مشخصات
| پارامتر | اطلاعات محصول |
|---|---|
| شکل عرضه | 380 mg / vial |
| PLLA | 200 mg |
| H-HA | 40 mg |
| L-HA | 40 mg |
| مانیتول | 100 mg |
| اندازه ذرات | 10–60 µm |
| ترکیب | 52.6% PLLA / 21.1% HA / 26.3% mannitol |
فناوری و مواد
منبع، میکروسفرهای PLLA، پاسخ بافتی و تشکیل کلاژن را مبنای مفهوم فرمولاسیون معرفی می‌کند. مدل‌های 380 mg و400 mg ترکیبات و پارامترهای آماده‌سازی متفاوت دارند؛ مشخصات آن‌ها نباید ترکیب شود.
آماده‌سازی حرفه‌ای
| پارامتر | اطلاعات محصول |
|---|---|
| آب قابل تزریق | 9.5 mL |
| لیدوکائین | 2.5 mL / 2% |
| زمان هیدراتاسیون | 3 ساعت |
| اختلاط ورتکس | 1–2 دقیقه در ابتدا و انتها |
برنامه ذکرشده توسط سازنده
سازنده 2–3 جلسه با فاصله حدود 4 هفته و اثر تخمینی 18–24 ماه پس از دوره اولیه را ذکر می‌کند. برنامه فردی را پزشک تعیین می‌کند و دوام اثر متفاوت است.
کاربری و مراقبت پس از آن
آماده‌سازی و پیگیری را پزشک معالج تعیین می‌کند. درد، کبودی، تورم و ندول ممکن است رخ دهد. با جذب مایع آماده‌سازی، ظاهر اولیه می‌تواند تغییر کند.
جزئیات کامل منبع انگلیسی
متن کامل انگلیسی راهنمای محصول در پایین حفظ شده است. معرفی و جدول‌های ترجمه‌شده بالا بازآرایی ساختاریافته مطالب هستند؛ فایل PDF سند اصلی سازنده یا منبع است.
Si Belle PLLA380+ combines 200 mg poly-L-lactic acid (PLLA), 40 mg high-molecular-weight hyaluronic acid, 40 mg low-molecular-weight hyaluronic acid and 100 mg mannitol in a 380 mg vial. The product information describes facial volume loss, wrinkles and contour concerns, and explains a progressive process involving PLLA microspheres, tissue response and collagen formation.
A four-ingredient formulation
Each vial contains PLLA 200 mg, H-HA 40 mg, L-HA 40 mg and mannitol 100 mg, for a total content of 380 mg.
The formulation combines PLLA microspheres with hyaluronic acid. PLLA-related tissue response is part of the manufacturer’s formulation rationale.
| Component | Amount per vial | Share stated in the catalogue |
|---|---|---|
| Poly-L-lactic acid (PLLA) | 200 mg | 52.6% |
| Hyaluronic acid: H-HA 40 mg + L-HA 40 mg | 80 mg total | 21.1% |
| Mannitol | 100 mg | 26.3% |
| Total | 380 mg | 100% |
PLLA material and microspheres
PLLA is poly-L-lactic acid, a polymer formed from L-lactic acid units. The supplied catalogue discusses biodegradation and the biological response around PLLA particles.
The product has a stated microsphere particle range of 10-60 µm. PLLA and HA are biodegradable materials.
Role and principle
The manufacturer describes a progressive process involving PLLA microspheres, tissue response and collagen formation.
| Stage | Description |
|---|---|
| 1. PLLA microspheres | Microspheres are introduced into the treatment area. |
| 2. Tissue response | The proposed process involves cell migration around the particles. |
| 3. Collagen formation | The manufacturer links this tissue response with collagen formation. |
Facial areas and treatment planning
The product information describes facial volume loss, wrinkles and contour concerns. Area selection and suitability are assessed by the treating clinician.
- Forehead
- Cheekbones
- Cheeks
- Nasolabial folds
- Chin
Professional preparation: 380 mg model
Preparation, treatment and follow-up are planned by the treating clinician for the individual patient. The following technical parameters are reproduced from the 380 mg model information.
| Parameter | Preparation details |
|---|---|
| Vial content | 380 mg |
| Water for injection | 9.5 mL |
| Lidocaine | 2.5 mL of 2% lidocaine |
| Hydration time | 3 hours |
| Vortex mixing | 1-2 minutes at the beginning and end |
Treatment schedule and reported duration
The manufacturer describes 2-3 sessions, approximately 4 weeks apart. The treating clinician determines the individual treatment plan.
The manufacturer cites an effect of approximately 18-24 months after an initial 2-3 sessions. This is a reported estimate; individual durability varies.
Aftercare and follow-up
Discuss swelling, skin changes and follow-up timing with your treating clinician.
Massage, cooling and other home-care measures should follow the treating clinician’s individual instructions.
Pain, bruising, injection marks and swelling may occur. Recovery and return to activities depend on the individual clinical response.
Nodules can occur and may require further treatment. The treating clinician assesses and manages individual concerns.
The manufacturer attributes some early volume to the preparation fluid. Swelling and appearance can change as that fluid is absorbed.
Questions and answers
| Question | Answer |
|---|---|
| Who is the facial treatment intended for? | The product information describes facial volume loss, wrinkles and contour concerns. Suitability is assessed for each patient. |
| What is in each vial? | PLLA 200 mg, H-HA 40 mg, L-HA 40 mg and mannitol 100 mg, for a total content of 380 mg. |
| How does it differ from an HA-only filler? | The formulation combines PLLA microspheres with hyaluronic acid. PLLA-related tissue response is part of the manufacturer’s rationale. |
| Are the polymer materials biodegradable? | PLLA and HA are biodegradable materials. Material characteristics do not replace an assessment of the finished product and patient. |
| What is the recommended treatment schedule? | The manufacturer describes 2-3 sessions, approximately 4 weeks apart. The treating clinician determines the individual treatment plan. |
| How long does the manufacturer report an effect? | Approximately 18-24 months after an initial 2-3 sessions. This is a reported estimate; individual durability varies. |
| What about recovery and daily activities? | Pain, bruising, injection marks and swelling may occur. Recovery and return to activities depend on the individual clinical response. |
| Can nodules occur? | Nodules can occur and may require further treatment. The treating clinician assesses and manages individual concerns. |
| Why can early appearance change after treatment? | The manufacturer attributes some early volume to the preparation fluid. Swelling and appearance can change as that fluid is absorbed. |
| How are bleeding or bruising addressed? | Bleeding and bruising are discussed in the product information. The treating clinician assesses and manages these concerns. |
Manufacturer application examples
The supplied brochure includes two nasolabial-region photograph sets: before and after 2 months; before and after 3 months.
استعلام حرفه‌ای
نام شرکت، کشور مقصد، مدل و تعداد موردنیاز را ذکر کنید. برنامه ایمیل باز می‌شود؛ استعلام خودکار ارسال یا ذخیره نمی‌شود.
alexmoon@ictmedicalco.com ↗