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HArmonyCa Lidocaine (2 x 1.25 ml)

HArmonyCa Lidocaine (2 x 1.25 ml)

HArmonyCa

Aesthetic injectables
  • CE Marked injectable facial implant (dermal filler) classified as a medical device in applicable EU/UK markets
  • Manufactured under Allergan Aesthetics’ ISO 13485 Compliant medical device quality management system
  • Supplied with Instructions for Use, patient information and implant card consistent with current medical device regulations
  • Latex Free, sterile, apyrogenic single Use device with validated manufacturing, sterilisation and packaging processes
Hybrid HA/CaHA dermal filler with lidocaine

Description

HArmonyCa Lidocaine 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 gel. Supplied as two pre-filled syringes (commonly 2 x 1.25 ml) containing 0.3% lidocaine for patient comfort, it is intended for facial soft tissue augmentation in adults and should be 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, helping to restore skin architecture, firmness and elasticity in patients with facial volume loss and laxity.

Bnefits

  • Dual-effect hybrid injectable that combines hyaluronic acid for immediate lift with calcium hydroxyapatite microspheres for sustained collagen stimulation and long-term support
  • Intended for facial soft tissue augmentation with visible improvement in volume, contour and overall skin quality
  • Designed for patients experiencing loss of facial elasticity and volume, particularly in the mid and lower face
  • Ready-to-use, pre-filled syringes with no need for reconstitution, improving convenience and workflow in clinic
  • Contains 0.3% lidocaine hydrochloride to reduce pain during injection and enhance patient comfort
  • Can provide a true instant lift that is maintained over many months, with ongoing collagen-mediated improvements
  • Helps restore skin quality attributes such as firmness and elasticity for a rejuvenated appearance
  • Sterile, pyrogen-free, latex-free and biodegradable injectable implant manufactured under medical device quality standards

Indications

  • Facial soft tissue augmentation in adults (18 years and over)
  • Treatment of age-related facial volume loss and loss of elasticity in the mid and lower face
  • Improvement of contour and projection in areas such as cheeks, jawline and chin within recommended treatment zones
  • Patients seeking combined immediate lifting with longer-term collagen-stimulating effects
  • Adjunctive treatment in broader facial rejuvenation plans when used by appropriately trained clinicians

Composition

  • Calcium hydroxyapatite (CaHA) microspheres, approximately 55.7% w/v, particle size typically 25–45 μm
  • Cross-linked sodium hyaluronate gel, 20 mg/ml (non-animal origin hyaluronic acid)
  • Lidocaine hydrochloride, 3 mg/ml (0.3% w/v) as a local anaesthetic to reduce injection pain
  • Phosphate buffer solution
  • Water for injection as part of the HA gel carrier

Formulation

  • Sterile, apyrogenic, viscous, opaque, injectable semi-solid dermal implant
  • Synthetic calcium hydroxyapatite microspheres homogeneously suspended in a cross-linked hyaluronic acid gel matrix
  • Latex-free, biodegradable implant intended for deep dermal and sub-dermal injection in specific facial regions
  • Contains 0.3% lidocaine for local analgesia during treatment

Packaging

  • Carton containing 2 single-use pre-filled glass syringes (each approximately 1.25 ml) of HArmonyCa Lidocaine
  • Two sterile, thin-walled, single-use 27G 1/2" needles for injection
  • Instructions for Use (IFU) and patient documentation / implant card in accordance with medical device regulations
  • Each syringe labelled with batch/lot number and expiry date for full traceability

Usage

  • HArmonyCa Lidocaine is for use only by suitably trained and qualified healthcare professionals experienced in dermal filler and deep-tissue injection techniques.
  • Before use, carefully read the full Instructions for Use (IFU), including indications, contraindications, warnings, precautions and detailed injection guidance.
  • Inspect outer packaging and syringes; do not use if blisters, syringes or seals are damaged, or if the gel appears discoloured or contains visible particulate matter inconsistent with the product description.
  • Maintain strict aseptic technique. Clean and disinfect the treatment area thoroughly prior to injection.
  • Attach the supplied sterile 27G 1/2" needle firmly to the syringe luer connection, prime the needle and expel air before injection.
  • Inject only into the deep dermal or sub-dermal layers of appropriate facial regions, avoiding high-risk anatomical areas and any zones contraindicated in the IFU.
  • Inject slowly in small aliquots, advancing with care and maintaining awareness of anatomical structures; aspirate in accordance with local practice where appropriate to reduce the risk of inadvertent intravascular injection.
  • Distribute the product evenly following the recommended injection patterns and volumes for each facial zone, taking care not to overcorrect.
  • After injection, gently mould or smooth the treated areas if needed and as tolerated by the patient, avoiding excessive pressure.
  • Provide patients with post-treatment advice, including information on common short-term reactions (e.g. swelling, redness, bruising), and instruct them to avoid extreme temperature exposure, vigorous exercise and manipulation of the treated areas for the period recommended in the IFU.
  • Single use only; do not resterilise. Dispose of any unused product, syringes, needles and associated materials in approved sharps and clinical waste containers in line with local regulations.

Contraindications

  • 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 or chronic skin disease, infection or inflammation at, or in the vicinity of, the intended injection sites
  • Patients with a history of severe allergic reactions or anaphylaxis to injectable implants or local anaesthetics
  • Patients with known bleeding disorders or those receiving significant anticoagulant or antiplatelet therapy where bleeding risk cannot be adequately managed by the clinician
  • Patients prone to keloid formation or hypertrophic scarring in the proposed treatment area
  • Pregnant or breastfeeding women (generally not recommended due to lack of safety data)
  • Use in minors under 18 years of age
  • Injection into high-risk anatomical regions (e.g. periocular, glabellar or certain nasal areas) or into blood vessels, as specified in the IFU and current best-practice guidelines

Adverse Effects

  • Common and usually transient injection-site reactions including redness (erythema), swelling, tenderness, pain, warmth and bruising
  • Localised itching or discomfort at or near the injection site
  • Formation of palpable or visible nodules, papules, indurations or irregularities in the treated area
  • Asymmetry or uneven correction if product distribution is suboptimal
  • Rare events such as local infection, abscess formation or delayed inflammatory / granulomatous reactions
  • Rare but serious complications associated with dermal fillers, including inadvertent intravascular injection leading to tissue ischaemia, necrosis or visual disturbance; these require immediate recognition and appropriate management by the treating practitioner
  • Other adverse reactions typical of injectable HA/CaHA implants as outlined in the official IFU

Storage Conditions

  • Store in the original blister/carton to protect from light and contamination until use.
  • Keep refrigerated or at controlled room temperature within the range specified in the IFU, typically between 2°C and 25°C; do not freeze.
  • Avoid exposure to excessive heat, direct sunlight or temperature extremes.
  • Do not use after the expiry date printed on the packaging and syringe labels.
  • Keep out of the sight and reach of children.

Duration

The visible lifting and volumising effect from the HA component is immediate, with collagen-stimulating benefits from the CaHA microspheres typically maintained for many months; clinical and promotional sources describe maintained improvement for around 12\u201318 months or longer, depending on patient factors, treatment area and injector technique.

Onset

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

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