PLURYAL CLASSIC LIDO (1x1ml)
Pluryal
Aesthetic / cosmetic injectableHyaluronic acid dermal filler with lidocaine
Certifications
- CE Marked Class III medical device for intradermal injection within the European market (Pluryal fillers, including Classic Lidocaine).
- Manufactured in Europe under ISO 13485 Certified quality management system for medical devices.
- Production in compliance with GMP (Good Manufacturing Practice) standards for sterile injectable products.
- Gel preparation under controlled clean Room conditions in accordance with EN ISO 14644 requirements.
- Biocompatibility assessment aligned with EN ISO 10993 guidelines for medical devices.
- Very low residual BDDE (≤ 2 ppm) and controlled levels of proteins and endotoxins, consistent with regulatory specifications for HA dermal fillers.
- Terminally sterilised by steam autoclave, providing a high sterility assurance level compared with aseptic filling alone.
- CE Marked Class III medical device for intradermal injection within the European market (Pluryal fillers, including Classic Lidocaine).
- Manufactured in Europe under ISO 13485 Certified quality management system for medical devices.
- Production in compliance with GMP (Good Manufacturing Practice) standards for sterile injectable products.
- Gel preparation under controlled clean Room conditions in accordance with EN ISO 14644 requirements.
- Biocompatibility assessment aligned with EN ISO 10993 guidelines for medical devices.
- Very low residual BDDE (≤ 2 ppm) and controlled levels of proteins and endotoxins, consistent with regulatory specifications for HA dermal fillers.
- Terminally sterilised by steam autoclave, providing a high sterility assurance level compared with aseptic filling alone.
Hyaluronic acid dermal filler with lidocaine
Description
PLURYAL CLASSIC LIDO (1x1ml) is a sterile, biodegradable, viscoelastic, clear, transparent and isotonic hyaluronic acid dermal filler with lidocaine from MD Skin Solutions (Luxembourg). It is a monophasic cross-linked sodium hyaluronate gel at 23 mg/ml with 0.3% lidocaine, obtained from non-animal (bacterial) origin and formulated in a physiologic buffer. Injected into the mid-dermis (and mucosa/lips), it corrects moderate to severe facial wrinkles and folds, smooths cutaneous fractures, restores volume and contours, and remodels the lips. Typical treatment areas include glabellar lines, nasolabial folds, marionette lines and the lip contour. The product provides natural-looking, long-lasting results (around 6–9 months) with added patient comfort due to lidocaine.
Bnefits
- Corrects moderate to severe facial wrinkles and folds, including nasolabial folds, glabellar lines and marionette lines
- Remodels and enhances lip volume and contour in the mid-dermis and mucosa
- Restores facial volume lost through ageing and environmental factors such as sun, tobacco and pollution
- Monophasic cross-linked HA gel provides smooth, homogeneous distribution and predictable correction
- Contains 0.3% lidocaine to reduce injection discomfort and improve patient tolerance
- High molecular weight (≈3 million Daltons) HA with optimised viscoelasticity (G' ≈ 95,000 mPa) for good lifting and support in mid-dermal tissues
- Non-animal, highly purified HA with very low residual BDDE, protein and endotoxin levels for safety and biocompatibility
- CE-marked medical device manufactured under strict ISO 13485 and GMP standards in Europe
- Natural, immediate aesthetic improvement with results typically lasting 6–9 months, depending on indication and patient
- Part of a complete Pluryal dermal filler and skinbooster range designed according to the P.R.E.M.I.U.M design concept for purity, elasticity and optimal rheology
Indications
- Aesthetic purpose: correction of moderate to severe facial wrinkles and folds, including nasolabial folds, glabellar lines and marionette lines
- Aesthetic purpose: increasing and contouring lip volume and reshaping the lip border
- Medical reconstructive purpose: correction of facial lipoatrophy, debilitating scars or morphological asymmetry
- Improvement of cutaneous fractures and skin creases in mid-dermal planes
