BELOTERO VOLUME LIDOCAINE

BELOTERO Volume 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: 26 mg/ml. Lidocaine hydrochloride: 3 mg/ml. Phosphate buffer pH7 q.b.: 1 ml. Residual BDDE: ≤ 10 ppm.
- Restoration of facial volumes.
- 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 VOLUME LIDOCAINE
- COMPOSITION: Sodium hyaluronate: 26 mg/ml. Lidocaine hydrochloride: 3 mg/ml. Phosphate buffer pH7 q.b.: 1 ml. Residual BDDE: ≤ 10 ppm.
- PRESENTATION: 2 x 1ml.
- NEEDLES: 2 x 27G½” and 2 x 30G ½”.
- INDICATIONS: Injection into the deep dermis for treatment to restore facial volumes.
- INJECTION DEPTH: Subcutaneous.
- DURATION: 12 to 18 months.
- USE: Strict medical use.

- Syringes: 2 x 1 ml.
- Needles: 2 x 27G x ½ and 2 x 30G ½”.
- The gel is sold in graduated, pre-filled, disposable syringes.
- Each box contains two 1mL syringes of BELOTERO Volume Lidocaine, 2 sterile disposable 27G1/2 needles, 2 sterile disposable 30G1/2 needles reserved exclusively for injecting BELOTERO Volume Lidocaine, instructions for use and four labels to ensure traceability.

Improvement of cheekbones, temples and chin. Treatment of severe nasolabial folds (NLF). Restoration of facial volumes.

- Sodium hyaluronate: 26 mg/ml.
- Lidocaine hydrochloride: 3 mg/ml.
- Phosphate buffer pH7 q.a.: 1 ml.
- Residual BDDE: = 10 ppm.

BELOTERO Volume Lidocaine is only indicated for subcutaneous injections. Inject BELOTERO Volume Lidocaine slowly to apply as little pressure as possible, according to the appropriate injection technique, using the needles provided. Generally recommended injection techniques are, for example: linear retrograde, fan, cross-hatching, or micro-bolus injection. 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 suctioning prior to 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. In general, injection of medical devices carries a risk of infection. Standard precautions associated with injectable materials should be observed. Limited clinical data are available on the injection of BELOTERO Volume Lidocaine in persons with Fitzpatrick phototype V/VI. Limited clinical data are available on the combination of Belotero products with botulinum toxin and/or calcium hydroxyapatite (i.e. Radiesse).

BELOTERO Volume Lidocaine is contraindicated in the following cases:
- known hypersensitivity to one or more components of the product, in particular
sodium hyaluronate, lidocaine hydrochloride, BDDE or
to 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 Volume Lidocaine:
- in the blood vessels
- in the glabellar or nasal region
- In the infraorbital cavities, eyelids and crow's feet
- In the lips
- For the correction of superficial wrinkles and fine lines (injection of the
produced in the superficial dermis)
- In skin areas affected by skin inflammation or infection
active due to, for example, immunological, allergic causes,
bacterial, fungal or viral
- In an area already treated with a permanent dermal filler.

BELOTERO Volume Lidocaine is indicated for subcutaneous injection in the face. BELOTERO Volume Lidocaine is an injectable implant, indicated for injection into the deep dermis for the improvement of cheekbones, temples and chin, for the treatment of severe nasolabial folds (NLF) and for the restoration of facial volumes. The presence of lidocaine is intended to reduce the patient's pain during treatment.

The contents of the BELOTERO Volume Lidocaine syringe are sterilised by moist heat. The 27G1/2” 30G1/2” needles are sterilised by irradiation.