CE Singfiller® (Cross-linked Sodium Hyaluronate Gel for Plastic Surgery)
CE1023
Composition
Sodium Hyaluronate ………………..20 mg/mL
NaCl ……………………………...…..…..8.5 mg/mL
Na2HPO4………………………..…..…..0.34 mg/mL
NaH2PO4………………………..…......0.25 mg/mL
Water for injection …………...…..….........q.s.
Description
Singfiller® (Cross-linked Sodium Hyaluronate Gel for Plastic Surgery) is a sterile, transparent gel of stabilized hyaluronic acid of origin. Singfiller® is supplied in a glass syringe with a luer-lock fitting. The contents of the syringe have been sterilized using moist heat. The product is for single use only. Disposable sterile needle is provided with each syringe. Information about the sterilization method of the needle is printed on its packaging.The needle is sterilized by radiation or ethylene oxide. The number of units per package and the volume contained in each syringe is as stated on the outer package.
Singfiller® includes four specifications, FINE, DERM, DEEP, DEEPER, the information and differences of the four specifications are shown in Table 1.
Intended use
Singfiller® is intended to be used for facial tissue augmentation. It is recommended to be used for the correction of wrinkles and for lip enhancement after accidents and trauma. Singfiller® FINE and DERM are intended for application in the epidermis, Singfiller® DEEP is intended to be applied in the papillary dermis, and Singfiller® DEEPER is intended to be applied in the reticular dermis or subcutaneous tissue shallow.
Mode of action
Singfiller® is a filler that adds volume to the tissue, thereby restoring the skin contours or enhancing the lips to the desired level of correction. The volume and the lifting capacity originate from the ability of hyaluronic acid to attract high amount of water, which is further increased by the stabilization process.
Singfiller® will in time undergo euvolemic degradation, which means that the product maintains its volume even during degradation.
Warning
● Singfiller® is only intended for use as an intradermal implant.
● Do not inject intravascularly. As for other injectable medical devices, inadvertent injection into blood vessels could potentially lead to vascular occlusion, ischemia and necrosis. Aspiration prior to injection is recommended.
● If blanching is observed, i.e. the overlying skin turns a whitish colour, the injection should be stopped at once and the area massaged until it returns to a normal colour.
● Do not use in patients with bleeding disorders or in patients who are taking thrombolytics or anticoagulants.
● Do not resterilize Singfiller®.
● Do not mix with other products prior to injection of the device.
● Singfiller® has to be used only once on a single patient during a single procedure.
Precautions
General considerations relevant to injectable medical devices
● Injection procedures are associated with a risk of infection. Aseptic technique and standard practice to prevent cross-infections are to be observed.
● Special caution should be exercised when treating areas in close proximity to permanent implant or vulnerable structures such as nerves, vessels, and other vital structures.
● Do not use where there is active disease such as inflammation, infection or tumours, in or near the intended treatment site.
● Injection procedures can lead to reactivation of latent or subclinical herpes viral infections.
● Patients who are using substances that affect platelet function, such as aspirin and non-steroidal 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.
● Do not use the product if package is damaged
Specific considerations relevant to the use of Singfiller®
● Do not inject Singfiller® into an area where another injectable implant is present, except for other products from the Singfiller® range of products. Singfiller® should not be injected into an area where a non-injectable implant has been placed.
● The patient should minimize exposure of the treated area to excessive sun or extreme cold at least until any initial swelling and redness has resolved.
● If laser treatment, chemical peeling or any other procedure based on active dermal response is performed after treatment with Singfiller®, there is a theoretical risk of eliciting an inflammatory reaction at the implant site. This also applies if Singfiller® is administered before the skin has healed completely after such a procedure.
● It is recommended that the human safety dosage is no more than 25 mL of Singfiller® per 60kg body mass per year.
● The interval between two injections should be at least 4 weeks.
Contraindication
Singfiller® must not be used in pregnant or breast-feeding women or children.
