REVANESSE® PURE™ with Lidocaine

Implantation life is dependent on depth and location of injection, and averages 4 weeks.

Revanesse® Pure™ is a cross linked hyaluronic acid gel that is indicated for the treatment of facial rhytides and lipoatrophy by injection into the skin. Implantation life is dependent on depth and location of injection, and averages 4 weeks.

Revanesse® Pure™ is a unique non-cross linked hyaluronic acid gel. Revanesse Pure is the purest non-cross linked gel in the Revanesse range. Revanesse Pure is to be injected into superficial dermis and is used to rehydrate the skin in the face, neck, hands and décolletage. The skin is left hydrated and over time skin elasticity is restored and the skin appears firmer, healthier, and younger.

• Revanesse® Pure™ should only be injected by or under the direct supervision of qualified physicians who have been trained on the proper injection technique for filling facial wrinkles.
• The area to be treated must be thoroughly disinfected. Be sure to inject only under sterile conditions.
• Inject the product slowly and apply the least amount of pressure necessary.
• Revanesse® Pure™ and needles packaged with it are for single use only. Do not re-use. If re-used, there is a risk of infection or transmission of blood borne diseases.
• Keep the product at room temperature for 30 minutes prior to injection.
• Before injecting, press on the plunger of the syringe until a small drop is visible at the tip of the needle.
• If the skin turns a white color (blanching), the injection should be stopped immediately and the area should be massaged until the skin returns to its normal color.
• Before injecting, press on the plunger of the syringe until a small drop is visible at the tip of the needle.

Contraindications

• Contains lidocaine and is contraindicated for patients with a history of allergies to such material.
• Do not inject Revanesse® Pure™ into eye contours (into the eye circle or eyelids).
• Pregnant women, or women during lactation should not be treated with Revanesse® Pure™.
• Revanesse® Pure™ is only intended for intradermal use and must not be injected into blood vessels. This may occlude and could cause an embolism.
• Patients who develop hypertrophic scarring should not be treated with Revanesse® Pure™.
• Contains trace amounts of gram positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material.
• Never use Revanesse® Pure™ in conjunction with a laser, intense pulsed light, chemical peeling or dermabrasion treatments.
• People under the age of 18 should not be treated with Revanesse® Pure™.
• Patients with acne and/or other inflammatory diseases of the skin should not be treated with Revanesse® Pure™.
• Patients with unattainable expectations.
• Patients with auto-immune disorders or under immunotherapy.
• Patients with multiple severe allergies.
• Patients with acute or chronic skin disease in or near the injection sites.
• Coagulation defects or under anti-coagulation therapy.
• Patients with sensitivity to hyaluronic acid.

After-care

• Avoid touching the treated area for 12 hours after injection and avoid prolonged exposure to sunlight, UV, as well as extreme cold and heat.
• Until the initial swelling and redness have resolved, do not expose the treated area to intense heat (e.g. solarium and sunbathing) or extreme cold.
• If you have previously suffered from facial cold sores, there is a risk that the needle punctures could contribute to another eruption of cold sores.
• If you are using aspirin, non-steroidal anti-inflammatory medications, St. John’s Wort of High doses of Vitamin E supplements prior to treatment or any similar medications be aware that these may increase bruising and bleeding at the injection site.
• Based on a toxicological risk assessment for lidocaine, patients should be limited to 20 mL per 60 kg (130 lbs) body mass per annum. The safety of injecting greater amounts has not been established.
• Patients who are visibly ill, with bacterial or viral infections, influenza, or active fever should not be treated until a resolution of their symptoms.