Belotero Volume Lidocaine 2x1ml

• Cross-linked sodium hyaluronate: 26 mg/ml, of non-animal origin, high molecular weight (3.0–3.3 m³/kg).
• Lidocaine hydrochloride: 3 mg/ml (0.3 %).
• Cross-linker: BDDE, degree of modification < 10 % — the highest in the range, the basis of its projection capacity. Residual BDDE ≤ 10 ppm.
• Physiological phosphate buffer pH 7 q.s. to 1 ml, with sodium chloride 8 mg/ml, sodium dihydrogen phosphate dihydrate 0.5 mg/ml and disodium phosphate dodecahydrate 2.4 mg/ml.
• CPM® technology: polydensified monophasic matrix. The denser gel fractions mechanically lift the area and provide structural support to the soft tissue; the lower-density fractions diffuse into the pericellular spaces, which maintains tissue integration even in a projecting gel.

Volume is the only gel in the range intended for the deep subcutaneous and supraperiosteal plane, and the only one with an Instructions for Use indication for the temples and chin.

Biodegradable injectable implant intended for the restoration of facial volumes in adults.

• Cheek enhancement
• Temples
• Chin
• Severe nasolabial folds

Must not be injected into the glabellar or nasal region, into blood vessels, into skin with active inflammation or infection, or into areas previously treated with a permanent filler.

Documented duration: up to 18 months in nasolabial folds and up to 12 months in cheeks, temples and chin, according to the manufacturer's clinical data.

• Injection plane: deep subcutaneous layers or above the periosteum.
• Needles included: each syringe is supplied with 2 sterile needles (27G ½" and 30G ½"); 4 needles per pack. The 30G ½" needle requires greater injection force.
• Recommended techniques: linear or serial threading, fanning, cross-hatching and serial (micro)puncture.
• Maximum volumes per indication: 8 ml in the cheeks, 6 ml in the temples, 5 ml in the chin and 4 ml in the nasolabial folds. Maximum 8 ml per session (equivalent to 24 mg of lidocaine). Treatments in the same anatomical region must be separated by at least 2 weeks.
• Vascular risk: injection in the area of the nasolabial folds or in the temples may cause vascular occlusion. Reduce the risk by prior aspiration, low volumes, serial injections, treating one side at a time and manual occlusion of the origin of the supratrochlear vessels.
• Combination: must not be combined with peeling, dermabrasion or laser before complete healing and, in any case, not before 2 weeks. It may be used with other BELOTERO products in the same session, but in different facial areas.
• Do not overcorrect. Gently massage the treated area if necessary.

• Storage: between 2 °C and 25 °C. Protect from light. Do not freeze. Store in a dry place and avoid mechanical impact.
• Visually inspect the integrity of the packaging and of the sterile barrier system before use. Do not use after the expiry date.
• Single-use product. Do not resterilise or reuse.
• The pack contains: 2 pre-filled glass syringes of 1.0 ml, 4 sterile needles (2 × 27G ½" and 2 × 30G ½"), traceability labels, implant card, instructions for use and patient information leaflet.

Contraindications: known hypersensitivity to any of the components, in particular to sodium hyaluronate, to BDDE, to lidocaine hydrochloride or to other amide-type local anaesthetics; pregnancy and breastfeeding; under 18 years of age; general infection; active autoimmune disease.

Do not inject into blood vessels, into the glabellar or nasal region, into skin with active inflammation or infection, or into areas treated with a permanent dermal filler.

Warnings: rare but serious events associated with intravascular injection of facial fillers have been reported — vascular occlusion, visual impairment, blindness, cerebral ischaemia or haemorrhage, skin necrosis. Stop the injection immediately in the event of changes in vision, signs of stroke, skin blanching or unusual pain, and refer for urgent medical care. Sodium hyaluronate precipitates in the presence of quaternary ammonium salts (e.g. benzalkonium chloride).

Precautions: individual assessment in cases of a history of multiple severe allergies or anaphylactic shock, epilepsy, cardiac disease, severe hepatic or renal impairment and porphyria; not recommended in cases of a history of streptococcal disease or a tendency to hypertrophic or keloid scarring; anticoagulants, antiplatelet agents and NSAIDs increase the risk of haematoma; lidocaine may give a positive result in anti-doping tests. The risk of granuloma, ischaemia, necrosis and vascular occlusion is greater with deep injections and high volumes.

Always consult the instructions for use included in the pack before application.