Restylane Defyne - Synthetic-fluid tissue reconstructive material, anaesthetic

Intended purpose

Restylane Defyne is intended to augment the volume of facial tissues. It is recommended to be used for correction of severe wrinkles, or to redefine the shape of the lips, cheeks or tear troughs. Depending on the area to be treated and the tissue support, the product should be injected in the mid to deep dermis, submucosal layer of the lips, subcutis or supraperiostic zone. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.

Functional description

Restylane Defyne is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid in phosphate buffered saline at a concentration of 20 mg/mL with the addition of lidocaine hydrochloride 3 mg/mL. The gel is supplied in a prefilled syringe (1mL) and sterilized using moist heat. The syringe is packaged individually in a blister, with two 27G x ½” Ultra thin wall needles. The needles have been sterilized using irradiation. The product is for single use only.