CE Approved polynucleotide injectable (listed among CE Approved polynucleotides in professional wholesale catalogues)
Manufactured under ISO 13485 Compliant quality management systems for medical devices (as stated for Ameela polynucleotide range)
Formulated using highly purified salmon DNA with traceable sourcing through a regulated supply chain
CE Approved polynucleotide injectable (listed among CE Approved polynucleotides in professional wholesale catalogues)
Manufactured under ISO 13485 Compliant quality management systems for medical devices (as stated for Ameela polynucleotide range)
Formulated using highly purified salmon DNA with traceable sourcing through a regulated supply chain
Intended for use by medical professionals in line with applicable medical device and aesthetic practice regulations in the EU/UK
Polynucleotide-based facial biostimulatory gel
Description
Ameela Face 2ml is an injectable, polymerised polynucleotide-based gel derived from highly purified salmon DNA, designed to deeply hydrate, regenerate and bio-stimulate skin tissue. Specifically formulated for the mid-face, jawline and selected body areas, it improves skin tone, firmness and elasticity while softening fine lines and enhancing overall complexion. The viscoelastic polynucleotide gel has antioxidant properties that protect against environmental and oxidative stress, supports deep tissue repair and can also be used as a post-surgical adjunct to accelerate healing and tissue improvement.
Bnefits
Deeply hydrates the skin for a smoother, more radiant appearance
Improves skin tone, firmness and elasticity
Softens fine lines and superficial wrinkles
Enhances skin texture and overall complexion quality
Promotes deep tissue repair and regenerative remodelling
Provides antioxidant protection against environmental and oxidative stressors
Supports bio-stimulation by encouraging collagen and elastin production
Helps refine facial contours, especially in the mid-face and jawline
Intended for use by medical professionals in line with applicable medical device and aesthetic practice regulations in the EU/UK
Polynucleotides (PDRN) of animal origin derived from highly purified salmon DNA
Molecular weight of polynucleotides: at least 1000 KDa
pH between 6.8 and 7.5
Viscosity: approximately 48–65 Pa·s (measured pre-sterilisation)
Sterile, viscoelastic, pyrogen-free injectable gel
Formulated in a physiological buffer suitable for intradermal/subdermal injection
Formulation
Polymerised polynucleotide (PDRN) gel specifically formulated for face and contouring areas
High-concentration polynucleotide content within the Ameela portfolio for enhanced tightening and contouring effects
Viscoelastic, non-crosslinked gel designed for intradermal or subdermal injection
Biocompatible and biodegradable formulation that integrates with tissue and is gradually resorbed
Non-volumising biostimulatory profile, acting primarily via regeneration, hydration and structural support
Packaging
Single pre-filled 2 ml syringe of Ameela Face polynucleotide gel
Syringe supplied in an individual branded Ameela Face box with protective blister
Labelling includes product name, volume (2 ml), concentration (25 mg/ml), batch/lot number, expiry date and regulatory marks
Intended for single-patient, single-use only; remaining product must not be stored or reused once opened
Usage
For professional medical aesthetic use only; treatment must be administered by suitably trained healthcare practitioners experienced in injectable procedures.
Assess the patient’s medical history, indications, expectations and suitability for polynucleotide treatment, and obtain informed consent before proceeding.
Cleanse and disinfect the treatment area thoroughly using an appropriate skin antiseptic, following clinic protocols.
If using topical anaesthetic, apply and allow adequate time to take effect, then remove completely prior to injection.
Using a fine needle or cannula of appropriate gauge and length, inject small aliquots of Ameela Face into the indicated planes (intradermal or subdermal) in the mid-face, jawline or selected body areas, following the manufacturer’s and clinic’s recommended techniques (e.g. micro-depot, linear threading or fanning).
Avoid intravascular injection and be mindful of anatomical danger zones; aspirate according to clinic policy and use appropriate injection technique to minimise risk.
Gently mould or smooth the treated area if required to ensure even distribution of product, avoiding excessive pressure.
Typical protocols involve a course of approximately 2–3 treatment sessions spaced about 2–3 weeks apart, adjusted to individual skin condition and practitioner judgement.
Maintenance treatments are commonly recommended at intervals of roughly 6–8 months, with 1–2 repeat sessions depending on age, lifestyle and skin quality.
Provide patients with clear post-treatment advice, including avoiding makeup on the treated area for the advised time, refraining from intense heat exposure and vigorous exercise for 24–48 hours, and not massaging the area unless instructed.
Dispose of used needles, syringes and associated consumables immediately after treatment in approved sharps and clinical waste containers.
Do not reuse the syringe or any residual product; Ameela Face is intended strictly for single use.
Contraindications
Known hypersensitivity or allergy to polynucleotides, salmon-derived products or any component of the formulation
Current or recent infection, inflammation, dermatitis or active skin disease at or near the intended injection site
History of severe allergic reactions or anaphylaxis (relative contraindication requiring careful risk–benefit assessment)
Autoimmune diseases or severe systemic illnesses where injectable biostimulatory treatments are not advisable without specialist input
Pregnancy and breastfeeding due to lack of sufficient safety data
Uncontrolled coagulation disorders or current use of anticoagulant or antiplatelet medication without appropriate medical assessment (relative contraindication)
Recent aggressive procedures (e.g. deep chemical peels, ablative lasers, surgery) in the intended treatment area where sufficient healing time has not elapsed
Any other condition that, in the treating practitioner’s judgement, makes injectable peri-facial or body polynucleotide treatment unsafe or inappropriate
Adverse Effects
Transient injection-site reactions such as redness, swelling, warmth, tenderness or mild pain
Localized bruising or small haematomas at injection points, especially in vascular areas
Temporary small papules, nodules or irregularities in the treated area, usually resolving as oedema subsides or with appropriate practitioner management
Mild pruritus, tightness or sensitivity in the treated regions during the early post-treatment phase
Rarely, more prolonged swelling or inflammatory response, particularly in patients with underlying sensitivities
Risk of infection, abscess or granulomatous reaction if aseptic technique is not strictly followed or in susceptible individuals
Very rare risk of intravascular injection or vascular compromise with any injectable treatment; practitioners must be prepared to recognise and manage such complications immediately
Any persistent, worsening or unusual adverse effect should prompt medical review and management according to local clinical and device-vigilance guidelines
Storage Conditions
Store in a clean, dry environment within the temperature range specified in the product leaflet (commonly between 2 °C and 25 °C).
Protect from direct sunlight and excessive heat or humidity.
Do not freeze, as freezing may damage the polynucleotide gel structure and compromise product integrity.
Keep the syringe in its original box and blister until immediately before use to maintain sterility and protect from light.
Do not use the product after the expiry date printed on the packaging or if the blister, box or syringe appears damaged or compromised.
Duration
Commonly performed as a course of 2\u20133 sessions spaced around 2\u20133 weeks apart, with results maintained for several months. Maintenance or booster treatments are typically performed every 6\u20138 months, with 1\u20132 sessions according to patient age, lifestyle and skin quality.
Onset
Patients often notice improved hydration and skin quality soon after treatment, with further enhancements in tone, elasticity and contour definition developing progressively over the weeks following each session and consolidating after completion of the treatment course.
