BELOTERO BALANCE LIDOCAINE

BELOTERO Balance 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: 22.5 mg/ml. Lidocaine hydrochloride: 3 mg/ml. Phosphate buffer pH7 q.b.: 1 ml. Residual BDDE: ≤ 2ppm
- Filling facial wrinkles / furrows and lip enhancement.
- 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 BALANCE LIDOCAINE
- COMPOSITION: Sodium hyaluronate: 22.5 mg/ml. Lidocaine hydrochloride: 3 mg/ml. Phosphate buffer pH7 q.b.: 1ml. Residual BDDE: ≤ 2ppm
- PRESENTATION: 1 x 1ml
- NEEDLES: 1x 27G½” and 1x 30G½”
- INDICATIONS: Injection into the superficial or mid dermis for the treatment of nasolabial folds, marionette wrinkles, perioral wrinkles and oral commissures. Lip enhancement.
- INJECTION DEPTH: submucosal or subcutaneous for lip enhancement.
- LENGTH: nasolabial folds: up to 12 months, marionette wrinkles: up to 17 days, perioral wrinkles: up to 4 months, oral commissures: up to 4 months, lip enhancement including lip contour: up to 6 months.
- USE: Strict medical use.

- Syringes: 1 x 1 ml.
- Needles: 1x 27G½” and 1x 30G½” (CE).
- The gel is sold in a pre-filled, disposable, steam-sterilised plastic syringe.
- Each box contains one 1mL syringe of BELOTERO Balance Lidocaine, 2 sterile disposable needles (1 x 27G1/2 and 1 x 30G1/2) reserved exclusively for injecting BELOTERO Balance Lidocaine, instructions for use and two labels to ensure traceability.

Treatment of nasolabial folds, marionette wrinkles, perioral wrinkles and oral clefts. Lip enhancement.

- Sodium hyaluronate: 22.5 mg/ml
- Lidocaine hydrochloride: 3 mg/ml
- Phosphate buffer pH7 q.b.: 1ml
- Residual BDDE: = 2ppm.

BELOTERO Balance Lidocaine is only indicated for subcutaneous and submucosal injections. Inject BELOTERO Balance Lidocaine slowly to apply as little pressure as possible, according to 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 supratrochlear 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, fan, 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. Limited clinical data are available on the injection of BELOTERO Balance Lidocaine in persons with Fitzpatrick phototype V/VI.

BELOTERO Balance 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 Balance Lidocaine:
- in the blood vessels
- In skin areas affected by inflammation or active skin infection due to
e.g. immunological, allergic, bacterial, fungal or viral causes
- In an area already treated with a permanent dermal filler.
- in the glabellar or nasal region.

BELOTERO Balance Lidocaine is indicated for submucosal or subcutaneous injection into the lips. BELOTERO Balance Lidocaine is an injectable implant, indicated for injection into the superficial or mid dermis, for the treatment of nasolabial folds, marionette wrinkles, perioral wrinkles and oral commissures. The presence of lidocaine is intended to reduce the patient's pain during treatment.

The contents of the BELOTERO Balance Lidocaine syringe are sterilised by steam. The 27G1/2” and 30G1/2” needles are sterilised by irradiation.