Medical network - on February 15, a large variety of new antibiotics adverse reactions: fluids can cause phlebitis.
▍ QuNa increase injection with ammonia, the adverse reaction
On February 14, the country's drug safety administration issued "about revised QuNa manual injection with ammonia, the announcement (no. 14, 2017). Decided to inject with ammonia QuNa manual 【 side effect 】 and 【 notes 】 to revise. (see the appendix of furniture list for detail)
Contrast before and after the modification of specifications, a significant change is the increase in adverse reactions item: intravenous dosing phlebitis can occur or thrombophlebitis, muscle injection can produce local discomfort or lumps, the incidence of about 1.9% and 1.9% respectively.
In addition, the ratio of systemic adverse reactions to clear more accurate; At the same time refining the classification rate is less than 1% of the adverse reaction.
▍ 2005 domestic began to production, the use of more than 10 years, a total of 65 domestic approval number, or known affected
Injection treatment with ammonia QuNa is suitable for sensitive aerobic infections caused by gram-negative bacteria, its effect is characterized by narrow antimicrobial spectrum, the second-line drugs, not a choice. Only if the indications for antibiotics such as cephalosporin, penicillin drugs has not, to consider using ammonia QuNa.
Even so, on the basis of the current antibiotics "abuse", its usage is also very surprising. According to the national food administration of drug safety database query, there are a total of 65 domestic approval number, manufacturer known thering is no lack of in the home. In 1986, ammonia QuNa in the United States food and drug administration (FDA) for registration, in June 2005 domestic corporate approval documents for production for the first time. 10 years of use, influence scope is wide, also called large varieties of antibiotics.
The increase of adverse reactions, it is according to the result of adverse drug reactions assessment and further to ensure the safety of the public administration. But on the other hand, may be the product of consumption is restricted.
▍ require drug firms to replace manual as soon as possible
General requirements, all QuNa injection with ammonia production enterprise shall be in accordance with the relevant provisions of the "drug registration management measures" and so on, in accordance with the requirements for injection with ammonia QuNa manual revision (see attachment), put forward to revise the description of the supplement, on April 15, 2017 provincial food and drug regulatory authorities for the record.
Revised content involves drug label, should be revised; Specification and other contents label shall be consistent with the original approval content. Within 6 months after the supplement for the record for the factory's instructions and labels to be replaced.
Asked to clinical doctors should carefully read the injection by ammonia QuNa manual revision content, when choosing drugs, shall be amended according to the new instruction to fully benefit/risk analysis.
Add: ammonia QuNa manual revision requirements for injection
1, 【 side effect 】 is modified to the following content:
Intravenous dosing phlebitis can occur or thrombophlebitis, muscle injection can produce local discomfort or lumps, the incidence of about 1.9% and 1.9% respectively. About 1% ~ 1% incidence of systemic adverse reactions, including nausea, vomiting, diarrhea and skin rash.
Incidence of less than 1% of the adverse reactions according to the classification system is as follows:
Allergic reaction: anaphylactic shock, angioneurotic oedema, bronchospasm, allergic reaction.
Skin and its accessories: toxic epidermal necrosis loose solution, purpura, erythema multiforme, exfoliative dermatitis, urticaria, and itching.
Respiratory system: cough, asthma, chest tightness, difficulty breathing, chest pain, laryngeal edema.
The digestive system: oral ulcers, tongue numbness, changes in taste, rare thing clostridium diarrhea, abdominal pain, including pseudo membranous enteritis and gastrointestinal bleeding.
Systemic damage: chills, fever, fatigue, discomfort, sweating, facial flush.
Neurological and psychiatric disorders: dizziness, headache, dizziness, insomnia, epilepsy, mental disorder, paresthesia, tremor.
Blood system: thrombocytopenia, leukopenia and neutropenia, anemia.
Cardiovascular system: heart palpitations, hypotension, transient electrocardiogram (ecg) changes (ventricular and PVC).
Liver system: abnormal liver function, AST, ALT elevations, jaundice, hepatitis.
Other: muscle pain, elevated creatinine, tinnitus, diplopia, abnormal vision.
【 notes 】 increase the following content:
1. In patients with damage to liver and kidney function, should observe the dynamic changes during treatment.
2. Combining with ammonia QuNa aminoglycoside antibiotics, especially the aminoglycoside drug use big or treatment period is long, the monitoring of renal function.
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