Hyastat 1% syringe 2 ml

A sterile prosthetic synovial fluid for intra-articular administration.

The mechanism of action:

Hyaluronic acid (HA, hyaluronate)-a natural, highly polymeric glycosaminoglycan composed of alternating components N-acetyl-glucosamine and glucuronic acid, which in normal tissues combine into long chains with molecular weights up to 10×10 Dalton. HA is synthesized in the cell membrane of synoviocytes and plays an essential role in joint function. The unique viscoelastic characteristics of synovial fluid directly depend on the molecular weight and degree of polymerization of HA:

• as a highly viscous fluid, it allows articular cartilage surfaces to slide without friction;
• with its elastic properties, it cushions and dampens sudden changes in intra-articular pressure caused by stress or impact. This factor is of particular importance for joints under prolonged stress.

These properties of the intra-articular fluid are normally due to the specific spatial organization of HA molecules with extremely long chains: in solutions they are organized as a disordered bulk grid, while under the action of shear forces they take a linear position.

The surface layer of cartilage is subject to continuous wear and always needs to be renewed. For this reason the maintenance of joint homeostasis is of paramount importance. Especially in terms of maintaining the level of synthesis of long HA chains by synoviocytes, as well as maintaining a constant concentration of HA in the intra-articular fluid and the barrier layer of the cartilage surface.

In osteoarthritis, the viscoelasticity of synovial fluid is dramatically reduced compared to a healthy joint, due to an increase in the relative number of low molecular weight molecules and a change in HA concentration.

This causes the protective (both lubricating and cushioning as well as molecular filtering) properties of synovial fluid to decrease significantly.

The protective effect of HA in various clinical forms of arthritis has been documented in many studies – at the coarse and fine tissue level, in studies of biochemical markers of cartilage breakdown and metabolism as well as at the functional level.

Hence, the introduction of exogenous HA into the intra-articular cavity can improve the viscoelastic properties of synovial fluid and enhance its protective characteristics.

Indications

GIASTAT™ is used in primary and secondary arthritis of joints, including those of traumatic genesis, for local restoration of synovial homeostasis, in order to achieve long-term clinical remission, relief of pain, restoration of mobility, reduction of functional impairment.

Active ingredient

Composition

Transparent opalescent 1% HA polymer hydrogel (as sodium salt), sterile in 2ml/20mg glass vials/syringes.

1 vial/syringe with a capacity of 2 ml. Contains;

The main substance GC: 20 mg.

Supplements:

Sodium chloride,

Phosphate buffer,

water.

How to take, the dosage

GIASTAT™ is administered inside the joint cavity. The maximum injection dose is 2ml/20mg per joint.

Injections can be made into several joints at the same time. The course of treatment includes 3 to 5 joint injections, 7 to 10 days apart.

The efficacy of GC with a course of less than three injections has not been reliably established.

Interaction

Incompatibility of GIASTAT™ with other solutions injected into the joint cavity has not been detected to date.

Special Instructions

Categorically forbidden:

Inject GIASTAT™ into the joint capsule, blood vessels, or misuse;

Change the viscosity of HIASTAT™ by diluting it or administering it in the same syringe with other substances;

Use GIASTAT™ with damaged original primary packaging;

Subject GIASTAT™ to re-sterilization or use with an expired shelf life.

Contraindications

Do not use GIASTAT™ if you are hypersensitive to one of its components;

Side effects

In some rare cases a number of transient local phenomena such as local soreness, swelling, redness may occur in the punctured joint within 24 hours after the GIASTAT™ injection procedure.

These manifestations are controlled by local cold therapy, nonsteroidal anti-inflammatory drugs and analgesics.

Rarely, synovitis is possible, and the injection is stopped until it is stopped.

Similarities