Примери за използване на Neurological adverse на Английски и техните преводи на Български
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NEUROLOGICAL ADVERSE REACTIONS.
However, the risk of serious neurological adverse reactions is increased.
Lower catheter tip placement, e.g. at the lumbar level,may reduce the incidence of ziconotide-related neurological adverse reactions.
Some neurological adverse events can occur.
Ipilimumab is associated with serious immune-related neurological adverse reactions.
Serious cardiovascular and neurological adverse events under normal conditions of use.
Therefore, infants≤ 4 months of age should be monitored for signs of neurological adverse reactions.
Serious cardiovascular and neurological adverse events in elderly patients and patients with renal impairment.
In an exploratory analysis, increasing age, especially aged 65 years and older,appeared to be associated with increased rates of neurological adverse events.
Metoclopramide has long been associated with a risk of serious neurological adverse reactions such as acute extrapyramidal symptoms and irreversible tardive dyskinesia.
Restriction of the treatment duration to 3 months in combination with monthly examination in an effort to limit the psychiatric and neurological adverse events.
The Committee considered that the risk of serious neurological adverse events can be minimised by using lower doses of metoclopramide and limiting treatment duration.
Metoclopramide crosses the blood-brain barrier and is associated to extrapyramidal disorders andother serious neurological adverse events, which are of particular concern in children.
Therefore, in order to minimise the risk of serious neurological adverse reactions such as acute extrapyramidal symptoms and irreversible tardive dyskinesia, the dose should be restricted to the minimum effective dose, which for adults is considered to be 10 mg three times daily.
However the safety data seems to indicate that methaemoglobinaemia occurs almost exclusively in children, andthat children are also at higher risk of serious neurological adverse reactions.
Ziconotide may cause confusion,somnolence and other neurological adverse reactions, therefore patients must be advised not to drive or operate machines if affected.
The EudraVigilance review identified 74 cases of adverse events associated with buflomedil,with a total of 35 cases recording cardiac adverse and 39 cases recording neurological adverse events.
The Committee considered that a number of serious cardiac and neurological adverse events have been reported with the use of buflomedil under normal conditions of use, particularly in elderly patients.
For therapeutic indications such as delayed CINV, prevention of RINV, prevention of PONV and symptomatic treatment of nausea and vomiting including migraine induced nausea and vomiting, data is indicative of efficacy at low doses(10mg, three times daily)which minimise the risk of serious neurological adverse reactions.
The Committee considered that metoclopramide is associated with a risk of serious adverse events,including neurological adverse events such as extrapyramidal symptoms and irreversible tardive dyskinesia.
In conclusion, taking into account the serious cardiac and neurological adverse events associated with the use of buflomedil-containing medicinal products under normal conditions of use, the evidence of limited clinical efficacy which is insufficient to compensate for the risks associated with the use of buflomedil and the established concerns regarding the effectiveness of the risk minimisation measures, the CHMP considered that the risk-benefit balance of buflomedil-containing medicinal products is not positive under normal conditions of use.
However, the CHMP considered that the risk minimisation measures proposed by the MAH are unlikely to reduce the serious cardiac and neurological adverse events associated with the use of buflomedil to a clinically acceptable level.
The Committee therefore concluded, in view of the available data,that the risks of serious cardiac and neurological adverse events associated with the use of buflomedil-containing medicinal products in the symptomatic treatment of chronic peripheral vascular disease, under normal conditions of use, outweigh the limited benefits.
Regarding risk minimisation measures, the CHMP noted the MAH proposals butconsidered that these are unlikely to be sufficient to prevent the occurrence of serious cardiac and neurological adverse events under normal conditions of use nor reduce the well identified risks of accidental overdoses and non-compliance with renal function monitoring associated with the use of buflomedil to an acceptable level.
The CHMP also considered a review of the individual case safety reports(ICSR)database conducted by the MAH, to identify cases of cardiological or neurological adverse events under normal conditions of use, i.e. cases where the dose did not exceed the maximum daily dose of 600mg, cases with accidental overdoses or cases including patients with known renal impairment requiring dose adjustment.
No neuropathology or adverse neurological effects were observed.
There were 6 cases of cardiovascular and 6 cases of neurological serious adverse events.
This product contains amitraz,which can lead to adverse neurological effects in humans and especially in children.
Lidocaine toxicity(neurological and cardiac adverse events) has been reported following co-administration with propranolol.
Although no adverse neurological effects have yet been demonstrated to be caused by gadolinium accumulation in the brain, long-term safety data are limited.