LINERASE Collagen powder (1x100mg)

LINERASE

Biostimulator / Injectable Collagen

Heterologous Type I collagen powder for skin bioregeneration

Class III CE Marked medical device based on heterologous Type I collagen.
Manufactured by TypeOne Biomaterials Srl under ISO 9001 and ISO 13485 certified quality management systems.
Intended for use only by qualified healthcare professionals in accordance with applicable medical device regulations.

Class III CE Marked medical device based on heterologous Type I collagen.
Manufactured by TypeOne Biomaterials Srl under ISO 9001 and ISO 13485 certified quality management systems.
Intended for use only by qualified healthcare professionals in accordance with applicable medical device regulations.

Heterologous Type I collagen powder for skin bioregeneration

Description

LINERASE Collagen powder (1x100mg) is a professional injectable biostimulator based on Heterologous Type I Collagen (HTIC) of equine origin, supplied as a sterile, pyrogen-free powder in a glass vial. After dilution with sterile water for injection (WFI) or sterile normal saline (0.9% sodium chloride solution), it is administered intradermally to promote skin bioregeneration with biorevitalising, toning and repairing action. By providing a natural scaffold for fibroblast adhesion, growth and differentiation, LINERASE supports regeneration and reconstruction of connective tissue in the dermis, counteracting chrono- and photoageing, improving elasticity and density, and reducing wrinkles, atrophic scars and stretch marks.

Bnefits

Professional skin bioregeneration treatment with biorevitalising, toning and repairing action.
Contains Heterologous Type I Collagen (equine origin) in sterile, pyrogen-free powder form.
Stimulates fibroblasts and supports physiological neoformation of collagen in the dermis.
Improves skin elasticity, firmness and density, counteracting chrono- and photoageing.
Effective in the regeneration and restoration of skin defects, including scars and stretch marks.
Helps reduce fine wrinkles and skin flaccidity on the face and body.
Can be used on face, neck, décolleté, hands and other body areas with atrophic or lax skin.
Treatment effects typically last 6–12 months after a full course, depending on individual factors.

Indications

Biorevitalisation and bioregeneration of the skin of the face, neck, décolleté and hands.
Treatment of skin atrophy, hypotonia and reduced skin elasticity.
Regeneration and restoration of skin defects and connective tissue damage.
Reduction of atrophic scars and stretch marks.
Reduction of wrinkles and skin flaccidity on the face and body.
Improvement of skin elasticity, firmness and overall skin quality.

Composition

100 mg Heterologous Type I Collagen (HTIC) powder of equine origin, sterile and pyrogen-free

Formulation

Micronised heterologous Type I collagen powder for injectable suspension after dilution with 5 ml sterile WFI or 0.9% sodium chloride solution
Single-use, sterile, pyrogen-free medical device intended for intradermal injection

Packaging

1 glass vial containing 100 mg powder of equine collagen Type I (LINERASE Collagen HTIC)
Packaged as a Class III medical device for professional injectable use

Usage

For professional use only by trained medical or aesthetic practitioners.
Immediately before use, reconstitute the 100 mg collagen powder with 5 ml of sterile water for injection (WFI) or sterile normal saline (0.9% sodium chloride solution), following the manufacturer’s instructions.
Mix gently until a homogeneous suspension is obtained; use the suspension immediately and discard any unused residue.
Administer via intradermal (or very superficial subdermal, as per protocol) injections using a fine needle (typically 30G–32G, approx. 4 mm).
Inject approximately 0.1 ml per point at intervals of about 2 cm over the treatment area (e.g. face, neck, décolleté, hands or other indicated body sites).
A typical course consists of 2–4 treatment sessions performed at intervals of 14–21 days.
Maintenance is usually 1 LINERASE Collagen 1x100mg treatment every 3 months or repetition of the full course after about 6–12 months, according to clinical assessment.
Observe strict aseptic technique during preparation and injection; do not use if the vial, packaging or suspension appears compromised.
Provide post-treatment care advice including avoiding make-up on treated areas for several hours, minimising sun exposure and extremes of temperature, and using recommended skincare.
Advise patients to report any persistent pain, unusual discolouration or signs of infection at injection sites.

Contraindications

Known hypersensitivity or allergy to collagen of equine origin or to any component of the product.
History of severe allergic reactions or anaphylaxis.
Active skin infection, inflammation or open wounds at or near the intended injection sites.
Autoimmune diseases or other conditions where collagen-based injectables are considered unsuitable by the treating physician.
Tendency to develop hypertrophic scars or keloids, subject to clinical judgement.
Pregnancy or breastfeeding, as elective aesthetic injectable treatments are generally not recommended.
Bleeding disorders or concurrent use of anticoagulants/antiplatelet agents when the risk of bruising or haematoma is considered unacceptable.
Serious systemic illness or dermatologic conditions that, in the practitioner’s opinion, make treatment inappropriate.

Adverse Effects

Transient erythema, swelling, tenderness or bruising at injection sites.
Mild pain or discomfort during and shortly after injection.
Small papules or nodules at injection points, usually resolving as the product integrates.
Occasional delayed inflammatory reactions or local irritation.
Risk of infection at injection sites if aseptic technique is not adequately maintained.
Very rare risk of more marked inflammatory or immune-mediated responses requiring medical evaluation.

Storage Conditions

Store in the original packaging until use.
Keep in a cool, dry place at controlled room temperature as specified in the product leaflet (commonly 2–25°C).
Do not freeze.
Protect from direct sunlight, heat sources and excessive humidity.
Keep out of the reach and sight of children.
Do not use after the expiry date or if the vial or packaging is damaged or previously opened.

Duration

Standard protocols generally involve 2\u20134 sessions at 14\u201321 day intervals, with maintenance sessions every 3 months or repetition of the full course after approximately 6\u201312 months, depending on clinical response and patient needs.

Onset

Initial improvements in skin texture and hydration may be observed within a few weeks of starting treatment, with more pronounced gains in elasticity, firmness and reduction of defects such as fine wrinkles, scars and stretch marks over subsequent sessions and the following months.