[Haemaccel 35: adverse reactions in a multicentric, prospective study]
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Abstract:
Polygeline (haemaccel 35 Behringwerke) was tested in 1147 patients in a prospective and multicentre study facing systemic anaphylactoid or cutaneous anaphylactoid side effects. 8 patients showed mainly cutaneous reactions (redness and itchy swelling) and only one an increase of ventilating pressure during anaesthesia (0.78%). Polygeline showed according to an improved preparation unexpected reactions only of the cutaneous anaphylactoid type (no severe systemic life threatening reaction, histamine liberation 1 ng/ml or less according to Lorenz).
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This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
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