State Drug Administration revises instruction manual for post-leaf injections of the pituitary gland

In order to further protect the public's drug safety, the State Drug Administration has decided to revise the instructions for the post-pitleaf injection sie, the precautions, etcThe relevant matters are announced as follows:, all pituitary after-leaf injection production enterprises should be in accordance with the requirements of the annex to revise the specification, before August 26, 2020 to the provincial drug regulatory department for the recordWhere the contents of therevision relate to drug labels, they shall be revised in a timely and; the instructions and other contents of the labels shall be consistent with the original approval contentAll factory-shipped drug specifications and labels shall be replaced within 9 months of the filing of the supplementary applicationthe above-mentioned pituitary after-leaf injection production enterprises should carry out in-depth study of the mechanism of new adverse reactions, take effective measures to do a good job of publicity and training on the use and safety issues, the content of the content strain involving drug safety should immediately notify the drug business and use units in an appropriate manner, guide physicians, pharmacists reasonable drug use, 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 instructionshereby make this announcementBlood pressure drop, tachycardia, etc.; '
mental nervous system: dizziness, headache, irritability, convulsions, numbness, appetite abnormalities, consciousness disorders, mental disorders, etc.;metabolic and nutritional disorders: mainly manifested as hyponatremia, but also blood potassium, blood chloride, blood calcium, blood magnesium reduction and other electrolyte abnormality reportedHyponatremia can occur with permeable demyelinization syndrome if corrected too quicklyrespiratory 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, vasculature, etc.;other: varicose, injected redness, blood, etcThere are reports of abnormal kidney functionTwo, "Notes" items should include:1If there is a serious adverse reaction such as palpitations, chest tightness, anaphylactic shock, etcafter the use of the drug, the drug should be stopped immediately2Pay attention to electrolyte monitoring after drug use, especially to the occurrence of hyponatremiaSodium supplementation should not be too fast in the correction of hyponatremia to avoid the appearance of permeable demyelin syndrome3When intravenous administration, avoid the appearance of skin necrosis caused by the oozing of the liquid4Hypertension, coronary artery disease, cerebrovascular disease patients and elderly patients with caution, if need to use, should strictly grasp the indications, strengthen monitoring, "taboo" items should include:1It is prohibited for anyone who is allergic to this product and the ingredients contained therein 2 This product is disabled for patients with myocarditis, vascular sclerosis, etc 3 Banned in patients with a history of caesarean section When proctoring, it is banned in patients with pelvic stenosis, twin births, too much amniotic fluid, excessive uterine swelling, prognosis obstruction, prenatal bleeding (pre-front placenta, early peeling of the placenta) Induction and gerrotomy of late pregnancy that is not open in the uterine vent 4 Moderate and severe renal insufficiency is disabled IV, "old age medication" items should include: elderly patients with caution, if need to use, should strictly grasp the indications, strengthen monitoring In the event of adverse reactions to immediately stop the drug, active rescue (Note: If the other contents of the specification are inconsistent with the above-mentioned revision requirements, they shall be revised together.) )