The State Food and Drug Administration revised the instructions for glycerol fructose and sodium chloride injection

On November 30, the State Food and Drug Administration issued an announcement stating that based on the results of adverse drug reaction assessments, in order to further protect the safety of public medication, the State Food and Drug Administration decided to uniformly revise the contents of the instructions for glycerol fructose and sodium chloride injection
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1.
The holders of the marketing authorization of the above-mentioned drugs shall be submitted to the National Drug Administration before February 28, 2022 in accordance with the "Drug Registration Management Measures" and other relevant regulations, in accordance with the revision requirements of the glycerol fructose sodium chloride injection instructions (see appendix) The Bureau’s Drug Evaluation Center or the Provincial Drug Supervision and Administration Department for the record
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If the revised content involves the drug label, it should be revised together; the instructions and other content of the label should be consistent with the original approved content
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Drugs produced from the date of filing shall not continue to use the original drug instructions
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The holder of the drug marketing authorization shall replace the instructions and labels of the drugs that have been shipped out of the factory within 9 months after filing
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2.
The drug marketing license holder shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to conduct publicity and training on drug use and safety issues, and guide physicians and pharmacists to rationally use drugs
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3.
Clinicians and pharmacists should carefully read the revised contents of the above-mentioned drug inserts, and when choosing medications, they should conduct a sufficient benefit/risk analysis based on the newly revised inserts
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4.
Patients should read the drug instructions carefully before taking the medicine, and if they use prescription drugs, they should strictly follow the doctor's advice
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5.
The provincial drug supervision and administration department shall supervise and urge the drug marketing authorization holders of the above-mentioned drugs in the administrative area to do the corresponding manual revision and label and manual replacement work as required, and severely investigate and punish violations of laws and regulations in accordance with the law.

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Attachment: Requirements for revision of the instructions for glycerol fructose sodium chloride injection 1.
[Adverse reactions] item added: Post-marketing monitoring data shows that the product can see the following adverse reactions/events: 1.
Systemic reactions: chills, fever, chills, high fever , Thirsty; 2.
Skin system: skin rash, itching, erythema, urticaria, hyperhidrosis; 3.
Gastrointestinal system: nausea, vomiting, abdominal pain, abdominal discomfort; 4.
Nervous system: headache, dizziness, hypoesthesia, tremor; 5.
Respiratory system: chest discomfort, chest pain, dyspnea, shortness of breath; 6.
Immune dysfunction and infection: allergic reaction, immediate severe allergic reaction, anaphylactic shock; 7.
Application site: pain, itching, redness and swelling at the injection site , Phlebitis; 8.
Other: palpitations, hemolysis, hematuria, hypokalemia
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2.
[Precautions] should include but not limited to: 1.
Use with caution in patients with severe circulatory system dysfunction, renal dysfunction, diabetes insipidus, diabetes and hemolytic anemia
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2.
Patients with active intracranial hemorrhage should be used with caution when there is no surgical condition.
The source of the bleeding should be treated first or the bleeding should be confirmed before applying this product
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3.
This product contains 0.
9% sodium chloride.
Pay attention to the patient's salt intake when taking the medicine
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4.
If the product is instilled too quickly, hemolysis may occur.
If the patient develops hemoglobinuria (soy sauce-colored urine), stop the infusion immediately
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5.
In patients with severe renal insufficiency, this product accumulates in the body due to decreased excretion, which may increase the blood volume significantly, aggravate the heart load, and induce or aggravate heart failure
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6.
For long-term use, attention should be paid to prevent water and electrolyte disorder
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7.
This product should be carefully checked before and during use, and it should not be used when it is found that the drug solution has turbidity, precipitation, discoloration, crystals and other drug properties changes, and the bottle body has leaks, cracks, etc.

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8.
For patients suffering from fructose-1,6-bisphosphatase (FBPase) deficiency (also known as hereditary fructose intolerance), this drug is not recommended
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9.
Type II citrullinemia is recurrent hyperammonemia and related neuropsychiatric symptoms, including convulsions, behavioral abnormalities, memory disorders, disorientation disorders, or disturbances of consciousness
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It has been reported that adult type II citrullinemia patients died after using the drug to treat cerebral edema
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Adult patients with type II citrullinemia are forbidden to use it
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