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Revitafill Xtra 4 (2 x 1 ml)

Revitafill Xtra 4 (2 x 1 ml)

Revitafill Xtra

Dermal filler
  • Class III medical device with CE marking under EU medical device regulations (as stated by Revitafill/Revitacare).
  • Produced by Laboratoires Revitacare, an ISO 13485 Certified manufacturer for medical devices.
  • Hyaluronic acid of biotechnological origin with documented microbiological safety and preclinical/clinical data supporting performance.
  • Intended exclusively for professional use in accordance with local regulations governing injectable medical devices and aesthetic medicine.
Cross-linked hyaluronic acid filler for volumisation and deep wrinkles

Description

Revitafill Xtra 4 (2 x 1 ml) is a monophasic, cross-linked hyaluronic acid dermal filler enriched with the amino acids glycine and proline. Developed by Laboratoires Revitacare, it is designed for deep dermal and subcutaneous injection to restore facial volume, particularly in the cheeks and chin, and to correct the deepest nasolabial folds. The combination of HA and amino acids provides powerful hydration, supports the skin’s own collagen synthesis and offers tissue-healing support, resulting in a renewed, radiant appearance with natural-looking volumisation and long-lasting effects.

Bnefits

  • Supports collagen synthesis via added amino acids (glycine and proline), improving skin firmness and quality.
  • Adds and restores volume in the cheeks and chin, enhancing facial contour and projection.
  • Reduces the appearance of deep wrinkles and furrows, including deep nasolabial folds.
  • Provides deep, long-lasting hydration and helps prevent transepidermal water loss in deeper skin layers.
  • Offers high biocompatibility and a homogeneous, cohesive monophasic gel for smooth, even integration.
  • Helps protect skin cells from the harmful effects of free radicals, supporting anti-ageing benefits.
  • Contributes to acceleration of tissue healing and repair processes following injection.
  • Long-lasting aesthetic result, with many patients maintaining improvement for 12–18 months depending on lifestyle, age and skin type.

Indications

  • Restoration and enhancement of facial volume, particularly in the cheeks and chin.
  • Correction of deepest nasolabial wrinkles and other deep facial folds.
  • Smoothing and rejuvenation of the skin in mid and lower face where volume loss is present.
  • Deep wrinkle reduction where a robust, cohesive filler is required.
  • Patients seeking long-lasting volumisation with additional collagen-supporting benefits.

Composition

  • Cross-linked hyaluronic acid 24 mg/ml – improves skin moisture and protects against moisture loss, even from deeper layers of the skin.
  • Glycine – amino acid that supports collagen synthesis, improves skin tension and firmness, increases hydration, provides antioxidant protection against free radicals, and helps reduce inflammatory processes.
  • Proline – amino acid that renews cells and collagen fibres, improves skin elasticity, brightens the skin, reduces wrinkles, protects against photoageing, supports skin repair processes and tissue healing, and binds water in deeper skin layers.

Formulation

  • Monophasic, viscoelastic, homogeneous, highly cohesive cross-linked hyaluronic acid gel combined with glycine and proline.
  • Cross-linked HA concentration: 24 mg/ml.
  • Biotechnological origin HA with high microbiological safety.
  • Sterile, pyrogen-free, non-animal origin injectable hydrogel for intradermal/subcutaneous use.

Packaging

  • Standard pack: 2 x 1 ml pre-filled glass syringes of Revitafill Xtra 4.
  • Each syringe supplied with 25G x 16 mm needles (quantity may vary by distributor; commonly 2 needles per pack).
  • Some distributors also offer single 1 ml syringes as repacked units (e.g. 1 x 1 ml with 2 needles).
  • Supplied in a sterile blister and outer carton bearing product name, batch number, expiry date, CE marking and manufacturer details.

Usage

  • For professional use only – Revitafill Xtra 4 must be injected by suitably qualified and trained healthcare professionals experienced in dermal filler procedures.
  • Indicated injection site: deep dermis or subcutaneous layer in areas such as cheeks, chin and deepest nasolabial folds.
  • Recommended needle: 25G x 16 mm (or equivalent cannula according to clinician preference and anatomy).
  • Injection technique: linear or linear-retrograde (retrotracing), placing small aliquots of product while withdrawing the needle or cannula to ensure even distribution.
  • Disinfect the treatment area thoroughly and maintain strict aseptic technique throughout the procedure.
  • Inject slowly and carefully, avoiding overcorrection; massage gently if required to ensure homogeneous distribution and smooth contours.
  • Do not inject intravascularly; aspirate where appropriate and respect anatomical danger zones to minimise risk of vascular compromise.
  • After treatment, advise the patient to avoid excessive touching or massaging of the area, intense heat or cold exposure, strenuous exercise, saunas and sunbeds for 24–48 hours or according to clinic protocol.
  • Record product name, batch number, injected volume, injection sites and date of treatment in the patient’s medical records for traceability.

Contraindications

  • Known hypersensitivity to hyaluronic acid, glycine, proline or any of the excipients in the formulation.
  • History of severe allergy or anaphylactic reaction to injectable fillers.
  • Presence of active skin infection, inflammation or lesions at or near the intended injection sites (e.g. acne, herpes, dermatitis).
  • Autoimmune diseases or immunocompromised state where dermal filler use is considered inappropriate by the treating physician.
  • Bleeding disorders or current anticoagulant/antiplatelet therapy that may increase risk of bruising or bleeding, unless carefully evaluated by a physician.
  • Pregnancy and breastfeeding (use is generally not recommended for elective aesthetic procedures in these groups).
  • History of hypertrophic scarring or keloid formation in areas to be treated, according to clinician judgement.
  • Do not inject into blood vessels, intramuscularly, or into areas with permanent fillers or significant structural abnormalities.

Adverse Effects

  • Common, usually transient effects at injection sites such as redness, swelling, tenderness, pain, itching, bruising or slight discolouration.
  • Small lumps or nodules at or near the injection site, which often resolve spontaneously or with massage; persistent nodules may require clinical management.
  • Rare inflammatory reactions or delayed hypersensitivity responses, which may present as prolonged swelling, induration or erythema.
  • Infection at the injection site if aseptic technique is not strictly followed; may require antibiotic treatment.
  • Very rare but serious complications such as vascular occlusion (e.g. blanching, severe pain, tissue ischaemia, visual disturbance or blindness if periocular vessels are affected), requiring immediate recognition and urgent management according to filler complication protocols (e.g. hyaluronidase use where appropriate).
  • Asymmetry or over/undercorrection, which may require further treatment or adjustment.
  • Any unexpected or persistent adverse effect should prompt review by the treating clinician and appropriate reporting according to local pharmacovigilance/device vigilance requirements.

Storage Conditions

  • Store at a controlled room temperature as stated on the packaging, typically between 2°C and 25°C.
  • Do not freeze.
  • Store in the original outer carton to protect from light and contamination.
  • Do not use after the expiry date printed on the syringe and carton.
  • Single-use only: once a syringe has been used for a patient, any remaining product must be discarded and must not be reused.

Duration

Aesthetic results are typically long-lasting; clinical and distributor information indicate a duration of approximately 12\u201318 months, although many practitioners repeat treatments every 3\u201312 months depending on the patient\u2019s lifestyle, age, metabolism and skin condition.

Onset

Immediate volumisation and wrinkle reduction are visible directly after injection, with further improvement over subsequent days as hydration increases and tissues settle.

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