The State Drug Administration revised the instruction manual for the post-leaf injection of the pituitary gland.

1. All pituitary after-leaf injection production enterprises shall, in accordance with the requirements of the annex, revise the specifications and report them to the provincial drug regulatory authorities for the record by August 26, 2020. Where the contents of the
revision involve drug labels, they shall be revised together; the specifications and other contents of the labels shall be consistent with the original approval content.
replace all factory-shipped drug specifications and labels within 9 months of the filing of the supplementary application.
the above-mentioned pituitary after-leaf injection production enterprises should carry out in-depth study of the mechanism of occurrence of new adverse reactions, take effective measures to do a good job of publicity and training on the use and safety issues, and immediately notify drug management and use units in an appropriate manner to inform drug operators and users of the content of the change sedatives, and guide physicians and pharmacists to use the drug rationally.
, clinicians and pharmacists shall carefully read the revised contents of the predibino post-leaf injection instructions, and shall conduct full benefit/risk analysis in accordance with the newly revised specification when selecting the drug.
, patients should strictly follow the doctor's instructions to use the drug, before taking the drug should carefully read the instructions.
hereby make this announcement.
Annex: Pituitary after-leaf injection instruction requirements I, "Adverse reactions" items should include: after the market adverse drug monitoring found that the following adverse reactions / event reports: digestive system: abdominal pain, diarrhea, nausea, vomiting, bloating, abdominal discomfort, er inverse, etc. Cardiovascular system: elevated blood pressure, palpitations, arrhythmia, angina, tachycardia, blood pressure drop, tachycardia, etc.; 'mental nervous system: dizziness, headache, irritability, convulsions, numbness, appetite abnormality, consciousness disorders, mental disorders, metabolic and nutritional disorders, etc.; metabolic and nutritional disorders: mainly manifested as hyposodium emis, blood potassium, blood chloride, calcium, blood magnesium reduction and other electrolyte abnormality reported.
hyponatremia can occur with permeable demyelination syndrome if corrected too quickly.
respiratory system: chest tightness, breathing difficulties, shortness of breath, etc.; systemic reactions: pale, weak, fever, chills, systemic discomfort, severe allergic reactions, allergic shock, etc.; skin and accessories: sweating, redness, redness, rash, itching, local skin necrosis, vascular edema, etc.;
there are individual reports of renal dysfunction.
2, "Precautions" items should include: 1. If there is a serious adverse reaction after the drug, such as palpitations, chest tightness, anaphylactic shock, etc., should be immediately discontinued.
2. Pay attention to electrolyte monitoring after medication, especially to the occurrence of hyponatremia.
sodium supplementation should not be too fast in the correction of hyponatremia to avoid the appearance of permeable demyelin syndrome.
3. When intravenous administration, avoid the appearance of skin necrosis caused by the oozing of the liquid.
4. Hypertension, coronary artery disease, cerebrovascular disease patients and elderly patients with caution, if need to use, should strictly grasp the indications, strengthen monitoring.
. 3. The "Taboo" item should include: 1. Prohibited for all allergies to this product and the ingredients contained.
2. This product is disabled for patients with myocarditis, vascular sclerosis, etc.
3. Banned in patients with caesarean section history.
is banned in patients with pelvic stenosis, twin births, too much amniotic fluid, excessive uterine swelling, birth obstruction, prenatal bleeding (pre-front placenta, early peeling of the placenta).
are banned from induced and oxytocinous late pregnancy without opening in the uterus.
4. Moderate and severe renal insufficiency is disabled.
Ivy, "Old age medication" item should include: elderly patients with caution, if need to use, should strictly grasp the indications, strengthen monitoring.
once adverse reactions to immediately stop the drug, active rescue.
(Note: If the other contents of the specification are inconsistent with the above revision requirements, they shall be revised together.)
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