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HYAMIRA FORTE (1x1ml) NYUMA APHARM

HYAMIRA FORTE (1x1ml) NYUMA APHARM

Hyamira

Injectable dermal filler
  • CE Marked class III medical device based on cross Linked hyaluronic acid for injectable facial augmentation and wrinkle correction (as per EU medical device classification for such fillers).
  • Manufactured in Italy in compliance with European medical device regulations and ISO Aligned quality management systems for sterile injectable products.
  • Non Animal Origin hyaluronic acid with strict controls on residual cross Linking agent (BDDE < 50 ppb) and low protein content, supporting high biocompatibility.
  • Intended exclusively for professional medical use in accordance with local aesthetic medicine regulations and professional guidelines.
Cross-linked hyaluronic acid volumizing filler for medium-to-deep wrinkles and facial contouring

Description

Hyamira FORTE (1x1ml) NYUMA APHARM is a CE-marked, colourless monophasic dermal filler gel based on cross-linked, non-animal hyaluronic acid. With a high HA concentration (labelled 25 mg/ml in technical descriptions, with some documentation listing 24 mg/ml), it is intended for the treatment of medium-to-deep facial wrinkles and folds, and for volumetric correction and reshaping of key facial structures including cheekbones, chin, bridge of the nose and lips. Injected into the deep hypodermis or onto the periosteum, Hyamira Forte restores lost facial volume, redefines the facial oval, reduces pronounced wrinkles, and provides deep hydration and elasticity. Its homogeneous texture and strongly reticulated HA provide a powerful, long-lasting volumizing and bio-revitalising effect while maintaining natural facial expression.

Bnefits

  • Treats medium-to-deep facial wrinkles and folds with a high-viscosity, strongly cross-linked HA gel.
  • Restores and enhances facial volumes in areas such as cheekbones, chin, nose and lips.
  • Redefines the facial oval and improves overall facial contours.
  • Provides deep hydration and improves skin elasticity, contributing to a smoother, firmer appearance.
  • Homogeneous monophasic texture allows effective filling of moderate-to-severe wrinkles and structural depressions.
  • Non-animal, biodegradable, low-protein cross-linked HA formulation designed to minimise immunogenicity and maintain natural facial movement.
  • Long-lasting effect, with clinical distributors indicating results around 9–12 months and some documentation suggesting up to 12–14 months depending on patient factors.
  • Part of a structured range (SOFT–BASIC–FORTE) that enables tailored treatment by wrinkle depth and volumetric requirements.

Indications

  • Injections aimed at giving volume to the entire face while avoiding the eye contours.
  • Volumetric correction and reshaping of cheekbones, chin, nasal bridge and lips.
  • Treatment and reduction of medium-to-deep facial wrinkles and folds (e.g. nasolabial and marionette lines).
  • Increase in volume of the cheekbones, chin, nose and lips, as well as correction of facial furrows.
  • Deep hydration and restoration of skin elasticity in volume-deficient facial areas.
  • Refreshing and smoothing the skin surface in areas of structural volume loss.

Composition

  • Cross-linked hyaluronic acid 24–25 mg/ml (high-concentration HA; technical description lists 25 mg/ml, composition section on some distributor documentation lists 24 mg/ml).
  • Hyaluronic acid molecular weight: approximately 2,400–4,000 kDa.
  • BDDE (1,4-butanediol diglycidyl ether) as cross-linking agent, with residual BDDE < 50 ppb.
  • Physiological buffer solution (water for injections, sodium chloride and excipients suitable for a sterile injectable HA medical device).
  • Non-animal-origin hyaluronic acid obtained via biofermentation.

Formulation

  • Colourless, monophasic, viscoelastic gel of cross-linked hyaluronic acid for deep subcutaneous and supraperiosteal injection.
  • Strongly reticulated, non-animal HA designed to provide robust volumization and structural support.
  • Biodegradable and highly tolerated, gradually resorbed by the body over many months.
  • Formulated to increase dermal–epidermal volume by attracting and binding water, integrating into the intercellular matrix and strengthening tissues.
  • Part of the Hyamira filler system (SOFT for fine lines, BASIC for medium-depth wrinkles, FORTE for deep wrinkles and volumetric correction).

