Dr. ArJo® Ultra Dermal Filler

Dr. ArJo

Medical Device – Dermal Filler

Cross-linked Hyaluronic Acid Filler

CE Marked hyaluronic acid dermal filler medical device for aesthetic use in eligible markets.
Manufactured in Germany in conformity with applicable European medical device regulations and quality standards.

CE Marked hyaluronic acid dermal filler medical device for aesthetic use in eligible markets.
Manufactured in Germany in conformity with applicable European medical device regulations and quality standards.

Cross-linked Hyaluronic Acid Filler

Description

Dr. ArJo® Ultra is a premium cross-linked hyaluronic acid dermal filler developed by DAPOU Pharma GmbH. Formulated with a high HA concentration of 25 mg/ml, it is designed for the treatment of medium to deep facial wrinkles and for volumising and sculpting key facial areas such as cheekbones, chin, jawline, lips, nose and periocular regions. The sterile hydrogel is supplied in a prefilled 1 ml syringe for injection into the deep dermis or supraperiosteal plane by suitably qualified medical professionals. Dr. ArJo® Ultra helps restore age-related volume loss, redefine facial contours and improve skin elasticity while providing natural-looking, long-lasting rejuvenation results, typically up to 12 months.

Bnefits

Restores facial volume and improves contour in areas such as cheekbones, chin, jawline, lips and nose.
Fills and smooths medium to deep facial wrinkles (e.g. mentolabial and nasolabial folds).
High concentration of cross-linked hyaluronic acid (25 mg/ml) for effective volumising and lifting.
Deeply hydrates and improves skin elasticity, contributing to a more youthful appearance.
Provides immediate visible results after treatment, enhancing patient satisfaction and self-esteem.
Long-lasting effect, with results typically maintained for up to 12 months depending on individual factors.
Formulated with reticulated HA of bacterial fermentation origin and very low BDDE residue (<50 ppb) for safety.
CE-marked sterile injectable hydrogel designed specifically for facial aesthetic procedures by trained clinicians.

Indications

Treatment of deep and medium-deep facial wrinkles and folds (e.g. nasolabial and mentolabial folds).
Volume augmentation and contouring of cheekbones (zygomatic area).
Chin and jawline definition and contouring.
Nose reshaping (non-surgical rhinoplasty) and correction of nose bridge irregularities.
Lip volumisation and contour enhancement.
Correction of age-related volume loss in mid and lower face.
Periocular rejuvenation in indicated areas such as upper eyelids and tear trough/dark circle region (for suitably trained practitioners).

Composition

Reticulated (cross-linked) hyaluronic acid 25 mg/ml (bacterial fermentation origin).
Cross-linking agent: BDDE (1,4-butanediol diglycidyl ether) with residual level < 50 ppb.
pH: approximately 6.0 – 7.5.
Initial hyaluronic acid molecular weight: approximately 2,400–4,000 kDa.
Total endotoxins: < 0.5 EU/ml.
Sterile water and buffer excipients suitable for injectable hydrogel (exact excipient profile as per official Instructions for Use within pack).

Formulation

Sterile, apyrogenic, viscoelastic cross-linked hyaluronic acid hydrogel.
Concentration: 25 mg/ml HA.
Presentation: 1 ml prefilled syringe.
Indicated injection depth: deep dermis or supraperiosteal hypodermis.
Source of HA: bacterial fermentation.

Packaging

Single-use 1 ml prefilled glass syringe of Dr. ArJo® Ultra hydrogel.
Each box contains: 1 x 1 ml prefilled syringe and 2 sterile disposable 27G 1/2" needles.
Sterile blister packaging enclosing syringe and needles.
Outer carton printed with product name, batch number, expiry date, CE mark and manufacturer details.
Supplied with Instructions for Use (IFU) leaflet for healthcare professionals.

Usage

For professional use only – to be administered exclusively by suitably qualified and trained medical practitioners with experience in injectable facial aesthetics.
Intended injection depth: deep dermis or supraperiosteal layer in the indicated facial areas, following established safe injection techniques.
Common technique: linear retrograde injection, avoiding overcorrection; alternative techniques should only be used by experienced injectors in line with the IFU.
Treatable areas include cheeks, chin, jawline, nose, lips, upper eyelids, tear trough/dark circles and other indicated facial contours, according to individual patient assessment.
Aseptic technique must be applied throughout the procedure; disinfect the treatment area before injection.
Do not inject intravascularly; avoid high-risk vascular zones and use aspiration and low injection pressure as per training and guidelines.
After injection, gently mould the product as required to achieve the desired contour, avoiding excessive pressure.
Inform patients to avoid extreme facial movements, strenuous exercise, saunas, sunbeds, alcohol and makeup on the treated area for approximately 24 hours or as per clinic protocol.
Do not use in combination with other facial implants in the same site unless clinically justified and in accordance with professional guidelines.

Contraindications

Known hypersensitivity or allergy to hyaluronic acid or any component of the product.
History of severe allergic reactions or anaphylaxis.
Presence of active skin infections, inflammation or lesions (e.g. acne, herpes, dermatitis) at or near the intended injection sites.
Autoimmune diseases or patients under immunotherapy, unless the physician has assessed that benefits outweigh risks.
Bleeding disorders or patients taking anticoagulant or antiplatelet therapy where the risk of bleeding or haematoma is considered unacceptable.
Pregnant or breastfeeding women (use is generally not recommended due to lack of safety data).
Known tendency to develop hypertrophic scars or keloids.
Previous permanent filler or foreign body in the proposed treatment area, unless carefully evaluated by an experienced practitioner.
Use in patients under 18 years of age.

Adverse Effects

Common, transient local reactions at the injection site such as redness (erythema), swelling, tenderness, pain, itching, bruising or slight discolouration.
Small lumps, nodules or palpable irregularities at or near the injection site, usually resolving spontaneously or with gentle massage or medical management.
Haematoma or ecchymosis in the treated area.
Temporary asymmetry or overcorrection if product placement or volume is suboptimal.
Infection at the injection site (including abscess formation) if aseptic technique is not strictly followed.
Hypersensitivity reactions, including local or more diffuse inflammatory responses; very rarely, delayed immune-mediated reactions or granuloma formation.
Tyndall effect (bluish discolouration) if the product is placed too superficially in certain areas.
Rare but serious vascular complications, including intravascular injection leading to tissue ischaemia or necrosis, and in extremely rare cases visual disturbance or blindness; these require immediate recognition and urgent specialist management.

Storage Conditions

Store in a clean, dry place at a controlled room temperature as indicated on the packaging (commonly between 2°C and 25°C).
Protect from freezing and excessive heat.
Keep the syringe in its original packaging until use to maintain sterility and protect from light.
Do not use after the expiry date printed on the carton and blister.
Single-use device – do not resterilise or reuse any part of the product.
Keep out of the sight and reach of unauthorised persons and children.

Duration

Clinical effects typically last up to 12 months, depending on factors such as treatment area, injection technique, amount of product used, patient age, metabolism, skin type and lifestyle. Repeat treatments can be performed to maintain results, following clinical assessment and recommended intervals.