Indication

HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).

Important Safety Information

HYMOVIS® ONE is contraindicated in patients with known hypersensitivity (allergy) to hyaluronate preparations or gram-positive bacterial proteins. Do not administer

HYMOVIS® ONE to patients with infections or skin diseases in the area of the injection site or joint. The safety and effectiveness of HYMOVIS® ONE have not been established in

pregnant women, nursing mothers, or children, or for use in joints other than the knee, or for concomitant use with other intra-articular (IA) injections. The effectiveness of

repeat treatment cycles of HYMOVIS® ONE has not been established. No serious adverse events or pseudoseptic reactions were reported in the HYMOVIS® ONE clinical study.

The adverse events experienced and reported in the HYMOVIS® ONE clinical study were joint swelling, metatarsalgia, neck pain, and headache.

 

Rx Only. See package insert for full prescribing information, including indications, contraindications, adverse events, warnings, precautions, and side effects.

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Hymovis® One

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