Sardenya Deep

Sardenya Deep

Sardenya Deep is a medium-density cross-linked hyaluronic acid (HA) dermal filler from RFBio Co., Ltd., South Korea. It contains 24 mg/ml HA and 0.3% lidocaine, and is intended for the correction of moderate to deep wrinkles and folds, such as the nasolabial folds, and for lip contouring, as specified in the official Instructions for Use (IFU). It is supplied in a 1.1 ml pre-filled syringe. For use by licensed physicians only.

主要特点

• Medium-Density Gel: Positioned between Sardenya Fine and Sardenya Shape for moderate to deep lines.
• HoPE Technology: The manufacturer’s Homogeneous Process and Equilibration method, designed for uniform cross-linking and a cohesive gel.
• HA 24 mg/ml: Cross-linked hyaluronic acid gel.
• With 0.3% Lidocaine: Included to help reduce discomfort during injection.
• Reversible: Hyaluronic acid can be dissolved with hyaluronidase by a qualified practitioner.

The Sardenya Range

The Sardenya range includes four gels of increasing density. The physician selects the product according to the treatment area, tissue depth and desired result.

• Sardenya Fine: The lightest gel, for fine lines and the lip contour.
• Sardenya Deep: Medium density, for moderate to deep wrinkles, nasolabial folds and lip contouring.
• Sardenya Shape: Volumising gel for contouring the cheeks, chin and jawline.
• Sardenya Implant: The densest gel, for structural augmentation in deeper layers.

预期用途

• Moderate to deep facial wrinkles and folds
• Nasolabial folds
• Lip contouring

Treatment area, injection depth, technique and volume must follow the official Instructions for Use and the treating physician’s assessment. Results and duration vary between individuals.

产品规格

• 品牌： Sardenya™
• Product: Sardenya Deep
• 制造商： RFBio Co., Ltd.
• 起源： South Korea
• Composition: Cross-linked hyaluronic acid 24 mg/ml, lidocaine 0.3%
• Gel Density: Medium
• Technology: HoPE (Homogeneous Process and Equilibration), manufacturer’s description
• Injection Depth: Mid to deep dermis, as specified in the IFU
• Contents: 1 × 1.1 ml pre-filled syringe
• 产品类型： Hyaluronic acid dermal filler (medical device)

施用

• For use only by licensed physicians trained in facial anatomy, dermal filler injection techniques and the management of filler complications.
• Inject under aseptic conditions.
• Injection depth, technique, volume and treatment interval must follow the IFU and the treating physician’s judgment.
• Do not self-administer.

防范措施

• Common reactions include redness, swelling, pain, tenderness, itching and bruising at the injection site.
• Lumps, nodules, asymmetry, infection and delayed inflammatory reactions may occur.
• Accidental injection into a blood vessel can cause vascular occlusion, skin necrosis and, rarely, visual impairment or blindness. The nasolabial folds and lips are higher-risk areas.
• Contains lidocaine. Not suitable for people with known allergy to lidocaine or other amide-type local anaesthetics.
• Hyaluronic acid can be dissolved with hyaluronidase. Practitioners should keep hyaluronidase and an emergency protocol available.
• Seek medical attention immediately for severe or increasing pain, skin blanching or colour change, or any change in vision after treatment.
• Do not use if the packaging is damaged, the syringe is cracked or the product is past its expiry date.
• Single use only. One syringe, one patient. Keep out of reach of children.

Who Should Consult a Physician First

• People with known allergy to hyaluronic acid, lidocaine or amide-type local anaesthetics
• Pregnant or breastfeeding women
• People with infection, inflammation, cold sores or skin disease at the treatment area
• People with bleeding disorders or taking medicines that affect blood clotting
• People with autoimmune disease, a history of keloids or severe allergies
• People with permanent fillers or implants in the treatment area
• People under 18 years of age

贮存

Store according to the instructions on the carton and in the IFU, in a dry place away from direct sunlight. Do not freeze. Refer to the carton for the expiry date.

Package Contents

• 1 × 1.1 ml pre-filled syringe of Sardenya Deep
• Instructions for Use

重要通知

For professional healthcare use only. This information is for general product reference. It does not replace medical advice, the official Instructions for Use or local regulations. This product is not intended to diagnose, treat, cure or prevent any disease. Results vary between individuals.