Each vial of dry powder contains: 150 mg of poly-L-lactic acid.
SCULPTRA is a poly-L-lactic acid implant in the form of a sterile non-pyrogenic suspension, which is reconstituted from a sterile dry powder by the addition of sterile water for injections (Ph.Eur.). This suspension contains microparticles of poly-L-lactic acid, the crystalline form of polylactic acid. Poly-L-lactic acid is a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family.
Excipients/Inactive Ingredients: Each vial of dry powder contains: 90 mg of sodium carboxymethylcellulose; 127.5 mg of non-pyrogenic mannitol.
Mode of Action: SCULPTRA is injected into the deep dermis or subcutaneous layer with a 26 G needle. The tight granulometric distribution of the microparticles of poly-L-lactic acid, its slow degradation kinetics, and a viscosity which is suitable for both deep intradermal or subcutaneous injections, gives SCULPTRA its mechanical properties and prolonged resorbability, which make this implant suitable for filling areas of depressed skin.
SCULPTRA is suitable for increasing the volume of depressed areas, particularly to correct skin depressions, such as in skin creases, wrinkles, folds, scars, and for skin aging.
SCULPTRA is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy).
SCULPTRA powder is reconstituted with 5 ml of sterile water for injections to form a sterile non-pyrogenic suspension.
Injection technique: The depth of injection and quantity of SCULPTRA used depend on the area to be treated and the result expected. Over-corrections should be avoided, but if they occur, the area concerned should be thoroughly massaged to ensure proper distribution of the product.
Do not use in the case of acute or chronic skin disease (infection or inflammation) in or near the area to be treated. SCULPTRA should not be used by any person who has an allergy to any of the constituents of the product.
SCULPTRA should only be used in the deep dermis or subcutaneous layer.
Avoid superficial injections in order to avoid the appearance of early papules or nodules at the injection site, which could be suggestive of improper injection techniques (superficial placement, excessive amount of product, incorrect reconstitution). In addition, massaging the treatment area to ensure proper distribution of the product may also minimize the appearance of papules or nodules.
SCULPTRA vials are for single patient and single session use only in order to avoid contamination. Do not re-use the vial or do not re-sterilize the vial. Discard immediately after use. Do not use if package or vial is opened or damaged.
Caution must be taken to avoid injection into the blood vessels. An introduction into the vasculature may occlude the vessels and could cause skin infarction or embolism.
Do not overcorrect (overfill) a contour deficiency because the depression should gradually improve within several weeks as the treatment effect of SCULPTRA occurs.
Do not inject into the red area of the lip (vermillion).
Always mix the powder with sterile water for injections (Ph.Eur.).
For injection of SCULPTRA, use the 26 G needles with single-use sterile syringes.
The following precautions should be observed: SCULPTRA should only be used by health care providers with expertise in the correction of volume defects after fully familiarizing themselves with the product, the product educational materials and its complete instruction leaflet.
The injection site should be cleaned with an antiseptic and free from inflammation or infection.
As with all injections, patients treated with anti-coagulants may run the risk of a haematoma or localized bleeding at the injection site.
No studies of interactions of SCULPTRA with drugs or other substances or implants have been made.
Caution must be taken when injecting SCULPTRA in areas of thin skin, such as the periorbital area. An increased risk of papules and nodules in the periorbital area has been reported (see Side Effects). Refer to the product educational materials for instructions regarding injection techniques.
The safety of using SCULPTRA in patients with susceptibility to keloid formation and hypertrophic scarring has not been established. SCULPTRA should not be used in patients with known history of or susceptibility to keloid formation or hypertrophic scarring.
If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with SCULPTRA, there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if SCULPTRA is administered before the skin has healed completely after such a procedure.
The patient should be informed that he or she should minimize exposure of the treatment area to sun and avoid UV lamp exposure until any initial swelling and redness has resolved.
Use in Pregnancy/Lactation/Children: The safety of SCULPTRA for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
The safety of SCULPTRA for use during pregnancy or in breastfeeding females has not been established.
The side effects usually resulting from the injections are transient bleeding from an area the size of the point of the needle or transient pain, localised redness at the injection site, ecchymosis, hematoma, or even slight oedema, which generally resolve within 2-6 days.
Based on data obtained through post-marketing surveillance and clinical studies, nodules have also been reported. Subcutaneous papules, invisible but palpable, or visible nodules including periorbital nodules, or areas of induration have been noted in the injection area and may be due to over-correction. Nodules are occasionally associated with inflammation or discoloration.
The early occurrence of subcutaneous nodules at the injection site (within 3 to 6 weeks after treatment) may be minimized by adhering to proper dilution and injection techniques (see Warnings).
Delayed occurrences of subcutaneous nodules at the injection site (within 1 to 14 months post injection) have been reported with sometimes a prolonged duration of up to 2 years.
For nodular areas or late granuloma formation, in some cases, they resolved spontaneously or following treatment with multiple intralesional injections of corticosteroids or other such agents. Surgical excision of the nodules was sometimes required when they were larger in size, occurring in difficult anatomical regions (e.g. lower eyelid) or persisting after other treatments.
Other rarely reported adverse events include injection site abscess, injection site infection including cellulitis (facial), staphylococcal infection, late granuloma formation, allergic reaction, injection site urticaria, skin hypertrophy and injection site atrophy, angioedema, telangiectasis, skin sarcoidosis, scarring, skin discoloration.
D11AX - Other dermatologicals ; Used in the treatment of dermatological diseases.
Powd for inj (vial) 150 mg x 1's.