RESTYLANE KYSSE

RESTYLANE KYSSE is a gel:
- Sterile, biodegradable, viscoelastic, non-pyrogenic, clear, colourless, flexible and homogeneous.
- Composed of hyaluronic acid of bacterial origin, with a moderate lifting capacity.
- Cross-linked with BDDE (1,4-butanediol diglycidyl ether).

- GALDERMA
- NAME: RESTYLANE KYSSE
- COMPOSITION: Sodium hyaluronate concentration of 20 mg/mL in pH 7 buffered saline, 3 mg/mL lidocaine hydrochloride.
- PRESENTATION: 1 x 1 ml.
- INDICATIONS: RESTYLANE KYSSE is used for volumetric filling and correction to add volume to the lips.
- NEEDLES: 2 x 30G½ TW (0.3x12mm).
- INJECTION DEPTH: Labial mucosa or deep dermis of the labial area.
- DURATION: Up to 12 months.
- USE: Strict medical use.

- Syringes: 1 x 1 ml.
- Needles: 2 x 30G½ TW (0.3x12mm).
- Each box contains one 1 mL syringe of RESTYLANE KYSSE, 2 sterile disposable 30G x ½” needles reserved exclusively for injection of RESTYLANE KYSSE, instructions for use and labels to ensure traceability.

Lips and lip contour.

Sodium hyaluronate concentration of 20 mg/mL in pH 7 buffered saline, 3 mg/mL lidocaine hydrochloride.

- Restylane® Kysse is packaged for use by a single patient and for a single session. Do not resterilise.
- Do not use if the packaging is opened or damaged.
- Restylane® Kysse must be used as supplied. Any modification or use not in accordance with the instructions may compromise the sterility, homogeneity and performance of the product.
- To minimise the risk of complications, the product should only be used by adequately trained health care professionals with experience and knowledge of the anatomy of the area to be treated.
- Healthcare professionals are encouraged to discuss all potential risks of soft tissue injections with patients prior to treatment and to inform them about signs and symptoms of possible complications.
- The maximum recommended volume per patient per treatment is 6 mL (3 mL for the lips and 3 mL for the perioral area).
- As with all transcutaneous procedures, the implantation of dermal fillers carries a risk of infection; standard precautions for injectable materials must be followed.
- Avoid injecting Restylane® Kysse in areas close to permanent implants, as this may aggravate latent adverse events or interfere with the aesthetic result. Data on use in the presence of non-hyaluronic acid implants are limited.
- Post-inflammatory pigmentary changes may occur after injection in patients with dark skin (Fitzpatrick IV-VI).
- Injection in patients with a history of herpes may be associated with reactivation of the infection.
- Use with caution in patients on immunosuppressive therapy.
- Use with caution in patients with coagulation disorders.
- Patients taking substances that may prolong bleeding (aspirin, NSAIDs, warfarin) may have an increased risk of bruising or bleeding at the treatment site.
- The safety of Restylane® Kysse in combination with other dermal therapies (hair removal, UV, laser, mechanical or chemical peeling) has not been evaluated in controlled studies.
- If such treatments are performed after the injection, there is a risk of causing an inflammatory reaction in the area of the implant; the same applies if the injection is performed before the skin has completely healed from such procedures.
- Patients should limit exposure to the sun, UV light and intense cold at least until the initial swelling and redness have resolved.
- The safety of Restylane® Kysse during pregnancy, breastfeeding or in patients under 22 years of age has not been established.
- Individual variations and the treatment area may influence the biodistribution and biodegradation of the product; residues of the filler may persist in the tissue even when the clinical effect has worn off.
- Failure to follow the needle attachment instructions may result in needle disconnection and/or loss of product.
- After use, used syringes and needles may pose a biohazard; they must be disposed of in accordance with local medical regulations.
- Restylane® Kysse injectable gel is a clear, colourless gel without particles.
- If the contents of the syringe appear turbid or show separation, do not use the syringe.
- Restylane® Kysse must not be mixed with other products before implantation.
- The total dose of lidocaine administered must be considered if topical lidocaine or a dental block is also used.
- High doses (over 400 mg) may cause acute toxicity with symptoms affecting the central nervous system and cardiac conduction.
- Lidocaine should be used with caution in individuals taking drugs related to amide anaesthetics (e.g. some antiarrhythmics), as the systemic toxic effects may add up.
- Use lidocaine with caution in patients with epilepsy, cardiac conduction disorders, severe hepatic impairment or severe renal dysfunction.

RESTYLANE KYSSE is contraindicated in the following cases:
- In patients with severe allergies, such as a history of anaphylaxis or the presence/history of multiple severe allergies.
- The product may contain traces of gram-positive bacterial proteins and is contraindicated in patients with a history of allergies to these substances.
- It contains lidocaine and is contraindicated in patients with a history of allergy to lidocaine or other amide-type anaesthetics.

RESTYLANE KYSSE is indicated for injection into the lips for lip volume augmentation and correction of upper perioral wrinkles in patients over 21 years of age.

The contents of the syringe are sterilised by moist heat. Needles are sterilised by irradiation.