HYALMASS SOFT Lidocaine 1x1ml

Hyalmass

Dermal filler

Hyaluronic acid dermal filler with lidocaine

CE Marked sterile absorbable injectable dermal filler with lidocaine (medical device, class dependent on local regulation)
Manufactured in South Korea by Genoss under ISO Based quality management systems for medical devices
Product documentation from the manufacturer describing Hy BRID cross Linking technology and low residual BDDE/endotoxin levels

CE Marked sterile absorbable injectable dermal filler with lidocaine (medical device, class dependent on local regulation)
Manufactured in South Korea by Genoss under ISO Based quality management systems for medical devices
Product documentation from the manufacturer describing Hy BRID cross Linking technology and low residual BDDE/endotoxin levels

Hyaluronic acid dermal filler with lidocaine

Description

HYALMASS SOFT Lidocaine 1x1ml is a CE-marked, cross-linked hyaluronic acid dermal filler with 0.3% lidocaine, designed for the correction of fine and very fine wrinkles and for subtle volumisation in delicate areas such as the lips, tear troughs and periocular region. Supplied as a sterile, prefilled 1.0 ml syringe with two 30G thin-wall needles, it uses Hy-BRID cross-linking technology to provide a smooth, cohesive gel with good viscoelasticity, natural-looking results and long-lasting yet reversible effects.

Bnefits

Smooths fine to very fine lines, including crow’s feet, smoker’s lines and other superficial wrinkles
Provides subtle volume and hydration in delicate areas such as the lips, tear troughs and periocular region
Contains 0.3% lidocaine to improve patient comfort during injection
Cross-linked, non-animal hyaluronic acid (24 mg/ml) for durable yet natural correction
Supplied with 30G thin-wall needles for more precise, low-resistance injection
CE-marked and manufactured under stringent quality controls with very low residual BDDE and endotoxin levels

Indications

Treatment of fine to very fine wrinkles
Smoothing of crow’s feet (periorbital lines)
Smoothing of glabellar lines and superficial forehead lines (depending on injection depth and technique)
Correction of perioral wrinkles and smoker’s lines
Lip contour definition and subtle lip enhancement
Correction of tear troughs and fine infra-orbital lines by experienced injectors
Treatment of superficial wrinkles in sensitive areas such as the eye area, neck, décolleté and hands (within the approved depth for the product)

Composition

Cross-linked hyaluronic acid 24 mg/ml (non-animal origin)
Lidocaine hydrochloride 3 mg/ml (0.3%)
Physiological buffer (pH approximately 6.5–7.5)
Residual BDDE < 2 ppm (below detection limit according to manufacturer testing)
Endotoxin level < 20 EU/g (below detection limit according to manufacturer testing)

Formulation

Transparent, colourless, sterile, pyrogen-free, cross-linked hyaluronic acid gel with lidocaine for injection into superficial dermal/epidermal layers
Single-use, prefilled 1.0 ml syringe designed for injection with 30G thin-wall needles
Non-animal hyaluronic acid processed using Hy-BRID cross-linking technology to provide a dense, uniform gel matrix

Packaging

Box containing 1 x 1.0 ml prefilled glass syringe of HYALMASS SOFT with lidocaine
2 x 30G thin-wall sterilised injection needles
Sterile blister pack with protective caps and plunger rod
Package insert / instructions for use

Usage

For professional use only: inject only by suitably trained and qualified healthcare professionals familiar with hyaluronic acid dermal fillers and facial anatomy.
Before treatment, obtain a full medical history, discuss expectations and obtain informed consent; avoid treatment in patients with known contraindications.
Cleanse and disinfect the treatment area using appropriate skin antisepsis, maintaining aseptic technique throughout the procedure.
Inject the gel slowly using the supplied 30G thin-wall needles into the recommended plane (epidermis/superficial dermis) depending on indication and local guidelines, using techniques such as linear threading, serial puncture or micro-bolus according to practitioner training.
Apply gentle massage if required to ensure even distribution and to smooth any palpable irregularities, taking care not to over-correct.
After treatment, advise the patient to avoid makeup on the treated area for several hours, and to minimise exposure to extreme temperatures, saunas, intense exercise or pressure on the area for 24–48 hours.
Monitor the patient for early signs of adverse events; have appropriate emergency protocols and hyaluronidase available according to local practice where permitted.

Contraindications

Known hypersensitivity to hyaluronic acid, lidocaine or other amide-type local anaesthetics, or to any component of the product
Patients with a history of severe allergy or anaphylactic reactions
Presence of active skin infection, inflammation or lesions (e.g., acne, herpes, dermatitis) at or near the intended injection site
Autoimmune diseases or immunosuppression where dermal fillers are considered unsuitable by the treating clinician
Bleeding disorders or current use of significant anticoagulation/antiplatelet therapy where injection risk is not acceptable (subject to prescriber risk assessment)
Pregnancy or breastfeeding (use generally not recommended due to lack of safety data)
Patients under 18 years of age
Previous permanent or non-resorbable filler in the same area where interactions are uncertain

Adverse Effects

Common, usually transient: erythema, swelling, tenderness, bruising, itching or pain at the injection site
Local lumps, nodules or unevenness that may require massage, observation or, in some cases, hyaluronidase or other management
Haematoma or ecchymosis at injection sites
Hypersensitivity reactions including localised or more generalised swelling, erythema or pruritus
Infection at the injection site or along the injection tract, including delayed biofilm-type infections in rare cases
Vascular compromise due to inadvertent intravascular injection or compression (e.g., blanching, severe pain, livedo, tissue ischaemia/necrosis) requiring urgent recognition and management
Very rare but serious events such as visual disturbance, retinal artery occlusion or stroke secondary to intra-arterial injection or embolisation; immediate emergency management is required

Storage Conditions

Store in a clean, dry environment at controlled room temperature, typically between 1°C and 30°C (often specified by distributors as 2°C–25°C).
Do not freeze; avoid exposure to excessive heat or direct sunlight.
Keep in the original outer carton to protect from light and contamination until use.
Do not use after the expiry date printed on the packaging or if the blister, syringe or needle packaging is damaged or opened.
Single-use only: once the syringe or needle has been used, discard any unused product according to local sharps and biomedical waste regulations.

Duration

Results are typically immediate after injection and can last up to approximately 9\u201312 months depending on the treatment area, injection technique, product volume and individual patient factors.

Onset

Visible improvement is usually immediate after injection due to volumisation, with final results apparent once initial swelling and redness resolve over the following days.