Restylane Kysse - Synthetic-fluid tissue reconstructive material, anaesthetic

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Disponible desde:

Galderma Australia Pty Ltd

clase:

Class III

Fabricado por:

Q-Med AB Seminariegatan 21, Uppsala, 75228 Sweden

Área terapéutica:

47887 - Synthetic-fluid tissue reconstructive material, anaesthetic

indicaciones terapéuticas:

Restylane Kysse is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid at a concentration of 20mg/mL in phosphate buffered saline with the addition of lidocaine hydrochloride 3 mg/mL. Gel is supplied in a prefilled syringe volume of 1 mL. Contents of the syringe are sterilized using moist heat. Syringe is packaged individually in a blister, with two 30G x ?" Ultra thin wall needles. The needles have been sterilized using ethylene oxide. Product is single use only Restylane Kysse is intended to restore or augment the volume of the lips. It should be injected into the submucosal layer of the lip. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.

Estado de Autorización:

A

Fecha de autorización:

2015-04-09