Packaging

  • Box containing 1 pre-filled sterile glass syringe with 1 ml of Hyamira Forte gel.
  • HA concentration on pack: typically indicated as 24–25 mg/ml depending on label version.
  • 2 sterile needles 27G 1/2" supplied with each syringe (per distributor pack description).
  • Outer carton with CE-marked medical device labelling, batch number and expiry date.
  • Package insert / instructions for use detailing indications, injection depth and precautions.

Usage

  • STRICT MEDICAL USE: Hyamira Forte must be administered only by qualified medical professionals experienced in dermal fillers and facial anatomy.
  • Before treatment, take a full medical history, assess facial anatomy and discuss expectations; obtain informed consent.
  • Cleanse and disinfect the treatment area thoroughly. Apply topical or local anaesthesia as required by the treatment plan and patient comfort.
  • Intended injection depth: deep hypodermis (deep subcutaneous) or onto the periosteum, depending on indication and anatomical area.
  • Recommended needles: 27G 1/2" (supplied) or equivalent, as appropriate for the area treated.
  • Use linear retrograde, serial puncture or combined techniques according to the practitioner’s skill to restore facial volume and reshape cheekbones, chin, nose and lips, and to treat medium-to-deep folds.
  • Avoid overcorrection; under-correct slightly and reassess after initial settling, with the option for touch-up treatments.
  • Do not inject into vascular structures, the periorbital fat pads or the immediate eye contour; follow safe-injection protocols, particularly in high-risk areas such as nose and glabella.
  • After injection, gently massage the treated area if necessary to ensure even distribution and to reduce the risk of lumps or irregularities.
  • Advise patients to avoid makeup on treated areas for several hours and to avoid strong facial massages, intense physical exercise, alcohol, saunas, and extreme heat or cold for 24–48 hours.
  • Instruct patients to use broad-spectrum sunscreen and adopt suitable skincare to maintain results and protect treated skin.
  • Keep hyaluronidase and full complication-management equipment and protocols available in the clinic for emergency management of potential vascular events.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, BDDE, or any component of the product.
  • Presence of active skin infection, inflammation or lesions (e.g. active herpes, severe acne, dermatitis) at or near the intended injection sites.
  • Autoimmune diseases or severe systemic illnesses where dermal filler use is considered unsafe by the treating physician.
  • History of severe allergic or anaphylactic reactions to injectable medical devices or dermal fillers.
  • Pregnancy or breastfeeding, due to lack of established safety data and standard aesthetic practice recommendations.
  • Known tendency to keloid or hypertrophic scarring in the planned treatment area, unless carefully assessed and justified.
  • Recent aggressive cosmetic procedures (deep chemical peels, ablative laser, dermabrasion) in the treatment area without sufficient healing time.
  • Use in patients under 18 years of age or outside age/indication limits defined by local regulations and professional guidelines.

Adverse Effects

  • Common, usually transient injection-site reactions such as redness, swelling, bruising, tenderness, itching or mild pain.
  • Temporary lumps, nodules or irregularities at the injection site, typically resolving with massage or over time; in some cases, further treatment may be required.
  • Mild asymmetry or uneven contours, which may require observation, additional product placement or adjustment.
  • Local inflammatory reactions or prolonged oedema, which are uncommon but may require medical evaluation and treatment.
  • Very rare infections at injection sites if aseptic technique or aftercare is inadequate.
  • As with all hyaluronic acid fillers, there is a rare but serious risk of intravascular injection resulting in vascular occlusion, tissue ischaemia or necrosis (and, in certain areas, risk to vision); practitioners must follow safe injection practices and be prepared to implement emergency management protocols including hyaluronidase use.

Storage Conditions

  • Store according to manufacturer recommendations, typically between 2°C and 25°C.
  • Do not freeze; protect from direct sunlight and excessive heat.
  • Keep the pre-filled syringe in its original blister and outer carton until use to maintain sterility and traceability.
  • Do not use after the expiry date shown on the packaging.
  • Do not use if the blister, syringe or needle packaging is damaged or shows signs of compromised sterility.

Duration

Distributor and range information indicates that the hyaluronic acid in Hyamira Forte is slowly resorbed over approximately 9\u201312 months, with some sources citing 12\u201314 months of effect depending on patient metabolism, treatment area, injection technique and lifestyle.

Onset

Volumizing and wrinkle-filling effects are visible immediately after injection, with final aesthetic results clarifying over several days as transient swelling subsides and the gel integrates with the surrounding tissues.

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