Restylane Skinboosters Vital

Restylane Skinboosters Vital Lidocaine/Restylane Skinboosters Vital Light Lidocaine is supplied in a glass syringe. The product has a built in dose-guide, Smart Click System, which when activated creates a clicking sound to indicate each injected dose. The 1 ml syringe gives approximately 100 doses. The contents of the syringe are sterilized using moist heat. The product is for single use only. Disposable 29G TW (thin-walled) needles, sterilized using ethylene oxide, are provided. To ensure traceability the patient record label (part of syringe label) should be attached to patient records.
Restylane Skinboosters Vital Lidocaine: Hyaluronic acid, stabilized 20 mg/mL; Lidocaine hydrochloride 3 mg/mL; Phosphate buffered saline q.s.
Restylane Skinboosters Vital Lidocaine is a sterile, transparent gel of stabilized hyaluronic acid of non-animal origin with the addition of 0.3% lidocaine hydrochloride.
Restylane Skinboosters Vital Light Lidocaine: Hyaluronic acid, stabilized 12 mg/mL; Lidocaine hydrochloride 3 mg/mL; Phosphate buffered saline q.s.
Restylane Skinboosters Vital Light Lidocaine is a sterile, transparent gel of stabilized hyaluronic acid of non-animal origin with the addition of 0.3% lidocaine hydrochloride.

Mode of action: This product is naturally integrated into the skin where it helps to restore skin hydrobalance, improve skin structure and the elasticity of the skin. This is accomplished by the water associated with the stabilized hyaluronic acid in the gel. The unique characteristics of the gel help maintain the effect for a long period of time.
Performance: In clinical studies with Restylane Vital, patients experienced significant improvement in dermal elasticity and skin morphology up to 6 months after initial treatment.

This product is intended to restore skin hydrobalance, improve skin structure and the elasticity of the skin. Restylane Skinboosters Vital Lidocaine should be injected in the dermal layer of the skin, preferably in the deeper part of dermis. Restylane Skinboosters Vital Light Lidocaine should be injected in the dermal layer of the skin.
Before the first treatment session, it is recommended to contact the local Galderma representative or Restylane distributor for more information about injection techniques and training opportunities. This product is only intended to be administered by authorized personnel in accordance with local legislation.
Restylane Skinboosters Vital Lidocaine/Restylane Skinboosters Vital Light Lidocaine: The addition of lidocaine provides increased overall treatment comfort.

Needle: Disposable sterile 29G TW needles are provided. Alternatively, a sterile blunt cannula 30G can be used. The size and the length of the cannula will affect the force needed to extrude the gel. If a thinner cannula is used the resistance during injection may be too high resulting in an increased risk for leakage or separation of the cannula and syringe. The same considerations are applicable for needles.
Assembly of needle to syringe: Use the thumb and forefinger to hold firmly around both the glass syringe and the luer-lock adapter. Grasp the needle shield (or hub if using cannula) with the other hand. To facilitate proper fastening, both push and rotate firmly. Strict aseptic technique must be followed.
Improper assembly may result in separation of the needle and syringe during injection.
Treatment procedure: The patient shall be informed about the indications, expected result, precautions and potential adverse events. The patient's need for pain relief should be assessed.
Clean the treatment site thoroughly with a suitable antiseptic solution.
To avoid breakage of the needle or cannula, do not attempt to bend or otherwise manipulate it before or during treatment.
The Smart Click System is activated by pressing down the button located on the finger grip until it locks into place.
Before injecting, remove the air by pressing the rod carefully until a small droplet is visible at the tip of the needle. When the Smart Click System is switched on, press the plunger rod carefully until the first click is heard to prime the system before use.
As an alternative to the needle, a blunt cannula can be used. After preparation as previously described, an entry point is made in the skin, e.g. with a sharp needle of appropriate size. Inject slowly. During injection, keep the side hole of the cannula facing downwards, away from the skin surface, to ensure that the flow of the gel is maintained at the correct tissue depth.
Do not apply excessive pressure to the syringe at any time. Presence of scar tissue may impede advancement of the cannula/needle. If resistance is encountered the cannula/needle should be partially withdrawn and repositioned or fully withdrawn and checked for function.
A too large volume or a too superficial injection may give bumps on the treatment site.
Treated areas can be gently massaged immediately after the injection if any irregularities are noted.
Restylane Skinboosters Vital Lidocaine: This product should be injected in the dermal layer of the skin, preferably in the deeper part of dermis.
A treatment plan for this product with three treatments 4 weeks apart is recommended. Generally, a maintenance treatment is repeated every 6 months, but results and patient preferences may vary.
Restylane Skinboosters Vital Light Lidocaine: This product should be injected into mid dermis of the skin.
A treatment plan for this product with three treatments 2-4 weeks apart is recommended. Generally, a maintenance treatment is repeated every 4-6 months, but results and patient preferences may vary.

Do not inject intravascularly. As for other injectable medical devices inadvertent injection into blood vessels could potentially lead to vascular occlusion, ischemia and necrosis.
If the overlying skin turns a whitish colour (blanching), the injection should be stopped immediately and the area massaged until it returns to a normal colour.
Do not use in patients with bleeding disorders or in patients who are taking thrombolytics or anticoagulants.
Do not resterilize.
Do not mix with other products prior to injection of the device.
Do not use in patients with known hypersensitivity to lidocaine or to amide-type local anaesthetics.

