Sculptra 2x5ml

• Poly-L-lactic acid (PLLA): 150 mg per vial. A synthetic, biocompatible and resorbable polymer.
• Sodium carboxymethylcellulose: 90 mg per vial (suspending agent).
• Non-pyrogenic mannitol: 127.5 mg per vial (bulking agent for lyophilisation).
• Mechanism: Sculptra is not a hyaluronic acid filler and does not in itself provide immediate volume. The PLLA microparticles induce a controlled tissue response that stimulates collagen neosynthesis; the result is progressive and builds up over several weeks after each session. The PLLA is resorbed; the visible effect corresponds to the newly formed collagen.
• Clinical consequence: the product is dosed by sessions, not by immediate correction. Overcorrecting in the first session is the most frequent error, because the effect is not yet visible at that moment.

Sculptra is supplied as a lyophilised powder and must be reconstituted before use.

• Diluent: 5 to 8 ml of sterile water for injection per vial.
• Optional anaesthetic: 1 ml of 2 % lidocaine may be added, giving a final volume of 6 to 9 ml per vial.
• Reconstitution needle: 18G. The 18G needle is used solely to reconstitute and to draw up, never to inject.
• Standing time: according to the current instructions for use, the reconstituted product may be used immediately or stored for up to 72 hours before injection.
• Storage of the reconstituted product: up to 72 hours, refrigerated (2–8 °C) or at room temperature (maximum 30 °C).
• Before drawing up: shake the vial to obtain a homogeneous suspension. The homogeneity of the suspension directly determines the risk of needle blockage and of irregular deposition.

Augmentation of facial volume in depressed areas, folds and wrinkles, and correction of facial fat loss (lipoatrophy).

• Malar region and midface
• Temporal region
• Nasolabial sulcus and preauricular area
• Jawline
• Facial lipoatrophy

Do not inject into the lips or into the periorbital region.

• Injection plane: deep dermis, subcutaneous tissue or supraperiosteal plane, according to the area.
• Injection needle: 25G or 26G.
• Technique: linear or fanning retrograde injection, depositing in continuous movement. Avoid a static bolus and superficial placement.
• First session: a limited correction must be performed. The result is not immediate and overcorrecting in the first session produces excess volume weeks later.
• Reassessment: not earlier than 4 weeks after the session. Only then is it decided whether a further session is appropriate.
• Number of sessions: several sessions are usually required, with a minimum interval of 4 weeks between them. The total number depends on the degree of correction achieved at each reassessment.
• After treatment: massage of the treated area according to the schedule indicated by the manufacturer, in order to favour homogeneous distribution of the product.

• Unopened vials: store at controlled room temperature, between 15 and 30 °C, protected from heat. Do not freeze. They do not require refrigeration.
• Reconstituted product: up to 72 hours, refrigerated (2–8 °C) or at room temperature (maximum 30 °C).
• Do not use after the expiry date stated on the pack.
• Single-use product. Do not reuse or re-sterilise.
• The pack contains: 2 single-use glass vials with 150 mg of lyophilised PLLA each and instructions for use. Sterile water for injection, lidocaine and needles are not included.

Contraindications (Galderma instructions for use): known hypersensitivity to any of the components; presence of active inflammation or infection in the area to be treated; history of severe allergies or of anaphylactic reaction.

Caution and individual assessment: history of hypertrophic or keloid scarring; coagulation disorders or anticoagulant or antiplatelet therapy; autoimmune disease; presence of permanent implants in the area.

Warnings: avoid superficial placement of the product, which is associated with the formation of subcutaneous nodules and papules. Do not inject intravascularly: intravascular injection may cause vascular occlusion, skin necrosis and serious complications, including visual disturbances or stroke. Do not inject into the lips or into the periorbital region.

Always consult the instructions for use included in the pack before treatment.