shall include: 1.
Adverse reactions of this product include anaphylactic shock, which should be used in medical institutions with rescue conditions, and users should receive anaphylactic shock rescue training, and allergic reactions or other serious adverse reactions after medication must be stopped immediately and treated
in time.
2.
Use in strict accordance with the functional indications specified in the drug instructions, and prohibit the use of superfunctional main drugs
.
3.
Strictly control the usage and dosage
.
Use the drug in accordance with the recommended dosage and dispensing requirements of the drug
label.
Do not overdose, too fast instillation and long-term continuous medication
.
4.
It is strictly forbidden to mix and match, and the combination of drugs
is cautious.
This product should be used alone, contraindicated to mix with other drugs
.
If it is necessary to combine other drugs, the interval with this product and drug interactions should be carefully considered, and the infusion pipeline should be flushed with an appropriate amount of dilution to avoid the risk of
mixing this product with other drug solutions in the pipeline.
5.
Improper storage of this product may affect the quality of
drugs.
Before and during use, this product and the drip solution should be carefully inspected, and it should not be used
when it is found that the drug solution is turbid, precipitated, discolored, crystallized and other drug properties change, and the bottle body has air leakage, cracks and other phenomena.
6.
Before taking the drug, the patient's condition, medication history and allergy history
should be carefully inquired.
People with allergies, patients with abnormal liver and kidney function, coagulation mechanism or platelet dysfunction, the elderly, lactating women, and patients who use Chinese medicine injections for the first time should use with caution and strengthen monitoring
.
7.
Strengthen medication monitoring
.
During medication, the reaction should be closely observed, 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
.
8
.
At present, there is no systematic research data on the application of this product in children, and it is not recommended for children.
9.
It is forbidden to use the method of intravenous bolus for administration
.
10.
The literature shows that bingerin (mainly containing baicalin) has the effects of reducing platelet count, inhibiting platelet aggregation, inhibiting internal coagulation, etc.
, in order to reduce the risk of bleeding, it is recommended that this product should be monitored when used at the same time with anticoagulants or antiplatelet drugs that may increase the risk of bleeding
.
04 Banlangen injection instructions revision requirements
<>.
Warnings should be added, which should include:
Adverse reactions of this product include anaphylactic shock, should be used in medical institutions with rescue conditions, users should receive anaphylactic shock rescue training, allergic reactions or other serious adverse reactions after medication must be stopped immediately and timely treatment
.
<>.
[Adverse reactions] shall include:
1.
Allergic reaction or anaphylactoid reaction: flushing, chills, fever, rash, itching, dyspnea, shortness of breath, palpitations, anaphylactic shock, etc
.
2.
Skin and its accessories: rash, itching, urticaria, erythema, sweating, etc
.
3.
Systemic reactions: chest discomfort, chills, fever, pain, fatigue, etc
.
4.
Respiratory system: dyspnea, shortness of breath, etc
.
5.
Gastrointestinal system: nausea, vomiting, diarrhea, etc
.
6.
Others: dizziness, palpitations, increased or decreased blood pressure, eyelid edema, etc
.
<>.
The subparagraph [Taboo] shall be added:
Those with a history of allergy or serious adverse reactions to this product and the ingredients contained in it are prohibited
.
4.
[Points to note] shall include:
1.
Adverse reactions of this product include anaphylactic shock, should be used in medical institutions with rescue conditions, users should receive anaphylactic shock rescue training, allergic reactions or other serious adverse reactions after medication must be stopped immediately and timely treatment
.
2.
Use in strict accordance with the functional indications specified in the drug instructions, and prohibit the use of superfunctional main drugs
.
3.
Strictly control the usage and dosage, and use the drug in accordance with the recommended dosage in the
drug instructions.
Not overdosed and long-term continuous medication
.
4.
Before taking the drug, the patient's condition, medication history and allergy history
should be carefully inquired.
Those with a history of drug allergy or allergic constitution should be used
with caution.
5.
Those with a family history of allergies should be used
with caution.
6.
For special groups such as the elderly and patients who use this product for the first time, it should be used with caution to strengthen clinical drug monitoring
.
7.
It is strictly forbidden to mix and match, and the combination of drugs
is cautious.
This product should be used alone, contraindicated to mix with other drugs
.
If it is necessary to combine other drugs, the interval with this product and drug interactions should
be carefully considered.
8.
Strengthen medication monitoring
.
During medication, the medication reaction should be closely observed, especially within 30 minutes
after medication.
If abnormalities are found, the drug is immediately discontinued, and active treatment measures are adopted to treat the patient
.
9.
Improper storage of this product may affect the quality of the drug, this product should be carefully checked before use, and it is forbidden to use
it when it is found that the drug liquid has turbidity, precipitation, discoloration, crystallization and other changes in drug properties, as well as air leakage, cracks and other phenomena in the bottle body.
