HYAMIRA SOFT (1X1ml) NYUMA APHARM

Hyamira

Injectable dermal filler

Cross-linked hyaluronic acid filler for superficial/light wrinkles

CE Marked medical device based on cross Linked hyaluronic acid for injection into the superficial to medium dermis.
Manufactured in Italy in compliance with European medical device regulations and ISO Aligned quality management standards for sterile injectable products.
Non Animal Origin, low Protein hyaluronic acid with tightly controlled residual BDDE (< 50 ppb), supporting high biocompatibility.
Intended exclusively for professional medical use by qualified practitioners, in accordance with local regulations and professional guidelines for aesthetic injectables.

CE Marked medical device based on cross Linked hyaluronic acid for injection into the superficial to medium dermis.
Manufactured in Italy in compliance with European medical device regulations and ISO Aligned quality management standards for sterile injectable products.
Non Animal Origin, low Protein hyaluronic acid with tightly controlled residual BDDE (< 50 ppb), supporting high biocompatibility.
Intended exclusively for professional medical use by qualified practitioners, in accordance with local regulations and professional guidelines for aesthetic injectables.

Cross-linked hyaluronic acid filler for superficial/light wrinkles

Description

HYAMIRA SOFT (1x1ml) NYUMA APHARM is a CE-marked, cross-linked hyaluronic acid dermal filler from Italian manufacturer Apharm (NYUMA Laboratory). It contains 15 mg/ml of non-animal, strongly reticulated hyaluronic acid in a sterile, viscoelastic gel designed to correct light wrinkles and small areas. Hyamira Soft targets superficial lines around the eyes, mouth and glabella (including fine crow’s feet and perioral/periorbital lines). Injected into the superficial-to-medium dermis, it provides natural, subtle rejuvenation with immediate effect and a typical duration of 3–4 months, thanks to its BDDE-cross-linked HA which is slowly resorbed while maintaining skin softness and expression.

Bnefits

Corrects light and superficial wrinkles such as periorbital (crow’s feet), perioral lines and glabellar lines.
Provides subtle, natural-looking rejuvenation suitable for fine lines and small treatment areas.
Cross-linked hyaluronic acid (15 mg/ml) offers better stability and longevity than non-cross-linked HA while remaining soft and flexible.
Non-animal, low-protein, highly biocompatible HA designed to minimise immunogenic reactions.
Maintains natural facial expression without creating a rigid or overfilled appearance.
Supports dermal-epidermal volume by binding water, improving skin turgor and fine surface texture.
Monophasic viscoelastic gel is easy to inject and integrates smoothly into superficial tissues.
Part of the structured Hyamira range (SOFT–BASIC–FORTE), allowing tailored treatment by wrinkle depth and anatomical layer.

Indications

Correction of light and superficial wrinkles on the face.
Surface lines around the eyes (periorbital area, fine crow’s feet).
Surface lines and fine wrinkles around the mouth (perioral lines).
Glabellar lines (frown lines) of mild depth.
Fine lines and small areas requiring delicate correction at the superficial-to-medium dermis.
Early, mild signs of facial ageing where subtle enhancement is preferred.

Composition

Cross-linked hyaluronic acid 15 mg/ml (non-animal origin).
Hyaluronic acid molecular weight: approximately 2,400–4,000 kDa.
BDDE (1,4-butanediol diglycidyl ether) cross-linking agent, residual < 50 ppb (≈ 0.05 ppm).
Sterile saline/physiological buffer solution q.s. for injectable viscoelastic gel.

Formulation

Sterile, apyrogenic, viscoelastic gel based on cross-linked hyaluronic acid of non-animal origin.
Colourless, monophasic HA gel supplied in a pre-filled, graduated, single-use glass syringe with Luer / Luer-Lock fitting.
Cross-linked HA concentration: 15 mg/ml, optimised for superficial-to-medium dermal placement and fine-line correction.
Biodegradable filler gradually resorbed by physiological processes while providing temporary volumisation and hydration.
Strongly reticulated HA with low protein content to ensure good tissue tolerance and natural integration.

