Revitrane Volume 1 x 1ml
Revitrane
Medical aestheticsHyaluronic acid dermal filler
Certifications
- CE Marked Class III medical device within the Revitrane hyaluronic acid dermal filler range.
- Manufactured under an ISO 13485 Compliant quality management system for medical devices.
- Produced in GMP Compliant facilities by BR PHARM Co., Ltd.
- Uses non Animal, high Purity, pharmaceutical Grade hyaluronic acid raw materials.
- Minimised BDDE cross Linking rate with advanced residual BDDE cleaning process.
- Low endotoxin levels designed to reduce the risk of inflammatory reactions.
- Distributed via regulated aesthetic pharmacies and wholesalers that comply with applicable EU/UK medical device and supply Chain standards.
- CE Marked Class III medical device within the Revitrane hyaluronic acid dermal filler range.
- Manufactured under an ISO 13485 Compliant quality management system for medical devices.
- Produced in GMP Compliant facilities by BR PHARM Co., Ltd.
- Uses non Animal, high Purity, pharmaceutical Grade hyaluronic acid raw materials.
- Minimised BDDE cross Linking rate with advanced residual BDDE cleaning process.
- Low endotoxin levels designed to reduce the risk of inflammatory reactions.
- Distributed via regulated aesthetic pharmacies and wholesalers that comply with applicable EU/UK medical device and supply Chain standards.
Hyaluronic acid dermal filler
Description
Revitrane Volume is a high-viscosity, cross-linked hyaluronic acid dermal filler designed to add long-lasting volume, restore facial contours and treat medium to deeper facial lines and wrinkles. Containing 20 mg/mL of pure cross-linked hyaluronic acid in a soft but structurally supportive gel, it is ideal for volumising and shaping lips (including hybrid lips), treating frown lines, nasolabial folds and marionette lines, and providing additional lift and support in areas such as the cheeks and chin. The high-quality, viscoelastic gel deeply hydrates and plumps the skin so the face appears smoother, firmer and more youthful, while still achieving natural-looking results.
Bnefits
- High-viscosity filler that restores volume in deeper wrinkles and facial lines.
- Provides long-lasting volume and definition for lips, including voluminous or hybrid lip techniques.
- Increases moisture levels in the skin so it feels plumper, smoother and more hydrated.
- Improves skin structure and adds lift in areas needing more structural support, such as cheeks and chin.
- Soft viscoelastic gel texture designed to create natural-looking results without a rigid or overfilled appearance.
- Helps reverse visible signs of ageing across the face by filling medium to deep folds and volume loss.
- Uses high-quality, pure cross-linked hyaluronic acid (20 mg/mL) for predictable, consistent outcomes.
- Uniform cross-linked HA structure for even tissue integration and stable placement in the mid-dermis.
- Low extrusion force compared to many fillers, improving injector control and patient comfort.
- Results are generally reported to last up to approximately 12 months, depending on patient and treatment factors.
Indications
- Medium to deeper facial wrinkles and lines requiring a high-viscosity filler.
- Frown lines (glabellar lines) where structural support and softening are needed.
- Nasolabial folds (smile lines) of moderate depth.
- Marionette lines extending from the corners of the mouth.
- Volumisation and contouring of thin lips; creation of fuller or hybrid lips.
- Areas requiring more structural support and lift, such as cheeks and chin.
- Slightly sunken or dehydrated facial areas where additional volume and hydration are desired.
Composition
- Cross-linked hyaluronic acid 20 mg/mL (high-purity, non-animal sourced).
- Cross-linking agent: BDDE (1,4-Butanediol diglycidyl ether) used at a minimised rate (residual levels reduced via advanced cleaning process).
- Physiological, sterile buffer solution as carrier (exact excipients as per official IFU).
- No added lidocaine (Revitrane Volume presentations from major UK/EU distributors are supplied without local anaesthetic).
Formulation
- Monophasic cross-linked hyaluronic acid gel with high viscosity for volumising and lift.
- Soft viscoelastic texture that provides natural volume while maintaining structural support.
- Uniform cross-linked HA structure designed to blend smoothly with surrounding tissue.
- High-quality raw materials with minimised chemical cross-linking rate using BDDE.
- Advanced residual BDDE cleaning process and low endotoxin levels for improved safety.
- Class III CE-marked injectable medical device intended for intradermal use in the mid to deeper dermis.
Packaging
- Each unit box contains 1 x 1ml pre-filled sterile glass syringe of Revitrane Volume.
- Typically supplied with 2 x 27G needles (as specified by several distributors).
- Syringe and needles are packaged in a sterile blister tray inside an outer printed carton.
- Carton labelled with product name, volume, batch/lot number, expiry date, CE marking, manufacturer (BR PHARM Co., Ltd.) and professional-use-only notice.
- Ergonomic syringe grip and thin-walled needles to aid precise, controlled injection.
