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Product:

RESTYLANE®

Manufacturer: Galderma
Active Substance(s) : Hyaluronic acid
Strength: 20mg/ml
Pack Size: 1-1ml prefilled syringe
Accessories: Package insert, 2-29G 1/2” needles, 2 tracebility labels

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What is Restylane 1ml?

Restylane 1ml is an injectable dermal filler meant for the treatment of moderate to severe facial wrinkles and folds, including nasolabial folds and marionette lines. Additionally, this versatile facial filler treatment can also be used for lip augmentation. Restylane uses ground-breaking NASHA Technology to bring about optimal results. A winning combination of versatility, excellent performance, and natural and long-lasting results makes Restylane the ideal treatment to combat facial signs of aging.

What is Restylane 1ml is formulated to do?

Restylane is a viscoelastic gel made of cross-linked hyaluronic acid and is implanted into dermal tissue to provide volume enhancement. This treatment revitalizes aging skin by softening facial wrinkles and smoothing out folds. Restylane 1ml is suitable for treating moderate to severe facial folds, such as nasolabial folds; wrinkles around the corner of the mouth; and marionette lines, which are lines that extends downward from the corners of the mouth to the jawline. Additionally, this facial filler is also suitable for use in the lips for enhancement and contouring purposes. All in all, Restylane 1ml is a versatile treatment that is highly effective at providing your patients with a more youthful appearance.


Manufacturer/Origin

  The manufacturer of Restylane 1ml is Galderma, an international pharmaceutical company that specializes in researching, developing, and commercializing treatments in the field of dermatology. Restylane is made in Europe.


What else you need to know

When can Restylane 1ml cause side effects?

Restylane 1ml can cause swelling, bruising, reddening, lumps, pain, and tenderness. These effects develop after the injection of Restylane 1ml and should dissipate on their own within a few days said injection into the skin and within a week after injection into the lips. Rarer but more severe effects include infection(s), inflammatory infection(s), discoloration, and the formation of nodules and papules. This may not be a complete list of side effects. Refer to the package insert for a full list of side effects, warnings, and contraindications. If any adverse effects are prolonged or worsen, your patient should contact you or another medical professional.


Which skin type is it good for?

You can use this filler for all skin types. This treatment is suitable for treating aging, mature skin.


What is Restylane 1ml made without?

The hyaluronic acid in Restylane 1ml is not made with any animal byproducts. As a result, a skin test is not necessary for patients before the injection process.


Information about packaging

This dermal injection is supplied in a glass syringe with a Luer-lock fitting.


Has the FDA approved Restylane 1ml?

Restylane received FDA approval for the treatment of moderate to severe facial wrinkles and folds and for use in augmenting the lips in individuals 21 and older. As well, this skin filler carries the CE marking of MDD 93/42/EEC.


What are the differences between the products in the Restylane line?

The Restylane line of dermal fillers include Restylane-L, Restylane Lyft with Lidocaine, Restylane Silk, Restylane Refyne and Restylane Defyne. These fillers are indicated for different purposes, ranging from correcting wrinkles to volume restoration.


Suggested usage

  • Employing the correct injection technique is essential to achieving optimal results.
  • Only authorized and trained personnel that meet the requirements of local legislation may administer Restylane 1ml.
  • Inform the patient on the indications, expected result, precautions, and potential side effects associated with Restylane treatment. Educating the patient on these matters is necessary to obtain their informed consent.
  • Assess the patient’s need for pain management. If treating wrinkles and folds, a local or topical anesthesia may be used. If Restylane is used in the lips, a nerve block may be preferable.
  • Inject Restylane into the mid-to-deep dermis if treating dermal tissue and into the submucosal layer if treating the lips.
  • After the injection, massage the treated area gently to contour the product to the surrounding tissues.

Composition

Restylane 1ml is a sterile, transparent gel consisting of phosphate buffered saline q.s. and 20mg/ml of stabilized, non-animal-derived hyaluronic acid.


What is in the box?

  • 1 prefilled syringe that contains 1ml of this product
  • 2-29G½” needles
  • Package insert
  • Recording label for the patient

Duration of effect

The duration of results depends largely on the area of treatment. In mobile areas of the body, such as the lips and the region surrounding the mouth, Restylane 1ml’s effects can last as long as 6–9 months. In areas that are less mobile, Restylane 1ml may last for a year or more.


Storage conditions

Store Restylane 1ml in its original packaging in an environment that has a temperature up to 25°C. Protect this product from freezing conditions and sunlight.


Expiry (shelf life)

  • The expiry date is indicated on the package.
  • Do not inject the product if it has expired.

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