ELEVA® Contour

ELEVA® must NOT be used in the following conditions:

• Intravascular injection (risk of vascular occlusion, embolization, ischemia, or necrosis).

• Glabellar and periorbital/tear trough injection with ELEVA® Shape and ELEVA® Contour (reserved exclusively for Fine/Balance where clinically indicated).

• Breast augmentation, gluteal enlargement, or implantation into bones, muscles, ligaments, or joints.

• Patients with known hypersensitivity to Hyaluronic Acid, Gram-positive bacterial proteins (Streptococcus), or Lidocaine/amide-type local anesthetics.

• Patients with active cutaneous inflammation or infection (acne, herpes simplex, dermatitis) in or near the target site.

• Patients with history of autoimmune disease, severe allergies, anaphylaxis, porphyria, or untreated epilepsy.

• Patients prone to keloids, hypertrophic scarring, or severe pigmentation disorders.

• Patients with coagulation disorders or receiving active anticoagulant/thrombolytic therapy.

• Pregnancy and breastfeeding.

• Patients under 18 years of age.

• Concomitant use with laser therapy, deep chemical peeling, or dermabrasion procedures until full re-epithelialization is achieved.

PRECAUTIONS & DRUG INTERACTIONS

• Medical Training: Must be administered exclusively by licensed, authorized, and certified medical practitioners trained in advanced injection anatomy.

• Incompatibilities & Chemical Interactions: Hyaluronic Acid precipitates in the presence of quaternary ammonium salts (such as benzalkonium chloride or cetylpyridinium chloride). Avoid contact between ELEVA® and instruments cleaned with the mentioned solutions.

• Drug Interactions: Patients taking antiplatelet agents, NSAIDs, high-dose Vitamin E, Vitamin C, Omega-3 fatty acids, or herbal supplements (Ginkgo Biloba, St. John’s Wort) may experience increased bruising and bleeding. Caution is advised in patients taking medications that inhibit hepatic metabolism or in those with pre-existing cardiac conduction disorders (due to lidocaine content).

• Pre-existing Implants: Do not inject into anatomical sites with permanent (silicone, PMMA) or semi-permanent (e.g., PLLA) fillers.

• Magnetic Resonance Imaging (MRI): ELEVA® is MRI-safe and non-paramagnetic.

• Product Inspection: Inspect syringe integrity prior to use. Do not use if the sterile barrier is compromised, the gel contains turbidity or particulate matter, or if the plunger rod does not glide smoothly. Do not re-sterilize or reuse.

PRE-INJECTION PATIENT CARE PROTOCOL

• 1 Week Prior: Discontinue elective blood thinners, NSAIDs, aspirin, high-dose Vitamin E/C, Ginkgo Biloba, and alcohol under physician supervision. Avoid tanning beds and intensive UV exposure.

• 3 Weeks Prior/After: Avoid invasive dental procedures, oral surgery, and facial tattooing.

• Herpes Prophylaxis: In patients with a history of recurrent herpes labialis undergoing perioral/lip injections, prophylactic oral acyclovir is strongly recommended.

• Skin Preparation: Thoroughly cleanse and disinfect the skin using chlorhexidine or alcohol-based antiseptics (avoiding quaternary ammonium compounds). Topical anesthetic cream may be applied 30 minutes prior if desired.