SCULPTRA

SCULPTRA is a solution that:
- It does not swell, but regenerates.
- It acts in a natural way that respects the identity of the face.
- It requires only 2-3 sessions spaced out over time.
- It offers a long-lasting and progressive result, without disruption.

- GALDERMA
- NAME: SCULPTRA
- COMPOSITION: Poly-L-lactic acid 150 mg, Sodium carboxymethyl cellulose 90 mg, Mannitol apyrogen 127.5 mg.
- PRESENTATION: 2 x 5 ml.
- INDICATIONS: Indicated for the correction of depressions of the facial contour, including facial wrinkles and furrows, and for the progressive restoration of volumes lost due to ageing.
- INJECTION DEPTH: Deep dermis or at the level of the periosteum.
- DURATION: Natural and gradual effect in 2-3 months. Results up to 2 years.
- USE: Strict medical use.

- Bottles: 2 x 5 ml.

Cheekbones and temples, hollow cheeks and mid-facial sagging, poorly defined facial contours, deep nasolabial wrinkles and marionette lines.

Poly-L-lactic acid 150 mg, Sodium carboxymethyl cellulose 90 mg, Mannitol apyrogen 127.5 mg.

- Sculptra is intended for a single patient and a single session; the vial must not be reused or re-sterilised and must be disposed of after use.
- The product should only be used by qualified healthcare professionals trained in the approved indication and injection technique.
- To reduce the risk of complications (papules, nodules, vascular or nerve damage), a thorough knowledge of the anatomy of the treatment area is necessary.
- Before treatment, the patient must be informed of the potential risks and signs of possible complications.
- Avoid superficial injections, which may increase the risk of papules and nodules, especially in patients with thin skin.
- The safety and efficacy of Sculptra have not been evaluated for dosages, frequencies, anatomical sites or combinations other than those indicated.
- Sculptra is not indicated for the lips and should not be injected into the vermilion.
- Injections carry a risk of infection: rules of asepsis and antisepsis must be strictly followed.
- Patients with coagulation disorders or on anticoagulant therapy may have an increased risk of haematoma or bleeding at the injection site.
- After treatment, the patient should limit exposure to the sun, UV light and extreme temperatures until swelling and redness have resolved.

SCULPTRA is contraindicated in the following cases:
- Do not use in patients with a history of hypersensitivity to any of the components of the product.
- Do not use reconstituted Sculptra with lidocaine in patients with a history of hypersensitivity to lidocaine or other amide-type local anaesthetics.
- Do not use in patients with severe allergies documented by a history of anaphylaxis or the presence or history of multiple severe allergies.
- Do not use in the presence of active disease, such as inflammation (rashes such as cysts, pimples, rash or hives), infection or tumours in or near the intended treatment area, until the underlying condition has been adequately controlled.

SCULPTRA is indicated for the correction of superficial to deep nasolabial contour depressions and other facial wrinkles, for use in immunocompetent subjects.
It is also indicated for the correction of fine lines and wrinkles in the cheek region, again in immunocompetent subjects.
SCULPTRA is also intended for the restoration and/or correction of signs of facial adipose tissue loss (lipoatrophy) in human immunodeficiency virus (HIV)-infected persons.