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Janovia Kiss

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.

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Description

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
Composition :
Each ml contains: Hyaluronic acid, stabilized 25mg/ml, Phosphate buffered saline q.s.

Description :
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.

Indication
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.

Contraindications:
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

Additional Informations

Directions for Assembly
Assembly of 27G needle to syringe.
For safe use of JANOVIA Kiss, it is important that the needle is properly assembled. Improper assembly may result in separation of the needle and syringe during implantation.
1. Unscrew the tip cap of the syringe carefully.
2. Grasp the narrow part of the needle shield loosely; mount the needle on the Luer-Lok by turning it clockwise until you feel counter-pressure. Grasp the wider part of the needle shield firmly.
3. Press and turn the needle shield 90º (a quarter turn). The quarter turn is necessary to lock the needle onto the syringe.
4. Pull off the needle shield.
5. Use the thumb and forefinger to hold firmly around both the glass syringe

Treatment Procedure
Pretreatment Guidelines
Prior to treatment, the patient should avoid taking aspirin, nonsteroidal anti-inflammatory medications, St. John’s Wort, or high doses of Vitamin E supplements. These agents may increase bruising and bleeding at the injection site.
1. It is necessary to counsel the patient and discuss the appropriate indication, risks, benefits and expected responses to the JANOVIA Kiss treatment. Advise the patient of the necessary precautions before commencing the procedure.
2. Assess the patient’s need for appropriate anesthetic treatment for managing comfort, i.e., topical anesthetic, local or nerve block.
3. The patient’s face should be washed with soap and water and dried with a clean towel. Cleanse the area to be treated with alcohol or another suitable antiseptic solution.
4. Sterile gloves are recommended while injecting JANOVIA Kiss.
5. Before injecting, press rod carefully until a small droplet is visible at the tip of the needle.
6. JANOVIA Kiss is administered using a thin gauge needle (27 G x ½”). The needle is inserted at an approximate angle of 30° parallel to the length of the lips. JANOVIA Kiss should be injected into the mid to deep dermis. If JANOVIA Kiss is injected too superficially this may result in visible lumps and/or bluish discoloration.
7. Inject JANOVIA Kiss applying even pressure on the plunger rod. It is important that the injection is stopped just before the needle is pulled out of the skin to prevent material from leaking out or ending up too superficially in the skin.
8. Only correct to 100% of the desired volume effect. Do not overcorrect. With cutaneous deformities the best results are obtained if the defect can be manually stretched to the point where it is eliminated. The degree and duration of the correction depend on the character of the defect treated, the tissue stress at the implant site, the depth of the implant in the tissue and the injection technique.
9. Typical usage for each treatment session is specific to the site as well as wrinkle severity.

Injection Techniques
1. JANOVIA Kiss can be injected by a number of different techniques that depend on the treating physician’s experience and preference, and patient characteristics.
2. Serial puncture involves multiple, closely spaced injections along lips. Although serial puncture allows precise placement of the filler, it produces multiple puncture wounds that may be undesirable to some patients.
3. Linear threading is accomplished by fully inserting the needle into the middle of the wrinkle or fold and injecting the filler along the track as a “thread.” Although threading is most commonly practiced after the needle has been fully inserted and is being withdrawn, it can also be performed while advancing the needle (“push-ahead” technique).
4. Serial threading is a technique that utilizes elements of both approaches.
5. Cross-hatching consists of a series of parallel linear threads injected at intervals of five to ten mm followed by a new series of threads injected at right angles to the first set to form a grid. This technique is particularly useful in facial contouring when coverage of the treatment region needs to be maximized.
6. The correct injection technique is crucial for the final result of the treatment. Dissection of the sub-epidermal plane with lateral movement of the needle, rapid flows (>0.3 mL/min), rapid injection or high volumes may result in an increase in short-term episodes of bruising, swelling, redness, pain, or tenderness at the injection site.
7. When the injection is completed, the treated site should be gently massaged so that it conforms to the contour of the surrounding tissues. If an overcorrection has occurred, massage the area firmly between your fingers or against an underlying superficial bone to obtain optimal results.
8. If so called “blanching” is observed, i.e., the overlying skin turns a whitish color, the injection should be stopped immediately and the area massaged until it returns to a normal color.
9. If the lip needs further treatment, the same procedure should be repeated until a satisfactory result is obtained. Additional treatment with JANOVIA Kiss may be necessary to achieve the desired correction.
10. If the treated area is swollen directly after the injection, an ice pack can be applied on the site for a short period. Ice should be used with caution if the area is still numb from anesthetic to avoid thermal injury.
11. Patients may have mild to moderate injection site reactions, which typically resolve in a few days. Storage Condition Store between 2? and 25?, away from sunlight Make sure there are no visible signs of damage to the packaging before use.

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