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FILLMED NCTF 135HA (5 x 3 ml)

FILLMED NCTF 135HA (5 x 3 ml)

FILLMED

Injectable mesotherapy / skin booster
  • NCTF 135 and NCTF 135HA are injectable medical devices bearing the CE mark (CE0297) for intradermal use.
  • Manufactured under an ISO 13485 Compliant quality management system for medical devices by Laboratoires FILL MED.
  • Conforms to applicable European and UK medical device regulations for injectable hyaluronic acid Based products intended for use by healthcare professionals.
  • Supplied with comprehensive Instructions for Use detailing indications, contraindications, precautions and vigilance reporting requirements.
Non-crosslinked hyaluronic acid polyrevitalising solution for anti-ageing mesotherapy

Description

FILLMED NCTF 135HA is a CE-marked, sterile, injectable polyrevitalising mesotherapy solution combining non-crosslinked hyaluronic acid (5 mg/ml) with a unique complex of 55 active ingredients. It is indicated for intense revitalisation and rehydration of tired or lax skin, treatment of superficial wrinkles, and optimisation of skin brightness and radiance. NCTF 135HA is designed for intradermal injection into the face, neck, décolleté, backs of the hands and other selected body areas by trained medical professionals, to improve skin quality by stimulating fibroblast activity and supporting collagen and elastin synthesis.

Bnefits

  • Intense skin revitalisation for tired, dull or devitalised skin
  • Deep and long-lasting hydration of the dermis thanks to non-crosslinked hyaluronic acid (5 mg/ml)
  • Improves skin brightness, radiance and overall complexion quality
  • Helps smooth and correct superficial wrinkles and fine lines
  • Enhances skin density, elasticity and firmness through fibroblast stimulation
  • Replenishes skin with a complex of 55 active ingredients including vitamins, amino acids, minerals, coenzymes, nucleic bases and antioxidants
  • Improves skin texture and tone on the face, neck, décolleté, hands and selected body areas
  • Acts as a positive pro-ageing skin booster, complementing other aesthetic treatments (e.g. peels, lasers, fillers) within professional protocols
  • Ready-to-use kit with syringes and needles for standardised mesotherapy protocols

Indications

  • Intense revitalisation of tired, devitalised skin
  • Hydration of dry or dehydrated skin
  • Treatment and prevention of superficial wrinkles and fine lines
  • Loss of skin radiance, dull or uneven complexion
  • Mild loss of elasticity and firmness in photoaged skin
  • Improvement of skin quality (tone, texture, turgor) on face, neck, décolleté and hands
  • Supportive treatment in anti-ageing programmes, including early signs of ageing and prevention
  • Optional treatment of selected body areas (inner arms, inner thighs, abdomen) when clinically appropriate

Composition

  • Non-crosslinked sodium hyaluronate (hyaluronic acid) 5 mg/ml
  • Total of 55 active ingredients in addition to hyaluronic acid, typically described as:
  • • 12 vitamins (A, B-group, C, E) to stimulate vital cell functions and provide antioxidant protection
  • • 24 amino acids to promote protein synthesis (collagen, elastin) and dermal matrix renewal
  • • 6 minerals (trace elements) to support cellular metabolism and ionic balance
  • • 6 coenzymes to catalyse biochemical reactions and energy metabolism
  • • 5 nucleic bases (nucleic acids) to support cell communication and DNA/RNA metabolism
  • • 2 additional antioxidant/functional components (including glutathione and others depending on source) to help protect against free radical damage
  • Excipient solution: buffered, isotonic aqueous vehicle with stabilisers and surfactant (e.g. polysorbate 80) – full qualitative and quantitative composition is detailed in the official Instructions for Use

Formulation

  • Sterile, apyrogenic, isotonic injectable solution for intradermal use
  • Non-crosslinked, highly purified hyaluronic acid of non-animal origin (biofermentation)
  • Polyrevitalising complex combining HA with 55 active ingredients
  • Transparent, colourless, viscoelastic solution supplied in pre-filled syringes or ampoules of 3 ml
  • Injectable medical device bearing the CE mark (CE0297), intended for professional use only

Packaging

  • Professional kit: 5 x 3 ml pre-filled glass syringes (or ampoules) of NCTF 135HA
  • 5 x 18G draw-off needles
  • 5 x 3 ml syringes (where applicable, depending on configuration)
  • 10 injection needles (typically 5 x 30G – 12 mm and 5 x 32G – 4 mm) for intradermal injection
  • Each syringe/vial individually packed in a sterile blister, supplied in an outer carton with Instructions for Use (IFU)
  • Labelling includes product name, batch/lot number, expiry date, CE mark and manufacturer details

