Summary of safety profile The possible undesirable effects due to the use of Ampres are generally similar to the undesirable effects of other local anaesthetics for spinal anaesthesia from the ester group. g. g. g. g. post-spinal headache).
Tabulated summary of adverse reactions The adverse reactions listed below in Table 1 are classified according to System Organ Class. The frequency of undesirable effects listed below is defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Table 1 – Adverse reactions Very common Common Uncommon Rare Very Rare Immune system disorders allergic reactions as a result of sensitivity to the local anaesthetic: characterized by signs such as urticaria, pruritus, erythema, angioneurotic oedema with possible airway obstruction (including laryngeal oedema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid type symptomatology (including severe hypotension) Injury, Poisoning and Procedural Complications anaesthetic complication.
Nervous system disorders anxiety, restlessness, paraesthesia, dizziness signs and symptoms of CNS toxicity (backache, headache, tremors possibly proceeding to convulsions, convulsions, circumoral paraesthesia, feeling of numbness affecting the tongue, hearing problems, visual problems, blurred vision, shaking, tinnitus, speech problems, loss of consciousness).
neuropathy, drowsiness merging into unconsciousness and respiratory arrest, spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function, arachnoiditis, persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months), cauda equina syndrome and permanent neurological injury.
Eye disorders diplopia Cardiac disorders arrhythmia, depression of the myocardium, cardiac arrest (the risk is increased by high doses or unintended intravascular injection). Vascular disorders hypotension bradycardia, hypertension, hypotension raised by high doses.
Respiratory, thoracic and mediastinal disorders respiratory depression Gastrointestinal disorders nausea vomiting Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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