CELOSOME SOFT WITH LIDOCAINE

Celosome Soft with Lidocaine

Celosome Soft with Lidocaine is a cross-linked sodium hyaluronate gel dermal filler from ExoCoBio, South Korea. It is the softest filler in the Celosome range and is designed for superficial injection to treat fine lines and to define the lip contour. It contains 0.3% lidocaine to improve comfort during injection. Each box contains one 1.1 ml pre-filled syringe. For use by licensed physicians only.

主要特点

• Softest Filler in the Range: The softest gel among the Celosome fillers, intended for superficial lines.
• Cross-Linked HA of Non-Animal Origin: Sodium hyaluronate gel, 24 mg/ml. According to the manufacturer, it is produced with HENM cross-linking technology and a multi-stage membrane purification process.
• With 0.3% Lidocaine: Helps reduce discomfort during injection.
• 可逆：由具备资质的专业人员使用透明质酸酶，即可溶解透明质酸。

The Celosome Range

The Celosome range includes products with different gel firmness. The physician selects the product according to the treatment area and tissue depth.

• Celosome Aqua: A skin booster for skin hydration, injected superficially.
• Celosome Soft: The softest filler, for fine lines and lip contour, injected superficially.
• Celosome Mid: For moderate wrinkles and folds, injected into the mid to deep dermis.
• Celosome Strong: For deep folds and facial volume, injected into the deep dermis to subcutaneous layer.
• Celosome Implant: The firmest gel, for facial contour, injected into the deep subcutaneous layer.

预期用途

• Fine forehead lines
• Lateral periorbital fine lines (crow’s feet)
• Perioral fine lines
• Lip contour definition and mild lip volume

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： Celosome
• Product: Celosome Soft with Lidocaine
• Company: ExoCoBio
• 起源： South Korea
• Composition: Cross-linked sodium hyaluronate 24 mg/ml (non-animal origin), lidocaine 0.3%
• Injection Depth: Superficial (between the epidermis and dermis)
• Contents: 1 × 1.1 ml pre-filled syringe, needles
• Shelf Life: Refer to the carton for the expiry date.
• 产品类型： Hyaluronic acid dermal filler (medical device)

施用

• For use only by licensed physicians trained in facial anatomy, filler injection techniques and the management of filler complications.
• Check that the packaging is intact and the product is within its expiry date before use.
• Inject under aseptic conditions at the depth specified in the IFU. Inject slowly in small amounts.
• Not intended for deep folds, facial volume or contour. Other products in the range are designed for those uses.
• Confirm the patient has no allergy to lidocaine or other amide-type local anaesthetics before use.
• Each syringe is for a single patient. Injection technique, volume and treatment interval must follow the IFU and the treating physician’s judgment.
• Do not self-administer.

禁忌症

General contraindications for hyaluronic acid fillers containing lidocaine are listed below. Refer to the official Instructions for Use for the complete list.

• Known hypersensitivity to hyaluronic acid, lidocaine or other amide-type local anaesthetics
• History of severe allergies or anaphylaxis
• Active infection, inflammation, wounds or skin disease at or near the injection site
• 怀孕或哺乳期
• Persons under 18 years of age

Who Should Consult a Physician First

• People with autoimmune disease, diabetes or epilepsy
• People with bleeding disorders or taking anticoagulant or antiplatelet medication
• People with a history of cold sores (herpes labialis), especially before lip treatment
• People with a tendency to hypertrophic scars or keloids
• People with heart rhythm disorders, severe liver disease or porphyria
• People with permanent fillers or implants in the treatment area

防范措施

• Common reactions include redness, swelling, pain, tenderness, itching and bruising at the injection site. Swelling may be more noticeable after lip treatment.
• Lumps, nodules, asymmetry, visible product or bluish discolouration in superficial placement, 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 lips and perioral area contain major arteries.
• Lip treatment may trigger a cold sore outbreak in people with a history of herpes labialis.
• 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 open or damaged, the syringe is cracked or the product is past its expiry date.
• Single use only. One syringe, one patient. Do not re-sterilise. Keep out of reach of children.

After Treatment

Follow the aftercare instructions given by the treating physician. Strenuous exercise, heat exposure and pressure on the treated area are generally avoided for the first 24 hours. Report any adverse reaction to the treating physician.

贮存

Store at 2–25°C. Protect from direct sunlight and freezing. Refer to the carton for storage conditions and the expiry date.

Package Contents

• 1 × 1.1 ml pre-filled syringe of Celosome Soft with Lidocaine
• Needles
• 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.