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Belotero Intense (1 x 1.0ml)

Belotero Intense (1 x 1.0ml)

Belotero

Dermal filler
  • CE Marked Class III medical device in the European and UK markets for aesthetic soft tissue augmentation.
  • Manufactured under ISO 13485 and Good Manufacturing Practice (GMP) quality systems for sterile medical devices.
  • Conforms to applicable EU Medical Device Regulation (MDR) / UK medical device requirements for safety and performance.
  • Biodegradable, non Animal Origin hyaluronic acid produced via controlled biofermentation.
Cross-linked hyaluronic acid (HA) filler for deep lines and volume enhancement

Description

Belotero Intense with Lidocaine (1 x 1.0ml) is a sterile, injectable, cross-linked hyaluronic acid dermal filler formulated using CPM (Cohesive Polydensified Matrix) technology for the correction of deep facial lines and folds and for volume enhancement. The filler contains 25.5 mg/ml of cross-linked sodium hyaluronate and 3.0 mg/ml lidocaine hydrochloride in a phosphate buffer at pH 7, supplied in a single-use 1 ml prefilled glass syringe with two 27G needles. Belotero Intense is designed for injection into the deep dermis or submucosa/subcutaneous tissue, providing strong lifting capacity, excellent tissue integration and a long-lasting, natural-looking result with high elasticity and cohesivity, particularly suited to highly mobile facial areas such as the nasolabial folds, marionette lines and lips.

Bnefits

  • Specifically formulated to correct fine to deep facial lines and folds, including nasolabial folds and marionette lines.
  • High lifting capacity suitable for deep wrinkles and volume restoration while maintaining a natural facial appearance.
  • CPM (Cohesive Polydensified Matrix) technology provides excellent tissue integration, minimising skin irregularities and producing smooth, natural-looking results.
  • Designed for highly mobile facial areas (perioral region, oral commissures, lips) while preserving normal facial expression.
  • Contains 3 mg/ml lidocaine to improve patient comfort during and immediately after injection.
  • Immediate visible improvement after treatment with typical longevity of results up to about 12 months, depending on area treated and patient factors.
  • Biodegradable, non-animal origin hyaluronic acid with high biocompatibility and low immunogenicity.
  • Supplied ready to use in a prefilled sterile syringe with two 27G needles for convenience and consistent dosing.
  • Can be combined with other Belotero fillers (Soft, Balance, Volume, Lips Shape/Contour) to tailor treatment to skin structure and functional needs.

Indications

  • Filling and correction of deep facial wrinkles and folds, particularly nasolabial folds (nose-to-mouth lines).
  • Treatment of marionette lines (lines from the corners of the mouth towards the chin).
  • Lip augmentation and enhancement of lip volume.
  • Definition and contouring of the lip border (Cupid’s bow and vermilion border).
  • Correction of oral commissures and perioral lines.
  • Restoration and enhancement of soft tissue volume and contour in indicated facial areas, especially zones of dynamic movement around the mouth and lower face.

Composition

  • Cross-linked sodium hyaluronate (hyaluronic acid) 25.5 mg/ml (non-animal origin, produced by biofermentation).
  • Lidocaine hydrochloride 3.0 mg/ml (local anaesthetic to reduce injection pain).
  • Phosphate buffer solution at pH 7 q.s. ad 1 ml (physiological buffer).

Formulation

  • Sterile, pyrogen-free, viscoelastic, colourless, homogeneous gel of cross-linked hyaluronic acid with lidocaine.
  • Hyaluronic acid concentration: 25.5 mg/ml.
  • Lidocaine hydrochloride concentration: 3.0 mg/ml.
  • Technology: CPM (Cohesive Polydensified Matrix) dynamic cross-linking technology for optimal combination of cohesivity, elasticity and plasticity.
  • Intended route: Injection into the deep dermis and/or submucosal/subcutaneous tissue depending on the indication and anatomical area.
  • Resorbable, biodegradable filler: gradually broken down over time by normal metabolic processes.

Packaging

  • Single-use, prefilled 1 ml sterile glass syringe containing Belotero Intense with Lidocaine, sterilised by moist heat.
  • Each box contains: one 1 ml prefilled syringe, two sterile CE-marked hypodermic needles 27G 1/2" (0.4 x 13 mm), two traceability labels and one instructions-for-use leaflet.
  • Outer carton labelled with product name, batch number, expiry date, CE marking, manufacturer details and storage conditions.

