REVANESSE® ULTRA™ with Lidocaine

REVANESSE® ULTRA™ is a cross-linked hyaluronic acid dermal filler designed to treat moderate to severe facial wrinkles, restore volume loss, and correct contour deficiencies. It is a sterile, transparent, and colorless gel of synthetic origin, preloaded in 1.2 mL syringes and includes 0.3% lidocaine for enhanced patient comfort during procedures. This filler is commonly used for deep wrinkle correction, lip augmentation, and facial volume restoration, with results lasting approximately 6 to 12 months depending on treatment area and depth. Its formulation is highly cohesive, making it ideal for mid to deep dermal implantation, and it is manufactured by Prollenium Medical Technologies Inc. for professional use only.

• Indicated for facial rhytides, lipodystrophy, and volume loss
• Contains 25 mg/mL hyaluronic acid + 0.3% lidocaine
• Effects typically last 6–12 months
• Supplied in two 1.2 mL prefilled syringes with 27G needles

REVANESSE® ULTRA™ must be injected intradermally by trained medical professionals using sterile technique. The product should reach room temperature for 30 minutes prior to use for optimal performance.

• Inject slowly using minimal pressure
• Use sterile 27G needles supplied with the kit
• Massage the area if skin blanching occurs
• Do not reuse syringes or needles
• Avoid injecting into areas containing other fillers or implants

REVANESSE® ULTRA™ is used for cosmetic and reconstructive purposes, including wrinkle correction and volume loss from lipoatrophy. It is contraindicated in patients with hypersensitivity, autoimmune conditions, or active skin disease.

Indications:

• Moderate to severe facial wrinkles
• Facial contour correction (e.g., lipoatrophy, trauma)
• Lip augmentation
• Hydration and volume restoration

Contraindications:

• Pregnancy or breastfeeding
• Allergy to lidocaine or gram-positive bacterial proteins
• Under 18 years of age
• Hypertrophic scarring, autoimmune disorders, coagulation defects
• Current infection, acne, or skin inflammation at injection site

Side Effects:

• Mild: Redness, swelling, itching, tenderness, lasting up to 1 week
• Moderate: Nodules, induration, hypersensitivity reactions
• Rare: Glabellar necrosis, abscess, granulomas, vascular occlusion
• <1 in 1500 experience delayed hypersensitivity

The formulation combines cross-linked hyaluronic acid with lidocaine in a buffered solution for effective and comfortable dermal implantation.

• 25 mg/mL cross-linked hyaluronic acid
• 0.3% lidocaine (3 mg/mL)
• Phosphate-buffered saline
• Cross-linked with Butanediol-diglycidyl ether (BDDE)

Each retail unit is packaged for single-use, clinical safety, and convenience.

• Two 1.2 mL prefilled syringes
• Up to two 27G sterile needles
• Sterile blister packaging
• Instructions for use leaflet

Like all dermal fillers, REVANESSE® ULTRA™ may cause temporary local or delayed reactions. Most are mild and resolve spontaneously.

• Injection site effects: redness, swelling, itching, pain, discoloration (≤1 week)
• Delayed effects: nodules, firmness, hypersensitivity (<1 in 1500)
• Rare: vascular complications, glabellar necrosis, granulomas
• Patient should report any inflammation lasting >1 week

Proper storage is necessary to maintain product stability and sterility.

• Store at 2°C to 25°C
• Do not freeze
• Protect from direct sunlight
• Allow to reach room temperature for 30 minutes before use
• Check the expiration date on each syringe