What it is
Belotero Lips Shape is an injectable, biodegradable implant of cross-linked sodium hyaluronate of non-animal origin, with 0.3% lidocaine hydrochloride, intended for lip enhancement.
Intended use (per instructions for use)
Indicated for submucosal or subcutaneous injection into the lips, and for injection into the deep dermis for the treatment of perioral lines and pronounced oral commissures. The lidocaine is intended to reduce local pain on injection. The documentation on the page is based on the manufacturer's instructions for use AU-V02 (29.09.2023).
Composition
Sodium hyaluronate 25.5 mg/ml, lidocaine hydrochloride 3 mg/ml, phosphate buffer pH 7 q.s. 0.6 ml.
Treatment
- Contents: 1 pre-filled 0.6 ml syringe and 2 sterile single-use needles (size stated on the outer box; 27G½″ recommended).
- Injection: submucosally or subcutaneously (lips); deep dermis (perioral lines and pronounced oral commissures). Inject slowly, aspirate before injecting and avoid overcorrection.
Important to know
For injection only by healthcare professionals with training and knowledge of the anatomy. Contraindicated in case of known hypersensitivity to the constituents (including sodium hyaluronate, BDDE, lidocaine or other amide-type local anaesthetics), in pregnant or breastfeeding women, under 18 years of age, in case of general infection and in active autoimmune disease. Do not inject into blood vessels, into skin with active inflammation or infection, into areas previously treated with a permanent skin filler, or into the glabella or nose area. Rare but serious events have been reported after unintentional injection into facial blood vessels (including vision impairment, blindness, stroke and skin necrosis). Single-use device; do not re-sterilise or reuse.
Storage and shelf life
Store at 2–25 °C, protected from light. Avoid mechanical shocks. Do not freeze. Check the packaging and expiry date before use.
Documentation and traceability
CE-marked (CE 0123). Manufacturer: Anteis SA, Plan-les-Ouates, Switzerland. Authorised representative in the EU: Merz Aesthetics GmbH, Frankfurt am Main, Germany. See the attached Norwegian translation of the instructions for use.
