Project Description
TrHLINE
Viscoelastic solution of high molecular weight sodium hyaluronate obtained from biofermentation source, highly purified and no inflammatory, transparent, sterile, free of endotoxins solved in an isotonic and physiologic buffer.
SPECIFICATIONS
NaHA polymer solution for viscosupplementation.
| MODELS | TrHLINE 1 % | TrHLINE 2 % | |
|---|---|---|---|
| VISCOSITY (cP)* | 3.000 – 6.000 | 40.000 – 60.000 | |
| STERILIZATION | Moist heat | ||
| EXPIRATION | 2 years | ||
* Viscosity, measured at shear rate (SR) 1s-1 a 25ºC. Measured after sterilization.
Indications
TrHLINE, intraarticular injection as a replacement for synovial fluid, is intended for the treatment of pain in knee osteoarthritis (KOA) in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
- Treatment of 3 intraarticular injections.
Material / Composition
TrHLINE contains only sodium hyaluronate of high molecular weight (1.9- 2.2MDa) obtained by bacterial biofermentation (Streptococcus zooepidermicus) pharma-grade injectable and high purity.
The other excipients are pharmacopoeial quality and water for injection (WFI).
Properties
Due to its rheological and physicochemical properties, TrHLINE gets:
- A lubricant effect in the osteoarthritical joint.
- Protect the chondrocytes.
- Reduce pain and increase mobility of the affected joint.
- It is easily absorbed by the body due to its endogenous nature.
Technical specifications
- Visual appearance: clear liquid without bubbles or particles. Seal integrity.
- pH=7.2-7.6
- Osmolarity = 250-350mOsm/kg
- Endotoxin content <0.5EU/mL
- STERILE
- Biocompatible product
Packaging
TrHLINE is supplied as a Pre-Filled Syringe (PFS) on apyrogenic Type I glass, ready to use.
- Presentation of 2 mL.
TECHNICAL DATE
