SKformula Sodium Hyaluronate Solution for Mesotherapy
【Product Name】
SKformula Sodium Hyaluronate Solution for Mesotherapy
【Model and Specification】
10mg/mL: 0.5mL, 1.0mL, 1.5mL, 2.0mL, 2.5mL, 3.0mL
【Description】:
The product consists of a pre-filled syringe and a sodium hyaluronate solution enclosed in the pre-filled syringe. The sodium hyaluronate solution is composed of sodium hyaluronate, sodium chloride, phosphate buffer salts and water for injection. Among them, the sodium hyaluronate raw material is obtained by microbial fermentation, and the labeled concentration of sodium hyaluronate is 10mg/mL. The sodium hyaluronate solution enclosed in the pre-filled syringe is sterilized by high-temperature steam. This product is for single use only.
【Indications】:
It is used in medical institutions and is intended for injection into the dermal layer of the skin (e.g., face, neck, hands, etc.). It can significantly boost hydration, enhance skin elasticity of sagging skin, improve dull skin tone, and smooth away fine lines.
【Mode of Action】:
After high-molecular-weight hyaluronic acid is injected into the dermal layer of the skin, the carboxyl groups and other polar groups in hyaluronic acid molecules can form hydrogen bonds with water to bind a large amount of moisture. This enhances the skin's hydration capacity, increases skin volume to fill superficial wrinkles, and improves skin moisture content from the inside out under the action of aquaporins—significantly boosting the moisture content of the stratum corneum, reducing fine lines, and enhancing skin elasticity. Meanwhile, sodium hyaluronate can also stimulate the proliferation of fibroblasts and promote the synthesis of collagen, which further enhances skin elasticity and helps restore firmness to sagging skin.
【Contraindications】:
1. It is contraindicated in patients with a history of autoimmune diseases or those undergoing immunotherapy;
2. It is contraindicated in patients with a history of severe allergic reactions;
3. It is contraindicated in patients with a scar-forming diathesis;
4. It is contraindicated to use on the areas affected by skin inflammation and/or infection (such as acne, herpes, etc.) or on the adjacent areas.
【Warnings】:
1.This product is restricted to use by personnel with relevant professional physician qualifications, and must be used strictly in accordance with the requirements of the product instruction manual and relevant clinical practice guideline.
2. This product is for single use only. Do not re-sterilize or use it in separate portions.
3. This product is strictly prohibited from being mixed with other injectable products.
4. Before use, please check the product specification and expiration date and batch number.
5. If the package is damaged, do not use the product.
6. This product is only for intradermal injection and must not be injected into blood vessels. Injection of this product into blood vessels may block the vessels, leading to infarction or embolism.
【Instructions for Use】:
1. Before Treatment: Physicians should assess whether this product is suitable for the patient. Prior to using this product for treatment, they should fully understand the patient’s medical history and clearly inform the patient of information such as the product’s scope of application, contraindications, warnings, precautions, side effects, and injection method. After confirming that the patient has thoroughly cleaned the treatment area, disinfect the injection area. Local anesthesia may be administered at the injection site as requested by the patient. The product should only be opened when ready for use.
2. The appropriate injection technique and injection equipment should be selected based on the patient's actual condition.
3. Injection Dosage and Frequency: One treatment course consists of three injections, with an interval of 4 weeks between each injection.
4. After Treatment: After injection, cold compresses may be applied for 20-30 minutes as needed. Do not clean or apply makeup to the treated area within 24 hours to avoid local infection. Within 1 week after injection, pay attention to sun protection, try to avoid eating irritating foods, and refrain from using saunas or engaging in strenuous exercise. Any abnormal conditions after use should be promptly reported to the physician.
【Assembly of this Product with Electronic Injector and Injection Needle】:
1. Conduct pre-operative preparations in accordance with the instructions for use of the electronic injector and injection needle.
2. Hold the syringe of this product and unscrew the protective cap from the syringe.
3. Accurately insert the injection needle connector into the Luer connector of the syringe, then rotate the injection needle clockwise to tighten it. There should be no skewing or gaps to ensure secure installation.
4. Push the syringe plunger to remove the air inside the injection needle, and confirm that the product is extruded from all needles.
5. Connect the injection needle to the suction tube.
6. Mount the syringe onto the electronic injector.
7. Use your thumb to insert the head of the syringe into the corresponding position of the front card slot.
8. Use your thumb to gently press the syringe into the syringe holder.
【Pre-Market Clinical Trial Information】:
1. Purpose of Clinical Trial: To evaluate the efficacy and safety of sodium hyaluronate solution for injection in improving facial skin condition.
