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Description
Runxin Biotech (Cross-linked Sodium Hyaluronate Gel for Plastic Surgery) is a sterile, transparent gel of stabilized hyaluronic acid of origin. Hyaluronic acid (HA) dermal fillers are composed of the naturally occurring hyaluronic acid and are used to fill in facial wrinkles, restore lost volume, enhance the lips, fill in acne scars, and provide contouring and definition to the jawline. With the hydrophilic hyaluronic acid, HA fillers are able to plump and hydrate the skin, filling in nasolabial folds, marionette lines, glabellar lines, under eye hollows, and provide volume to thinning lips and a receding chin. The naturally occurring hyaluronic acid means there is a very low risk for allergic reactions or adverse events, and the long-lasting treatment can be performed with no downtime.
Runxin Biotech 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.
Runxin Biotech includes four specifications, FINE, DERM, DEEP, DEEPER, the information and differences of the four specifications are shown in Table 1.
Intended use
Runxin Biotech 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. Runxin Biotech FINE and DERM are intended for application in the epidermis, Runxin Biotech DEEP is intended to be applied in the papillary dermis, and Runxin Biotech DEEPER is intended to be applied in the reticular dermis or subcutaneous tissue shallow.
Mode of action
Runxin Biotech 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.
Runxin Biotech will in time undergo euvolemic degradation, which means that the product maintains its volume even during degradation.
Warning
● Runxin Biotech 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 Runxin Biotech.
● Do not mix with other products prior to injection of the device.
● Runxin Biotech 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 Runxin Biotech
● Do not inject Runxin Biotech into an area where another injectable implant is present, except for other products from the Runxin Biotech range of products. Runxin Biotech 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 Runxin Biotech, there is a theoretical risk of eliciting an inflammatory reaction at the implant site. This also applies if Runxin Biotech 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 Runxin Biotech per 60kg body mass per year.
● The interval between two injections should be at least 4 weeks.
Contraindication
Runxin Biotech must not be used in pregnant or breast-feeding women or children.
Anticipated injection-related reactions
After the injection of Runxin Biotech, 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.
Performance
In a controlled multicenter study with Runxin Biotech for the correction of nasolabial folds 70% of the subjects maintained a clinically significant improvement 6months after treatment.
In a controlled multicenter study with Runxin Biotech 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 Runxin Biotech, 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 Runxin Biotech be injected on two or more separate occasions.
•After the first treatment,additional implantations of Runxin Biotech 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 Runxin Biotech 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
Description
Runxin Biotech (Cross-linked Sodium Hyaluronate Gel for Plastic Surgery) is a sterile, transparent gel of stabilized hyaluronic acid of origin. Hyaluronic acid (HA) dermal fillers are composed of the naturally occurring hyaluronic acid and are used to fill in facial wrinkles, restore lost volume, enhance the lips, fill in acne scars, and provide contouring and definition to the jawline. With the hydrophilic hyaluronic acid, HA fillers are able to plump and hydrate the skin, filling in nasolabial folds, marionette lines, glabellar lines, under eye hollows, and provide volume to thinning lips and a receding chin. The naturally occurring hyaluronic acid means there is a very low risk for allergic reactions or adverse events, and the long-lasting treatment can be performed with no downtime.
Runxin Biotech 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.
Runxin Biotech includes four specifications, FINE, DERM, DEEP, DEEPER, the information and differences of the four specifications are shown in Table 1.
Intended use
Runxin Biotech 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. Runxin Biotech FINE and DERM are intended for application in the epidermis, Runxin Biotech DEEP is intended to be applied in the papillary dermis, and Runxin Biotech DEEPER is intended to be applied in the reticular dermis or subcutaneous tissue shallow.
Mode of action
Runxin Biotech 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.
Runxin Biotech will in time undergo euvolemic degradation, which means that the product maintains its volume even during degradation.
Warning
● Runxin Biotech 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 Runxin Biotech.
● Do not mix with other products prior to injection of the device.
● Runxin Biotech 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 Runxin Biotech
● Do not inject Runxin Biotech into an area where another injectable implant is present, except for other products from the Runxin Biotech range of products. Runxin Biotech 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 Runxin Biotech, there is a theoretical risk of eliciting an inflammatory reaction at the implant site. This also applies if Runxin Biotech 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 Runxin Biotech per 60kg body mass per year.
● The interval between two injections should be at least 4 weeks.
Contraindication
Runxin Biotech must not be used in pregnant or breast-feeding women or children.
Anticipated injection-related reactions
After the injection of Runxin Biotech, 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.
Performance
In a controlled multicenter study with Runxin Biotech for the correction of nasolabial folds 70% of the subjects maintained a clinically significant improvement 6months after treatment.
In a controlled multicenter study with Runxin Biotech 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 Runxin Biotech, 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 Runxin Biotech be injected on two or more separate occasions.
•After the first treatment,additional implantations of Runxin Biotech 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 Runxin Biotech 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