Product Name: Restylane ®Injectable Gel
Applicant: Medicis Aesthetics Holdings, Inc
Address: 8125 N Hayden Road Scottsdale , AZ 85258
Approval Date: March 25, 2005
What is it?
Restylane ® is a transparent hyaluronic acid gel that is injected into facial tissue to smooth wrinkles and folds, especially around the nose and mouth (nasolabial folds). Hyaluronic acid is a protective, lubricating and binding gel substance that is produced naturally by the body.
How does it work?
Restylane ® works by temporarily adding volume to facial tissue and restoring a smoother appearance to the face. The effect lasts for about 6 months.
When is it used?
Restylane ® is injected by a doctor into areas of facial tissue where moderate to severe facial wrinkles and folds occur. The gel temporarily adds volume to the skin and can give the appearance of a smoother surface.
What will it accomplish?
Restylane ® will help smooth moderate to severe facial wrinkles and folds. In a clinical study most patients needed one injection to achieve optimal wrinkle smoothing; about one-third of patients needed more than one injection to get a satisfactory result. The smoothing effect lasted about six months.
Side effects of Restylane™ include:
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bruising
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redness
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swelling
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pain
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tenderness
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itching
When should Restylane not be used?
Restylane ® should not be used in patients who have:
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severe allergies marked by a history of anaphylaxis ( hypersensitivity to the ingestion or injection of a drug or protein)
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multiple severe allergies
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severe allergies to gram-positive bacterial proteins
Restylane™ should not be used for:
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breast augmentation
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implantation into bone tendon, ligament, or muscle, or
implantation into blood vessels, because it may obstruct blood flow.
Additional information:
Summary of Safety and Effectiveness and labeling will be available at:
www.FDA.gov
Put the word "Restylane" into the search box.
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