Intraline ONE 1 x 1ml

Intraline

Medical device

Hyaluronic acid dermal filler (biphasic)

CE Marked hyaluronic acid dermal filler in accordance with applicable EU/UK medical device regulations.
Manufactured under ISO 13485 Compliant quality management system.
Non Animal, biodegradable hyaluronic acid produced by controlled bacterial fermentation.

CE Marked hyaluronic acid dermal filler in accordance with applicable EU/UK medical device regulations.
Manufactured under ISO 13485 Compliant quality management system.
Non Animal, biodegradable hyaluronic acid produced by controlled bacterial fermentation.

Hyaluronic acid dermal filler (biphasic)

Description

Intraline ONE is a CE-marked biphasic hyaluronic acid dermal filler (20 mg/ml cross-linked sodium hyaluronate of non-animal origin) designed to treat medium to deep facial wrinkles and folds and to restore or enhance lip volume and contour. Using Intraline’s Spherification Technology, the filler’s HA molecules are reshaped into smooth spherical particles, providing higher molecular density, improved integration and natural-looking results. The transparent, viscoelastic gel is supplied in a 1 ml prefilled syringe with 2 x 27G Terumo needles for mid-dermal injection by trained medical professionals.

Bnefits

Treats medium to deep facial wrinkles and folds, including nasolabial folds and marionette lines.
Provides subtle yet effective enhancement and definition of the lips, cupid’s bow and labial commissures.
Indicated for tear troughs, perioral “smoker’s lines”, crow’s feet and other fine to medium lines in delicate areas.
Biphasic gel structure (cross-linked HA in a non-cross-linked carrier) offers balanced lift, support and tissue integration.
Spherification Technology creates spherical HA particles for smoother, more natural results and improved product density.
Non-animal, cross-linked hyaluronic acid produced by bacterial fermentation reduces risk of allergic reactions.
Results typically last up to 6–12 months depending on treatment area, technique and patient factors.
Supplied ready to use in a 1 ml prefilled syringe with two 27G needles for precise mid-dermal placement.

Indications

Correction of medium to deep facial wrinkles and folds.
Treatment of nasolabial folds.
Treatment of marionette lines and oral commissures (labial commissure).
Treatment of frown lines and other expression lines in suitable candidates.
Lip augmentation and contouring, including cupid’s bow definition and volume enhancement.
Treatment of perioral “smoker’s lines”.
Treatment of tear troughs and other fine to medium lines such as crow’s feet/fine periocular lines, as per professional judgement.

Composition

Cross-linked sodium hyaluronate (hyaluronic acid) 20 mg/ml of non-animal origin.
Cross-linking agent: BDDE (1,4-butanediol diglycidyl ether), residual level <1 µg/ml.
Physiological buffer (e.g. phosphate-buffered saline) and water for injections.
Sterile, pyrogen-free, viscoelastic HA gel with spherical particle structure.
No added lidocaine.

Formulation

Biphasic hyaluronic acid gel: cross-linked HA particles suspended in non-cross-linked HA carrier.
HA concentration: 20 mg/ml.
Average HA sphere size: medium (designed for mid-dermal placement).
Non-animal origin HA produced via proprietary bacterial fermentation.
Transparent, sterile, non-pyrogenic, viscoelastic injectable gel.
Intended level of injection: mid dermis.
Administration using 27G needles supplied in the pack.

Packaging

1 x 1 ml prefilled glass syringe of Intraline ONE.
2 x 27G Terumo needles.
2 traceability/patient record labels.
Package insert with instructions for use and safety information.
Sterile blister pack, CE-marked and tamper-evident outer packaging.

Usage

For use only by appropriately trained and qualified medical professionals in accordance with local regulations.
Review patient medical history, indications and contraindications; obtain informed consent.
Clean and disinfect the treatment area thoroughly; apply topical or local anaesthesia if required.
Attach one of the supplied 27G needles securely to the prefilled syringe and expel air from the system.
Inject slowly into the mid-dermal layer using appropriate techniques (e.g. linear threading, serial puncture, fanning) depending on the treatment area.
Gently massage the treated area to ensure even distribution and to mould the filler as needed.
Do not overcorrect; reassess after initial swelling has subsided and perform touch-ups at a later visit if necessary.
Dispose of any unused product, syringe and needles as clinical sharps waste; do not resterilise or reuse.
Advise the patient on aftercare: avoid makeup on the treatment area for several hours, avoid extreme temperatures, saunas, vigorous exercise and alcohol for 24 hours, and avoid pressure or massage on the treated area unless instructed.

Contraindications

Hypersensitivity or allergy to hyaluronic acid, BDDE or any component of the product.
History of severe allergic reactions or anaphylaxis.
Presence of active skin infections, inflammation or lesions at or near the intended injection sites (e.g. acne, herpes, dermatitis).
Autoimmune diseases or immunocompromised states, unless the practitioner considers treatment appropriate and safe.
Tendency to develop hypertrophic scars or keloids in the proposed treatment area.
Pregnancy or breastfeeding (use is not recommended due to lack of clinical data).
Use in children or adolescents under 18 years of age.
Intravascular injection or injection into highly vascular structures is strictly contraindicated.

Adverse Effects

Common, usually transient effects at the injection site: redness, swelling, pain, tenderness, bruising, itching, firmness or lumps/bumps.
Temporary dyschromia or mild inflammatory reactions at the treated area.
Nodules or palpable indurations, which may require massage, medical treatment or, rarely, hyaluronidase.
Infection, abscess formation or granulomatous reactions, potentially requiring medical or surgical management.
Allergic or hypersensitivity reactions ranging from localised swelling to more generalized responses.
Vascular complications, including blanching, skin necrosis or, in rare cases, visual disturbances or blindness if injected intravascularly or if vascular compromise occurs; these events require immediate emergency management.
Other rare complications as described in the product’s instructions for use.

Storage Conditions

Store between 2°C and 25°C.
Do not freeze.
Store in the original packaging, protected from light and direct heat.
Do not use after the expiry date printed on the packaging.
Keep out of the reach and sight of children.

Duration

Clinical effects are typically maintained for approximately 6\u201312 months depending on individual factors such as patient age, skin type, lifestyle, treatment area, injection technique and volume used.

Onset

Immediate visible volumising and wrinkle-correcting effect after injection, with final results evident once initial swelling and redness subside over the following days.