Belotero Intense Lidocaine 1x1ml

• Cross-linked sodium hyaluronate: 25.5 mg/ml, of non-animal origin, high molecular weight (2.7–3.0 m³/kg).
• Lidocaine hydrochloride: 3 mg/ml (0.3 %).
• Cross-linker: BDDE, degree of modification < 8 %. 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: monophasic gel of variable cross-linking density. The denser zones provide filling and structural support; the lower-density zones diffuse into the fine pericellular spaces, which allows homogeneous tissue integration even in high-concentration gels.

Intense and Lips Shape share the same concentration (25.5 mg/ml); the difference lies in the intended use and in the presentation: Lips Shape is directed specifically at the labial mucosa and the vermilion border.

Biodegradable injectable implant created to fill deep facial wrinkles and folds and to restore and enhance the soft tissue, in adults.

• Deep dermis: nasolabial folds and marionette lines.
• Submucosal or subcutaneous: lip enhancement.

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 12 months in nasolabial folds and marionette lines, and up to 3 months in lip enhancement, according to the manufacturer's clinical data.

• Needles included: 2 × 27G ½". A smaller needle diameter requires greater injection force.
• Injection plane: deep dermis; submucosal or subcutaneous for the lips.
• Recommended techniques: linear or serial threading, fanning, cross-hatching and serial (micro)puncture.
• Vascular risk: the practitioner must be familiar with the distribution of the labial arteries. Reduce the risk by prior aspiration, low volumes, serial injections in high-risk areas and treating one side at a time.
• Maximum volume: 7 ml per session (equivalent to 21 mg of lidocaine); maximum annual dose 14 ml. 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. 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: 1 pre-filled syringe of 1.0 ml, 2 sterile 27G 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. 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.