RESTYLANE® 1ml

RESTYLANE® 1ml Product Description

RESTYLANE® 1ml is a non-lidocaine hyaluronic acid-based dermal filler designed for correcting facial wrinkles, folds, and volume loss. Produced through Streptococcus species bacteria and chemically cross-linked with BDDE, it stabilizes at a concentration of 20 mg/mL. It is suspended in phosphate-buffered saline at a neutral pH.

• Type: Hyaluronic acid dermal filler.
• Primary Component: Non-lidocaine formula for patients sensitive to anesthetics.

RESTYLANE® 1ml Key Features and Benefits

RESTYLANE® 1ml provides multiple benefits, including hydration, wrinkle smoothing, and long-lasting results. It promotes skin elasticity restoration and volume enhancement in treated areas.

• Hydration: Enhances skin moisture retention.
• Elasticity: Improves skin firmness and reduces sagging.
• Longevity: Results last 6–12 months, depending on the patient and treatment area.
• Safety: Proven efficacy with a favorable safety profile in clinical studies.

RESTYLANE® 1ml Composition

RESTYLANE® 1ml contains the following active ingredients:

• Sodium Hyaluronate: 20 mg/mL.
• Cross-Linking Agent: BDDE for gel stabilization.
• Other Components: Phosphate-buffered saline to maintain pH balance.

RESTYLANE® 1ml Intended Purpose / Indications

This product is designed for moderate to severe facial wrinkles and folds, particularly:

• Nasolabial Folds: Lines extending from the nose to the mouth.
• Lips: Volume augmentation and contour enhancement.
• Cheeks and Chin: Restores volume and defines contours.
• General Wrinkle Reduction: Targets moderate to deep wrinkles in various facial areas.

RESTYLANE® 1ml Injection and Treatment Areas

The product is designed for implantation into the mid-to-deep dermis. Recommended areas include:

• Nasolabial Folds
• Cheeks
• Chin
• Lips

It is critical to avoid vascular-rich areas to minimize risks.

RESTYLANE® 1ml Reconstitution and Preparation Guidelines

RESTYLANE® 1ml is pre-filled in syringes and requires no reconstitution. Preparation steps include:

1. Ensure aseptic conditions during treatment.
2. Use compatible needles provided with the product.
3. Check for product integrity before use (e.g., no cloudiness or separation).

RESTYLANE® 1ml Administration and Dosage

• Injection Technique: Linear threading or serial puncture techniques are recommended.
• Dosage:
  • Up to 1.5 mL per session per area.
  • Avoid exceeding 6 mL per patient per treatment session.
• Practitioner Guidance: Only trained professionals should administer injections.

RESTYLANE® 1ml Storage Instructions

• Temperature: Store between 2°C and 25°C.
• Precautions: Avoid freezing and protect from direct sunlight or excessive heat.

RESTYLANE® 1ml Contraindications

The product is contraindicated in patients with:

• Severe allergies or history of anaphylaxis.
• Hypersensitivity to hyaluronic acid or BDDE.
• Bleeding disorders or anticoagulant use.
• Inflammatory skin conditions or infections in the treatment area.

RESTYLANE® 1ml Precautions and Warnings

• Avoid Intravascular Injection: Can lead to vascular occlusion and ischemia.
• Post-Treatment Risks: Swelling, redness, and tenderness may occur.
• Patient Discussion: Inform patients of risks, signs of complications, and expected results.

RESTYLANE® 1ml Post-Treatment Care

Patients should follow these guidelines to optimize results:

• Avoid Makeup: Refrain from using makeup for 12 hours post-treatment.
• Sun Protection: Minimize UV exposure and use sunscreen.
• Temperature: Avoid extreme heat or cold for 48 hours.

RESTYLANE® 1ml Side Effects and Adverse Reactions

Potential side effects include:

• Common: Redness, swelling, tenderness, and bruising at the injection site.
• Rare: Papules, granulomas, or hypersensitivity reactions.
• Severe: Signs of vascular compromise (blanching, pain) require immediate medical attention.

RESTYLANE® 1ml Patient Eligibility

• Age: Suitable for patients over 18 years.
• Health Conditions: Avoid in pregnant, breastfeeding, or immunocompromised patients.

RESTYLANE® 1ml Follow-Up and Maintenance

• Initial Follow-Up: Evaluate results at 2 weeks.
• Maintenance: Recommend retreatment every 6–12 months, depending on individual response.

RESTYLANE® 1ml Manufacturer and Regulatory Information

• Manufacturer: Galderma Laboratories.
• Regulatory Compliance: CE-marked and FDA-approved for specific indications.
• Batch and Expiry: Always verify batch number and expiry date before use.

RESTYLANE® 1ml FAQ

• Can RESTYLANE® 1ml be used for lip augmentation?
  Yes, it enhances lip volume and definition.
• How long do the effects last?
  Typically 6–12 months, depending on the patient and treatment area.
• What should patients avoid post-treatment?
  Avoid makeup, sun exposure, and extreme temperatures for the first 48 hours.