SCULPTRA (2 bottles of 5 ml) GALDERMA
NEW BOX. SCULPTRA is designed to restore a more youthful look naturally and gradually. SCULPTRA is a unique collagen replenishing treatment that helps to slowly and subtly reduce your lines, wrinkles and folds. Unlike traditional dermal fillers, SCULPTRA works to replace lost collagen and replenish volume in your face more subtly over time, giving you a more natural looking appearance.
Description
SCULPTRA (2 bottles of 5 ml) GALDERMA
MEDICAL USE STRICT.
DESCRIPTION
SCULPTRA Aesthetic is an injectable implant containing microparticles of poly-L-lactic acid (PLLA), carboxymethylcellulose (USP), non-pyrogenic mannitol (USP) and sterile water for injection (USP). SCULPTRA Aesthetic is available in 367.5 mg dose vials and is to be reconstituted prior to use by the addition of 5 mL of Sterile Water for Injection, USP (SWFI) to form a sterile non-pyrogenic suspension.
- Each vial of SCULPTRA Aesthetic is packaged for single-use only.
- The SCULPTRA Aesthetic implant package (i.e., lyophilized vials) is provided sterile.
- SCULPTRA MAY STIMULATE COLLAGEN GROWTH WHICH HELPS TO RESTORE FACIAL VOLUME AND THE LOOK OF FULLNESS TO WRINKLES AND FOLDS OVER TIME.
- Unique collagen stimulator, poly-L-lactic acid PLLA for facial rejuvenation.
- FDA approved injectable that helps gradually replace lost collagen an underlying cause of facial aging for results that can last more than two years.
COMPOSITION FOR EACH VILAS of SCULPTRA
- 150 mg d’acide L-polylactique.
- 90 mg de carboxyméthylcellulose sodique.
- 127,5 mg de mannitol apyrogène.
CAUTION
Federal (USA) law restricts this device to sale by or on the order of a licensed physician or properly licensed practitioner. Information for the use of SCULPTRA Aesthetic is provided in this Labeling for Physicians and the Instructions for Use, as well as in Labeling for Patients. BEFORE USING SCULPTRA Aesthetic PLEASE READ THE FOLLOWING INFORMATION THOROUGHLY.
RESULTS SCULPTRA
- The result gives a more youthful and natural-looking appearance.
- SCULPTRA literally refreshes the way you look by restoring skin’s own natural contours and smoothing out wrinkles, creases and folds.
- Traditional dermal fillers only address wrinkles, line and folds.
- SCULPTRA works differently.
- SCULPTRA replenishes lost volume by stimulating growth of your own natural collagen to treat the underlying causes of facial ageing.
INJECTION AREAS SCULPTRA
SCULPTRA replaces lost collagen in the middle to lower face and chin area. It treats the following areas:
- Upper Face: Sculptra is used to treat temples.
- Middle part: Nasolabial folds.
- Tear through check augmentation: Submalar volumising.
- Lower part of the face: Marionette lines, Pre-jowl sulcus, Mandibular line.
CONTRAINDICATIONS
SCULPTRA Aesthetic should not be used in any person who has hypersensitivity to any of the components of SCULPTRA Aesthetic. SCULPTRA Aesthetic should not be used in patients with known history of or susceptibility to keloid formation or hypertrophic scarring.
DEPTH OF INJECTION
SCULPTRA Aesthetic should be injected into the deep dermis with tunneling (threading) technique. SCULPTRA Aesthetic should be injected into tissue that is medial to the nasolabial fold wrinkle defect. To guide the needle to the deep dermal plane, create a firm needle insertion plane by stretching the skin.