Juvéderm®(Juvéderm® is a registered trademark of Corneal Industrie SAS .)
JUVÉDERM VOLUMA® XC, JUVÉDERM® XC, and JUVÉDERM® Ultra XC Important Information Approved Uses
JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over 21.
JUVÉDERM® XC injectable gel is for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
JUVÉDERM® Ultra XC is for injection into the lips and perioral area for lip augmentation in adults over 21.
Important Safety Information
Are there any reasons why I should not receive any JUVÉDERM® injectable gel formulation?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the gram-positive bacterial proteins used in these products.
What precautions should my doctor advise me about?
- Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied
- The safety of JUVÉDERM® XC and JUVÉDERM® Ultra XC injectable gels in patients under 18 years, and the safety of JUVÉDERM VOLUMA® XC in patients under 35 years or over 65 years has not been studied
- The safety and effectiveness of JUVÉDERM® XC for areas other than facial wrinkles and folds, and JUVÉDERM® Ultra XC for areas other than the lips and perioral area for lip augmentation, or facial wrinkles and folds, have not been established in clinical studies
- The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area have not been established in clinical studies
- Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation
- Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
- Patients who experience skin injury near the site of injection with these products may be at a higher risk for side effects
- Tell your doctor if you are on immunosuppressive therapy used to decrease the body’s immune response, as use of these products may result in an increased risk of infection
- Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site
- Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment
What are possible side effects?
The most common side effects include tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. With JUVÉDERM® XC and JUVÉDERM® Ultra XC injectable gels, most side effects are mild or moderate and last 14 days or less. For JUVÉDERM VOLUMA® XC, side effects are moderate (uncomfortable) and last 2 to 4 weeks. One of the risks with using this product is unintentional injection into a blood vessel, and while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.
As with all skin injection procedures, there is a risk of infection.
To report a side effect with JUVÉDERM® XC, JUVÉDERM® Ultra XC, or JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.
For more information, please see Juvederm.com or call Allergan Medical Information at 1-800-433-8871.
What does Radiesse® have in common with…?
Rio de Janeiro, hummingbirds, the Oktoberfest, and Radiesse® – they share more than just a number. They all tell stories of outstanding achievements. From the world’s most famous carnival and beer festival to a tiny bird putting all its might into crossing the Gulf of Mexico, Radiesse® adds its own account. Trusted by physicians and patients worldwide, 6 million Radiesse® syringes were shipped to date.
Radiesse® – a success story that keeps unfolding.
THE BENEFITS OF RADIESSE®:
- More than 10 years on the market
- More than 200 clinical studies1 and scientific publications1
- Clinical data on more than 5,000 patients1 in over 100 centres1
- High patient satisfaction (90 % patient satisfaction after 12 months2)
- As Best Filler of the Year 20133, Radiesse® is the preferred choice of many physicians across the globe
LATEST ACHIEVEMENTS OF RADIESSE®:
- 1st and only FDA-approved* dermal filler for face and hands4
- Trusted worldwide with more than 6 million syringes shipped!
The Restylane family of products includes Restylane®, Restylane-L®, Restylane® Silk, Perlane®, and Perlane-L®. Restylane, Restylane-L, Perlane, and Perlane-L can be used to add volume and fullness to the skin to correct moderate to severe facial wrinkles and folds, such as the lines from your nose to the corners of your mouth (nasolabial folds). Restylane, Restylane-L and Restylane Silk may also be used for lip enhancement in patients over 21 years. Restylane Silk can be used to treat lip lines in patients over 21 years. Ask your doctor which is right for you.
Important Safety Considerations for the Restylane family of products
Products in the Restylane family should not be used by people with previous bad allergies, particularly to microorganisms known as gram-positive bacteria, or by people with serious allergies to drugs that have previously required in-hospital treatment. These products should not be used by people with bleeding disorders. Products should not be injected anywhere except the skin, just under the skin (Perlane and Perlane-L only), or in the lips (Restylane, Restylane-L and Restylane Silk only). Restylane-L, Restylane Silk and Perlane-L should not be used by anyone with a known allergy to lidocaine.
Use at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. In these instances, product use could delay healing or make your skin problems worse. After treatment, you might have some swelling, redness, pain, bruising, or tenderness. These are typically mild in severity and normally last less than 7 days in nasolabial folds and less than 14 – 18 days in lips. Swelling may be more likely in patients under 36 years, and bruising may be more likely in patients over 35 years. Rarely, the doctor may inject into a blood vessel, which can damage the skin. Although rare, red or swollen small bumps may occur. If you have had facial cold sores before, an injection can cause an outbreak. To avoid bruising and bleeding, you should not use the products if you have recently used drugs that thin your blood or prevent clotting. Products should not be used during pregnancy, when breastfeeding, or in patients under 18 years for nasolabial folds.
Treatment volume should be limited to 6.0 mL in wrinkles and folds, such as nasolabial folds, limited to 1.5 mL per lip (Restylane, Restylane-L or Restylane Silk only), and 1.0 mL in lip lines (Restylane Silk), as greater amounts significantly increase moderate and severe injection site reactions. The safety of effectiveness of treatment in areas other than nasolabial folds (Restylane, Restylane-L, Perlane, and Perlane-L), lips (Restylane, Restylane-L, and Restylane Silk), and lip lines (Restylane Silk) has not been established in controlled clinical studies.
The Restylane family of products is available only through a licensed practitioner.
“My skin has responded well to the skin treatments, becoming more resilient and smooth, as well as losing much of the redness caused by the rosacea. My skin feels ten years younger and I feel confident without make-up for the first time ever!!!”
– Juvederm Patient