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Fillmed M HA 10 (3 x 3 ml)

Fillmed M HA 10 (3 x 3 ml)

FILLMED

Dermal fillers / Mesotherapy
  • CE Marked medical device based on non Crosslinked hyaluronic acid for intradermal injection in mesotherapy, with efficacy and safety supported by clinical use and documentation.
  • Manufactured under quality management systems consistent with medical device production standards (e.g., ISO 13485) as communicated by Laboratoires FILLMED.
  • Complies with European and UK regulations applicable to injectable hyaluronic acid medical devices intended for use by healthcare professionals.
  • Supplied through licensed pharmacies and medical wholesalers that comply with local regulations for the distribution of aesthetic medical devices.
Non-crosslinked hyaluronic acid skin booster for mesotherapy

Description

Fillmed M-HA 10 is a sterile, viscoelastic, non-crosslinked hyaluronic acid skin booster intended for intradermal injection as part of anti-ageing mesotherapy. Supplied as three 3 ml vials or syringes, it is designed to replenish age-related loss of endogenous hyaluronic acid, deeply hydrate the skin, restore radiance and elasticity, and act as a filling agent for fine lines such as crow’s feet, perioral lines, and other superficial wrinkles on the face, neck, décolleté, and hands.

Bnefits

  • Replenishes hyaluronic acid lost through skin ageing to restore hydration balance
  • Provides deep, immediate and long-lasting hydration of the superficial and mid dermis
  • Improves skin radiance, tone, and luminosity in tired, dull-looking skin
  • Enhances skin elasticity and firmness, helping skin feel smoother and less lax
  • Softly fills fine lines and superficial wrinkles (e.g., crow’s feet, perioral lines, smoker’s lines)
  • Optimises skin quality on the face, neck, décolleté, and hands as a skin booster treatment
  • Viscoelastic, highly purified, non-crosslinked hyaluronic acid designed for high biocompatibility
  • Suitable as a standalone mesotherapy treatment or combined protocol with other aesthetic procedures (e.g., peels, NCTF, laser) according to professional guidance

Indications

  • Treatment of pronounced skin dehydration and dryness
  • Dull, tired-looking skin lacking radiance and glow
  • Early to moderate fine lines and superficial wrinkles (e.g., periorbital, perioral, crow’s feet)
  • Mild loss of elasticity and firmness in the face, neck, décolleté, and hands
  • Improvement of overall skin quality (tone, texture, and turgor) via mesotherapy skin booster protocols
  • Supportive treatment for photoaged skin when combined with other aesthetic procedures as advised by a clinician

Composition

  • Active ingredient: sodium hyaluronate (hyaluronic acid) 10 mg/ml, non-animal origin, obtained by biofermentation
  • Non-crosslinked, highly purified hyaluronic acid with molecular weight comparable to endogenous hyaluronic acid to optimise biocompatibility
  • Sterile, viscoelastic, limpid, colourless, transparent, isotonic, biodegradable injectable implant
  • Excipients: physiological buffer and vehicle solution (full qualitative and quantitative composition detailed in the official M-HA 10 Instructions for Use)

Formulation

  • Injectable, non-crosslinked hyaluronic acid dermal implant for mesotherapy
  • Viscoelastic solution intended for intradermal (upper to mid dermis) injection as a skin booster
  • Colourless, transparent, isotonic, sterile, biodegradable formulation supplied in ready-to-use vials or syringes
  • Designed to be used alone or in combination protocols for skin hydration and radiance

Packaging

  • Box containing 3 x 3 ml glass vials or prefilled syringes of Fillmed M-HA 10 (pack description varies slightly by market)
  • Each vial/syringe contains 3 ml of sodium hyaluronate solution at 10 mg/ml
  • Sterile packaging including traceability and batch/lot labelling in accordance with medical device standards
  • Instruction leaflet (Instructions for Use) included in each pack for healthcare professionals

