RESTYLANE SILK PP
Generic Name and Formulations:
Hyaluronic acid 20mg/mL, 0.3% lidocaine; injectable gel implant.
Galderma Laboratories, Inc.
Indications for RESTYLANE SILK:
Lip augmentation. Correction of perioral rhytids.
See full labeling. Inject slowly with least amount of pressure necessary. Individualize. Lip: (<22yrs): not established; (>22yrs): inject into submucosal layer (avoid IM inj); max 1.5mL/lip per treatment. Rhytids (>21yrs): inject into the mid-to-deep dermis; max 1mL 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-perioral 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 Silk or if product is given before skin has healed completely after such a procedure. Known susceptibility to keloid formation: not studied. 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, hypersensitivity reactions.
Single-use syringe—1 (w. needles)