JUVEDERM SKINVIVE

SKINVIVE by JUVÉDERM® is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colourless and homogeneous injectable gel. It consists of hyaluronic acid (HA) produced by bacteria of the genus Streptococcus, cross-linked with 1,4-butanediol diglycidyl ether (BDDE), formulated at a concentration of 12 mg/mL with 0.3% w/w lidocaine in a physiological buffer.
USE MEDICAL STRICT. Medical device. Injection of hyaluronic acid. Use reserved for dermatologists and aesthetic doctors because they require a medical procedure.

[INCOMPATIBILITY].
Hyaluronic acid is known to be incompatible with quaternary ammonium salts such as benzalkonium chloride. Therefore, SkinVive® by Juvéderm® should never be brought into contact with these substances or with medical-surgical instruments treated with such compounds.
There are no known interactions with other local anaesthetics.[/INCOMPATIBILITY].
[PRECAUTIONS FOR USE].
- SKINVIVE injectable gel from JUVÉDERM® is packaged for single-patient use. Do not re-sterilise. Do not use if the packaging is opened or damaged.
- To reduce the risk of complications, the product should only be used by healthcare professionals with adequate training, experience and knowledge of the anatomy of the injection site.
- Healthcare professionals are encouraged to discuss all potential risks of soft tissue injections with patients prior to treatment, making sure they are aware of the signs and symptoms of possible complications.
- Based on preclinical studies and a toxicological risk assessment, a maximum of 20 mL of any JUVÉDERM® injectable gel per 60 kg body weight (130 lbs) per year should be administered to patients. The safety of higher doses has not been established.
- This product is intended to improve the smoothness of the cheek skin. Safety and efficacy for the treatment of other anatomical regions have not been established in controlled clinical studies.
- Treatments involving injections exceeding 6.0 mL of SKINVIVE by JUVÉDERM® (initial treatment and recalls included) have not been studied to improve cheek skin smoothness.
- As with all transcutaneous procedures, injections carry a risk of infection. Standard precautions for injectable materials must be followed.
- SKINVIVE by JUVÉDERM® must be used as supplied. Modifications or uses outside the instructions for use may compromise the sterility, homogeneity and performance of the product.
- The safety of use during pregnancy, in lactation and in patients under 22 years of age has not been established.
- Safety in patients with a known predisposition to keloids, hypertrophic scars or pigmentation disorders has not been studied.
- SKINVIVE by JUVÉDERM® should be used with caution in patients on immunosuppressive therapy.
- Patients taking substances that can prolong clotting (such as aspirin, non-steroidal anti-inflammatory drugs and warfarin) may, as with any injection, experience increased bruising or bleeding at injection sites.
- Patients may experience late adverse events with the use of injectable gels, including SKINVIVE by JUVÉDERM®. Please refer to the ADVERSE EVENTS section for details.
- After use, syringes and needles are biologically hazardous materials. Handle and dispose of according to accepted medical practices and local, state and federal requirements.
- SKINVIVE by JUVÉDERM® is a clear, colourless gel with no visible particles. If the contents of a syringe show signs of separation or appear cloudy, do not use the syringe; contact Allergan Product Surveillance at 1-877-345-5372.
- SKINVIVE by JUVÉDERM® should only be used by experienced health professionals who are informed about the anatomy and use of the product on the face.
- If a laser treatment, chemical peel or other procedure that stimulates the dermal response is considered after treatment with SKINVIVE by JUVÉDERM®, there is a risk of an inflammatory reaction at the site of the implant. An inflammatory reaction is also possible if the product is administered before the skin has completely healed from the procedure.
- Failure to follow the needle assembly instructions may result in needle detachment and/or leakage of product into the LUER-LOK® connection and needle hub.