DESCRIPTION.

Kysense® Precise / Kysense® Touch / Kysense® Define / Kysense® Volume / Kysense® Extreme is a sterile, transparent and resorbing gel of cross-linked hyaluronic acid of non-animal origin. The product is supplied in plastic syringe and it is intended for single use only. The volume of each syringe is 1 mL for Kysense® Precise / Kysense® Define / Kysense® Volume / Kysense® Extreme. Kysense® Touch exists with a volume of 0.5 mL per syringe.

Each box contains four graduated pre-filled syringes of Kysense® Precise or Kysense® Touch or Kysense® Define or Kysense® Volume or Kysense® Extreme, an instruction leaflet, a set of traceability labels and four single-use sterile needles of 30G ½ for Kysense® Precise / Kysense® Touch / Kysense® Define and of 27G ½ for Kysense® Volume / Kysense® Extreme. For each syringe, one label is to be given to the patient, the other one is to be added to the patient record.

The content of Kysense® Precise / Kysense® Touch / Kysense® Define / Kysense® Volume / Kysense® Extreme syringes is sterilised by moist heat.
The 30G ½ or 27G ½ needles are sterilised by radiation.

The intended purpose of Kysense® Precise / Kysense® Touch / Kysense® Define / Kysense® Volume / Kysense® Extreme is to modify the anatomy and / or to alleviate a physiological process at the level of the face.

COMPOSITION

*The hyaluronic acid has been crosslinked with BDDE.

COMPOSITION

 

INTERACTIONS

Treatment with Kysense® Precise / Kysense® Touch / Kysense® Define / Kysense® Volume / Kysense® Extreme in combination with drugs and other devices has not been clinically evaluated. The treatment with Kysense® Precise / Kysense® Touch / Kysense® Define / Kysense® Volume / Kysense® Extreme can be performed in combination with an appropriate quantity of lidocaine solution.

PROCEDURE OF ADMINISTRATION

Treatment with Kysense® Precise / Kysense® Touch / Kysense® Define / Kysense® Volume / Kysense® Extreme is only intended to be administrated by an authorized healthcare professional in accordance with the local legislation. The healthcare professional shall have a deep knowledge of the anatomy of the area to be treated and shall be used to performing similar intervention (i.e. cross-linked hyaluronic injection in the face area).

Kysense® Precise / Kysense® Touch / Kysense® Define / Kysense® Volume / Kysense® Extreme is to be used as supplied. Modification or use of the product outside of the instruction for use may adversely impact the sterility and / or the performance of the device. A correct injection technique is important for the clinical outcome of the treatment. The injection technique varies depending on the treatment site, the depth of injection and the gel quantity to be injected.

1. Before starting treatment, the patient should be informed of the product’s indications, contra-indications, precautions, warnings, expected results and potential adverse events and questioned on her / his medical history.
2. The injected area must be disinfected with an appropriate antiseptic solution.
3. Assemble the supplied sterile needle and syringe.
4. Do not apply extensive pressure to the syringe at any time. If such resistance is encountered, remove and replace the needle and check for function.
5. Kysense® Precise / Kysense® Touch / Kysense® Define / Kysense® Volume / Kysense® Extreme should be administrated slowly in the tissues. The injection volume varies depending on the correction required. Do not overcorrect. Kysense® Precise / Kysense® Touch is indicated for injection into the dermis or lips mucosa. Kysense® Define is indicated for injection into the deep dermis or lips mucosa. Kysense® Volume is indicated for injection into the subcutaneous fat tissue or into the supraperiostic zone. Kysense® Extreme is indicated for injection into the subcutaneous fat tissue or into the supraperiostic zone.
6. For optimal clinical results, gentle massage by the healthcare professional of the treated area is recommended to ensure uniform distribution of the material.

ADVERSE EVENTS

Healthcare professional shall inform the patients about potential adverse events related to the injection procedure and / or the use of the product Kysense® Precise / Kysense® Touch / Kysense® Define / Kysense® Volume / Kysense® Extreme, occurring immediately after injection or after a delay.

These adverse events include but are not limited to:
-Events which are naturally resolved within one week in most cases:

• Injection-related events and / or inflammatory reactions such as bleeding, ecchymosis, erythema, haematoma, skin redness, bruising, swelling, oedema and infection which may be associated with local pain or itching, occurring after injection.
• Sensitivity at the injection site.
• Hardness, lump or nodule at the injection site.
• Skin coloration or discoloration at the injection site.

-Events which are delayed after the injection:

• Immediate or delayed hypersensitivity to hyaluronic acid.
• Nodule, abscesses or granuloma.
• Vascular compromise may occur due to inadvertent intravascular injection or as a result of vascular compression associated with implantation of any injectable soft tissue filler. This may manifest as blanching, discoloration, necrosis or ulceration at the implant site or in the area supplied by the blood vessels affected; or rarely as ischemic events in other organs due to embolization. Isolated rare cases of ischemic events affecting the eye leading to visual loss, and the brain resulting in cerebral infarction, following facial aesthetic treatments have been reported. These rare cases of vascular events are mostly reported in glabella, in and around the nose, in forehead and in periorbital area.
• Infection or reactivation of a previous infection.
• Displacement of the gel.
• Inflammatory reactions which persist for more than one week, or any other adverse event which develops, must be reported by the patients to their healthcare professional. In this case, if required, the healthcare professional should use an appropriate treatment.

Any adverse events and complications must be reported to the local representative of Kylane Laboratoires.

WASTE DISPOSAL

• At the end of the session, opened and used syringe as well as all injection materials (e.g. needle) shall be discarded in respect of the medical practices and in accordance with the applicable regulations on waste disposal (e.g. specific waste container).

STORAGE CONDITIONS

• Shelf life of the product is indicated on each syringe and product must not be used after this date.
• Store between 2°C and 25°C away from direct sunlight.
• Make sure there is no visible signs of damage to the packaging before use.

MEANING OF THE SYMBOLS ON THE PACKAGING: