Generic Name and Formulations:
Hyaluronic acid 20mg/mL; injectable gel implant.
Galderma Laboratories, Inc.
Indications for RESTYLANE :
Correction of moderate-to-severe facial wrinkles and folds (eg, nasolabial folds). Lip augmentation.
See full labeling. Inject slowly with least amount of pressure necessary. Individualize. Wrinkles/folds: inject into the mid-to-deep dermis; max 6mL/patient per treatment. Lip: (<21yrs): not established; (>21yrs): inject into submucosal layer (avoid IM inj); max 1.5mL/lip per treatment. Both: may require repeat treatments to achieve desired effects. Follow-up session is recommended if optimal response requires ≥3mL.
History of anaphylaxis or presence of multiple severe allergies. Allergies to Gram (+) bacterial proteins. Bleeding disorders. Implantation in areas other than the dermis or lip submucosa.
Should only be used by trained and experienced healthcare practitioners. Obtain patient's complete medical history prior to initiation. Avoid intravascular inj; discontinue immediately if changes in vision, signs of stroke, blanching of skin or unusual pain during or shortly after procedure occurs. Avoid implantation in or near blood vessels or vascular rich areas (eg, glabella, nose). Risk of infection. Defer if active inflammatory process or infection is present at specific sites. Use in non-lip or non-nasolabial areas: not established. Concomitant epilation, UV irradiation, or laser, mechanical or chemical peeling procedures: not evaluated. Possible risk of an inflammatory reaction at implant site if laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after Restylane or if product is given before skin has healed completely after such a procedure. Risk of herpes reactivation in patients with a history of herpetic eruption. Avoid excessive sun, UV lamp exposure, or extreme cold weather. Patients (<18yrs), pregnancy, nursing mothers: not established.
Caution with concomitant immunosuppressants or in those who have undergone therapy with thrombolytics, anticoagulants, or platelet aggregation inhibitors in the preceding 3wks. Increased bruising or bleeding at inj sites with concomitant aspirin, NSAIDs, St. John's Wort, high dose Vit. E; avoid.
Inj site reactions (eg, bruising, redness, swelling, pain, tenderness, itching, contusion), delayed inflammatory papules, hyperpigmentation, keloid formation; rare: severe lip/face swelling, hypersensitivity reactions.
Single-use syringe—1 (w. needles)
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