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FILLMED NCTF 135HA (5 x 3ml)

FILLMED NCTF 135HA (5 x 3ml)

FILLMED

Medical Aesthetics
  • CE Marked injectable medical device for intradermal use in skin revitalisation.
  • Manufactured under a certified quality management system consistent with ISO 13485 for medical devices.
  • Complies with applicable European medical device regulatory requirements for sterile, apyrogenic injectable products.
Skin Boosters & Mesotherapy

Description

FILLMED NCTF 135HA is an injectable, hyaluronic acid–based polyrevitalising solution designed for anti-ageing mesotherapy and intensive skin rejuvenation. Each pack contains 5 vials of 3 ml, combining non-cross-linked hyaluronic acid (5 mg/ml) with an extensive complex of more than 50 biologically active ingredients (vitamins, amino acids, coenzymes, nucleic bases, minerals and antioxidants). The formula targets dehydration, fine lines, loss of radiance and decreased dermal density by re-boosting fibroblast activity and improving the quality of the skin. NCTF 135HA is indicated for revitalisation and hydration of tired or loose skin, treatment of superficial wrinkles and improvement of skin tone and luminosity on the face, neck, décolletage and hands. It is supplied as a CE-marked injectable medical device for professional use only.

Bnefits

  • Intense skin revitalisation and hydration of tired, dull or loose skin.
  • Improves skin tone, texture, radiance and dermal density.
  • Helps reduce the appearance of fine lines and superficial wrinkles.
  • Polyrevitalising complex of hyaluronic acid plus multiple vitamins, amino acids, coenzymes, nucleic bases, minerals and antioxidants supports fibroblast activity and extracellular matrix quality.
  • Non-cross-linked hyaluronic acid (5 mg/ml) provides deep hydration without volumising the tissues or altering facial features.
  • Indicated for multiple treatment areas including face, neck, décolletage and backs of the hands.
  • Can be combined with other aesthetic treatments (e.g. fillers, toxins, lasers, biostimulators, surgery, threads, PRP) as part of a global anti-ageing protocol, when judged appropriate by the treating clinician.
  • CE-marked injectable medical device manufactured under stringent quality and safety standards.

Indications

  • Intense revitalisation and hydration of tired, dull or loose skin.
  • Treatment and prevention of superficial wrinkles and early signs of skin ageing.
  • Improvement of skin brightness, radiance and overall quality.
  • Increase in skin density and firmness in mature or lax skin.
  • Reduction of enlarged pores and improvement of skin texture.
  • Treatment areas typically include face (including periorbital region), neck, décolletage and backs of the hands, and may also include other suitable body areas as per professional judgement.

Composition

  • Non-cross-linked hyaluronic acid: 5 mg/ml.
  • Polyrevitalising complex of more than 50 active ingredients, including:
  • • Vitamins (e.g. A, B-group, C, E) to stimulate vital cellular functions.
  • • Amino acids to support synthesis of structural skin proteins such as collagen and elastin.
  • • Coenzymes to catalyse biochemical reactions in skin tissue.
  • • Nucleic bases / nucleic acids to support cellular communication and renewal.
  • • Minerals (e.g. Magnesium, Sodium, Potassium, Calcium) to replace cutaneous deficiencies and support ionic balance.
  • • Antioxidants and other actives (e.g. glutathione and related components) to help protect against free-radical damage.
  • Sterile, apyrogenic, non-animal–origin injectable solution presented in 3 ml vials.

Formulation

  • Sterile, apyrogenic injectable mesotherapy solution.
  • Concentration: 5 mg/ml non-cross-linked (non-volumising) hyaluronic acid.
  • Polyrevitalising complex with multiple vitamins, amino acids, coenzymes, nucleic bases, minerals and antioxidants.
  • Pack content (typical professional kit): 5 x 3 ml vials of NCTF 135HA; ancillary items such as 3 ml syringes, 18G draw-off needles and 30G/32G injection needles may be included depending on kit configuration.
  • Intended for intradermal or superficial dermal injection using micro-injection, nappage, point-by-point, linear retro-tracing or mesotherapy device techniques by trained professionals.
  • Injectable medical device (skin booster / mesotherapy) and not a volumising dermal filler.

Packaging

  • Carton containing 5 single-dose 3 ml glass vials of NCTF 135HA.
  • Depending on kit format: 5 x 3 ml syringes, 5 x 18G draw-off needles and up to 10 injection needles (commonly 5 x 30G 13 mm and 5 x 32G 4 mm) to facilitate product withdrawal and administration.
  • Vials supplied sterile, apyrogenic and ready for use by healthcare professionals.
  • Outer packaging printed with product name, batch/lot number, expiry date, CE mark and manufacturer details.

