RELYNART 1 Pre-filled Syringe 40mg 2ml

Relynart 40 Mg Sodium Hyaluronate for Intra-articular Use

Description
Relynart 40 mg is a biodegradable and isotonic sterile injectable gel for intra-articular use.
It consists of a medium molecular weight hyaluronic acid (1.0-1.5x10 ⁶ Dalton), produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer.
Thanks to its viscoelastic properties, it promotes the normalization of the viscosity of the synovial fluid present in the intra-articular cavity and the restoration of the rheological conditions of the joints, altered in case of degenerative or post-traumatic conditions.
The product exerts a protective action on the joints and improves joint functionality, as well as reducing painful symptoms. It acts only at the level of the joint where it is injected, without exerting any systemic action.

Relynart 40 mg is a medical device in the category of healthcare products.

Composition
Sodium hyaluronate (20 mg/ml), sodium chloride, monobasic sodium phosphate dibydrate, dibasic sodium phosphate dodecahydrate, water for injection.

Instructions for use
Remove any joint effusion before injecting Relynart 40 mg; the same needle must be used for removal of the effusion and injection.
Remove the protective cap from the syringe with particular care to avoid contact with the opening.
Firmly screw the needle (with a diameter between 18 and 22 G) onto the luer lock closure following the instructions. Before the injection, treat the site with an appropriate disinfectant. Inject Relynart 40 mg using aseptic technique. Inject only into the joint cavity.
It is recommended to carry out an initial cycle of three treatment sessions, at intervals of one week apart, followed possibly by maintenance sessions according to the doctor's prescription.

Instructions for assembling the needle onto the syringe:
- carefully unscrew the cap from the tip of the syringe, taking particular care to avoid contact with the opening;
- gently grasp the needle protector and mount the needle onto the luer-lock connector, screwing tightly until a slight counter-pressure is felt to ensure a tight seal and prevent the gel from leaking during administration.

Warnings
Relynart 40 mg is indicated only for intra-articular injections and must be dispensed only by a physician who has received specific training in intra-articular injection technique.
Infiltration should be avoided in case of active infections or inflammatory conditions of the skin near the site of infiltration.
It is recommended, after the intra-articular injection, to avoid strenuous physical activities for the joint and to resume normal activities after a couple of days.

Keep out of reach of children.
Treatment is not recommended in children.

Storage
Store at a temperature between 2-25°C in a dry place in the original box. Protect from light, heat, and frost.

Format
Package containing one pre-filled syringe of 40 mg of 2 ml of apyrogenic gel, sterilized with moist heat.