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Revolax Sub Q with Lidocaine (1 x 1.1ml)

Revolax Sub Q with Lidocaine (1 x 1.1ml)

Revolax

Dermal filler (medical device)
  • CE Marked Class III hyaluronic acid dermal filler (Revolax range: Fine, Deep and Sub Q with Lidocaine)
  • Manufactured under ISO 13485 Compliant quality management system for medical devices
  • Produced according to Good Manufacturing Practice (GMP) standards
  • Hyaluronic acid derived from Streptococcus zooepidemicus with high purification and low endotoxin levels (<1.2 IU/ml)
  • 100% cross Linked HA with BDDE as cross Linking agent; residual BDDE not detected in final product according to manufacturer data
  • Intended and certified for deep subcutaneous injection for the correction of very deep wrinkles and volume augmentation
High-viscosity monophasic cross-linked hyaluronic acid dermal filler for very deep wrinkles and structural facial augmentation

Description

Revolax Sub Q with Lidocaine (1 x 1.1ml) is the thickest and most robust monophasic cross-linked hyaluronic acid dermal filler in the Revolax range, specifically formulated for deep subcutaneous implantation. Using high-purity, non-animal HA at 24 mg/ml combined with 0.3% lidocaine, this CE-marked Class III medical device is designed to correct deep to extremely severe wrinkles, such as nasolabial folds and laugh lines, and to provide strong structural augmentation of the nose, cheeks, jawline and chin. Its highly viscoelastic (≈280 MPa), cohesive, crystal-clear gel offers advanced ability to mould, maintain structure and deliver long-lasting volume and contour improvements, typically lasting 12–18 months while integrating naturally with skin tissue.

Bnefits

  • Thickest, highest-complex-viscosity filler in the Revolax portfolio (approx. 280 MPa) for maximum lift and structural support
  • Monophasic, highly cohesive gel that moulds well while strongly maintaining shape and projection
  • Designed for deep subcutaneous implantation to treat deep to extremely severe wrinkles and facial depressions
  • Ideal for structural augmentation of nose, cheeks, chin and jawline where a thicker substance is required
  • Non-animal-based, highly purified hyaluronic acid with very low endotoxin levels (<1.2 IU/ml as per manufacturer data)
  • Contains 0.3% lidocaine for greater injection comfort and reduced pain
  • Provides long-lasting effects, typically 12–18 months depending on patient and treatment area
  • Biodegradable and fully resorbable, gradually broken down by the body over time
  • Regular, dense lattice structure of the gel contributes to durable, natural-looking aesthetic outcomes

Indications

  • Deep to extremely severe facial wrinkles and folds
  • Severely deep lines including pronounced nasolabial folds and laugh lines
  • Deep forehead wrinkles in thicker skin areas
  • Nose correction and non-surgical rhinoplasty (bridge and tip contouring)
  • Cheek augmentation and contouring
  • Chin augmentation and projection
  • Jawline definition and contouring
  • Deep subcutaneous volume restoration in midface and lower face in suitable patients

Composition

  • Cross-linked sodium hyaluronate (hyaluronic acid) 24 mg/ml
  • Lidocaine hydrochloride 0.3% for local anaesthetic effect
  • Hyaluronic acid derived from Streptococcus zooepidemicus fermentation with high purification, endotoxin level < 1.2 IU/ml (per manufacturer/Medica Depot data)
  • Cross-linking agent BDDE (1,4-butanediol diglycidyl ether) with non-detectable / negligible residual level in final product (per Revolax materials data)
  • Phosphate-buffered saline (physiological buffer), pH approximately 7.0
  • Sterile, pyrogen-free excipient system suitable for injectable HA gels

Formulation

  • Monophasic, crystal-clear cross-linked hyaluronic acid gel with uniform consistency
  • High-viscoelasticity (complex viscosity ≈ 280) for strong lifting and sculpting capacity
  • Biodegradable, non-animal-derived HA with 100% cross-linked gel phase
  • Optimised for deep subcutaneous injection and structural contouring
  • Sterile, pyrogen-free gel supplied in a single-use prefilled syringe