Usage
- For professional use only by suitably trained and qualified healthcare practitioners with experience in injectable dermal fillers.
- Take a detailed medical history, including allergies, medications (especially anticoagulants/antiplatelets), autoimmune conditions and previous aesthetic treatments; obtain informed consent after explaining risks, benefits and alternatives.
- Visually inspect the packaging and syringe; do not use if sterility is compromised, the blister pack is damaged or the product is past its expiry date.
- Thoroughly cleanse and disinfect the treatment area using an appropriate skin antiseptic, avoiding contact with eyes and mucous membranes.
- Attach a suitable sterile needle (commonly 27G) or cannula firmly to the syringe and expel any air, ensuring a small droplet of gel is visible at the tip before injection.
- Inject slowly into the recommended tissue planes (usually mid to deep dermis and, where appropriate, subcutaneous tissue) using suitable techniques such as linear threading, fanning, serial puncture or small depot injections according to anatomical area and training.
- For wrinkles (frown lines, nasolabial folds, marionette lines), inject along the line or fold and gently mold the product to achieve a smooth contour.
- For lips, inject carefully into the vermilion and/or body of the lip to create volume, contour and hybrid lip effects, continually assessing symmetry and avoiding overcorrection.
- For cheeks and chin, place the filler in deeper planes for structural support and lift, using conservative volumes and assessing profile changes throughout.
- After treatment, gently massage the treated areas as appropriate to refine shape and ensure even distribution, avoiding excessive pressure that could displace the product.
- Advise patients to avoid makeup on treated areas for several hours and to avoid alcohol, vigorous exercise, extreme temperatures (saunas, steam rooms, sunbeds) and direct pressure or massage on the treated areas for 24–48 hours.
- Instruct patients to contact the clinic immediately if they experience severe or disproportionate pain, blanching, colour changes, visual disturbances, pronounced swelling, signs of infection or any other concerning symptoms.
- Dispose of used syringes, needles and other sharps in approved clinical waste containers according to local regulations.
Contraindications
- Known hypersensitivity or allergy to hyaluronic acid or any excipient in the product.
- History of severe anaphylactic reactions or multiple serious allergies.
- Active skin infection, inflammation or disease (e.g., acne, herpes simplex, dermatitis) at or near the intended injection site.
- Previous injection of permanent or semi-permanent fillers in or near the treatment area, unless the practitioner is fully confident it is safe to treat.
- Uncontrolled bleeding disorders or current use of significant anticoagulant or antiplatelet therapy without appropriate risk assessment.
- Pregnancy and breastfeeding, as safety data are lacking and treatment is generally not recommended in these groups.
- Severe autoimmune disease or significant immunosuppression, unless treatment is undertaken following specialist assessment.
- Intravascular injection is strictly contraindicated; do not inject into blood vessels or use techniques that significantly increase the risk of intravascular placement.
Adverse Effects
- Common, usually transient injection-site reactions: redness, swelling, tenderness, pain, bruising, itching and local warmth; these typically resolve within a few days to two weeks.
- Temporary palpable nodules or lumps and minor asymmetry, which often improve as the product integrates or after gentle molding or clinical review.
- Less common reactions: local infection, prolonged edema, delayed-onset nodules, granulomatous reactions or inflammatory responses.
- Vascular occlusion resulting from inadvertent intravascular injection or external compression, which may present with severe pain, blanching, livedo reticularis, tissue ischemia and possible necrosis if not treated urgently; this is a medical emergency.
- Very rare but serious complications associated with dermal filler injections, particularly in high-risk zones: visual disturbances, vision loss, stroke-like symptoms or other neurological deficits due to embolisation of filler material.
- Immediate or delayed hypersensitivity reactions, including rare anaphylactic events.
- Any persistent, unusual or severe adverse event should prompt urgent clinical evaluation and, where appropriate, reporting to relevant regulatory authorities.
Storage Conditions
- Store the product in its original packaging at a controlled temperature as specified in the product leaflet (typically around 2°C to 25°C or similar); do not freeze.
- Protect from direct sunlight, excessive heat and moisture.
- Do not use if the syringe has been frozen, overheated or otherwise improperly stored, or if the packaging is damaged or opened before intended use.
- Keep out of the reach of children and unauthorised individuals.
- Single-use sterile device: once opened and used on a patient, any remaining filler must be discarded in accordance with clinical waste protocols.
Duration
Clinical and commercial sources report that Revitrane Volume delivers long-lasting results, typically up to around 12 months, depending on the treatment area, injection technique, product volume, and individual patient factors such as metabolism, lifestyle and skin quality.
Onset
Volumising, wrinkle-filling and lip-enhancing effects are visible immediately after injection, with final results becoming more evident as initial swelling and bruising subside over the first few days; tissue integration and hydration effects may continue to refine the outcome over subsequent weeks.
