RESTYLANE® 1ml

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153

Manufacturer: Galderma
Active Substance(s): HYALURONIC ACID
Strength: 20mg/ml HA
Pack Size: 1 x 1ml Pre-Filled Syringe, 2 x 29G 1/2” Needles
Restylane® is used to add volume and fullness to the skin and to correct fine lines and wrinkles between the eyebrows, on the forehead and the bilateral lines between the nose and mouth (nasolabial folds). Restylane filler can also be used for lip enhancement. Intended to be used for facial augmentation. It is recommended to be used for correction of wrinkles and for lip enhancement.

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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:

Ensure aseptic conditions during treatment.
Use compatible needles provided with the product.
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.