Belotero Soft Lidocaine 1x1ml

• Cross-linked sodium hyaluronate: 20 mg/ml, of non-animal origin, high molecular weight (2.7–3.3 m³/kg).
• Lidocaine hydrochloride: 3 mg/ml (0.3 %).
• Cross-linker: BDDE, degree of modification < 5 % — the lowest in the range. Residual BDDE ≤ 2 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: monophasic matrix of variable cross-linking density. The denser gel fractions fill the tissue and the lower-density ones diffuse into the fine pericellular spaces, which allows a homogeneous distribution in superficial planes without an accumulation effect.

Soft and Revive share the same HA concentration (20 mg/ml) and degree of modification (< 5 %), but differ in purpose: Soft is a filler for fine lines; Revive is a revitaliser with glycerol.

Biodegradable injectable implant created to fill perioral expression lines in adults.

• Instructions for Use indication: injection into the superficial to mid dermis for the treatment of fine perioral lines.

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: at least 6 months according to the manufacturer's clinical data.

• Needles included: 2 × 30G ½". Use of the supplied needles is recommended.
• Injection plane: superficial to mid dermis.
• Recommended techniques: linear or serial threading, fanning, cross-hatching and serial (micro)puncture.
• Reduction of vascular risk: prior aspiration, low volumes and serial injections in high-risk areas, treating one side at a time, pinching or stretching the skin and manual occlusion of the origin of the supratrochlear vessels.
• Maximum volume: 3 ml per session (equivalent to 9 mg of lidocaine). The treatment of perioral lines may be repeated after 6 months. Treatments in the same anatomical region must be separated by at least 2 weeks.
• Combination: must not be combined with peeling, dermabrasion or laser before complete healing and, in any case, not before 2 weeks.
• Do not overcorrect. Gently massage the treated area if necessary to distribute the product evenly.

• 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: 1 pre-filled syringe of 1.0 ml, 2 sterile 30G ½" needles, 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. 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.

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