Hyalgan

Hyalgan Adverse Reactions

sodium hyaluronate

Manufacturer:

Fidia

Distributor:

Pharmaforte
Full Prescribing Info
Adverse Reactions
Pain, swelling, heat and redness may occur sporadically at the injection site. Such symptoms are transient and usually disappear spontaneously within a few days (usually 1-4). If they should occur, rest the affected joint and apply ice locally.
Isolated cases of an anaphylactic-like reaction have been reported. There were only two cases in approximately 950,000 treated patients (approximately 4,750,000 injections) in post-marketing experience and they had favourable outcomes. No case of anaphylactic-like reactions have been reported during clinical trials.
There is the potential for rare allergic reactions, both local and systemic, to occur. The incidence of this (3 out of 5,376 patients treated with Hyalgan during clinical trials and 3 out of 950,000 patients treated during post-marketing experience), could be attributable to avian proteins, which although present in minimal amounts in Hyalgan, may induce reactivity in patients with a history of avian allergy.
In a 495-patient US multicentre placebo- and naproxen-controlled clinical study, the following adverse events occurred with a frequency greater than 5% in the Hyalgan group (versus placebo); headache 18% (17%), rash 7% (9%), ecchymosis 7% (6%) and pruritus 7% (4%). As these events occurred with equal frequency in the placebo group, there is no proven causality in respect of Hyalgan.
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