(b)(4).The case comes from eudravigilance (country: (b)(6)).The patient, after the use of the product hyalgan, had: pain localised and vasovagal reaction characterized by nausea, dizziness and malaise.The case has been deemed as serious by the reporter due to a medical important event.The case has been deemed as serious/expected for pain localised and serious/ unexpected for vasovagal reaction and nausea, dizziness and malaise.The causality relationship has been evaluated as probable by the company for pain localised and remote for vasovagal reaction and related symptoms as vasovagal reaction could be occurred not for the product hyalgan but due to a reaction to the acute localised pain and, e.G., strong emotions, fear and excessive fright and perception of particularly annoying or irritating sensations.No new signal alert has been detected.No additional information is required to perform this medical evaluation from the pv physician.This case comes from the country (b)(6) in which hyalgan is classified a drug.
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This is a spontaneous report (initial and follow-up) by a pharmacist, downloaded by fidia from eudravigilance on 07-feb-2019 (authority number: (b)(4)).It is a medically confirmed case.A (b)(6)-year-old female patient was treated with hyalgan 20mg/2 ml solution for injection (sodio ialuronato), by intra-articular route, at the dose of 1 dosage form in total, on (b)(6) 2019, for gonarthrosis.On (b)(6) 2019, the patient experienced pain localized, nausea, dizziness, vasovagal reaction and malaise.The events were reported as serious due to medically important condition.At the time of the reporting, the events were resolving.Reaction as described by the primary source: vasovagal reaction after knee infiltration with hyalgan: nausea, dizziness, malaise, and local severe pain.Concomitant medications: dicloreum 50 mg gastro-resistant tablet (diclofenac sodium), at an unknown dose, for aching joints, torvast 20 mg chewable tablet (atorvastatin calcium), at an unknown dose, for dyslipidaemia, peptazol 20 mg gastro-resistant tablet (lansoprazole), at an unknown dose, for gastrooesophageal reflux, bivis 40 mg/5 mg film-coated tablet (olmesartan medoxomil/amlodipine besilate), at an unknown dose, for hypertension.
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