BELOTERO INTENSE LIDOCAINE

BELOTERO Intense 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: 25.5 mg/ml. Lidocaine hydrochloride: 3 mg/ml. Phosphate buffer pH7 q.b.: 1 ml. Residual BDDE: ≤ 10 ppm
- Filling deep facial furrows and wrinkles and restoring and remodelling soft tissue
- 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 INTENSE LIDOCAINE
- COMPOSITION: Sodium hyaluronate: 25.5 mg/ml. Lidocaine hydrochloride: 3 mg/ml. Phosphate buffer pH7 q.b.: 1 ml. Residual BDDE: ≤ 10 ppm
- PRESENTATION: 1 x 1ml
- NEEDLES: 2x 27G½”
- INDICATIONS: Injection into the deep dermis for the treatment of nasolabial folds and marionette wrinkles. BELOTERO Intense Lidocaine is indicated for submucosal or subcutaneous injection for lip enhancement.
- INJECTION DEPTH: Injection into the deep dermis. Subcutaneous or submucosal for the lips.
- DURATION: Up to 12 months for the treatment of nasolabial folds and marionette wrinkles and up to 3 months for lip enhancement.
- USE: Strict medical use.

- Syringes: 1 x 1 ml.
- Needles: 2x 27G½” (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 27G½” reserved exclusively for injecting BELOTERO Intense Lidocaine, instructions for use and two labels to ensure traceability.

Filling deep furrows and wrinkles in the face and restoring and remodelling soft tissue. BELOTERO Intense Lidocaine is indicated for submucosal or subcutaneous injection for lip enhancement.

- Sodium hyaluronate: 25.5 mg/ml
- Lidocaine hydrochloride: 3 mg/ml
- Phosphate buffer pH7 q.a.: 1 ml
- Residual BDDE: = 10 ppm.

BELOTERO Intense Lidocaine is only indicated for injections into the superficial to medium dermis. Inject BELOTERO Intense 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 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-shaped, 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 combination of Belotero products with botulinum toxin and/or calcium hydroxyapatite (i.e. Radiesse). No clinical data are available on the injection of BELOTERO Intense Lidocaine in subjects with Fitzpatrick phototype V/VI.

BELOTERO Intense 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 Intense 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 Intense Lidocaine is indicated for injection into the deep dermis.
BELOTERO Intense Lidocaine is an injectable implant indicated for filling deep facial furrows and wrinkles and restoring and remodelling soft tissue. BELOTERO Intense Lidocaine is indicated for submucosal or subcutaneous injection for lip enhancement. The presence of Lidocaine is intended to reduce the patient's pain during treatment.

The contents of the BELOTERO Intense Lidocaine syringe are sterilised by steam. The 27G½” needles are sterilised by irradiation.