Belotero Balance Lidocaine 1x1ml

• Cross-linked sodium hyaluronate: 22.5 mg/ml, of non-animal origin, high molecular weight (2.7–3.3 m³/kg).
• Lidocaine hydrochloride: 3 mg/ml (0.3 %), to reduce local pain associated with injection.
• Cross-linker: 1,4-butanediol diglycidyl ether (BDDE), degree of modification < 8 %. 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: the gel presents variable cross-linking densities within a single monophasic phase. The denser gel zones fill and expand the tissue, while the lower-density zones diffuse into the fine pericellular spaces. Hence its homogeneous intradermal distribution and its tolerance of superficial planes.

The progression of the range is defined not only by HA concentration, but by the degree of modification of the cross-linker and, consequently, by the injection plane for which each gel is intended.

Biodegradable injectable implant indicated for filling facial wrinkles and folds and for volume enhancement, in adults.

• Superficial to mid dermis: nasolabial folds, marionette lines, perioral lines, horizontal forehead lines and oral commissures.
• Submucosal or subcutaneous: lip enhancement.
• Supraperiosteal plane: filling of the infraorbital hollow, including the tear troughs.

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.

Duration documented by the manufacturer according to clinical data: nasolabial folds up to 12 months; horizontal forehead lines up to 6 months; lip enhancement, including the contour, up to 6 months; perioral lines and oral commissures up to 4 months; infraorbital hollow, including the tear troughs, up to 18 months.

• Needles included: 1 × 27G ½" and 1 × 30G ½". The 30G ½" needle requires greater injection force. A sterile 27G blunt cannula may also be used at the practitioner's discretion.
• Recommended techniques: linear or serial threading, fanning, cross-hatching and serial (micro)puncture. Balance permits the blanching technique (very superficial infiltration).
• Infraorbital hollow: inject deeply onto the bone, in the supraperiosteal plane, beneath the orbicularis muscle.
• Reduction of vascular risk: prior aspiration, low volumes and serial injections in high-risk areas, treating one side at a time and manual occlusion of the origin of the supratrochlear vessels.
• Maximum volume: 8.0 ml per session for the whole face (equivalent to 24 mg of lidocaine); maximum annual dose 16.0 ml. Treatments in the same anatomical region must be separated by at least 2 weeks.
• Maximum volumes per indication: nasolabial folds up to 4.8 ml; marionette lines and oral commissures up to 3.0 ml; perioral lines up to 1.0 ml; lips up to 1.5 ml; horizontal forehead lines up to 5.5 ml; infraorbital hollow up to 3.0 ml (maximum 1 ml per side and session).
• Combination: must not be combined with peeling, dermabrasion or laser before complete healing and, in any case, not before 2 weeks.

• 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 needles (27G ½" and 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. Injection into the infraorbital hollow is associated with a greater frequency, duration or severity of local side effects.

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