BELOTERO LIPS SHAPE

BELOTERO Lips Shape is a sterile gel:
- Apyrogenic and physiological cross-linked hyaluronic acid of non-animal origin.
- Biodegradable, transparent, colourless and homogenised viscoelastic implant.
- Cross-linked sodium hyaluronate: 25.5 mg/ml. Lidocaine hydrochloride: 3.0 mg/ml. Phosphate buffer pH 7 q.a.: 0.6 ml.
- Lip volume creation. Definition and remodelling of the lip area.
- CPM (Cohesive Polydensified Matrix) TECHNOLOGY.
- Cohesive, flexible, unique formulation for controlled and precise injection with homogeneous distribution in the dermis.

- MERZ PHARMA ITALIA S.R.L.
- NAME: BELOTERO LIPS SHAPE
- COMPOSITION: Cross-linked sodium hyaluronate: 25.5 mg/ml. Lidocaine hydrochloride: 3.0 mg/ml. Phosphate buffer pH 7 q.a.: 0.6 ml
- PRESENTATION: 1 x 0.6ml.
- NEEDLES: 2 x 27G x ½.
- INDICATIONS: Injection into the deep dermis for the treatment of perioral lines and severe oral fissures.
- INJECTION DEPTH: Subcutaneous or submucosal.
- DURATION: 6 to 9 months.
- USE: Strict medical use.

- Syringes: 1 x 0.6 ml.
- Needles: 2 x 27G x ½ (CE 0120).
- The gel is sold in a pre-filled, disposable graduated syringe.
- Each box contains one 0.6mL syringe of BELOTERO Lips Shape, 2 sterile disposable 27G1/2 needles reserved exclusively for injecting BELOTERO Lips Shape, instructions for use and two labels to ensure traceability.

Treatment of deep perioral lines. Treatment of oral commissures. Lip reshaping.

- Cross-linked sodium hyaluronate: 25.5 mg/ml
- Lidocaine hydrochloride: 3.0 mg/ml
- Phosphate buffer pH 7 q.a.: 0.6 ml.

BELOTERO Lips Shape is only indicated for subcutaneous and submucosal injections. Inject BELOTERO Lips Shape slowly to apply as little pressure as possible, depending on the appropriate injection technique, using the needles provided. General recommended injection techniques are, for example: linear or serial injection, fan technique, lattice technique or serial (micro)puncture technique. The amount of product to be injected depends on the area to be corrected. The risk of intravascular injection can be reduced by using several strategies, including suction before injection, using smaller volumes and serial injections in high-risk areas, treating one side at a time, pinching/tensing the skin to provide more surface area to the branches of the main arteries, and manually occluding the origin of the supratrochlear vessels with the non-dominant finger. A blunt-tipped cannula can reduce, but not eliminate, the risk. In general, injection of medical devices carries a risk of infection. Standard precautions associated with injectable materials should be observed. No clinical data are available on the injection of BELOTERO Lips Shape in patients with Fitzpatrick skin type V/VI.

BELOTERO Lips Shape is contraindicated in the following cases:
- In case of known hypersensitivity to one or more components of the product, in particular to sodium hyaluronate, lidocaine hydrochloride,
to BDDE or amide local anaesthetics;
- In pregnant or breastfeeding women;
- In young patients under 18 years of age;
- In patients with a general infection;
- In patients with an active autoimmune disease.
Do not inject BELOTERO Lips Shape into the blood vessels.
Do not inject BELOTERO Lips Shape into areas of the skin where there is active skin inflammation or infection due to, for example
for example, to immunological, allergic, bacterial, fungal or viral causes.
Do not inject BELOTERO Lips Shape into an area previously treated with permanent dermal filler.
Do not inject BELOTERO Lips Shape into the glabellar and nasal region.

BELOTERO Lips Shape is indicated for submucosal or subcutaneous injection into the lips. BELOTERO Lips Shape is an injectable implant, indicated for injection into the deep dermis for the treatment of perioral lines and severe oral fissures. The presence of Lidocaine is intended to reduce patient pain during treatment.

The contents of the BELOTERO Lips Shape syringe are sterilised by moist heat. The 27G1/2” needles are sterilised by irradiation.