Revitrane HA10 Classic 1 x 1ml
Revitrane
Medical aestheticsHyaluronic acid dermal filler
Certifications
- CE Marked Class III medical device (Revitrane HA series, including HA10 Classic).
- CE mark number 2292 referenced in manufacturer and brand materials for the Revitrane range.
- Manufactured under ISO 13485 Compliant quality management system for medical devices.
- Use of pharmaceutical Grade, non Animal, high Purity hyaluronic acid raw material.
- Minimised BDDE cross Linking rate and advanced BDDE residue cleaning process for improved safety profile.
- CPM (Cohesive Polydensified Matrix) or comparable cross Linking technology for uniform gel structure and tissue integration.
- Produced in GMP Compliant facilities operated by BR PHARM Co., Ltd. in South Korea.
- Distributed through CE Compliant aesthetic wholesalers and, in the UK, via supply chains operating under MHRA Regulated or GDP principles for medical devices where applicable.
- CE Marked Class III medical device (Revitrane HA series, including HA10 Classic).
- CE mark number 2292 referenced in manufacturer and brand materials for the Revitrane range.
- Manufactured under ISO 13485 Compliant quality management system for medical devices.
- Use of pharmaceutical Grade, non Animal, high Purity hyaluronic acid raw material.
- Minimised BDDE cross Linking rate and advanced BDDE residue cleaning process for improved safety profile.
- CPM (Cohesive Polydensified Matrix) or comparable cross Linking technology for uniform gel structure and tissue integration.
- Produced in GMP Compliant facilities operated by BR PHARM Co., Ltd. in South Korea.
- Distributed through CE Compliant aesthetic wholesalers and, in the UK, via supply chains operating under MHRA Regulated or GDP principles for medical devices where applicable.
Hyaluronic acid dermal filler
Description
Revitrane HA10 Classic is a low-viscosity, ultra-fine, cross-linked hyaluronic acid dermal filler specifically designed for treating the finest areas of the face and for detailed lip augmentation. Containing 20 mg/mL of cross-linked hyaluronic acid in a smooth, viscoelastic monophasic gel, it is ideal for soft correction of light forehead lines, crow’s feet, perioral (smoker’s) lines and thin lips. The filler delivers natural volume, lift and refined contouring with minimal swelling, making it particularly suitable for precise techniques such as Russian lip augmentation where superior definition and long-lasting yet natural results are required.
Bnefits
- Low-viscosity, ultra-fine gel designed for high-precision work in delicate facial areas.
- Creates natural-looking volume and lift in superficial and mid-dermal tissues without a bulky or overfilled appearance.
- Helps correct fine lines and shallow wrinkles including crow’s feet, light forehead lines and perioral (smoker’s) lines.
- Perfectly contours and defines the lips, supporting techniques such as Russian lips and detailed border work.
- High cohesiveness and soft viscoelastic texture improve implant stability and integration with surrounding tissue.
- Smooth, controlled extrusion force for predictable, comfortable injections.
- Minimised BDDE cross-linking rate and advanced purification processes for a cleaner gel with reduced residue levels.
- Natural, long-lasting results typically maintained for around 7–10 months depending on area, technique and patient factors.
- Designed to cause less swelling, making it suitable for areas that require subtle, refined volume.
- Part of the CE-marked Revitrane HA10 range, giving practitioners a consistent portfolio across indications.
Indications
- Correction of fine, superficial facial lines and wrinkles in the mid-dermis.
- Light forehead lines that require subtle softening rather than deep volumisation.
- Crow’s feet and fine periorbital lines (with appropriate technique and patient selection).
- Perioral lines (smoker’s/lip lines) requiring delicate filling and smoothing.
- Thin lips requiring subtle to moderate volumisation and improved contour.
- Detailed lip augmentation including Russian lip techniques and edge/border definition.
- Site-specific contouring of small facial areas where a soft, low-viscosity filler is preferred.
- General soft-tissue refinement in areas needing natural volume with minimal swelling.
- Not indicated for deep wrinkles, severe folds or large-volume structural augmentation (for those, higher-viscosity Revitrane products such as Premium or Premium Sub-Q are recommended).
Composition
- Cross-linked hyaluronic acid 20 mg/mL (HA10 concentration).
- Hyaluronic acid cross-linked using BDDE (1,4-Butanediol diglycidyl ether) at a minimised cross-linking rate (exact BDDE content as per product IFU).
- Physiological buffer solution (sterile, pyrogen-free carrier; exact excipients as listed on the official carton/leaflet).
- No added lidocaine (Revitrane Classic presentations distributed by LPG Clinics Wholesale and several other EU/UK wholesalers are supplied without lidocaine).
Formulation
- Monophasic cross-linked hyaluronic acid gel with very fine HA particles.
- Low-viscosity, ultra-soft viscoelastic texture tailored for superficial and mid-dermal injections and delicate lip work.
- Manufactured using Revitrane’s double cross-linking and CPM (Cohesive Polydensified Matrix) technology to achieve a uniform, cohesive gel with high tissue integration and low migration risk.