General considerations relevant to injectable medical devices: Injection procedures are associated with a risk of infection. Aseptic technique and standard practice to prevent cross-infections are to be observed.
Special caution should be exercised when treating areas in close proximity to permanent implant.
Knowledge of the anatomy of treatment site and special caution are required in order to avoid perforation or compression of vessels, nerves and other vulnerable structures.
Special caution should be exercised when treating areas with limited collateral circulation, due to increased risk of ischemia.
Special caution should be exercised in patients with previous rhinoplasty since the vascular supply may be affected.
Special caution should be exercised in treating facial areas with limited soft tissue support or soft tissue cover, such as the periorbital area, to avoid formation of palpable lumps.
Patients with pre-existing pigmented dark lower eye lid circles, thin skin and pre-existing tendency toward edema formation are not suitable candidates for treatment of the lower periorbital region.
Do not use where there is active disease such as inflammation, infection or tumours, in or near the intended treatment site.
Injection procedures can lead to reactivation of latent or subclinical herpes viral infections.
Patients who are using substances that affect platelet function, such as aspirin and non-steroidal anti-inflammatory drugs may, as with any injection, experience increased bruising or bleeding at injection sites.
Patients with unattainable expectations are not suitable candidates for treatment.
Do not use the product if package is damaged.
Specific considerations relevant to the use of this product: Do not inject this product into an area where an implant of non hyaluronic acid has been placed.
Patients should avoid excessive sun or extreme cold at least until any initial swelling and redness has resolved.
If laser treatment, chemical peeling or any other procedure based on active dermal response is performed after treatment with this product there is a theoretical risk of eliciting an inflammatory reaction at the injection site. This also applies if the product is administered before the skin has healed completely after such a procedure.
Temporary palpable lumpiness has been noted in some patients. Do not inject too large volumes or too superficially, as the product then may cause intradermal lumps.
This product has not been tested in pregnant or breastfeeding women or in children.
Considerations should be given to the total dose of lidocaine administered if dental block or topical administration of lidocaine is used concurrently. High doses of lidocaine (more than 400 mg) can cause acute toxic reactions manifesting as symptoms affecting the central nervous system and cardiac conduction.
Lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics e.g., certain anti-arrhythmics, since the systemic toxic effects can be additive.
Lidocaine should be used cautiously in patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
Peribulbar injections of local anaesthetics carry a low risk of persistent ocular muscle dysfunction.

Anticipated injection-related reactions: Injection-related reactions might occur. These reactions include bruising, erythema, itching, swelling, pain or tenderness at the implant site. Typically resolution is spontaneous within a few days after injection into the skin, and within one week after injection of the lips.
Post marketing adverse event reporting: The frequency of post market adverse event reporting is calculated on the estimated number of treatments performed with the Restylane Skinboosters range of products.
1/10 000 - 1/50 000: Erythema, inflammation, pain/tenderness, papules/nodules, swelling.
1/50 000 - 1/100 000: Bruising, induration.
<1/100 000: Abscess, acne, atrophy/scarring, blisters, dermatitis, discolouration, granuloma, hypersensitivity, infection, ischemia/necrosis, mass, neurological symptoms such as paresthesia, pruritus, rash, reactivation of herpes infection, short duration of effect, telangiectasia, urticaria.
Vascular compromise may occur due to an inadvertent intravascular injection or as a result of vascular compression associated with implantation of any injectable product. This may manifest as blanching, discolouration, necrosis or ulceration at the implant site or in the area supplied by the blood vessels affected.
Isolated rare cases of visual disturbance as a result of inadvertent intravascular injection have been reported. Isolated rare cases of ischemia/necrosis affecting the nose have been reported after injection, especially in patients who had prior rhinoplasty.
In rare cases intradermal lumps have been reported to remain for several months or very rarely, longer than one year.
As for injectable dermal fillers, symptoms of inflammation at the implant site commencing either shortly after injection or after a delay of 2-4 weeks have been reported. In case of unexplained inflammatory reactions infections should be excluded and treated if necessary since inadequately treated infections may progress into complications such as abscess formation. Treatment using only oral corticosteroids without concurrent antibiotic treatment is not recommended. The prolonged use of any medication, e.g. corticosteroids or antibiotics in treatment of adverse events has to be carefully assessed, since this may carry a risk for the patient. In case of persistent or recurrent inflammatory symptoms, consider removal of the product by aspiration/drainage, extrusion or enzymatic degradation (hyaluronidase injections). Before any removal procedure is performed, the swelling may be reduced by using e.g. NSAID for 2-7 days or a short course of corticosteroids for less than 7 days, in order to more easily palpate any remaining product.
For patients who have experienced clinically significant reactions, a decision for retreatment should take into consideration the cause and significance of previous reactions.
Post inflammatory pigmentation changes have been observed in clinical studies in people with dark skin (Fitzpatrick Type IV-VI).
For reporting of adverse event contact the local Galderma representative or Restylane distributor for this product.

The syringe with finger grip and plunger rod, disposable needle/blunt cannula and any unused material must be discarded immediately after the treatment session and must not be reused due to risk for contamination of the unused material and the associated risks including infections. Disposal should be in accordance with accepted medical practice and applicable national, local or institutional guidelines.

Store up to 25°C. Protect from freezing and sunlight.

Other Dermatologicals

D11AX - Other dermatologicals ; Used in the treatment of dermatological diseases.