SCULPTRA® 2 Vials
Active Compositions: Poly-L-Lactic Acid (150 mg); Sodium carboxymethyl-cellulose (90 mg); Non-pyrogenic mannitol (127,5 mg).
Volume & Packaging: Two vials
Manufacturer: Sanofi-aventis S.p.A.
Also Included: Package Insert only. It is recommended to use a 26G needle (obtained separately) for injection.
Storage: Store up to 30℃. Upon reconstitution, it can be stored up to 72 hours at refrigeration (2-8℃) or room temperature up to 30℃. Do not freeze.
Remarks: Sterile packaging
WHAT IS SCULPTRA?
Sculptra is an injectable soft tissue filler derived from poly-L-lactic acid (PLLA) and is manufactured by Galderma. This PLLA-based filler is non-toxic, biodegradable, and synthetic, and is intended for the correction and restoration of lipoatrophy, wrinkles, and facial volume. The addition of Sterile Water for Injection reconstitutes the filler base to form a sterile non-pyrogenic suspension. A single pack of this product comes in two glass vials filled with microparticles of poly-L-lactic acid (150 mg), sodium carboxymethylcellulose (90 mg) and mannitol (127.5 mg).
WHAT IS IT USED FOR?
Use Sculptra to help correct fine to deep wrinkles and folds. Skin depressions in lower-half of the face, particularly nasolabial folds (the deep creases from the nose to the mouth) and marionette lines (drooping corners of the mouth) can benefit from Sculptra. As well, use this cosmetic filler to improve volume loss around the jawline, cheeks, temple, and pre-jowl fold due to conditions such as AIDS or HIV.
HOW LONG DOES IT LAST?
The initial result of the treatment give the area a full look due to the water content of the injection. This fullness will reduce within a few days after the procedure, although the full effect may not be evident for a few weeks. You may wish to reassess the results a minimum of four weeks after the initial treatment to determine if a followup procedure is necessary. The results can last up to 2 years after the initial session.
HOW DOES THIS DERMAL FILLER WORK?
The topic of skin health is never complete without discussing collagen. Collagen is a type of structural protein found abundantly in the body. It is an extremely versatile protein, because it provides different grades of mechanical strength to numerous tissues—from bones to the skin. In the skin, collagen is usually concentrated in the dermis layer. It forms the firm structural framework which supports the it, while other components like elastin and hyaluronic acid provide elasticity and hydration to skin.
As the skin ages, skin health diminishes due to intrinsic and extrinsic aging. After the age of 20, collagen production in the skin reduces by 1% each year—which means your patients’ needs will also change over time. External factors will intensify intrinsic aging, also causing a drop in collagen production. As well, the elastin and hyaluronic acid production rate is also affected, and wrinkles and lines start to appear. Some of your clients might even experience fat loss, causing sunken cheeks and temples.
Sculptra aims to fight these aging signs by stimulating collagen production in the skin. The PLLA compound actually invigorates the fibroblasts in the skin, promoting collagen production. Since the filler works deep within the skin, the desirable effects can be delayed. Nevertheless, your patients will see gradual long-term improvements to their problematic areas without an “overdone” look. The face appears fuller and the appearance of wrinkles is decreased.
HOW TO INJECT IT?
Remove the flip-cap from the provided vile, and disinfect the penetrable topper. Take a sterile, single-use syringe and an 18G sterile needle and attach the two together. Draw 5ml of sterile water into the syringe, and slowly deposit it into the dry powder. Leave mixture to sit for a minimum of 2 hours. Do not shake. Prior to injection, agitate the vial until a homogeneous translucid suspension is obtained. Immediately prior to treatment, disinfect the penetrable topper again. Use an 18G–26G needle and draw the required amount into a sterile syringe, ensuring to use a 26G needle for injection. Inject into the deep dermis or subcutaneous layer using a cross-hatch technique. To withdraw the remaining contents, repeat the agitation process and disinfect the topper. After injection, have your client apply ice to the treatment area to reduce swelling and bruising. Apply cream and massage the area to uniformly distribute the product. Advise your patient to periodically massage the area using the three-five rule—five times daily with each session lasting for five minutes for at least five days.
To avoid complications, ensure that this cosmetic filler is administered by a medical professional with adequate training in filler injection techniques.
IS THIS PRODCUT SAFE?
Yes, Sculptra is safe and biodegradable. As it is synthetic, it does not require an allergy test. However, there are some contraindications for certain groups of people, including pregnant or lactating women and anyone with a hypersensitivity to any the Sculptra’s components.
Use of this product on inflamed or infected area (e.g. pimples, cysts, rashes) should be postponed until the skin has healed.
WHAT ARE THE SIDE EFFECTS?
Patients can experience common injection-related side effects. As this filler is commonly used for large volume corrections of lipoatrophy, it is important that your patient follows your aftercare instructions to reduce the duration of side effects.
COMMON INJECTION-RELATED REACTIONS
- Localized Redness
- Transient Bleeding
These side effects generally resolve themselves within 2–6 days after the procedure. Your patient may experience rare side effects.
RARE ADVERSE EFFECTS
- Nodule Formation
- Injection Site Infection
- Skin Sarcoidosis
Advise your patients to obtain emergency care if any of these side effects last for more than two weeks.
WHAT IS IT MADE OF?
Sculptra is made from bioresorbable synthetic PLLA compound that is not derived from animal sources.
Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.
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