BELOTERO SOFT LIDOCAINE

BELOTERO Soft Lidocaine is a sterile gel:
- Apyrogenic and physiological cross-linked hyaluronic acid of non-animal origin.
- Biodegradable, transparent, colourless and homogenised viscoelastic implant.
- Sodium hyaluronate compound: 20 mg/ml. Lidocaine hydrochloride: 3 mg/ml. Phosphate buffer pH7 q.b.: 1 ml. Residual BDDE: ≤ 2 ppm
- Filling thin perioral lines.
- 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 SOFT LIDOCAINE
- COMPOSITION: Sodium hyaluronate: 20 mg/ml. Lidocaine hydrochloride: 3 mg/ml. Phosphate buffer pH7 q.b.: 1 ml. Residual BDDE: ≤ 2 ppm
- PRESENTATION: 1 x 1ml.
- NEEDLES: 2x 30G½”.
- INDICATIONS: Injection into the superficial to medium dermis for the treatment of fine perioral lines.
- INJECTION DEPTH: Superficial to medium injection into the dermis.
- DURATION: At least 6 months.
- USE: Strict medical use.

- Syringes: 1 x 1 ml.
- Needles: 2x 30G½” (EC).
- The gel is sold in a pre-filled, disposable, steam-sterilised plastic syringe.
- Each box contains one 1mL syringe of BELOTERO Soft Lidocaine, 2 sterile disposable needles 2x 30G½” reserved exclusively for injecting BELOTERO Soft Lidocaine, instructions for use and two labels to ensure traceability.

Treatment of fine perioral lines.

- Sodium hyaluronate: 20 mg/ml
- Lidocaine hydrochloride: 3 mg/ml
- Phosphate buffer pH7 q.a.: 1 ml
- Residual BDDE: = 2 ppm.

BELOTERO Soft Lidocaine is only indicated for injections into the superficial to medium dermis. Inject BELOTERO Soft Lidocaine slowly to apply as little pressure as possible, depending on the appropriate injection technique, using the needles provided. 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 space for branches of the main arteries, and manually occluding the origin of the opratrochlear vessels with the non-dominant finger. A blunt cannula may reduce, but not eliminate, the risk. Generally recommended injection techniques are, for example, linear retrograde, fanning, cross-hatching, or micro-bolus injection. In general, injection of medical devices carries a risk of infection. Standard precautions associated with injectables should be observed. No clinical data are available on the injection of BELOTERO Soft Lidocaine in subjects with Fitzpatrick phototype V/VI.

BELOTERO Soft Lidocaine is contraindicated in the following cases:
- known hypersensitivity to one or more components of the product, in particular to hyaluronate
sodium, lidocaine hydrochloride, BDDE or amide local anaesthetics
- pregnant and breastfeeding women
- persons under 18 years of age
- subjects with a general infection
- individuals with an active autoimmune disease
Do not inject BELOTERO Soft Lidocaine:
- in the blood vessels
- In skin areas affected by active skin inflammation or infection due, for example, to immunological, allergic, bacterial, fungal or viral causes.
- In an area already treated with a permanent dermal filler.
- in the glabellar or nasal region.

BELOTERO Soft Lidocaine is indicated for injection into the superficial to medium dermis.
BELOTERO Soft Lidocaine is an injectable implant, indicated for injection into the superficial to medium dermis, for the treatment of fine perioral lines. The presence of Lidocaine is intended to reduce the patient's pain during treatment.

The contents of the BELOTERO Soft Lidocaine syringe are sterilised by steam. The 30G1/2” needles are sterilised by irradiation.