LINERASE Collagen Powder 1 x 100mg

LINERASE

Biostimulator / Injectable Collagen

Heterologous Type I collagen for skin bioregeneration

Class III CE Marked medical device based on heterologous Type I collagen for injectable use.
Manufactured in accordance with applicable European medical device regulations and quality standards for sterile injectable devices.

Class III CE Marked medical device based on heterologous Type I collagen for injectable use.
Manufactured in accordance with applicable European medical device regulations and quality standards for sterile injectable devices.

Heterologous Type I collagen for skin bioregeneration

Description

LINERASE Collagen Powder 1 x 100mg is a professional, injectable biostimulator based on heterologous Type I collagen (HTIC) in sterile micronised powder form. After reconstitution with saline, it is injected intradermally to promote physiological skin bioregeneration with biorevitalising, toning and repairing action. By providing an optimal scaffold for fibroblast adhesion and activity, LINERASE stimulates the natural synthesis of new collagen and other extracellular matrix components, counteracting chrono- and photoageing, improving elasticity and firmness, and helping to reduce wrinkles, scars and stretch marks. Following treatment, the skin appears more elastic, compact and radiant.

Bnefits

Professional bioregeneration treatment with biorevitalising, toning and repairing action.
Heterologous Type I collagen (HTIC) stimulates fibroblasts and supports physiological neoformation of collagen.
Improves skin elasticity, firmness and density, counteracting chrono- and photoageing.
Helps reduce fine lines, wrinkles, scars and stretch marks.
Enhances skin texture, hydration and overall radiance.
Supports reconstruction of connective tissue in the dermis for long-term quality improvement.
Non-toxic, fully biodegradable atelocollagen with very good tolerability.
Can be used on face, neck, décolleté, hands and other body areas with atrophic or lax skin.

Indications

Skin bioregeneration and biorevitalisation of the face, neck, décolleté and hands.
Treatment of skin atrophy, hypotonia and reduced elasticity.
Improvement of skin texture, firmness and density.
Softening and smoothing of fine lines and wrinkles.
Reduction of atrophic scars (including acne scars) and stretch marks.
Adjunctive treatment in areas of post-traumatic or post-surgical skin damage.
General anti-ageing treatments for chrono- and photoaged skin on face and body.

Composition

100 mg heterologous Type I collagen (HTIC), atelocollagen of equine origin, in sterile micronised powder
Sterile primary packaging vial suitable for reconstitution with 0.9% sodium chloride solution (saline)

Formulation

Sterile, pyrogen-free heterologous Type I collagen in micronised powder form for injectable suspension.
Presented as a single-use vial to be reconstituted immediately before intradermal injection with 5 ml of sterile 0.9% NaCl (with or without small volume of local anaesthetic solution as per protocol).

Packaging

1 x 100 mg vial of micronised heterologous Type I collagen powder (LINERASE).
Packaged as a Class III medical device with instructions for reconstitution and professional use.

Usage

For professional use only by suitably trained and qualified medical or aesthetic practitioners.
Immediately before use, reconstitute the 100 mg collagen powder with 5 ml of sterile 0.9% sodium chloride solution (optionally combining 0.5 ml of 2% lidocaine with 4.5 ml NaCl according to local protocol) to obtain a 5 ml suspension.
Shake or gently swirl until a homogeneous suspension is obtained; use immediately and discard any unused product.
Inject intradermally (or very superficial subdermal, depending on protocol) using a fine needle (commonly 30G–32G, approx. 4 mm).
Administer small wheals of about 0.1 ml every ~2 cm over the treatment area (e.g. face, neck, décolleté, backs of hands or other indicated sites).
Typical initial course consists of 2–4 treatment sessions spaced approximately 14–21 days apart, depending on indication and patient response.
Maintenance: repeat a single LINERASE 1 x 100 mg session every 3 months or repeat the full course after approximately 6–12 months, according to clinical judgment and patient needs.
Observe strict aseptic technique during reconstitution and injection; do not use if the vial or packaging is damaged or if sterility is in doubt.
Provide post-treatment advice including avoidance of make-up on treated areas for several hours, minimising sun/UV exposure and extreme heat or cold, and using appropriate skincare as recommended.
Instruct patients to report any unusual or severe pain, colour change, or persistent inflammation at the 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 infections, inflammatory dermatoses or open wounds at or near the intended injection sites.
Autoimmune diseases or conditions where collagen implants/biostimulators are considered unsuitable by the treating physician.
Tendency to form hypertrophic scars or keloids, subject to clinical judgment.
Pregnancy and breastfeeding, as elective aesthetic injectable treatments are generally not recommended.
Bleeding disorders or concurrent anticoagulant/antiplatelet therapy where the risk of haematoma is considered unacceptable by the clinician.
Any serious systemic illness or dermatologic condition that, in the opinion of the practitioner, makes treatment inappropriate.

Adverse Effects

Transient erythema, swelling, tenderness, itching or bruising at the injection sites.
Mild pain or discomfort during and shortly after injection.
Small papules or nodules at injection points that usually resolve as the product integrates and remodels.
Occasional delayed inflammatory reactions or local irritation.
As with all injectable products, there is a low risk of infection if aseptic technique is not strictly observed.
Very rare risk of more significant inflammatory or immune-mediated responses; such events should be evaluated and managed by an appropriate specialist.

Storage Conditions

Store in its original packaging until use.
Keep in a cool, dry place, typically at controlled room temperature as specified in the product leaflet (commonly 2–25°C).
Protect from direct sunlight, excessive heat and humidity.
Do not freeze.
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

A standard treatment cycle usually comprises 2\u20134 sessions performed 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.

Onset

Initial improvements in skin texture, tone and hydration may be visible within a few weeks after starting treatment, with progressive gains in elasticity, firmness and scar/stretch mark appearance over subsequent sessions and months as new collagen is formed.