OneFill Deep Hyaluron Filler 1 ml
OneFill
InjectablesHyaluronic Acid Dermal Filler
Certifications
- CE Marked cross Linked hyaluronic acid dermal filler with lidocaine in accordance with applicable European medical device regulations.
- Manufactured under ISO 13485 Certified quality management systems as stated by JDBIO.
- Developed using HCCL/HBCT crosslinking technologies aimed at minimising residual BDDE and enhancing stability and safety.
- Produced using premium HTL France hyaluronic acid raw material, as stated by the manufacturer.
- Marketed by professional aesthetics distributors (including Aesthetics Warehouse) as a CE Regulated injectable for use by qualified medical professionals only.
- CE Marked cross Linked hyaluronic acid dermal filler with lidocaine in accordance with applicable European medical device regulations.
- Manufactured under ISO 13485 Certified quality management systems as stated by JDBIO.
- Developed using HCCL/HBCT crosslinking technologies aimed at minimising residual BDDE and enhancing stability and safety.
- Produced using premium HTL France hyaluronic acid raw material, as stated by the manufacturer.
- Marketed by professional aesthetics distributors (including Aesthetics Warehouse) as a CE Regulated injectable for use by qualified medical professionals only.
Hyaluronic Acid Dermal Filler
Description
OneFill Deep Hyaluron-Filler 1 ml is an advanced, cross-linked hyaluronic acid dermal filler with lidocaine, designed for the treatment of deeper facial lines, folds and volume loss. Based on highly purified HA at 24 mg/ml with 0.3% lidocaine, it is engineered using HCCL technology to provide a durable gel with high cohesivity, elasticity and plasticity, while minimising residual BDDE. Its stable, consistent monophasic gel structure is intended to integrate smoothly with facial tissues, restoring natural contours and delivering noticeable yet natural-looking volume in areas such as nasolabial folds, marionette lines, cheeks, chin, lips and deeper forehead/glabella lines when injected by trained medical professionals.
Bnefits
- Specifically formulated to fill moderate to deep wrinkles and folds, including nasolabial folds and marionette lines.
- Restores and enhances natural facial contours, providing noticeable volume in cheeks, chin and lips.
- Engineered with HCCL (High Cross-linking Concentration Level) technology for enhanced durability and reduced degradation, supporting longer-lasting aesthetic results.
- Smooth, stable and consistent monophasic gel structure for natural look and feel and predictable injection behaviour.
- Balanced cohesivity, elasticity and plasticity to support good tissue integration while maintaining shape and projection.
- High concentration of highly purified hyaluronic acid (24 mg/ml) for effective volumisation and hydration.
- Contains lidocaine 0.3% to improve patient comfort during injection.
- Designed as part of the OneFill portfolio using advanced crosslinking technologies (HCCL / HBCT) and premium HTL France HA raw material for safety and performance.
- CE-marked dermal filler supplied in a sterile pre-filled syringe with needles for professional use.
Indications
- Nasolabial folds (smile lines).
- Marionette lines (lines running from the mouth corners towards the chin).
- Cheeks for augmentation, contouring and volume restoration.
- Chin for augmentation and contouring.
- Lips for volume enhancement and definition.
- Glabella lines (frown lines).
- Forehead lines and other deeper facial folds where a higher lifting capacity filler is indicated, as assessed by a qualified practitioner.
Composition
- Cross-linked hyaluronic acid (non-animal origin) 24 mg/ml.
- Lidocaine 0.3% (3 mg/ml) as a local anaesthetic.
- Physiological buffer solution and excipients to maintain isotonicity and appropriate pH (full list as per official instructions for use).
Formulation
- Monophasic cross-linked hyaluronic acid dermal filler gel with lidocaine, produced using HCCL/HBCT crosslinking technologies to provide a durable, viscoelastic gel with high cohesivity, elasticity and plasticity, designed for the correction of deeper wrinkles, folds and volume deficits.
Packaging
- 1 x 1 ml sterile pre-filled glass syringe of OneFill Deep Hyaluron-Filler.
- Sterile single-use needles, typically 1 x 25G and 1 x 27G (needle configuration may vary by batch/market; see pack).
