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Product:

SCULPTRA® 2 vials

Manufacturer: Q-Med
Active Substance(s) : Poly-L-lactic acid
Strength: 150mg/ml
Pack Size: 2 vials
Accessories: Package insert, 4 traceability labels
 
 
 
 
You can save $60.00 if you add an additional 5 units to your cart.
Product: SCULPTRA® 1 vial
Manufacturer: Sanofi Aventis
Active Substance(s) : Poly-L-lactic acid
Strength: 150mg/ml
Pack Size: 1 vial
Accessories: Package insert, 2 tracebility labels

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What is Sculptra?

Sculptra is an injectable filler formulated with poly-L-lactic (also known as polylactic acid). It is indicated for the treatment of facial wasting associated with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS). As well, it is effective in treating facial lines and wrinkles. The injectable is supplied as a freeze-dried powder in a sterile glass vial and comes with a product leaflet. Sculptra is developed by the US-based Galderma Laboratories.

What Sculptra is formulated to do

Sculptra is indicated for the treatment of lipodystrophy associated with HIV and AIDS. It is also used to correct the appearance of wrinkles and folds (e.g. nasolabial fold). The filler helps increase the thickness of the skin while enhancing facial volume. As a result, the skin looks younger and healthier. Once injected, the microscopic crystals in the filler stimulates collagen production to increase facial volume. At the same time, the beads also helps to fill folds and wrinkles.

Having undergone extensive safety assessments, Sculptra is generally safer than other injectables. It is also longer-lasting, delivering results that last for up to 2 years. Conventional fillers can only last for several months. The treatment is associated with little or no downtime. Most patients are able to resume their daily activities immediately after treatment.

Manufacturer/Origin

Sculptra is manufactured by Galderma Laboratories, a leading pharmaceutical corporation based in Fort Worth.  Galderma offers a wide range of dermatological products for skin conditions such as rosacea, psoriasis, skin cancer, acne, onychomycosis and steroid-responsive dermatoses. Since its inception in 1961, the company has been enhancing the lives of patients worldwide through its innovative healthcare solutions. Previously known as Owen Laboratories, Galderma Laboratories is now a subsidiary of Galderma S.A.

What else you need to know

Some of the side effects of Sculptra include lumps/nodules, granulomas, redness, tenderness, swelling, itching, bruising, reactivation of herpes infection, neurological symptoms, infection, abscess, reduced visual acuity, drooping eyelid, blindness, pain, hypersensitivity, induration, ischemia, necrosis, transient blurred vision, watery eyes, dry eye and skin discoloration. In addition, the filler may result in injection site reactions such as irritation, facial asymmetry, acne, scarring and burning sensation. The injectable could also cause non-dermatological adverse events such as joint pain, nausea, difficulty breathing, swollen lymph nodes, headache, depression and anxiety.
The filler is available in the form of microcrystals powder mixed with sterile water. Sculptra is FDA-approved.

Suggested usage

  • Sculptra is designed to be administered under the skin (not into the skin). The filler should only be injected by authorized medical practitioners.
  • Using a fine-gauge syringe, administer the filer with multiple small injections in a grid pattern.
  • Massage the treated area for a few minutes to allow even distribution of the suspension. This also prevents nodules/bumps from forming under the skin. 
  • Dilute the injectable with lidocaine as needed. Lidocaine (a local anesthetic) helps reduce pain and discomfort associated with injection. If needed, an ice pack can be used to alleviate redness at the injection site.

Composition

The formulation contains polylactic acid as its main ingredient. Poly-L-lactic acid is sourced from lactic acid, a naturally-occurring compound that is essential to cell metabolism. For more than three decades, it has been used in medical products such as absorbable sutures and dissolvable stitches, or as a medium for drug delivery. Poly-L-lactic acid beads promote the generation of collagen to increase facial volume. At the same time. The beads also fill and smooth wrinkle to restore a youthful appearance.
The filler contains non-pyrogenic mannitol and sodium carboxymethylcellulose as its excipients.

What is in the box?

  • 2 sterile glass vials containing poly-L-lactic acid. Each glass vial comes with an aluminum seal and a penetrable stopper.
  • Product information, which contains essential information such as precautions, contraindications, directions for use and special warnings.

Duration of effect

Sculptra is specially formulated to deliver durable anti-aging results. In general, the results of the filler can last for about 2 years. The effects may not be immediately visible after treatment. It may take a few weeks (or months) before the results become apparent.

Storage conditions

Keep the injectable at a room temperature of less than 86°F (or 30°C). Protect from freezing. Do not refrigerate.

Expiry (shelf life)

  • Check the expiry date before use. Do not use the filler after its expiration date, as the active ingredient may have lost its efficacy.
  • To prolong the shelf life of Sculptra, follow the storage instruction strictly. Failure to comply with the instructions could result in the degradation of active ingredients before the expiry date.

Disclaimer: Raskel Medical offers only genuine products made by their original manufacturer. All brands are trademarks of their respective owners. Raskel Medical is not operated by, supported by, or affiliated with the manufacturer in any way. Product packaging may not be exactly as shown.