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Indication: RestylaneⓇ Defyne is indicated for injection into the mid-to-deep dermis for correction of moderate to severe, deep facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21. Restylane Defyne is also indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion over the age of 21.
Restylane Defyne contains traces of gram-positive bacterial protein and is contraindicated for patients with allergies to such material or for patients with severe allergies that have required in- hospital treatment. Restylane Defyne should not be used by patients with bleeding disorders, with hypersensitivity to amide-type local anesthetics, such as lidocaine, or by women who are pregnant or breastfeeding.
The most commonly observed side effects include swelling, redness, pain, bruising, tenderness, lump formation, and itching at the injection site. Use at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete.
This product should not be injected into the blood vessels as it may cause vascular occlusion, infarction, or embolic phenomena. Use with caution in patients recently treated with anticoagulant or platelet inhibitors to avoid bleeding and bruising.
Restylane Defyne is available only through a licensed practitioner. Complete Instructions for Use are available at www.RestylaneUSA.com.
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