Anticipated injection-related reactions
After the injection of Singfiller®, some common injection-related reactions might occur. These reactions include erythema, swelling, pain, itching, bruising or tenderness at the implant site. Typically resolution is spontaneous within a few days after injection into the skin and within a week after injection into the lips.
Adverse events
The most common adverse events reported post marketing for the Singfiller® range of products are swelling, bruising, erythema, mass, pain and tenderness.
Rare cases of the following adverse events have been reported and these include pruritus, hypersensitivity reactions, reactivation of subclinical herpes infection in the face, acne-like lesions, granuloma, blisters, vesicles, induration, swelling of the face, urticaria, dermatitis, scarring or skin atrophy, short duration of effect, ischemia, injection site necrosis and telangiectasia.
Isolated rare cases of transient visual disturbance following inadvertent intra-arterial injection in the upper half of the face have been reported.
Symptoms of inflammation including a combination of redness, swelling, tenderness and induration at the implant site have been reported. These reactions may commence either shortly after injection or after a delay of 2-4 weeks. Infections should be excluded or treated if necessary. In pronounced cases a short course of oral corticosteroids may prove effective for implant site inflammation. For patients who have experienced clinically significant reactions, a decision for retreatment should take into consideration the cause and significance of previous reactions.
Post inflammatory pigmentation changes due to deposit of melanin have been observed in clinical studies in people with dark skin.
Adverse events must be reported to Singfiller® distributor.
Performance
In a controlled multicenter study with Singfiller® for the correction of nasolabial folds 70% of the subjects maintained a clinically significant improvement 6months after treatment.
In a controlled multicenter study with Singfiller® using a retreatment schedule at 4.5 months or 9 months for correction of nasolabial folds, 95% of the nasolabial folds maintained a clinically significant improvement 18 months after the initial treatment.
Assembly of needle to syringe
For safe use of Singfiller®, it is important that the needle is properly assembled to the syringe. Improper assembly may result in separation of the needle and
syringe during injection. Use the thumb and forefinger to hold firmly around both the glass syringe barrel and the luer-lock adapter.
Grasp the needle shield with the other hand. To facilitate proper assembly, both push and rotate firmly. See picture.
Treatment procedure
The correct injection technique is important for the final result of the treatment. The product must be used by medical practitioners who have undertaken specific training in injection techniques for filling. Before starting the treatment the patient shall be informed about the indications, expected result, precautions and potential adverse events. The patient's need for pain relief should be assessed. For optimal patient comfort, topical or local anaesthesia is recommended when treating wrinkles. For lip augmentation, anaesthesia through a nerve block can be used.
•Clean the treatment site thoroughly with a suitable antiseptic solution.
•To avoid needle breakage, do not attempt to bend the needle.
•Before injecting, remove the air by pressing the rod carefully until a small droplet is visible at the tip of the needle.
•Aspiration prior to injection is recommended.
•Inject slowly into the dermis while pulling the needle backwards using the needle provided. Injection should stop just before the needle is pulled out from the skin to prevent material from leaking out from the injection site.
•For each treatment site a maximum dosage of 2 mL per treatment session is recommended.
•Defects shoule be fully corrected, but not overcorrected, at each treatment session.
•The correction site should be massaged to conform to the contour of the surrounding tissues.
•lf the skin of the patient is very loose, it is recommended that Singfiller® be injected on two or more separate occasions.
•After the first treatment，additional implantations of Singfiller® may be necessary to achieve the desired level of correction. Periodic follow-up injections help sustain the desired degree of correction.
•Depending on desired effect of contouring, degree of correction and individual patient need it may in some cases be beneficial to combine different products from the Singfiller® range of products.
The syringe, the needle and any unused material must be discarded immediately after the treatment session and must not be reused due to risk for contamination of the unused material and the associated risks including infections. Disposal should be in accordance with accepted medical practice and applicable national, local or institutional guidelines.
Storage condition
1.Temperature:0 ℃-30℃ , Relative humidity≤80%
2.No corrosive gas, dry, well ventilated
3.Avoid direct exposure to the sunlight and freezing
Latest version 8.08.04.310 B5 lssued date: 2022-04-24
