Janovia Plus

Janovia Plus is a sterile pyrogenic — free physiological solution of cross — linked hyaluronic acid which is not of animal origin. The gel is presented, pre-filled, disposable syringe.

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Each box contain syringe of 1.1 mL Janovia plus 2 single — use 256 1/2″ sterile needles to be used only for injection Janovia plus an i nstruction leaflet and a set of labels in order to ensure traceability .

INDICATION

Janovia plus is an injectable implant used for filling any deep depressions of the skin via deep dermis injection, as well as for lip enhancement and cheekbone augmentation.

MODE OF ACTION

This product is designed to be injected into the dermis or the mucous membrane of the lips by an authorized medical practitioner in accordance with local applicable regulation. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling.

Janovia plus is to be used as supplied. Modification or use of the product outside the Directions for use may adversely impact the sterility, homogeneity and performance of the product and it can therefore no longer be assured.

Before starting treatment patients should be informed of the product’s indications, contra-indications, incompatibilities and potential undesirable effects.

The area to be treated should be disinfected thoroughly prior to the injection. Remove tip cap by pulling it straight off the syrings as shown in fig. then firmly push the needle provided in the box into the syringe, screwing it gently clockwise. Twist once more until it is fully locked and has the needle cap.

Next, remover the protective cap by holding the body of the syringe in one hand, the protective cap in the other, and pulling the two hands in opposite directions.

INJECT SLOWLY

Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage luer-lock level.

The amount injected will depend on the areas which are to be corrected.

It is important to massage the area treated after the injection in order to ensure that the substance has been uniformly distributed.