HYAMIRA BASIC (1x1ml)
Hyamira
Dermal fillerCross-linked hyaluronic acid dermal filler
Certifications
- CE Marked medical device for injectable dermal filling with hyaluronic acid.
- Non Animal, highly purified hyaluronic acid with low protein content to minimise immunogenicity.
- Residual BDDE content controlled to < 50 ppb according to product specifications.
- Manufactured in accordance with applicable European medical device quality and safety standards for sterile injectable HA fillers.
- CE Marked medical device for injectable dermal filling with hyaluronic acid.
- Non Animal, highly purified hyaluronic acid with low protein content to minimise immunogenicity.
- Residual BDDE content controlled to < 50 ppb according to product specifications.
- Manufactured in accordance with applicable European medical device quality and safety standards for sterile injectable HA fillers.
Cross-linked hyaluronic acid dermal filler
Description
Hyamira Basic (1x1ml) is a sterile, viscoelastic dermal filler based on non-animal cross-linked hyaluronic acid (20 mg/ml), developed by the Italian laboratory Apharm (Nyuma Pharma). It is indicated for the correction of medium-depth wrinkles and for lip and eyebrow contouring, as well as treatment of perioral lines, nose–cheek wrinkles, forehead lines, tear trough and temples. Injected into the deep dermis, it restores dermo-epidermal volume by attracting and binding water molecules, filling intradermal spaces and strengthening tissues. The high molecular weight hyaluronic acid (2,400–4,000 kDa) is cross-linked with BDDE, providing a long-lasting, stable and biocompatible filler effect with natural-looking results and slow resorption over several months. Hyamira Basic is a CE-marked medical device intended strictly for professional medical use.
Bnefits
- Effective correction of medium-depth facial wrinkles, including perioral lines and nasolabial folds.
- Enhances and defines lip and eyebrow contours with a natural aesthetic result.
- Suitable for the treatment of dark circles and volume deficiency in the tear trough region when used by experienced practitioners.
- Viscoelastic, cross-linked hyaluronic acid gel provides durable yet natural-looking volume restoration.
- Non-animal, highly purified HA with low protein content reduces immunogenic risk.
- Strongly reticulated structure offers improved longevity compared with many non-cross-linked or weakly cross-linked fillers.
- Maintains skin hydration by attracting and retaining water molecules, improving dermal turgor and texture.
- Biodegradable and slowly resorbed, allowing for adjustment of results over time and reducing the risk of permanent overcorrection.
- Does not usually produce a rigid facial expression, maintaining softness and facial dynamics when correctly injected.
- CE-marked medical device manufactured under controlled quality standards for injectable HA fillers.
Indications
- Correction of medium-depth wrinkles on the nose–cheek area (nasolabial folds).
- Perioral wrinkles and lip contouring.
- Lip volumisation and shaping (moderate augmentation).
- Eyebrow contouring and support.
- Forehead wrinkles of moderate depth.
- Tear trough and dark circle treatment (for appropriately trained injectors).
- Wrinkles and volume loss in the temple region.
- General restoration of dermo-epidermal volume where a medium-consistency HA filler is indicated.
Composition
- Cross-linked sodium hyaluronate (hyaluronic acid) 20 mg/ml.
- Hyaluronic acid molecular weight: approximately 2,400–4,000 kDa.
- Cross-linking agent: 1,4-butanediol diglycidyl ether (BDDE).
- BDDE residual: < 50 ppb.
- Non-animal origin hyaluronic acid.
- Buffered, isotonic excipient solution (physiological pH and osmolarity).
Formulation
- Sterile, apyrogenic, viscoelastic gel of cross-linked hyaluronic acid for injectable use.
- Single-use, pre-filled 1 ml syringe intended for deep dermal injection.
- Non-animal sourced HA with high molecular weight and strong cross-linking for extended longevity.
- Biodegradable filler gradually resorbed over several months while maintaining volume and hydration during its lifespan.
