Description

SYNVISC (CANADIAN PACKAGING-ENGLISH) (HYLAN)

Designed to treat osteoarthritis knee joint pain by restoring the combined elasticity and viscosity within the joint.

Hylane G-F 20 is available in two forms:

Synvisc, 2 ml: 2.25 ml glass syringe (cans of 1 [ACL 3401078489921] and 3 [ACL 3401076479283]).

Synvisc-One, 6 ml: 10 ml glass syringe (ACL 3401048640222).

Hylan G-F is a sterile, pyrogen-free, viscoelastic liquid containing the hylan A and hylan B polymers produced from a highly purified bird extract. Hylans are derivatives of hyaluronan (sodium hyaluronate), and they are composed of recurrent disaccharide units of N-acetylglucosamine and sodium glucuronate.

Hylan A has an average molecular weight of 6,000,000 daltons and hylan B is a hydrated gel. Hylan G-F contains hylan A and hylan B (8.0 mg ± 2.0 mg / ml) in a physiological saline solution of buffered sodium chloride (pH 7.2 ± 0.3).

Composition:
For 1 ml (Hylan G-F 20): hylan 8.0 mg, sodium chloride 8.5 mg, disodium phosphate 0.16 mg, sodium dihydrogen phosphate 0.04 mg, water for injections qs.

Synvisc contains 2 ml of Hylan G-F 20. Synvisc-One contains 6 ml of Hylan G-F 20.

properties:
Hylan G-F is biologically similar to hyaluronan. Hyaluronan is a component of the synovial fluid that gives it its viscoelasticity. The mechanical (viscoelastic) properties of Hylane G-F, however, are superior to those of synovial fluid and hyaluronan solutions of similar concentrations. Hylane GF 20 has an elasticity (storage coefficient G ‘) at 2.5 Hz of 111 ± 13 pascals (Pa) and a viscosity (loss coefficient G’ ‘) of 25 ± 2 Pa. The elasticity and the viscosity of the synovial fluid of the knee of subjects aged 18 to 27 years measured with a method comparable to 2.5 Hz are G ‘= 117 ± 13 Pa; G ” = 45 ± 8 Pa. Hylans are metabolized in the body by the same route as hyaluronan and the products of their degradation are not toxic.

Instructions for use, Dosage:
Prior to injection, inform the patient that Synvisc and Synvisc-One consist of highly purified hyaluronic acid from an avian source.

Synvisc should only be administered intra-articularly and by a physician to relieve pain associated with osteoarthritis of the knee, hip, ankle and shoulder.

Synvisc-One should only be administered intra-articularly and by a physician to relieve the pain associated with osteoarthritis of the knee.

Aspirate synovial fluid or any effusion before each injection of Hylan G-F 20.

Inject Synvisc at room temperature.

To remove the syringe from the blister (or platen), grasp it by the body without touching the plunger rod.

Inject Synvisc by applying strict aseptic methods and paying particular attention to removing the cap at the tip of the syringe.

Unscrew the gray cap at the end of the syringe before removing it to minimize product leakage.

Use a needle of the appropriate diameter:

Synvisc: 18 to 22 gauges;

Use a needle of adequate length, depending on the joint to be treated.

Synvisc-One: 18 to 20 gauges.

To ensure a tight connection and prevent leakage during administration, securely attach the needle to the Luer type clamp on the syringe.

Do not squeeze or exert excessive pressure to fix the needle or remove its sheath as this may break the tip of the syringe.

Inject only in the synovial space, performing the operation, if necessary, under fluoroscopic guidance, especially in the case of treatment of the hip and shoulder joints.

The contents of the syringe are for single use only. As recommended by the dosage, inject the entire volume of the syringe (2 ml for Synvisc and 6 ml for Synvisc-One). Discard any unused Synvisc / Synvisc-One product remaining.

Storage conditions:
The contents of each syringe are sterile and not pyrogenic. Store between + 2 ° C and + 30 ° C. Do not freeze.