Usage

  • Belotero Intense with Lidocaine is for professional use only and must be administered exclusively by suitably trained and licensed healthcare professionals experienced in dermal filler injections and facial anatomy.
  • Before treatment, obtain a full medical history including allergies (especially to hyaluronic acid, lidocaine or amide-type local anaesthetics), bleeding disorders, autoimmune disease, history of severe allergies or anaphylaxis, and previous filler treatments.
  • Cleanse and disinfect the treatment area thoroughly using an appropriate antiseptic solution.
  • Attach one of the supplied 27G needles securely to the syringe, ensuring the connection is tight and any air bubbles are expelled according to the instructions for use.
  • Inject slowly into the deep dermis or appropriate submucosal/subcutaneous plane using techniques such as linear threading, serial puncture or fanning, depending on the area and clinical objective.
  • Typical treatment areas include nasolabial folds, marionette lines, lips, oral commissures and Cupid’s bow; avoid intravascular injection and critical vascular structures at all times.
  • Do not overcorrect; gradual layering and assessment is recommended to achieve natural-looking results.
  • After injection, gently massage the treated area to ensure even distribution and smooth contour, unless contraindicated by the specific injection site.
  • Use aseptic technique throughout; each syringe is for single patient, single use only and any unused product must be disposed of according to local regulations for medical sharps and pharmaceutical waste.
  • Provide the patient with post-treatment advice, including avoiding excessive facial movements, makeup, intense heat or cold, and vigorous exercise for a short period as per local protocols, and instruct them to report immediately any signs of infection, severe pain, blanching or visual disturbance.
  • Record the batch number, injection sites, volume used and any immediate reactions in the patient’s record; affix traceability labels as required by local regulations.

Contraindications

  • Known hypersensitivity to hyaluronic acid, lidocaine, other amide-type local anaesthetics or any of the excipients (including phosphate buffer components).
  • History of severe allergies or anaphylactic reactions, or presence of multiple severe allergies.
  • Known allergy to gram-positive bacterial proteins (as the hyaluronic acid is produced by bacterial fermentation).
  • Presence of active skin disease, infection, inflammation, or lesions (e.g. cold sores, acne, dermatitis, cysts) at or near the intended injection site.
  • Tendency to develop hypertrophic scars or keloids.
  • Use in patients with bleeding disorders or those on anticoagulant or antiplatelet therapy requires particular caution and risk–benefit assessment.
  • Injection into blood vessels (intravascular injection) is strictly contraindicated because of the risk of vascular occlusion, ischaemia or embolic events.
  • Not recommended for use in pregnant or breastfeeding women, or in patients under 18 years of age, due to lack of clinical data.
  • Avoid injection into areas previously treated with permanent or semi-permanent fillers unless the practitioner judges it safe and appropriate.

Adverse Effects

  • Common, usually transient injection-site reactions: redness (erythema), swelling, tenderness, pain, itching, bruising, induration or lumpiness at the treatment site.
  • Mild to moderate oedema and sensitivity in the lips or perioral region when treated, which typically resolves within a few days.
  • Haematoma or bruising related to needle insertion, particularly in highly vascular areas.
  • Nodules, palpable beads, or unevenness in the treated area, usually manageable with massage or, if persistent, further medical management.
  • Hypersensitivity or allergic reactions, including localised swelling, erythema or more generalised reactions; immediate medical evaluation is required if severe.
  • Infection at the injection site (cellulitis, abscess) if aseptic technique is not strictly followed or if post-treatment care is inadequate.
  • Very rare but serious vascular complications (e.g. arterial occlusion, tissue necrosis, visual disturbances or blindness) resulting from inadvertent intravascular injection; these require urgent specialist management.
  • Delayed inflammatory reactions or granulomas, although these are uncommon with modern HA fillers.

Storage Conditions

  • Store between 2°C and 25°C in a dry place.
  • Do not freeze.
  • Keep the syringe in its original blister and outer carton to protect from light until use.
  • Do not use after the expiry date indicated on the packaging.
  • Do not use if the packaging, blister or syringe is damaged or if the solution appears cloudy or discoloured.
  • Keep out of the sight and reach of children and unauthorised persons.

Duration

Results are typically visible immediately after injection and generally last around 9\u201312 months for most patients, depending on the treated area, injection technique, volume used, patient age, skin quality, metabolism and lifestyle. In some cases, results may persist longer, but touch-up or repeat treatments are usually required to maintain the desired effect.

Onset

The filling and smoothing effect is usually apparent immediately after injection due to the volume of the hyaluronic acid gel, with final appearance stabilising over several days as any initial swelling or redness subsides.

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