Description
Stylage XL Lidocaine is indicated for the restoration of facial volumes for the purpose of restoring or augmenting them (e.g., cheekbones, facial oval, treatment of mild ptosis, etc.) by injections into the deep dermis or subcutaneously; and as a filler for deep facial wrinkles and thick skin. It is also indicated for the treatment of facial lipodystrophies, including in HIV-infected patients, and/or for hand rejuvenation by subcutaneous injection into the backs of the hands.
With aging in addition to wrinkles comes a loss of volume that makes facial aging caused by gravity, redistribution and loss of subcutaneous fat, chronic sun exposure, bone remodeling, hormonal imbalance smoking, and more, very evident.
Description Stylage XL Lidocaine:
Stylage XL Lidocaine is an injectable implant consisting of 2 Syringes Prefilled Vials 26 mg/g – 2 x 1 ml of:
Cross-linked Hyaluronic Acid with BDDE (butanediol diglycidyl ether) 26 mg
With lidocaine hydrochloride 3 mg
Injectable Hyaluronic Acid conforming to the European Pharmacopoeia, obtained by biofermentation
Interpenetrating agent: BDDE (butanediol diglycidyl ether) < 2 ppm
Phosphate buffer (pH 7.2) q.s. 1g
IPN-Like technology With natural antioxidant: mannitol
Isosmolarity 300-350 mOsm
Apirogen (no endotoxins) < 0.3 EU/g
Sterile SAL 10 -6 (Sterility Assurance Level)
Borosilicate glass syringe, Class I, conforming to the European and American Pharmacopoeia (Eur. Ph. <3.2.1>; USP 661) or syringe made of cycloolefin copolymer, conforming to the European and American Pharmacopoeia (Eur. Ph. <3.2.9>; USP 381), latex-free.
Stylage XL Lidocaine Format:
– 2 syringes (2 x 1 ml)
– needles:1 x 27G ½ and 1 23G 1¼ per syringe
Stylage XL Lidocaine Storage:
2- 25°C for 30 months
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