Ellansé

Indication — Ellansé® is indicated for subdermal implantation in the face for the lasting correction of wrinkles and facial aging signs or conditions. Ellansé® uses the body's natural response to encapsulate the microspheres and stimulate the formation of connective tissue. Indications for the product may vary depending on different variant and the product registration status across different jurisdictions. Individual effects may vary.
Important safety information — Ellansé® should only be administered by healthcare practitioners with expertise in soft tissue augmentation who have familiarised themselves with the product and its complete Instructions for Use, in accordance with local regulations. Ellansé® should not be used in patients with: a history of anaphylaxis or multiple severe allergies; known hypersensitivity to any component; acute or chronic skin disease (infection or inflammation); known susceptibility to keloid formation or hypertrophic scarring; current cortisone treatment; active sepsis or infection, or active (or history of) autoimmune disease. Ellansé® should not be injected into the periorbital region (eyelids, under-eye area and crow's feet) or the glabella (the area between the eyebrows), because of the risk of reduced blood flow to the eye, which can lead to loss of vision.The safety of Ellansé® during pregnancy, in breastfeeding females, or in patients under 18 years has not been established. Patients using medications that can prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection site. The safety and effectiveness of Ellansé® in the lips has not been established. Ellansé® should not be mixed with other dermal filler or neurotoxin products prior to injection. After treatment, minimise exposure of the treated area to excessive sun, UV lamps and extreme cold until any initial swelling and redness has resolved.
Adverse event reporting — All potential adverse effects and incidents should be reported to the quality@sinclair.com.
This is a global website. Product availability, intended use, indications and regulatory approvals may vary by country. Subject to the current local IFU — where this website and the current local IFU conflict, the local IFU prevails. Ellansé is a medical device administered by a trained healthcare professional; it is not suitable for everyone. Models are not actual patients; images are for illustrative purposes. Conceptual illustrations are not actual photographs or clinical images.
00002_0000000640