SCULPTRA (2 flacons de 5 ml) GALDERMA

SCULPTRA (2 flacons de 5 ml) GALDERMA

NEW BOX.MEDICAL USE STRICT. SCULPTRA Aesthetic (injectable poly-L-lactic acid). Each vial of SCULPTRA Aesthetic is packaged for single-use only. The SCULPTRA Aesthetic implant package (i.e., lyophilized vials) is provided sterile.

DESCRIPTION

SCULPTRA MAY STIMULATE COLLAGEN GROWTH WHICH HELPS TO RESTORE FACIAL VOLUME AND THE LOOK OF FULLNESS TO WRINKLES AND FOLDS OVER TIME. SCULPTRA is a unique collagen stimulator, poly-L-lactic acid (PLLA, Sculptra®, Sinclair Pharmaceuticals) for facial rejuvenation. SCULPTRA is an FDA approved injectable that helps gradually replace lost collagen an underlying cause of facial aging for results that can last more than two years. SCULPTRA is a biocompatible and biodegradable injectable material known as poly-L-lactic acid that naturally stimulates your cells to produce their own collagen.
SCULPTRA is a volumiser designed to stimulate collagen. Your natural beauty in total discretion.

COMPOSITION FOR EACH VILAS of SCULPTRA

• 150 mg d’acide L-polylactique.
• 90 mg de carboxyméthylcellulose sodique.
• 127,5 mg de mannitol apyrogène.

HOW SUPPLIED

SCULPTRA Aesthetic is supplied as a sterile freeze-dried preparation for injection in a clear glass vial, which is sealed by a penetrable stopper, covered by an aluminum seal with a flip-off cap. Each carton of SCULPTRA Aesthetic contains two vials of poly-L-lactic acid, sodium carboxymethylcellulose (USP), non-pyrogenic mannitol (USP).

DEVICE 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.

INTENDED USE / INDICATIONS

SCULPTRA Aesthetic is indicated for use in immune-competent people as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.

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.

ACTIONS

• SCULPTRA is a facial injectable that works gradually in a series of treatments.
• SCULPTRA works differently.
• SCULPTRA replenishes lost volume by stimulating growth of your own natural collagen to treat the underlying causes of facial ageing.

USE SCULPTRA

An average of 3 injection sessions with an interval of 4 to 6 weeks between each session work to produce a refined, more youthful-looking appearance.

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.

INJECTION NEEDLE

SCULPTRA Aesthetic should be injected using a sterile 26 G needle. SCULPTRA Aesthetic should not be injected with needles with a diameter smaller than 26 G or needles that have been bent. To maintain a uniform suspension throughout the procedure, intermittently agitate SCULPTRA Aesthetic in the syringe. Before initial injection, expel a few drops of SCULPTRA Aesthetic through the attached 26 G needle to eliminate air and to check for needle blockage. If the needle becomes occluded or dull during an injection session needle replacement is necessary. If clogging occurs, remove the needle, expel a small amount of product, attach a new sterile 26g needle, then expel a few drops of SCULPTRA Aesthetic to eliminate the air and re-check for needle blockage.

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.

BEFORE TREATMENT

With SCULPTRA Aesthetic, a patient should be provided patient labeling and completely informed by the treating physician of the intended use, indications for use, as well as the contraindications, warnings and precautions for use, expected correction, and possible side effects and mode of administration of SCULPTRA Aesthetic. Each patient should be informed that the amount of SCULPTRA Aesthetic and the number of injection sessions will depend on the patient's need.

INSTRUCTIONS FOR USE

SCULPTRA Aesthetic has only been evaluated in immune-competent people as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate. SCULPTRA Aesthetic use should be limited to use in a single regimen of up to four sessions with three week interval using the threading or tunneling technique in grid pattern (see Figures 3- 7) to inject a maximum of 2.5 mL of SCULPTRA Aesthetic per site into the deep dermis medial to the nasolabial fold contour deficiency.