On March 23, the State Food and Drug Administration issued an announcement on revising the instructions for mouse nerve growth factor for injection, and decided to revise the instructions for mouse nerve growth factor for injection [adverse reactions], [precautions] and medications for special populations.
Among them, [Note] stressed that the increase "should be strictly in accordance with the instructions provided for the use of dose administration is strictly prohibited to change the route of administration.
Revision requirements of the instructions for mouse nerve growth factor for injectionRevision requirements of the instructions for mouse nerve growth factor for injection
[Adverse reactions] should include the following:
Systemic diseases and various reactions at the administration site: fever, chills, chest tightness, fatigue, peripheral edema; pain at the injection site, rash at the injection site, induration at the injection site, swelling at the injection site, itching at the injection site, pain in the lower extremity of the injection side, etc.
Skin and subcutaneous tissue diseases: itching, maculopapular rash, urticaria, erythema, etc.
There are case reports of toxic epidermal necrolysis.
Neuropsychiatric diseases: dizziness, headache, local numbness, limb tremor, convulsions, insomnia, excitement, sleep disorders, mental disorders, etc.
Gastrointestinal diseases: nausea, vomiting, abdominal pain, diarrhea and other gastrointestinal reactions, elevated transaminase, abnormal liver function.
Various musculoskeletal and connective tissue diseases: muscle pain, etc.
Immune system diseases: allergic-like reactions, anaphylactic shock, etc.
Others: conjunctival hyperemia, palpitations, arrhythmia, dyspnea, laryngeal edema, granulocytosis, thrombocytosis, abnormal renal function, etc.
Increase "should be strictly predetermined according to the use amount of administration instructions.
Prohibited to change the route of administration.
[Medicine for pregnant women and lactating women]
The expressions "this product has the effect of promoting growth and development on the nervous system" and "please follow the doctor's advice" are deleted, and the content related to this special group of people is reserved.
Only keep the relevant statements that there are no medication data for children.
If there is "Children's medication please follow the doctor's advice" in this item, please delete it.
(Note: If the other contents of the manual are inconsistent with the above revision requirements, they should be revised together.