JUVEDERM VOLBELLA XC PP
Generic Name and Formulations:
Hyaluronic acid 15mg/mL, 0.3% w/w lidocaine; injectable gel implant.
Indications for JUVEDERM VOLBELLA XC:
Lip augmentation. Correction of perioral rhytids.
See full labeling. Inject slowly with least amount of pressure necessary. Wait 3 secs after injecting first small amount before proceeding with rest of the inj. May use supplementary anesthesia during and post-inj. >21yrs: Individualize. Initial treatment: usually 2.6mL; max 6mL per inj; repeat treatment: usually 1.6mL. Max limit: 20mL/60kg per year. May require touch-up treatments to achieve desired effect.
History of anaphylaxis or presence of multiple severe allergies. Allergies to Gram (+) bacterial proteins, lidocaine.
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. 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. 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 Juvederm Volbella XC or if product is given before skin has healed completely after such a procedure. Known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders: not studied. Advise patients to avoid strenuous exercise, extensive sun or heat, and alcoholic beverages 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, swelling, tenderness, firmness, bruising, lumps/bumps, redness, pain, discoloration, itching, dryness); rare: vision impairment, blindness, cerebral ischemia/hemorrhage, stroke, skin necrosis, facial structure damage.
Single-use syringe—1 (w. needles)
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