- Restoration of facial harmony in cases of age-related volume loss and contour irregularities in the lower and mid-face
Composition
- Monophasic cross-linked sodium hyaluronate (hyaluronic acid) 23 mg/ml (2.3% w/v), non-animal, bacterial origin (Streptococcus equi)
- Lidocaine 0.3% (local anaesthetic for pain reduction during injection)
- Non-cross-linked hyaluronic acid: approximately 10% of total HA content
- Cross-linking agent: BDDE (1,4-Butanediol Diglycidyl Ether), cross-linking grade BDDE +++
- Residual BDDE: ≤ 2 ppm
- Protein content: trace
- Residual endotoxins: < 5 EU/ml
- Rheology: G' factor ≈ 95,000 mPa (indicating appropriate firmness and lifting capability for mid-dermis)
- Molecular weight of HA: approximately 3 million Daltons
- Physiologic phosphate-citrate buffer (isotonic, pH balanced) and excipients suitable for sterile injectable HA gels
Formulation
- Sterile, apyrogenic, viscoelastic, clear and transparent monophasic HA gel implant
- Biodegradable cross-linked sodium hyaluronate at 23 mg/ml, stabilised with BDDE
- Contains 0.3% lidocaine hydrochloride to improve comfort during injection
- Homogenised, isotonic formulation designed for intradermal (mid-dermis) and mucosal (lip) injection
- Non-animal HA produced by bacterial fermentation, purified and terminally sterilised by steam autoclave
Packaging
- Box containing 1 pre-filled 1 ml glass syringe of PLURYAL CLASSIC LIDO gel
- 2 x 27G 1/2" Terumo ultra-thin wall needles supplied in the pack
- Package insert with instructions for use and safety information
- 2 traceability labels for patient record and practitioner documentation
- Single-patient, single-use sterile medical device packaging with tamper-evident seals
Usage
- PLURYAL CLASSIC LIDO is a medical device intended for medical use only and must be administered exclusively by appropriately trained and qualified healthcare or aesthetic professionals who have received specific training in soft tissue augmentation and filler injection techniques.
- Before treatment, perform a complete medical history and facial assessment, identify aesthetic or reconstructive indications, evaluate injection areas (glabellar lines, nasolabial folds, marionette lines, lip contour/volume) and rule out contraindications. Obtain informed consent and document baseline appearance.
- Cleanse and disinfect the treatment area thoroughly. Topical anaesthetic may be applied according to clinic protocol and patient needs, even though the product already contains 0.3% lidocaine.
- Open the sterile blister, remove the pre-filled 1 ml syringe and attach one of the supplied 27G 1/2" Terumo ultra-thin wall needles under aseptic conditions. Expel any air bubbles and check smooth extrusion of the gel before injection.
- Inject PLURYAL CLASSIC LIDO into the mid to deep dermis of the targeted area, or into the mucosa/lips for lip contouring and volume, using appropriate techniques such as linear threading (retrograde or anterograde), serial puncture, fanning or cross-hatching, in accordance with manufacturer recommendations and injector training.
- Treat the indicated areas: glabellar lines, nasolabial folds, marionette lines and lip contour/lip volume. Adjust injection depth, volume per point and technique based on tissue thickness, defect severity and desired correction.
- Inject slowly with low to moderate pressure, aspirating where appropriate and monitoring tissue response continuously to minimise the risk of intravascular injection and overcorrection. Stop immediately if the patient reports severe pain or if blanching or colour change is observed.
- After injection, gently massage the treated area if necessary to ensure even distribution of the gel and to smooth any visible irregularities, taking care not to compress excessively.
- The usual frequency of repeat treatments for PLURYAL CLASSIC LIDO is every 6–9 months, depending on the treated area (wrinkles vs. lips), patient metabolism, lifestyle and aesthetic goals. Some patients may require touch-up sessions shortly after the initial injection to optimise symmetry and results.
