RESTYLANE DEFYNE PP
Generic Name and Formulations:
Hyaluronic acid 20mg/mL, lidocaine 3mg/mL; injectable gel implant.
Galderma Laboratories, Inc.
Indications for RESTYLANE DEFYNE:
Correction of moderate-to-severe, deep facial wrinkles and folds (eg, nasolabial folds).
See full labeling. Inject slowly into the mid-to-deep dermis with least amount of pressure necessary. May use supplementary anesthesia during and post-inj. >21yrs: Individualize. Initial treatment: usually 1.4mL per site; repeat treatment: usually 0.7mL per site. May require touch-up treatments to achieve desired effects.
History of anaphylaxis or presence of multiple severe allergies. Allergies to Gram (+) bacterial proteins.
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 sites with permanent implant. Risk of infection. Defer if active inflammatory process, infection or tumor is present at specific sites. Use in non-facial areas: not established. 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 Defyne or if product is given before skin has healed completely after such a procedure. Bleeding disorders. Risk of herpes reactivation in patients with a history of herpetic eruption. Advise patients to avoid strenuous exercise and extensive sun or heat exposure within first 24hrs. Patients (<22yrs), pregnancy, nursing mothers: not established.
Caution with concomitant immunosuppressants. Increased bruising or bleeding at inj sites with concomitant aspirin, NSAIDs, warfarin.
Inj site reactions (eg, redness, swelling, bruising, lump/bump formation, pain/tenderness, itching).
Single-use syringe—1 (w. needles)