Sculptra Caution For Usage

Treatment procedure: Refer to the product educational materials for instructions regarding injection techniques.
Reconstitution instructions: Sculptra is reconstituted extemporaneously in the following way: 1. Remove the flip-off cap from the vial and clean the penetrable stopper of the vial with an antiseptic.
Note that the following steps 2-5 should be performed, irrespective of the final desired reconstitution volume. This, to ascertain air pressure relief in the vial and to allow for sufficient head-space when shaking the vial to dissolve the content.
2. Attach an 18G sterile needle to a sterile single-use 5 ml syringe.
3. Draw 5 ml of sterile water for injection into the 5 ml syringe.
4. Introduce the 18G sterile needle into the stopper of the vial, find the open slit in the stopper and slowly add all sterile water for injection into the vial letting the water flow on to the inner wall of the vial. Remove the syringe and needle.
5. Shake the vial vigorously by hand or by single vial swirling agitator for about 1 minute to dissolve the excipients. Inspect the vial for any remaining lumps, and if needed shake more. A translucent suspension with some foam on the top will be obtained.
6. If desired, add up to 3 ml of additional sterile water for injection using the syringe and a new 18G needle. Remove the syringe and needle. Shake again in order to get a homogenous suspension.
Following reconstitution, Sculptra can be used immediately or may be stored for up to 72 hours prior to injection. Refrigeration is not required.
7. Product should be gently agitated immediately prior to use. Agitate the vial until a homogenous translucent suspension is obtained. A single vial swirling agitator may be used. As it is a single use vial, discard any material remaining after use or after 72 hours following reconstitution (see Storage).
8. Clean the penetrable stopper of the vial with an antiseptic, and use a new 18G sterile needle to withdraw an appropriate amount of the suspension (typically 1 ml) into a single-use 1 ml sterile syringe. Tilt the vial horizontally and withdraw suspension from the lower lateral of the vial to avoid withdrawing foam. Do not store the reconstituted product in the syringe.
9. Replace the 18G needle with a 25G or 26G sterile needle before injecting the product into the deep dermis or subcutaneous layer. Do not inject Sculptra using needles of an internal diameter smaller than 25G or 26G.
10. To withdraw remaining contents of the vial, repeat steps 8 through 9. Do not inject the foam.
Optional addition of local anaesthetic lidocaine: If desired for the purpose of providing pain relief during the injection procedure, after completion of step 6 of the Reconstitution instructions described previously, add another 1 ml of 2% (20 mg/ml) lidocaine solution to the vial immediately prior to injection. Clean the penetrable stopper of the vial with an antiseptic, add the lidocaine solution using a single-use 1 ml sterile syringe and an 18G sterile needle and shake the suspension. Go to step 7 of the Reconstitution instructions described previously and complete the procedure. It should be noted that the addition of lidocaine according to these instructions will lead to a final vial volume of 6-9 ml with a lidocaine concentration of 3.3-2.2 mg/ml.
Patient treatment: A complete medical history should be taken to determine if the treatment is appropriate.
Before treatment with Sculptra, the patient should be informed completely of the indications, contraindications, warnings, and precautions for use, possible side effects and mode of administration of Sculptra. Each patient should be informed that the amount of Sculptra and the number of injection sessions will depend on the patient's need and the severity of the depressed area based on the mode of action of the product.
Make sure to work under aseptic and hygienic conditions. Clean the injection site with an antiseptic.
Sculptra powder should be reconstituted extemporaneously with 5-8 ml of sterile water for injection. Prior to injection, optionally add another 1 ml of local anaesthetic lidocaine (20 mg/ml) to the vial.
Sculptra should be injected into the deep dermis or subcutaneous layer.
Perform the injections using 25G or 26G needles. To avoid breakage of the needle, do not attempt to bend it before or during treatment. If the needle gets bent, discard it and complete the procedure with a replacement needle.
To maintain a homogeneous suspension throughout the procedure, intermittently, agitate the product in the syringe. Before initial injection, expel a few drops of the product through the attached needle to eliminate air and to check for needle blockage. If the needle becomes occluded or dull during an injection session, replacement may be necessary. If clogging occurs, remove the needle, expel a small amount of product, attach a new sterile needle, then expel a few drops of Sculptra to eliminate the air and re-check for needle blockage.
In order to control the injection depth of Sculptra, stretch/pull the skin opposite to the direction of the injection to create a firm injection surface. The sterile needle, bevel up, should be introduced into the skin at an angle of approximately 30-40 degrees, until the desired skin depth is reached. A change in tissue resistance is felt when the needle crosses from the dermis into subcutaneous layer. If the needle is inserted at too shallow (small) an angle or if the needle tip is not sufficiently advanced, then the needle tip may be in the mid or superficial papillary dermis, the needle bevel may be visible through the skin. If product is injected too superficially the injected area will blanch immediately or shortly after injection. If this occurs, the needle should be removed and the treatment area gently massaged. In the event that the blanching does not disappear, the patient should not be re-injected.
During the first treatment session with Sculptra, only a limited correction should be made. The patient should then be evaluated at no sooner than four weeks post-treatment to determine if additional correction is needed.
After the injection session, ice (in a suitable cloth, avoiding any direct contact with the skin) should be applied to the treatment area in order to reduce swelling and/or bruising.
It is important to thoroughly massage the treated area(s) to evenly distribute the product (use of an appropriate cream may help to reduce the friction on the skin surface during massaging).
The patient should periodically massage the treated areas for five minutes, five times per day for five days after the treatment to ensure a natural-looking correction.
Sculptra may be visualised with ultrasound imaging and MRI. It is not observed with CT scans and radiography.