Janovia Body Contour Gel, (BCG) is sterile, transparent gel of stabilized hyaluronic acid of non-animal origin, the product have a pH of 6~7.5
Janovia Body Contour Gel is designed deep tissue implantation and differ with respect to the physical structure of the gel.
Janovia Body Contour Gel is supplied in plastic syringes with luer-lock, Each syringe is terminally moist heat sterilized in its package and packed in a PET tray and tyvek sealing in a paper carrion.
The product is for single use only. The volume contained in each syringe is as stated on the outer package. A patient record label is a part of the syringe label and extra labels are provided in the package. These labels are to be attached to the patient records to ensure traceability of the product.
JANOVIA Body Contour, is intended to be used for volume restoration and contouring of body surfaces. the product is not intended for facial tissue augmentation. In general, deep subcutaneous administration is recommended. For this product sufficient tissue cover and support are important parameters to achieve a good esthetic treatment outcome. A minimum of 1cm skin thickness, including subcutaneous fat, is usually required to attain good results. The injection should be made by physicians who have thorough knowledge of anatomy of the treatment site and are experienced with injection techniques in the relevant area. The treatment facility must be suitable for performance of aseptic procedures.
MODE OF Action
JANOVIA Body Contour, act by adding volume to the tissue, thereby restoring and enhancing and enhancing body contours. The peoduct will be degraded over time.
- Do not inject intravascular. As for other injection medical devices, inadvertent medical devices, inadvertent injection into blood vessels could potentially lead to vascular occlusion, ischemia and necrosis . This risk can be minimized by using blunt cannulas.
- Do not use in patients with bleeding disorders or in patients who are taking thrombolytics or anticoagulants.
- Janovia Body Contour should not be used in the breast as the product may interfere with the reading of mammograms.
- Do not in the hands and penis because the benefit risk has not been adequately investigated in prospective clinical studies.
- Do not use in the patients previously treated with facial filler gel products and who, in connection therewith, have experienced delayed inflammatory reaction or implant complication that required medical treatment .
- Do not use during pregnancy or lactation.
- Do not re-sterilize Janovia body Contour Gel as this damages the product.
- Do not mix with other products.
General considerations relevant to implantation of medical devices.
- Implantation of medical devices is associated with a risk of infection. Aseptic technique and standard practice to prevent preoperative injection are to be observed. Soft issue infection following injection treatment have been observed.
- Special caution should be exercised when treating areas in close proximity to permanent implant or vulnerable structures such as nerves, vessels and viscera.
- Do not use where there ia a condition, I or near the intended treatment site that might increase the risk for development of adverse events following treatment, e.g. inflammation, infection or tumors.
- Patient who are using substances that affect platelet functions, such as aspirants and non-stertoidal anti-inflammatory drugs may, as with any injection, experience increased bruising or bleeding at injection sites.
- Patients with unattainable expectations are not suitable candidates for treatment.
- Scarring might occur at the insertion site. Some patients are know to have higher risk for scarring, e.eg. previous history of keloid formation or darker skin type Fitzpatrick IV-VI .
- Do not use the product if package is damaged.
OTHER CONSIDERATIONS RELEVANT TO THE USE OF JANOVIA
- Surgical and trauma scars involving more pronounced fibrosis should be treated with caution as the scars may need release of fibrous banks. Markedly indurated defects may be difficult to treat .
- There is no clinical data on the use of Janojvia Body Contour Gel in children.
- Do not inject more than 600ml Janojvia Body Contour Gel at one treatment.
ANTICIPATED TREATMENT- RELATED REACTION
Anticipated treatment-related reaction
After the injection of Janovia Body Contour Gel, some common injection related reactions might be occur. These reactions include erythema, swelling, tenderness, pain, bruising or itching at the implant site. Typically resolution is spontaneous within one to two weeks. Encapsulation Janovia Body Contour Gel occurs , similar to permanent implants , as part of the healing process.
Local mobility, implant displacement and implant site lumps have been observed. Adequate soft tissue cover and support, as well as implant placement and injection technique are important parameters to minimize occurrence of these events. If any of these described events are disturbing, aspiration of gel can be attempted.
Symptoms of inflammation including a combination of pain, redness and swelling have been reported. The possibility of infection should in all case of inflammation . Preoperative infections have been reported . A few of these cases were associated with fever or localized abscess formation. For more severe cases of infection, removal of the gel by drainage was used in addition to antibiotics. Implant site leakage and leakage that leads to a collection of Janovia Body Contour Gel at insertion site have been observed. To minimize the occurrence of leakage, see Treatment procedure, point 7.
Capsular contractures and palpable lumps of gel have been reported after treatment in the breasts. Isolated cases of late onset infection after treatment on the back of hands and localized injection site infection following implantation through previous scar have also been reported. Rare cases of granuloma and hyperpigmentation at the injection site have been reported. Erectile difficulties have been reported after treatment in the penis. Adverse events must be reported after treatment in the penis. Adverse events must be reported to the local Janovia Body Contour Gel representative Janovia Body Contour Gel distributor.
Treatment with Janovia Body Contour Gel in combination with drug and other devices has not been evaluated in controlled studies, other than use of lidocaine.
It is recommended that Janovia Body Contour Gel , is injected through a 15G, or blunt cannula. The cannula must be sterile.
ASSEMBLY OF CANNULA TO SYRINGE
For safe of Janovia Body Contour Gel it is important that the cannula is properly assembled to the syringe. It is important to use an appropriate cannula with a hub that fits the luer-lock in order to tighten the cannula hub to te bottom of the luer-lock of the syringe. Remove the tip cap of syrings. Grasp the hub. Press and turn it clockwise on the syringe untile it is tight. Make sure that the hub is as tightly fixed to the bottom of the luer-lock as possible. Different hubs may tighten at different.