Usage

  • For professional use only: NCTF 135HA must be administered exclusively by appropriately trained and licensed healthcare professionals in accordance with local regulations.
  • Before treatment, assess patient suitability, medical history, contraindications and expectations; obtain informed consent and document baseline skin condition.
  • Ensure strict aseptic technique. Disinfect the treatment area according to clinic protocol.
  • Withdraw the required volume of NCTF 135HA from a 3 ml vial into a sterile 3 ml syringe using an 18G draw-off needle, then replace with a suitable micro-injection needle (commonly 30G or 32G).
  • Inject intradermally or into the superficial dermis using appropriate mesotherapy techniques (e.g. micro-papules, nappage, point-by-point, linear retro-tracing) over the selected treatment zones (face, neck, décolletage, hands, etc.).
  • Standard protocol: 5 treatment sessions – the first 3 sessions spaced approximately 15 days apart, followed by 2 further sessions spaced about 1 month apart. Maintenance courses are typically recommended 1–2 times per year, according to clinical judgement and patient response.
  • Adjust volume per session, injection depth and pattern based on indication, treatment area, skin quality and professional experience.
  • After injection, gently massage if required to ensure even distribution, then apply appropriate post-treatment care (e.g. cooling, soothing topical products) as per clinic protocol.
  • Provide the patient with written post-treatment instructions, including guidance on sun protection, avoidance of intense heat, vigorous exercise and manipulation of treated areas for a specified period.
  • Record product details (batch/lot number, expiry date, treated areas, injected volume) in the patient file for traceability.
  • Dispose of all sharps, vials and consumables in approved clinical waste containers in accordance with local regulations. Do not reuse any component.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid or any component of the formulation.
  • Active local or systemic infection, inflammation or skin disease at or near the intended injection sites.
  • Autoimmune or immunosuppressive conditions without prior medical clearance and careful risk–benefit assessment.
  • Severe coagulation disorders or current use of significant anticoagulant therapy, unless specifically evaluated by a physician.
  • History of severe allergic reactions or anaphylaxis to injectable products.
  • Pregnancy and breastfeeding (elective aesthetic mesotherapy is generally avoided).
  • Injection into blood vessels, eyelids, mucous membranes or areas with compromised skin integrity is contraindicated.
  • Any other contraindication identified in the official instructions for use or determined by the treating healthcare professional during clinical assessment.

Adverse Effects

  • Common, usually transient injection-related reactions such as redness (erythema), swelling, tenderness, itching, warmth, bruising or mild pain at the injection site.
  • Small papules or nodules at injection points that typically resolve as the product is integrated into the tissue.
  • Haematoma or ecchymosis in the treated area, particularly in patients with fragile vessels or on antithrombotic therapy.
  • Temporary asymmetry or irregularity of skin surface immediately post-treatment, usually resolving as oedema subsides.
  • Infection at the injection site if aseptic technique is not strictly followed, potentially requiring medical treatment.
  • Hypersensitivity or inflammatory reactions (e.g. persistent erythema, oedema, induration) that may require clinical management.
  • Very rare but serious complications related to injection procedures in general (e.g. accidental intravascular injection, vascular compromise, tissue necrosis, visual disturbance) – practitioners must be familiar with facial anatomy and emergency management protocols.
  • Any unexpected or persistent adverse effects should be evaluated and managed according to local medical guidelines and reported via appropriate device vigilance channels.

Storage Conditions

  • Store between 2°C and 25°C (36–77°F).
  • Keep in a dry place, protected from light and moisture.
  • Do not freeze.
  • Store in the original, sealed packaging until use to maintain sterility and protect from contamination.
  • Do not use after the expiry date printed on the vial and outer carton.
  • Do not use if the packaging or sterile barrier is opened, damaged or compromised.

Duration

A standard initial course consists of 5 sessions: 3 sessions at 15-day intervals followed by 2 sessions at 1-month intervals. Maintenance treatments are commonly performed once or twice per year, depending on skin condition and practitioner recommendation. The biological effects and visible improvement can persist for many months following a completed course.

Onset

An immediate improvement in hydration and skin glow is often observed after the first sessions, with progressive benefits (smoother texture, reduced fine lines, enhanced elasticity and radiance) developing over several weeks as fibroblast activity and dermal matrix quality improve.

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