STYLAGE® M BI-SOFT® with Lidocaine

Description

Name: Stylage® M BI-SOFT® with Lidocaine
Manufacturer: Vivacy
Active Substance(s): CROSS LINKED HYALURONIC ACID, MANNITOL, LIDOCAINE
Strength: 20mg/g HA, 9mg/ml Mannitol, 3mg/ml Lidocaine
Pack Size: 1-1ml prefilled syringes
Accessories: 2 x 1ml Pre-Filled Syringes, 2 x 30 G ½ Needles

STYLAGE® M BI-SOFT® with Lidocaine is a monophasic hyaluronic acid-based dermal filler developed by Laboratoires VIVACY for the correction of medium to deep wrinkles. Designed with IPN-Like Technology, it incorporates Mannitol for antioxidant protection and Lidocaine (0.3%) to minimize pain during injection. The Bi-SOFT® syringe system enhances precision, stability, and comfort for both practitioner and patient, allowing smooth and efficient aesthetic treatments.

• Hyaluronic Acid Concentration: 20 mg/g, cross-linked
• Lidocaine Content: 0.3% for localized anesthetic effect
• Duration of Results: Typically 6 to 12 months per treatment

STYLAGE® M BI-SOFT® with Lidocaine is packaged in sterile boxes containing 2 x 1 ml prefilled syringes. Each unit includes two 30G½” needles, and the syringe is ergonomically enhanced with the Bi-SOFT® Injection Technology. For added safety, the packaging integrates an RFID chip, allowing traceability and authenticity verification via smartphone apps or NFC readers.

The composition includes:

• 20 mg/g cross-linked hyaluronic acid using patented IPN-Like Technology
• 0.3% Lidocaine hydrochloride for reduced injection pain
• Mannitol, a potent antioxidant that minimizes inflammation and oxidative degradation
• Phosphate buffer to maintain iso-osmolarity and ensure biocompatibility

This filler is indicated for correcting moderate to deep facial wrinkles, including nasolabial folds, marionette lines, and cheek wrinkles. It can also enhance lip contours and restore facial volume in specific regions. The Lidocaine formulation provides added comfort, making it ideal for patients sensitive to pain.

Indications:

• Nasolabial folds, marionette lines, perioral wrinkles
• Lip contour definition and mild volume restoration
• Injection into the mid to deep dermis

Contraindications:

• Allergies to hyaluronic acid, Mannitol, or Lidocaine
• Patients who are pregnant or breastfeeding
• Autoimmune disorders, active infections, or skin inflammation at injection site

Side Effects:

• Pain, redness, swelling, or bruising at the injection area
• Sensitivity, induration, or itching
• These effects usually resolve within 7 days, with no long-term adverse outcomes reported in clinical studies
  

The product is intended for administration by trained medical professionals using a 30G½” needle, with injection into the mid to deep dermis. Common methods include retrograde linear threading, serial puncture, or microbolus techniques, depending on the area and desired aesthetic effect. The Bi-SOFT® syringe provides excellent handling and reduces injection force, improving precision and patient comfort.

Recommended Injection Techniques:

• Retrograde linear threading
• Microbolus or multi-point technique
• Serial puncture for wrinkle filling

Storage Requirements:

• Store between 2°C and 25°C
• Avoid freezing and protect from light exposure
• Do not use past the expiry date printed on the package

Proper storage and professional administration ensure that the filler maintains its viscosity, sterility, and clinical effectiveness throughout its shelf life.

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.