Instructions for use,
JANOVIA Kiss, lip enhancement Gel is intended to be used for volume restoration and shaping of lips.
To be injected by authorized personnel.
JANOVIA Kiss, Lip Shaping Gel
Each ml contains: Hyaluronic acid, stabilized 25mg/ml, Phosphate buffered saline q.s.
JANOVIA Kiss is a transparent, no pyrogenic, sterile gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically cross-linked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 25 mg/ml. Each carton contains one prefilled syringe of JANOVIA Kiss. For each syringe, the box contains two sterile 27G1/2 needles and two tracobility labels (one to be given to the patient, and one to be kept by the doctor in the patient’s file). The volume of each syringe is shown on the package carton as well as on each syringe.
JANOVIA Kiss is indicated for mid-to-deep dermal implantation for the filling of depressions due to scars, reconstruction of volumes lost by lipoatrophy. JANOVIA Kiss indicated for increasing lip volume and for the correction of moderate to deep lines at the corners of the mouth.
Mode of Action
JANOVIA Kiss is injected into the mucosa for the treatment of lips and into the deep dermis for the correction of cutaneous depression. JANOVIA Kiss thus creates a volume that corrects wrinkles and restores the lip volume.
JANOVIA Kiss is biodegradable and is absorbed slowly over time. According to the depth of the wrinkles or the volume of lips to be treated, normally one to three treatment sessions are necessary to obtain optimal level of correction. Periodic touch-up sessions following the treatment maintain the desired level of correction.
Do not inject in to blood vessels.
• JANOVIA Kiss must not be used:
- for injections other than intradermal,
- the combination with peeling, laser treatment or ultra-sound,
- if the patient has cutaneous disorder, inflammation or infection at the treatment site or near to this site,
- in the case of patients have a known hypersensitivity to hyaluronic acid, with a history of severe allergy or anaphylactic shock,
- in case of the patients with autoimmune diseases,
- Due to possible interactions with other filling implants, which have not been researched, it is inadvisable to inject JANOVIA Kiss into sites in the presence of other filling implants.
- in pregnancy, breast-feeding mother, or in children
Warnings and Side Effects
- Defer use of JANOVIA Kiss at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present until the process has been controlled.
- Injection site reactions (e.g., swelling, redness, tenderness, or pain) to JANOVIA Kiss have been observed as consisting mainly of short-term minor or moderate inflammatory symptoms starting early after treatment and with less than 7 days duration. Refer to the adverse experiences section for details.
- JANOVIA Kiss must not be implanted into blood vessels. Localized superficial necrosis may occur after injection in or near dermal vessels, such as the glabellar area. It is thought to result from the injury, obstruction, or compromise of blood vessels.
- Delayed onset inflammatory papules have been reported following the use of dermal fillers.
- Inflammatory papules that may occur rarely should be considered and treated as a soft tissue infection.
Posology and Precautions :
• JANOVIA Kiss is only to be carried out by practitioners trained in injection techniques for products designed to correct wrinkles and increase lip volume.
• JANOVIA Kiss is packaged for single patient use. Do not resterilize. Do not use if package is opened or damaged. • As with all transcutaneous procedures, JANOVIA Kiss implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.
• The safety of hyaluronic acid filler for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
• Hyaluronic acid filler injection may cause hyperpigmentation at the injection site.
• JANOVIA Kiss should be used with caution in patients on immunosuppressive therapy.
• Bruising or bleeding may occur at JANOVIA Kiss injection sites. JANOVIA Kiss should be used with caution in patients who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
• After use, syringes and needles should be handled as potential biohazards. Disposal should be in accordance with accepted medical practice and applicable local, state and federal requirements.
• Patients should minimize exposure of the treated area to excessive sun, UV lamp exposure and extreme cold weather at least until any initial swelling and redness has resolved.
• JANOVIA Kiss is a clear, colorless gel without particulates. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe. Glass is subject to breakage under a variety of unavoidable conditions. Care should be taken with the handling of the glass syringe and with disposing of broken glass to avoid laceration or other injury.
• JANOVIA Kiss should not be mixed with other products before implantation of the device
. STERILE NEEDLE(S)
• Follow national, local or institutional guidelines for use and disposal of medical sharp devices. Obtain prompt medical attention if injury occurs.
• To help avoid needle breakage, do not attempt to straighten a bent needle. Discard it and complete the procedure with a replacement needle.
• Do not reshield used needles. Recapping by hand is a hazardous practice and should be avoided