- Sterile blister packaging and outer carton with product labelling and instructions for use.
Usage
- For use only by appropriately trained and qualified healthcare professionals experienced in dermal filler injections.
- Obtain a complete medical history, including allergies (especially to hyaluronic acid, lidocaine or other amide-type local anaesthetics), autoimmune conditions, medications (e.g. anticoagulants) and previous filler treatments.
- Clean and disinfect the treatment area in accordance with clinic protocol, maintaining strict aseptic technique throughout the procedure.
- Attach the supplied needle (typically 25G or 27G) securely to the pre-filled syringe and expel any air before injection.
- Inject slowly using appropriate techniques (e.g. linear threading, fanning, serial puncture or small boluses) at the recommended depth for the indication (usually mid to deep dermis or supraperiosteal / subcutaneous planes for volume restoration, depending on area and practitioner judgement).
- Continuously aspirate and monitor during injection where appropriate and inject minimal volumes per pass to reduce the risk of intravascular injection.
- Assess symmetry and contour frequently, massaging gently if necessary to distribute the product evenly and avoid lumps or overcorrection.
- Provide post-procedure advice such as avoiding makeup on treated areas for several hours, avoiding extreme heat or cold, intensive exercise, alcohol and massage of the area for the period recommended in the IFU/clinic protocol.
- Schedule follow-up reviews if required to assess results and determine the need for touch-up treatments, respecting intervals and maximum recommended volumes.
- Refer to and follow the official instructions for use for detailed indications, injection depths, warnings, precautions and management of complications.
Contraindications
- Known hypersensitivity or allergy to hyaluronic acid, lidocaine or other local anaesthetics of the amide type, or to any component of the product.
- History of severe anaphylactic reactions or multiple severe allergies without appropriate specialist assessment and precaution.
- Injection into or near areas of active skin disease, inflammation or infection (e.g. acne, dermatitis, herpes) at the intended treatment site.
- Presence of permanent or semi-permanent fillers or implants in the intended treatment area, unless carefully evaluated by an experienced practitioner.
- Autoimmune or connective tissue diseases and immune-compromised states, where filler use should be considered with extreme caution and specialist guidance.
- Bleeding disorders or use of anticoagulants/antiplatelet agents that significantly increase bleeding risk, unless the risk–benefit has been assessed.
- Pregnancy and breastfeeding, as safety of dermal fillers has not been established in these populations.
- Do not inject into blood vessels, glabellar artery-rich “danger zones”, or intramuscularly in high-risk areas; intravascular injection is a strict contraindication and an emergency if suspected.
Adverse Effects
- Common, usually transient injection-site reactions: redness (erythema), swelling, pain, tenderness, itching, bruising, induration or slight discolouration.
- Localised oedema or palpable nodules/lumps which often resolve spontaneously or with gentle massage; persistent nodules may require clinical management.
- Temporary altered sensation or discomfort in treated areas related to injection trauma, lidocaine or local swelling.
- Less common adverse reactions include delayed-onset nodules, granuloma formation, prolonged inflammatory reactions, or hypersensitivity responses.
- Rare but serious complications associated with HA dermal fillers include intravascular injection leading to vascular occlusion, tissue necrosis, visual disturbance, or blindness; practitioners must be trained in early recognition and emergency management (including the use of hyaluronidase and appropriate referral).
Storage Conditions
- Store in the original packaging at a controlled room temperature as specified in the IFU (commonly between 2 °C and 25 °C); do not freeze.
- Protect from direct sunlight, extreme heat and excessive humidity.
- Do not use after the expiry date printed on the syringe or outer carton.
- Do not use if the packaging (blister or syringe) is opened, damaged or shows signs of compromised sterility.
- Single-use product: do not resterilise, reuse or share any syringe or needle between patients.
- Keep out of the reach of children and unauthorised persons.
Duration
Clinical effects typically last approximately 9\u201312 months in deeper indication areas (e.g. nasolabial folds, marionette lines, cheeks and chin), depending on injection site, volume, technique and individual patient factors; retreatment intervals should be determined by the treating practitioner.
Onset
Immediate volumising and smoothing effect visible after injection; final aesthetic outcome usually stabilises over several days as transient swelling or redness resolves.
