HArmonyCa Lidocaine 2 x 1.25ml

HArmonyCa Lidocaine 2 x 1.25ml

HArmonyCa

Aesthetic injectables
  • CE Marked injectable facial implant (dermal filler) under applicable EU/UK medical device regulations
  • Manufactured under Allergan Aesthetics’ ISO 13485 Compliant quality management system for medical devices
  • Sterile, apyrogenic, latex Free single Use medical device with validated manufacturing, sterilisation and packaging processes
  • Includes patient and practitioner information leaflets and implant card in line with MDR requirements in relevant markets
Hybrid HA/CaHA dermal filler with lidocaine

Description

HArmonyCa Lidocaine (2 x 1.25ml) is a dual-effect hybrid dermal filler from Allergan Aesthetics that combines calcium hydroxyapatite (CaHA) microspheres with cross-linked hyaluronic acid (HA) in a single injectable implant. Supplied as two prefilled 1.25ml syringes containing 0.3% lidocaine for patient comfort, it is intended for facial soft tissue augmentation in adults and is injected into the deep dermal and sub-dermal layers. The HA component provides an immediate lifting and volumising effect, while the CaHA microspheres stimulate endogenous collagen production over time, improving skin architecture, firmness and long-lasting support in the mid and lower face.

Bnefits

  • Dual-effect hybrid filler combining hyaluronic acid for immediate lift with CaHA microspheres for long-term collagen stimulation
  • Designed for facial soft tissue augmentation with visible improvement in volume, contour and skin quality
  • Deep dermal and sub-dermal placement supports mid and lower face lifting and structural support
  • Contains 0.3% lidocaine hydrochloride to reduce pain during injection and improve treatment comfort
  • Provides gradual, sustained results as new collagen forms around the CaHA microspheres
  • Latex-free, bio-degradable dermal implant supplied sterile and apyrogenic in prefilled syringes
  • Can be used in appropriately selected patients as an alternative or complement to traditional HA fillers and stand-alone biostimulators

Indications

  • Facial soft tissue augmentation in adults (18+)
  • Improvement of volume loss and contour deficiencies in the mid and lower face
  • Support and lift of areas affected by age-related laxity and structural decline
  • Enhancement of skin architecture, firmness and elasticity through collagen stimulation
  • Patients seeking a combination of immediate lifting with longer-term biostimulatory effects

Composition

  • Calcium hydroxyapatite (CaHA) microspheres, 25–45 μm diameter, 55.7% w/v
  • Cross-linked sodium hyaluronate gel, 20 mg/ml (non-animal origin)
  • Lidocaine hydrochloride, 3 mg/ml (0.3% w/v)
  • Phosphate buffer solution
  • Water for injection (in the HA gel matrix)

Formulation

  • Sterile, apyrogenic, viscous, opaque, injectable semi-solid dermal implant
  • Synthetic calcium hydroxyapatite microspheres embedded in a cross-linked hyaluronic acid gel carrier
  • Latex-free, bio-degradable implant intended for deep dermal and sub-dermal use in specific facial regions
  • Pre-filled, graduated 1.25 ml glass syringes with 0.3% lidocaine

Packaging

  • Box containing 2 pre-filled 1.25 ml glass syringes of HArmonyCa Lidocaine
  • 2 single-use 27G 1/2" thin-wall sterile needles
  • Instructions for Use (IFU) and patient information materials as supplied by Allergan Aesthetics

Usage

  • For professional use only by suitably trained and qualified healthcare practitioners experienced in dermal filler injection techniques.
  • Carefully review the full Instructions for Use (IFU) before treatment, including indications, contraindications, warnings and injection guidelines.
  • Inspect the packaging and syringes; do not use if the blister, syringe or security seals are damaged, or if the contents appear discoloured or contain particulate matter inconsistent with the product description.
  • Clean and disinfect the treatment area using appropriate aseptic technique prior to injection.
  • HArmonyCa Lidocaine is intended for injection into the deep dermal and sub-dermal layers of specific facial regions; do not inject superficially or into unintended anatomical areas.
  • Attach the supplied sterile 27G 1/2" needle securely to the syringe, ensuring the luer connection is tight and free of leaks, then expel air and prime the needle.
  • Inject slowly using small aliquots, advancing with care while aspirating in accordance with local practice where appropriate to reduce the risk of inadvertent intravascular injection.
  • Distribute the product evenly according to the treatment plan, respecting facial anatomy, depth and recommended techniques described in the IFU.
  • After injection, gently mould or smooth the treated area if required and as tolerated by the patient; avoid excessive pressure.
  • Provide post-treatment advice, including information on possible short-term reactions (swelling, redness, bruising) and guidance on avoiding extreme temperature exposure, strenuous exercise and manipulation of the treated areas for the period recommended by the manufacturer.
  • Do not resterilise; single-use only. Any unused product, used needles and syringes must be disposed of in accordance with local biohazard and sharps regulations.

Contraindications

  • Known hypersensitivity or allergy to any component of the product, including hyaluronic acid, calcium hydroxyapatite, lidocaine hydrochloride, other amide-type local anaesthetics or gram-positive bacterial proteins
  • Presence of active skin disease, infection or inflammation (acute or chronic) at or near the intended injection sites
  • Patients who are prone to keloid formation, hypertrophic scarring or significant inflammatory skin disorders in the treatment area
  • History of severe allergic reactions or anaphylaxis to injectable implants or local anaesthetics
  • Untreated epilepsy or porphyria as listed in clinical consent documentation for HArmonyCa treatment
  • Pregnancy or breastfeeding (use is generally not recommended due to lack of safety data)
  • Known coagulation disorders or ongoing anticoagulant/antiplatelet therapy where the bleeding risk cannot be adequately managed by the treating clinician
  • Injection into high-risk anatomical regions (such as periorbital, glabellar and certain nasal areas) is contraindicated or strongly discouraged as per the IFU and current best practice

Adverse Effects

  • Common, usually transient injection-site reactions including redness, swelling, tenderness, pain, warmth and bruising
  • Itching or localised discomfort at or near the injection site
  • Formation of palpable or visible nodules, papules or indurations in the treated area
  • Asymmetry, irregularity or uneven correction if the product is not evenly distributed
  • Rare events such as infection, abscess formation or delayed inflammatory reactions
  • Rare but serious complications associated with dermal fillers, including intravascular injection leading to tissue ischaemia, necrosis or visual disturbance, require immediate recognition and management by the treating practitioner
  • Potential migration of material if injected into or near contraindicated regions (for example, reports of material migration into the lips when injected incorrectly)

Storage Conditions

  • Store in the original packaging to protect from light and contamination until use.
  • Maintain storage at controlled room temperature within the range specified in the official IFU; do not freeze.
  • Do not expose to excessive heat, direct sunlight or extremes of temperature.
  • Do not use after the expiry date printed on the packaging and syringe label.
  • Keep out of the sight and reach of children.

Duration

Clinical effects typically persist beyond those of standard hyaluronic acid fillers, with collagen-mediated benefits generally maintained for many months; published and promotional materials describe sustained improvement for approximately 12\u201318 months or more, depending on patient factors, treatment plan and injector technique.

Onset

Immediate visible lifting and volumising effect due to the hyaluronic acid gel carrier, followed by progressive improvement in skin architecture and firmness over weeks to months as new collagen forms around the CaHA microspheres.

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