- Provide post-treatment advice: avoid makeup, vigorous massage, extreme temperatures (sauna, steam room, very hot or cold environments), alcohol and strenuous exercise for at least 24 hours; protect treated areas from intense sun or UV exposure for several days; avoid dental work or other facial procedures in the immediate post-treatment period if possible.
- Instruct patients to contact the clinic promptly if they experience persistent or worsening pain, pronounced redness, blanching, discolouration, hard nodules, signs of infection (fever, increased warmth, pus) or any visual disturbances.
- Consult the official PLURYAL CLASSIC LIDO Instructions for Use and professional product presentations for detailed guidance on recommended injection techniques, volumes, specific indications, precautions and complication management.
Contraindications
- Hypersensitivity or allergy to hyaluronic acid, lidocaine or any of the components of the formulation (including BDDE or excipients).
- History of severe anaphylactic or allergic reactions to local anaesthetics of the amide type (e.g. lidocaine, mepivacaine, bupivacaine).
- Presence of active infection, inflammation or skin disease at or near the intended injection sites (e.g. cold sores/herpes labialis, bacterial or fungal infections, dermatitis).
- Autoimmune diseases or immunodeficiency conditions where injectable HA fillers may be inappropriate, unless the patient has been assessed and cleared by a specialist.
- Known tendency to hypertrophic scarring or keloid formation in the treatment area.
- Bleeding disorders, uncontrolled coagulation abnormalities or current use of significant anticoagulant/antiplatelet therapy that increases bleeding risk, unless a medical prescriber has evaluated and approved treatment.
- Pregnancy and breastfeeding (commonly listed as contraindications or strong precautions for aesthetic injections).
- Previous permanent or semi-permanent fillers in the intended treatment area where interactions or irregularities may occur, unless evaluated by an experienced injector.
- Any other contraindications and warnings detailed in the official PLURYAL CLASSIC LIDO Instructions for Use and local regulatory or professional guidelines.
Adverse Effects
- Common, usually transient injection-site reactions such as redness (erythema), swelling, oedema, tenderness, pain, warmth, itching, minor bruising or slight bleeding.
- Transient lumps, papules or nodules at injection points, which generally resolve as the product integrates and swelling diminishes; persistent nodules require clinical evaluation.
- Temporary asymmetry, overcorrection or irregular contours, usually improving as oedema subsides or with minor corrective treatment.
- Local hypersensitivity or inflammatory reactions that may manifest as prolonged redness, swelling or induration.
- Infection at injection sites if aseptic technique is not strictly observed, requiring appropriate medical treatment.
- Very rare but serious complications associated with all dermal fillers, including intravascular injection leading to ischaemia, tissue necrosis, scarring, or ocular complications (visual disturbance, blindness) if injected near vascular structures; these are medical emergencies requiring immediate specialist management according to established filler complication protocols.
- Any other adverse effects described in the official PLURYAL CLASSIC LIDO Instructions for Use, which practitioners must review before administration.
Storage Conditions
- Store in a clean, dry place at controlled room temperature, typically between 2°C and 25°C, as indicated on the packaging.
- Protect from direct sunlight, heat sources and freezing; do not freeze the product.
- Keep the syringe in its original blister and outer carton until use to maintain sterility and product integrity.
- Do not use if the packaging, blister, syringe or needle sterility seals are damaged or opened prior to use.
- Do not use the product after the expiry date printed on the packaging.
- Discard any unused product remaining in the syringe after treatment; PLURYAL CLASSIC LIDO is intended for single-patient, single-use only.
Duration
Typical duration of effect is approximately 6\u20139 months for wrinkles and volume correction, with some sources noting that Pluryal products in general may last 6\u201312 months for wrinkles/volume and around 6 months for lips. Individual duration depends on treatment area, injected volume, technique, skin type, metabolism and lifestyle factors.
Onset
Results are usually immediate and natural-looking due to the volumising and hydrating effects of the hyaluronic acid gel, with final appearance stabilising over the following days as initial swelling subsides and the product integrates into the tissue.