Packaging
- Box containing 1 x 1 ml pre-filled sterile syringe of Hyamira Basic (20 mg/ml HA).
- Includes 2 disposable sterile needles (27G 1/2" or 26G 1/2", depending on pack configuration).
- Sterile blister packaging for syringe and needles.
- Package leaflet / instructions for use for healthcare professionals.
- Labelled as a CE-marked medical device for professional medical use only.
Usage
- For strict medical use only; must be administered by a qualified physician or appropriately trained healthcare professional experienced in dermal filler injections.
- Perform a full medical history, aesthetic assessment and informed consent prior to treatment.
- Cleanse and disinfect the treatment area according to aseptic technique.
- If appropriate, apply topical or local anaesthesia according to clinical judgement and patient needs.
- Inject Hyamira Basic into the deep dermis using a 27G or 26G 1/2" needle, avoiding intravascular injection.
- Indicated areas include nose–cheek wrinkles, perioral lines, lips, forehead, tear trough and temples, as well as lip and eyebrow contouring.
- Use serial puncture or linear retrograde (threading) techniques depending on area, desired effect and practitioner skill; avoid overcorrection.
- Massage gently if required to mould the product and achieve an even distribution, taking care not to apply excessive pressure.
- Advise patients to avoid extreme facial movements, strong pressure on treated areas, intense physical exercise, saunas, steam rooms and significant heat or sun exposure for at least 24–48 hours after injection.
- Inform patients about common, transient reactions (erythema, swelling, tenderness, bruising) and provide aftercare instructions, including when to seek medical attention for unusual or prolonged symptoms.
- Schedule follow-up appointments as needed to assess results and determine whether touch-up treatments are required.
Contraindications
- Hypersensitivity or known allergy to hyaluronic acid, BDDE or any component of the product.
- History of severe allergic reactions or anaphylaxis.
- Presence of active or chronic skin disease, infection or inflammation (e.g., acne, herpes, dermatitis) in or near the intended treatment area.
- Autoimmune diseases or ongoing immunosuppressive therapy, unless the treating physician judges the procedure to be appropriate.
- Known tendency to keloid or hypertrophic scarring in the planned treatment region.
- Pregnancy or breastfeeding (use generally not recommended due to lack of safety data).
- Patients with coagulation disorders or those on anticoagulant or antiplatelet therapy, unless carefully evaluated and managed by the physician.
- Previous permanent fillers or foreign bodies in the intended injection area where interactions could occur, unless carefully assessed by an expert injector.
Adverse Effects
- Common, usually transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching, bruising or slight bleeding.
- Localised lumps or nodules, which may require massage or medical management if persistent.
- Asymmetry or irregularity of correction if product placement or integration is uneven.
- Delayed-onset inflammatory reactions, including rare granuloma formation.
- Infection at the injection site if aseptic technique is not strictly followed.
- Vascular complications, including rare but serious events such as vascular occlusion, tissue ischaemia or necrosis, and, in extremely rare cases, visual disturbances or blindness if filler is inadvertently injected into a vessel; requires immediate recognition and emergency management.
- Hypersensitivity reactions ranging from localised swelling to, very rarely, systemic allergic responses.
Storage Conditions
- Store in the original packaging to protect from light.
- Keep at a controlled room temperature as specified by the manufacturer (typically between 2°C and 25°C).
- Do not freeze.
- Do not use after the expiry date indicated on the packaging.
- Do not use if the blister or packaging is damaged or if the sterility of the syringe or needles is compromised.
- Keep out of the reach of children.
Duration
According to manufacturer and distributors, the aesthetic results of Hyamira Basic typically last approximately 8\u201312 months, with some sources noting that hyaluronic acid is slowly reabsorbed over about 6\u20138 months; longevity varies with treatment area, injection technique, patient metabolism and lifestyle.
Onset
Immediate volumising and wrinkle-correcting effect is visible directly after injection, with final results stabilising over the subsequent days as initial swelling subsides.