Usage

  • For professional use only: NCTF 135HA must be injected by physicians or suitably qualified healthcare professionals trained in mesotherapy and intradermal injection techniques.
  • Before treatment, take a full medical history and examine the patient to ensure there are no contraindications; obtain informed consent explaining indications, expected results, possible side effects and post-treatment care.
  • Cleanse and disinfect the treatment area thoroughly, observing strict aseptic technique for all materials and the injection field.
  • Withdraw product if supplied in vials, or prepare the pre-filled syringes as per the Instructions for Use; attach a sterile 30G–32G needle or a suitable mesotherapy device (e.g. gun, roller or Nanosoft microneedles) following manufacturer recommendations.
  • Inject NCTF 135HA into the superficial to mid dermis using appropriate techniques such as micro-papular (point-by-point), nappage, or linear retro-tracing along wrinkles, depending on the area treated and practitioner preference.
  • Typical treatment areas include face, neck, décolleté, backs of the hands and selected body areas (inner arms, inner thighs, abdomen) while avoiding high-risk vascular structures and strictly avoiding intravascular injection.
  • Standard protocol commonly consists of an intensive phase of several sessions (e.g. 3–5 sessions) spaced about 15 days apart, followed by maintenance sessions every 3–6 months according to skin condition and practitioner protocol.
  • Following injection, gently massage treated areas if necessary to distribute product evenly, taking care not to compress papules excessively if micro-papular technique is used.
  • Advise patients to avoid makeup for several hours post-treatment, to avoid saunas, intense heat or cold, vigorous exercise and alcohol for 24 hours, and to follow an appropriate skincare routine including sun protection.
  • Always follow the latest official FILLMED NCTF 135HA Instructions for Use for detailed injection techniques, dosage, frequency, indications, contraindications, precautions and management of potential adverse reactions.

Contraindications

  • Hypersensitivity or known allergy to hyaluronic acid or any of the components of NCTF 135HA
  • History of severe allergic reactions or anaphylaxis
  • Active skin infections or inflammatory skin disease (e.g. herpes, bacterial or fungal infections, dermatitis) at or near the intended injection site
  • Autoimmune diseases or immune system disorders, unless the treating physician judges treatment acceptable with appropriate precautions
  • Tendency to develop hypertrophic scars or keloids, or known poor wound healing, unless carefully evaluated by a physician
  • Concurrent use of certain medications or treatments that may interfere with healing or increase risk (e.g. anticoagulants, strong immunosuppressants), as assessed by the clinician
  • Recent deep chemical peels, ablative laser resurfacing or dermabrasion at the proposed injection sites, until complete healing has occurred
  • Pregnancy and breastfeeding (generally not recommended due to lack of sufficient clinical data)
  • Use in children or minors, as safety and efficacy have not been established in this population
  • Intravascular injection is strictly contraindicated; avoid injection into or near blood vessels

Adverse Effects

  • Common, usually transient injection-site reactions such as redness (erythema), swelling (oedema), pain or tenderness, itching, bruising (haematoma) and small papules at injection points
  • Temporary discolouration or slight irregularities in skin surface at injection sites, generally resolving within a few hours to days
  • Rare localised infections or abscesses if aseptic technique or aftercare is inadequate
  • Rare inflammatory reactions such as prolonged redness, induration, nodules or granuloma formation; these should be evaluated and managed by a physician
  • Very rare vascular complications (e.g. ischaemia, tissue necrosis, visual disturbance) in case of accidental intravascular injection or vascular compression, which constitute medical emergencies requiring immediate expert management
  • Rare hypersensitivity or allergic-type reactions; treatment should be discontinued and appropriate medical care instituted if these occur
  • Any severe, unexpected or persistent adverse event should be reported to the manufacturer and to competent regulatory authorities according to local medical device vigilance requirements

Storage Conditions

  • Store between 2°C and 25°C (36°F–77°F) in a dry place, protected from light.
  • Do not freeze; avoid exposure to excessive heat or direct sunlight.
  • Keep syringes/vials in their original outer packaging until use to maintain sterility and protect from physical damage.
  • Do not use if the blister, vial, syringe or packaging is damaged or if the solution is not clear and colourless.
  • Do not use after the expiry date indicated on the packaging.
  • Discard used syringes, needles and remaining product as medical sharps waste in accordance with local regulations.

Duration

Treatment is typically performed as a course of multiple sessions: an initial intensive phase of around 3\u20135 sessions spaced approximately every 2\u20133 weeks, followed by maintenance sessions every 3\u20136 months as clinically indicated. Total duration and number of sessions are determined by the treating practitioner based on patient age, skin condition and treatment goals.

Onset

Patients often notice initial improvements in hydration and skin glow within days after the first sessions, with more pronounced effects on skin texture, fine lines, density and radiance becoming apparent over the full course of treatment (several sessions) and maintained with regular maintenance treatments.

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