Device Dossier
CINGAL® - Cross-linked Hyaluronic Acid with ancillary Triamcinolone Hexacetonide - Synovial fluid supplementation substance
Device Dossier for CINGAL® - Cross-linked Hyaluronic Acid with ancillary Triamcinolone Hexacetonide - Synovial fluid supplementation substance (Synovial…
- GMDN category: Synovial fluid supplementation substance
Intended purpose
Cingal® is indicated as a viscoelastic supplement or a replacement for synovial fluid in the knee. Cingal® is well suited for rapid and long term relief of the symptoms of knee joint dysfunctions such as osteoarthritis. The actions of Cingal® are long term relief of symptoms by lubrication and mechanical support supplemented by short-term pain relief provided by triamcinolone hexacetonide.
Functional description
Cingal® is an off-white, opaque, sterile, single-use suspension of a cross-linked HA gel and an ancillary corticosteroid, TH. Cingal® is biocompatible and non-pyrogenic. The cross-linked HA and TH in Cingal® do not physically or chemically interact, as micronized particles of the TH are suspended in the viscoelastic HA gel and reside in the product as a separate solid phase.