BELOTERO REVIVE

BELOTERO Revive 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: 20 mg/ml. Glycerol: 17.5 mg/ml. Phosphate buffer pH 7 to 1.0 ml
- Revitalisation of facial skin by rehydrating, improving elasticity and firmness of dry and very dry skin and smoothing fine and superficial wrinkles by reducing skin roughness.
- 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 REVIVE
- COMPOSITION: Cross-linked sodium hyaluronate: 20 mg/ml. Glycerol: 17.5 mg/ml. Phosphate buffer pH 7 to 1.0 ml.
- PRESENTATION: 1 x 1ml.
- NEEDLES: 2x 30G × ½”.
- INDICATIONS: Resorbable implant intended for the revitalisation of prematurely photodamaged facial skin characterised by dehydration, loss of elasticity and firmness and the presence of fine and superficial wrinkles.
- INJECTION DEPTH: Injection into the superficial or mid-superficial dermis.
- DURATION: Up to 9 months. Varies from person to person.
- USE: Strict medical use.

- Syringe: 1 x 1 ml.
- Needles: 2x 30G × ½” (EC).
- The gel is sold in a pre-filled glass disposable syringe, sterilised with moist heat.
- Each box contains one or more 1mL syringes of BELOTERO Revive, 2 sterile disposable 30G × ½” needles reserved exclusively for injecting BELOTERO Revive, instructions for use and two labels per syringe to ensure traceability.

Face; revitalising facial skin by rehydrating, improving the elasticity and firmness of dry and very dry skin and smoothing fine and superficial wrinkles by reducing skin roughness.

- Cross-linked sodium hyaluronate: 20 mg/ml.
- Glycerol: 17.5 mg/ml.
- Phosphate buffer pH 7 to 1.0 ml.

BELOTERO Revive is only suitable for injections into the superficial to medium dermis. Inject BELOTERO Revive 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 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. General recommended injection techniques are, for example: linear or serial injection, fan technique, grid technique or serial (micro)puncture technique. The amount of product to be injected depends on the area to be corrected. In general, the injection of medical devices carries a risk of infection. The standard precautions associated with injectable materials must be observed. BELOTERO Revive can only be used in combination treatments with, for example, botulinum toxin and/or calcium hydroxyapatite (Radiesse®) when injected into different facial areas. No clinical data are available on the injection of BELOTERO Revive in patients with a Fitzpatrick skin type of phototype V/VI.

BELOTERO Revive is contraindicated:
- In case of known hypersensitivity to any of the product's components, particularly sodium hyaluronate, glycerol or BDDE,
- In pregnant and breastfeeding women
- In patients under 18 years of age,
- In patients with a general infection,
- In patients with an active autoimmune disease.
Do not inject BELOTERO Revive into blood vessels.
Do not inject BELOTERO Revive into areas of the skin where there is active skin inflammation or infection due to, for example,
immunological, allergic, bacterial, fungal or viral causes.
Do not inject BELOTERO Revive into an area previously treated with permanent dermal filler.
Do not inject BELOTERO Revive into the glabellar and nasal region.

BELOTERO Revive is indicated for injection into the superficial or mid-superficial dermis.
BELOTERO Revive is a resorbable implant intended for the revitalisation of prematurely photodamaged facial skin characterised by dehydration, loss of elasticity and firmness and the presence of fine, superficial wrinkles.

The contents of the BELOTERO Revive syringe are sterilised by moist heat. The 30G × ½” needles are sterilised by irradiation.