Restylane Volyme - Synthetic-fluid tissue reconstructive material, anaesthetic

Intended purpose

Restylane Volyme is intended to augment the volume of facial tissues. It is recommended to be used for the correction of facial volume, for instance cheeks and chin. Depending on the area to be treated and the tissue support, the product should be injected into the supraperiostic zone or subcutis. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.

Functional description

Restylane Volyme is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid in phosphate buffered saline at a concentration 20mg/mL with the addition of lidocaine hydrochloride 3 mg/mL. The gel is supplied in a pre-filled syringe (1mL) and is sterilized using moist heat. The syringe is packaged individually in a blister, with two 27G x1/2” Ultra thin wall needles. The needles have been sterilized using irradiation. The product is for single use only.