REVANESSE® ULTRA™ with Lidocaine

Description

Name:REVANESSE® ULTRA™ with Lidocaine
Manufacturer: Prollenium Medical Technologies Inc
Active Substance(s): HYALURONIC ACID, LIDOCAINE
Strength: 25mg HA, 3mg/ml Lidocaine
Pack Size: 2-1.2ml prefilled syringes
Accessories: 2 x 1.2ml Pre-Filled Syringes, 2 x Needles

REVANESSE® ULTRA™+ with Lidocaine is a cross-linked hyaluronic acid (HA) dermal filler developed for the treatment of moderate to severe facial wrinkles and lipoatrophy. The product contains 25 mg/mL of HA and 0.3% lidocaine, providing a smooth, transparent, and odorless gel suitable for intradermal injection. Designed to restore facial volume and contour, it delivers long-lasting results, typically lasting 6 to 12 months, depending on injection depth and anatomical site.

Manufactured by Prollenium Medical Technologies Inc., REVANESSE® ULTRA™+ is intended for use by trained healthcare professionals. The added lidocaine minimizes patient discomfort during treatment. It is packaged in sterile, single-use syringes for precise and safe application.

• 25 mg/mL cross-linked hyaluronic acid for durable facial volume restoration
• 0.3% lidocaine for improved injection comfort
• 6 to 12 months of average aesthetic longevity

The product is delivered in single-use, sterile packaging, offering convenience and safety in clinical environments. Each unit is prepared for direct professional administration.

Packaging contents:

• • Two 1.2 mL pre-filled syringes
  • Up to two sterilized 27G needles
  • Glass syringes with tamper-evident Luer-lock closures
    

Active ingredients:

• • Hyaluronic Acid: 25 mg/mL, cross-linked with BDDE (Butanediol Diglycidyl Ether)
  • Lidocaine Hydrochloride: 0.3% w/w
  • Phosphate Buffered Saline: isotonic carrier medium

Revanesse® Ultra™+ is indicated for the correction of facial rhytides (wrinkles) and tissue volume loss caused by lipoatrophy. It is formulated for intradermal injection into the mid to deep dermis, allowing for structural support and aesthetic enhancement.

Indicated uses:

• • Correction of moderate to deep facial wrinkles
  • Lipoatrophy volume restoration
  • Facial contouring in mid-to-deep dermal layers
    

Contraindications:

• • Allergy to lidocaine, hyaluronic acid, or BDDE
  • Pregnancy or lactation
  • Use in eye contours or blood vessels
  • Patients under 18 years or over 65 without confirmed safety
  • Autoimmune disorders, multiple severe allergies, or coagulation defects
  • Active skin disease, acne, or infections
  • Previous permanent filler use in the treatment area
  • Concurrent treatments with lasers, IPL, or chemical peels
    

Possible side effects:

• • Injection-site reactions (e.g., redness, swelling, pain, itching) lasting up to 1 week
  • Nodules or induration
  • Rare: glabellar necrosis, granulomas, hypersensitivity (<1 in 1500), visual impairment, or stroke

Revanesse® Ultra™+ should only be administered by trained physicians under sterile conditions. Injection technique and anatomical knowledge are crucial for safe and effective treatment.

Administration procedure:

• • Bring syringe to room temperature for 30 minutes prior to use
  • Thoroughly disinfect the treatment area
  • Inject slowly with minimal pressure
  • If blanching occurs, stop immediately and massage the area
  • Expel a small drop from the needle tip before injecting
  • Use only sterile, single-use needles and syringes
    

Precautionary measures:

• • Avoid treating areas with other fillers or implants
  • Do not allow contact with benzalkonium chloride or quaternary ammonium compounds.
  • Refrain from touching treated areas for 12 hours
  • Avoid UV exposure, heat, cold, or sunbathing until swelling resolves
  • Limit total annual lidocaine dose to 20 mL per 60 kg body weight
    

Storage instructions:

• • Store between 2°C and 25°C
  • Keep away from freezing and direct sunlight
  • Use before the expiry date indicated on the packaging
    

Revanesse® Ultra™+ provides a reliable, long-lasting dermal filler solution with proven safety and performance, ideal for deep facial wrinkle correction and volume enhancement.

Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.