FILLMED® ART FILLER® UNIVERSAL with Lidocaine

FILLMED® ART FILLER UNIVERSAL with Lidocaine is a high-performance hyaluronic acid (HA) dermal filler designed for treating moderate to deep facial wrinkles, especially nasolabial folds, and for volumizing targeted facial areas. Engineered with Tri-Hyal Technology, it combines long, very long, and free HA chains for optimal tissue integration, durability, and natural-looking results. Its formulation includes 25 mg/mL of HA and 0.3% lidocaine to enhance patient comfort during injections. Clinical trials showed that 100% of subjects maintained visible improvement at 12 months, and 98.4% still had improved results at 18 months, demonstrating its long-lasting effect and excellent tolerability. Evaluation by dermal high-frequency ultrasound confirmed no inflammatory nodules in the 18-month observation period, supporting the product’s high safety profile.

This product is indicated for deep dermal injections targeting moderate to severe wrinkles or volume loss.

Key Features:

• Formulated for nasolabial folds, marionette lines, and facial contouring
  
• Contains 25 mg/mL HA and 0.3% lidocaine for reduced injection discomfort
  

Protocol:

• Inject using 27G or 30G needles, typically 13 mm in length
  
• Administer into the deep dermis or subcutaneous tissue
  
• Typical dosage: 0.5–1.5 mL per session depending on the treated area
  
• Touch-up allowed after 14 days if needed
  
• Reinjection may be considered after 6 to 12 months based on patient results

Indications:

• Treatment of moderate to deep wrinkles, such as nasolabial folds
  
• Restoration of facial volume in areas like the cheeks and chin
  
• Facial contour enhancement
  

Contraindications:

• Known hypersensitivity to hyaluronic acid or lidocaine
  
• Presence of skin infections, inflammatory conditions, or autoimmune diseases
  
• Use in pregnant or breastfeeding women
  
• Patients under 18 years of age
  

Side Effects:

• Local swelling, redness, bruising
  
• Mild itching, tenderness, or discoloration
  
• Rare complications: granulomas, hypersensitivity reactions, nodules (none reported in clinical studies)

• Hyaluronic Acid (HA): 25 mg/mL, non-animal origin, cross-linked
  
• Lidocaine Hydrochloride: 0.3% for anesthetic effect
  
• Tri-Hyal Technology: synergistic blend of free, long-chain, and very long-chain HA

Each unit contains:

• 1 pre-filled 1.0 mL syringe
  
• 2 sterile 27G or 30G needles
  
• Traceability labels for medical record documentation
  
• Sterile packaging in a tamper-evident blister

Side effects are typically mild and self-limiting.

Common Side Effects:

• Redness, bruising, swelling, and pain at injection sites
  
• Transient itching or sensitivity
  

Rare Adverse Events:

• Nodules or lumps
  
• Hypersensitivity
  
• Delayed inflammatory responses
  

Safety Note:

• A blinded 18-month study found no inflammatory nodules using dermal high-frequency ultrasound evaluation

• Store between 2°C and 25°C
  
• Do not freeze
  
• Keep away from light and heat
  
• Single-use only; discard after opening
  
• Ensure aseptic handling before and during application