2. Clinical Trial Design: A prospective, multi-center, randomized, placebo-controlled, assessor-blinded, and superiority clinical trial design was conducted. A total of 484 subjects were enrolled, with a 3-month follow-up period. The subjects were adults in need of temporary improvement in facial skin condition (such as dry skin and dull skin tone).
3. Efficacy Evaluation Indicators: Skin improvement effective rate, Global Aesthetic Improvement Scale (GAIS) effective rate, evaluation of dull skin tone improvement effect, subject satisfaction score, fine line scale, treatment effective rate (skin roughness scale), skin moisture, and skin elasticity.
4. Safety Evaluation Indicators: Adverse events, expected injection-related reactions, laboratory tests, device defects, and vital signs.
5. Summary of Clinical Trial Results and Conclusions: In terms of efficacy evaluation, the proportion of patients with sustained skin improvement for 4 weeks was 92.6%, and for 3 months was 89.1%; the proportion of patients with sustained Global Aesthetic Improvement Scale (GAIS) effect for 4 weeks was 93.9%, and for 3 months was 89.5%. The effective rate of the test group was superior to that of the blank control group (no product injected). Among the evaluation indicators, the differences between groups in the evaluation of dull skin tone improvement effect, subject satisfaction score, fine line scale, treatment effective rate (skin roughness scale), skin moisture, and skin elasticity were all statistically significant.
6. In terms of safety evaluation, some patients in the test group experienced relatively common local reaction symptoms after the injection, such as redness, swelling, fever, itching, bruising and ecchymosis. Most of these symptoms would recover on their own within 1 to 2 weeks. The safety and effectiveness of the product met clinical expectations, and the test equipment was safe and reliable in clinical applications.
【Expected Adverse Reactions】:
1. Pain may occur during injection. There are individual differences due to varying personal pain thresholds, and it also depends on certain specific factors, such as the depth of the injection site layer, the proficiency of injection techniques, and post-injection management. To alleviate this, the use of topical anesthetics or ice compresses may be considered.
2. A small amount of local bleeding may occur after injection, which can stop spontaneously within a short period.
3. If allergic reactions such as rash occur during injection, the use of the product should be stopped immediately.
4. The skin barrier system may be damaged during injection, which may lead to infection. The following measures must be taken to prevent infection:
A. Before use, confirm that the package of the sodium hyaluronate solution for injection is intact;
B. Strictly disinfect the surgical area;
C. Provide the patient with appropriate and reasonable post-injection advice and guidance.
5. After injection, complications or side effects such as induration, itching, pain, redness and swelling, fever, bruising, congestion, ecchymosis, infection, local inflammatory reaction, scar formation, skin erosion, necrosis, skin pigmentation, displacement or protrusion of the implant, nodules, granulomas, needle hole formation, failure to achieve the expected correction effect, and allergies may occur. Improper injection may lead to severe complications such as facial nerve injury, syncope, and blindness.
6. Any adverse reactions encountered during use can be directly reported to the distributor, or feedback can be submitted to the manufacturer by visiting https://www.singclean.net/
【Precautions】:
1. This product must be used with caution after carefully reading the Instructions for Use. Failure to use it in accordance with the Instructions may compromise the sterility of the product, and thus its effectiveness cannot be guaranteed.
2. If the product is found to be turbid, discolored, or has precipitates, do not use it.
3. This product is a single-use medical device. All remaining product, syringes, and needles must be discarded after use and handed over to the medical waste recycling department for special disposal.
4. If laser therapy, chemical peeling, or any other skin-reaction-based treatment is received after injection therapy with this product, there is a risk of inducing an inflammatory reaction at the injection implantation site. Similarly, if injection therapy with this product is received before the skin has fully recovered after undergoing the aforementioned treatments, there is also a risk of an inflammatory reaction occurring at the injection implantation site.
5. The safety and efficacy of this product for use in pregnant women, lactating women, and minors have not been verified by clinical trials.
6. For patients taking drugs that affect platelet function, any injection procedure may cause bruising at the injection site or trigger a bleeding reaction.
【Shelf Life and Storage Conditions】:
Shelf Life is 2 years. Store in a dry environment at 2-30℃; freezing is not allowed.
8.69.04.0311-A0
Issue Date: 2025.12.17