- Designed to provide high cohesiveness and good elasticity while maintaining a low extrusion force for smooth injection.
- Class III CE-marked injectable medical device based on high-purity, non-animal hyaluronic acid.
Packaging
- Each unit box contains 1 x 1 mL pre-filled, sterile glass syringe of Revitrane HA10 Classic.
- Supplied with 2 x 30G 1/2" (13 mm) sterile needles (needle specification may vary slightly by market but 30G is typical for Classic).
- 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 mark, manufacturer (BR PHARM Co., Ltd.) and instructions for professional use.
- Intended strictly for single patient use; any unused gel after treatment must be discarded.
Usage
- For professional use only; injectors must be appropriately trained and qualified healthcare professionals experienced in dermal filler procedures.
- Review the patient’s medical history, allergies, current medications and prior aesthetic treatments; obtain informed consent following local regulations.
- Examine facial anatomy and dynamic movement to plan injection sites, volume and technique tailored to the patient’s needs.
- Ensure the product is within its expiry date and the packaging is intact; do not use if the blister or syringe is damaged or if sterility is compromised.
- Cleanse and disinfect the treatment area using an appropriate skin antiseptic, avoiding eye and mucosal contact.
- Attach the supplied sterile 30G needle securely to the Luer lock of the syringe and expel a small drop of gel to remove air.
- Inject slowly into the recommended tissue plane (typically superficial to mid dermis for fine lines and lip vermilion/vermillion border for augmentation) using techniques such as linear threading, small aliquots, serial puncture or fanning, according to training and patient indication.
- Avoid overcorrection; gradually build volume and regularly assess symmetry and contour during injection.
- After injection, gently mold and smooth the area with light fingertip pressure to optimise contour and integration, avoiding excessive force.
- Provide post-treatment advice: avoid makeup on the treated area for several hours; avoid extreme heat or cold, vigorous exercise, alcohol and massaging the area for 24–48 hours; protect skin from excessive sun exposure.
- Instruct patients to contact the clinic immediately if they experience severe pain, blanching, discolouration, unexpected swelling, visual disturbances or any other signs suggestive of vascular compromise or serious adverse reactions.
- Dispose of used needles and syringes as clinical sharps in accordance with local medical waste regulations.
Contraindications
- Known hypersensitivity or allergy to hyaluronic acid or any excipient in the product.
- History of severe anaphylactic reactions or multiple severe allergies.
- Presence of active skin infection, inflammation or disease (e.g., acne, herpes simplex, dermatitis) at or near the intended injection site.
- Injection into areas previously treated with permanent or semi-permanent fillers, unless the practitioner is confident it is safe to do so.
- Patients with known bleeding disorders or those receiving significant anticoagulant or antiplatelet therapy (relative contraindication requiring individual risk assessment).
- Patients who are pregnant or breastfeeding, due to insufficient safety data; use is generally not recommended.
- Patients with severe autoimmune diseases or significant immunosuppression, where dermal filler treatment may carry higher risk, unless under specialist guidance.
- Do not inject into blood vessels or intramuscularly; intravascular injection is strictly contraindicated.
Adverse Effects
- Common, usually transient injection-site reactions: redness, swelling, tenderness, pain, bruising, itching, firmness or small palpable nodules; these typically resolve within a few days to two weeks.
- Possible temporary asymmetry, contour irregularities or overcorrection, which may require massage, further adjustment or time to settle.
- Less common complications: local infection, prolonged edema, delayed-onset nodules or granulomatous reactions, or hypersensitivity-type responses.
- Vascular occlusion from inadvertent intravascular injection or compression, presenting with severe pain, blanching, livedo, discolouration or tissue ischemia; if untreated, this can lead to necrosis and scarring and constitutes a medical emergency.
- Rare but serious events associated with dermal fillers in high-risk facial zones: visual disturbance, blindness, stroke-like symptoms or neurological deficits due to embolisation of filler material.
- In rare cases, immediate or delayed systemic hypersensitivity or anaphylactic reactions may occur.
- Any persistent, unexpected or severe adverse effect should prompt urgent clinical review and, where appropriate, reporting to relevant health authorities.
Storage Conditions
- Store in the original packaging at a controlled room temperature as specified in the product leaflet (commonly between 1°C and 30°C); do not freeze.
- Protect from direct sunlight and excessive heat or cold.
- Do not use if the product has been frozen, overheated, improperly stored or if the packaging is damaged or opened.
- Keep out of the reach of children and unauthorised persons.
- Single-use product: once the syringe has been used on a patient, any remaining gel must be discarded and not reused.
Duration
Clinical and commercial sources report that results with Revitrane HA10 Classic typically last around 7\u201310 months, with the manufacturer\u2019s materials commonly citing approximately 8\u201310 months of effect depending on treatment area, injection technique, patient metabolism and lifestyle factors.
Onset
Immediate volumising, contouring and wrinkle-smoothing effect at the time of injection, with the final aesthetic result usually apparent after initial swelling and minor bruising resolve over the first few days; subtle refinement can continue over subsequent weeks as the gel integrates and tissue hydration stabilises.