Usage

  • For professional use only: Fillmed M-HA 10 must be injected by qualified medical professionals trained in intradermal injection techniques and familiar with hyaluronic acid-based implants.
  • Administer by intradermal injections into the superficial to mid dermis using appropriate needles or devices (e.g., multipuncture technique, micro-papular injections, or cannula techniques following manufacturer guidance and local practice).
  • Commonly treated areas include the face, periorbital region, perioral region, neck, décolleté, and hands, avoiding intravascular injection and high-risk anatomical structures.
  • Standard protocol typically consists of 3 treatment sessions spaced about 1 month (3–4 weeks) apart, as per Fillmed professional protocols.
  • Maintenance treatment is generally recommended every 6 months or as clinically indicated based on skin condition and patient expectations.
  • Inject slowly with minimal pressure; aspirate where appropriate to minimise intravascular risk and discontinue injection immediately if blanching, pain, or other signs of vascular compromise occur.
  • Do not inject into areas with active inflammation, infection, or damaged skin; ensure proper antiseptic preparation of the treatment area.
  • After treatment, advise patients to avoid makeup for several hours, intense heat/cold exposure, and strenuous physical activity for at least 24 hours, and to follow post-treatment care recommendations.
  • Use each vial or syringe for a single patient only, respecting aseptic technique and local regulations regarding medical devices and sharps disposal.
  • Always refer to and follow the latest official Fillmed M-HA 10 Instructions for Use for detailed injection techniques, indications, contraindications, and precautions.

Contraindications

  • Hypersensitivity or known allergy to hyaluronic acid or any component of the formulation
  • History of severe allergic reactions or anaphylaxis
  • Active infection, inflammation, or skin disease (e.g., herpes, acne flare, dermatitis) at or near the intended injection site
  • Autoimmune diseases or patients undergoing immunotherapy, unless the treating physician decides the procedure is appropriate with precautions
  • Tendency to develop hypertrophic scars or keloids or known poor wound-healing, unless assessed and cleared by a physician
  • Recent laser, deep chemical peel, dermabrasion, or other aggressive skin procedures on the intended treatment area (treatment should be delayed until complete healing and skin recovery)
  • Pregnancy and breastfeeding (use generally not recommended in the absence of sufficient clinical data)
  • Use in children or minors, as safety and efficacy have not been established for this population
  • Intravascular injection or injection into highly vascular or high-risk anatomical zones where there is risk of embolisation is strictly contraindicated

Adverse Effects

  • Common, transient injection-site reactions such as redness (erythema), swelling (oedema), pain, tenderness, itching, discolouration, or bruising
  • Small papules or nodules at injection points, usually resolving within days as the product integrates and hydrates the tissue
  • Rare but more significant events such as infection, abscess, granuloma formation, persistent nodules, or inflammatory reactions
  • Very rare vascular complications (e.g., ischemia, necrosis, visual disturbance) if accidental intravascular injection occurs; these constitute a medical emergency requiring immediate management by a qualified physician
  • In rare cases, hypersensitivity or allergic-type reactions; treatment should be discontinued and appropriate medical care instituted
  • Any severe, unusual, or persistent adverse effect should be reported to the manufacturer and relevant regulatory authorities according to medical device vigilance requirements

Storage Conditions

  • Store between 2°C and 25°C in a dry place, protected from light and moisture.
  • Do not freeze and do not expose to excessive heat.
  • Keep in the original outer carton until use to protect from light and mechanical damage.
  • Handle with care; do not use if packaging or sterile barrier is damaged.
  • Do not use after the expiry date printed on the pack and label.

Duration

Typical mesotherapy protocol consists of 3 sessions spaced approximately 1 month apart, followed by maintenance sessions about every 6 months; the overall treatment course and duration are adjusted by the treating clinician according to patient needs, skin condition, and response.

Onset

Hydration and radiance improvements are often visible immediately or within days after injection, with progressive enhancement of skin elasticity, smoothness, and fine-line reduction over the full 3-session protocol; maintenance treatments help sustain results over time.

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