Packaging

  • Box containing 1 x 1.1 ml prefilled glass syringe of Revolax Sub Q with Lidocaine
  • Teleta notes pack contains 1 x 27G needle, while most manufacturer-based sources specify 2 x 25G needles; configuration may vary by distributor
  • Package insert / Instructions for Use (IFU)
  • Outer carton with CE Class III medical device labelling and batch/expiry information

Usage

  • For professional use only; Revolax Sub Q with Lidocaine must be administered by appropriately trained, qualified medical or aesthetic practitioners.
  • Indicated injection depth is the deep subcutaneous layer of the skin, targeting areas with thick dermis and pronounced volume loss.
  • Typical treatment areas include nasolabial folds, severe laugh lines, deep forehead wrinkles in thick skin, and structural augmentation of nose, cheeks, jawline and chin.
  • Prepare the patient by cleansing and disinfecting the treatment area thoroughly; adhere strictly to aseptic technique.
  • Attach an appropriate needle (commonly 25G per manufacturer; some distributors provide 27G) and expel any air from the syringe before injecting.
  • Inject slowly with minimal pressure, depositing small boluses or using linear threading/fanning in the deep subcutaneous plane according to anatomy and desired correction.
  • Avoid intravascular injection; aspirate in line with clinic protocol and continuously monitor for signs of vascular compromise, especially in high-risk regions such as the nose and glabella.
  • After injection, gently mould and shape the filler to optimise contour, symmetry and surface smoothness.
  • Advise patients to avoid makeup on treated areas for several hours post-procedure and to refrain from strenuous exercise, alcohol, and exposure to extreme heat or cold (e.g. saunas, sunbeds, cold outdoor temperatures) for at least 24 hours or as per clinic policy.
  • Always consult and follow the official Instructions for Use (IFU) supplied with the product for the most accurate and comprehensive guidance on indications, contraindications, injection techniques and aftercare.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, lidocaine, BDDE or any other component of the product
  • History of severe allergies or anaphylactic reactions unless comprehensively evaluated and cleared by a physician
  • Presence of active skin infection, inflammation or dermatologic disease at or near the intended injection site (e.g. herpes simplex, active acne, dermatitis)
  • Pregnancy and breastfeeding (Revolax fillers are not recommended for pregnant or breastfeeding patients as per official materials)
  • Patients with a known tendency to develop hypertrophic or keloid scars
  • Patients presenting with cutaneous inflammation or signs of infection at the planned treatment area
  • Immediately before or after aggressive skin treatments such as laser therapy, chemical peeling or dermabrasion
  • Autoimmune diseases or significant immunosuppression unless the risk–benefit profile has been individually assessed by the treating clinician
  • Use in patients under 18 years of age
  • Planned injection into blood vessels or in high-risk vascular planes without appropriate expertise and safety protocols

Adverse Effects

  • Common, usually mild and transient injection-site reactions such as redness, swelling, tenderness, pain, itching, bruising or minor bleeding
  • Temporary lumps, nodules, papules or contour irregularities at or near the injection site, which often resolve spontaneously or with gentle massage or minor corrective measures
  • Localised infection or abscess formation if aseptic technique is not strictly followed
  • Immediate or delayed hypersensitivity or inflammatory reactions, including prolonged swelling, erythema, induration or pruritus
  • Very rare but serious complications seen with HA fillers generally, including vascular occlusion, tissue ischemia or necrosis, and visual disturbances or blindness if filler is inadvertently injected into an artery; these events require urgent specialist assessment and treatment
  • Any unusual, persistent or severe adverse reaction should be promptly evaluated and managed by a qualified medical professional

Storage Conditions

  • Store at 2–25 °C as indicated in Revolax technical materials and product brochures.
  • Do not freeze.
  • Protect from direct sunlight and excessive heat.
  • Keep the syringe in its original sterile blister and outer carton until use to maintain sterility and traceability.
  • Do not use after the expiry date printed on the packaging or if the blister, syringe or carton appears damaged, previously opened or compromised.
  • Keep out of the reach of children.

Duration

Manufacturer and distributor information indicates a typical duration of effect of approximately 12\u201318 months, although actual longevity varies depending on area treated, injection technique, patient age, skin quality, metabolism and lifestyle.

Onset

Lifting, volumising and wrinkle-correcting effects are visible immediately after injection, with final aesthetic results becoming fully apparent once any initial swelling or redness has subsided over several days.

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