FILORGA® ART FILLER UNIVERSAL with Lidocaine

Product Description

FILORGA® ART FILLER UNIVERSAL is a premium cross-linked hyaluronic acid dermal filler designed for professional aesthetic applications. This sterile, transparent, and pyrogen-free gel contains 25 mg/mL of cross-linked hyaluronic acid, combined with 3 mg/mL lidocaine, for enhanced patient comfort during treatment. FILLMED Laboratories manufactures the filler and represents advanced technology in facial rejuvenation products.

Each package contains 2 pre-filled syringes of 1.2ml each, along with 4 sterile 27G needles and traceability labels. This medical device is exclusively reserved for qualified healthcare professionals who have received appropriate training in injection techniques.

FILORGA® ART FILLER UNIVERSAL Dosage and Administration

Key administration guidelines include:

• Maximum injection volume: 2ml per treatment site per session
• Injection depth: Mid to deep dermis
• Technique varies according to the treatment area
• Avoid over-correction during application

Ingredient Information

FILORGA® ART FILLER UNIVERSAL contains two primary active components:

1. Cross-linked hyaluronic acid (25mg/ml): A biocompatible substance naturally present in skin tissues, providing volume and hydration while supporting tissue structure.
2. Lidocaine (3mg/ml): A local anesthetic agent that ensures patient comfort during injection procedures by providing immediate pain relief at the injection site.

The formulation is sterile, non-pyrogenic, and derived from non-animal sources, ensuring biocompatibility and reducing the risk of allergic reactions.

Storage Instructions

Proper storage of FILORGA® ART FILLER UNIVERSAL is essential for maintaining product integrity:

• Store at controlled room temperature between 2°C and 25°C

• Protect from direct sunlight and extreme temperatures

• Do not use beyond the expiration date printed on product labels

• Maintain sterile conditions until use

FILORGA® ART FILLER UNIVERSAL Contraindications

This dermal filler should not be used in the following circumstances:

• • Patients with known hypersensitivity to hyaluronic acid or lidocaine
  • Individuals with an autoimmune disease history or receiving immunotherapy
  • Patients with uncontrolled epilepsy or porphyria
  • Those prone to hypertrophic scarring

• Pregnant or breastfeeding women

• Pediatric patients

• Areas with active inflammatory or infectious skin conditions
• Patients with recurrent angina associated with acute rheumatic fever

FILORGA® ART FILLER UNIVERSAL Precautions and Warnings

Healthcare professionals must observe specific precautions when administering this filler:

• Injection safety: Avoid intravascular injection, which may cause serious complications, including embolization, vision problems, or tissue necrosis.
• Patient selection: Exercise caution in patients with cardiac conduction disorders or hepatocellular insufficiency.
• Drug interactions: Consider potential interactions with anticoagulant medications, as these may increase the risk of bleeding.
• Pre-treatment guidelines: Patients should avoid aspirin and high-dose vitamins C and E for one week before treatment.
• Post-treatment care: No makeup application for 12 hours post-injection; avoid extreme temperatures and UV exposure for two weeks.

FILORGA® ART FILLER UNIVERSAL Manufacturer and Regulatory Information

FILLMED Laboratories manufactures FILORGA® ART FILLER UNIVERSAL under stringent quality control standards. The company maintains dedicated production facilities utilizing cutting-edge technology specifically designed for art filler manufacturing.

The manufacturer invests 20% of its annual revenue in research and development, ensuring continuous innovation in aesthetic medicine products. All syringes undergo individual manual and visual inspection to guarantee maximum quality and safety standards.