Packaging

Outer carton containing 1 pre-filled sterile glass syringe with 1 ml of Hyamira Soft gel.
Two sterile disposable 30G 1/2" needles supplied in many packs (per technical listings), suitable for superficial/medium-dermis injection.
Blister pack for syringe and needles ensuring sterility and full traceability.
CE medical device labelling with brand, concentration (15 mg/ml), batch number, expiry date and manufacturer information.

Usage

For professional use only: Hyamira Soft must be injected exclusively by qualified healthcare professionals experienced in facial anatomy and dermal filler techniques.
Thoroughly cleanse and disinfect the treatment area; apply topical or local anaesthesia if required, following clinic protocol.
Indicated injection depth: superficial-to-medium dermis (often referred to as epidermal/superficial intervention in product descriptions).
Recommended needles: 30G 1/2" as supplied or equivalent, using gentle injection pressure appropriate to the viscoelasticity of the gel.
Use appropriate techniques such as serial puncture or linear retrograde threading to treat surface lines around the eyes, mouth and glabella.
Inject small amounts per pass, avoiding overcorrection; build results gradually with the possibility of touch-up sessions.
After injection, gently massage the area if necessary to distribute the gel evenly and minimise palpable irregularities.
Advise patients to avoid makeup on treated areas for several hours and to refrain from intense facial movements, vigorous exercise, alcohol, saunas and strong sun/heat exposure for 24–48 hours.
Provide post-treatment guidance on using broad-spectrum sunscreen and gentle skincare to optimise and maintain results.
Retreatment or touch-up sessions may be planned according to the patient’s response, typical duration (3–4 months) and aesthetic goals.

Contraindications

Known hypersensitivity or allergy to hyaluronic acid, BDDE or any component of the product.
Pregnancy and breastfeeding, due to a lack of established safety and standard aesthetic practice recommendations.
Use in minors (under 18 years of age).
Presence of active skin infections, inflammatory lesions or disease (e.g. active herpes, severe acne, dermatitis) at or near the intended injection sites.
History of severe allergic reactions or anaphylaxis to injectable medical devices or dermal fillers.
Tendency to keloid or hypertrophic scarring in the planned treatment area, unless carefully evaluated and justified.
Previous treatment of the same area with permanent or semi-permanent fillers, unless fully assessed and deemed safe by the practitioner.
Serious systemic or autoimmune diseases where dermal filler injections are contraindicated according to the treating physician’s judgement.

Adverse Effects

Common transient injection-site reactions such as redness, swelling, bruising, tenderness, itching or mild pain.
Temporary small lumps, papules or nodules at injection points, typically resolving over time or with light massage.
Mild asymmetry or irregularity in the treated area, which may require observation or touch-up treatment.
Rare local inflammatory reactions or prolonged oedema that may require medical evaluation and, if necessary, treatment.
Very rare risk of infection at injection sites if aseptic technique or post-treatment care is inadequate.
As with all hyaluronic acid fillers, rare but serious risk of intravascular injection leading to vascular occlusion, tissue ischaemia or necrosis; practitioners must follow safe-injection protocols and have complication-management plans and hyaluronidase available.

Storage Conditions

Store according to manufacturer recommendations, typically between 2°C and 25°C.
Do not freeze; protect from direct sunlight, moisture and excessive heat.
Keep the syringe in its original blister and outer carton until time of 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 needles show signs of damage, tampering or compromised sterility.

Duration

Most distributors and technical sheets report that results from Hyamira Soft typically last about 3\u20134 months, with some sources indicating a possible range up to approximately 3\u20136 months depending on injection technique, treatment area, skin type and patient lifestyle.

Onset

Effect is immediate, with visible correction of fine lines and small wrinkles directly after injection; final aesthetic result refines over the following days as any minor swelling resolves and the gel integrates into the tissue.