Teosyal RHA 3 2x1ml
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
Teosyal RHA® 3 occupies the intermediate position of the Resilient Hyaluronic Acid range: 23 mg/ml of hyaluronic acid with cross-linking below 5 %, more cross-linked than RHA 2 and less than RHA 4. It is the versatile reference of the range — deep wrinkles, midface volume and remodelling of the lower third — and the first to be supplied with a 27G ½" needle.
- HA 23 mg/ml
- Cross-linking < 5 % (NMR)
- Lidocaine 0.3 % (3 mg/ml)
- Contents 2 syringes × 1 ml
- Needles 4 × 27G ½"
- Duration 12–18 months
Composition and technology
- Cross-linked hyaluronic acid: 23 mg/ml.
- Degree of cross-linking: < 5 %, measured by nuclear magnetic resonance. Intermediate cross-linking within the RHA range, above RHA 2 and below RHA 4 (FDA, Summary of Safety and Effectiveness Data P170002).
- Lidocaine hydrochloride: 0.3 % by mass (3 mg/ml).
- Residual BDDE: < 1 ppm.
- Phosphate buffer pH 7.3 q.s. for 1 ml.
- RHA technology (Resilient Hyaluronic Acid): Teoxane's patented manufacturing process (Preserved Network Technology) that applies minimal chemical modification and preserves the long hyaluronic acid chains. The result is a gel of low cross-linking (< 5 %) able to stretch and recover its shape with facial movement, instead of resisting it like a conventional rigid gel.
- Practical consequence: a gel with the capacity to sustain volume in the midface and to fill deep folds, while maintaining the adaptation to movement that characterises the range. The step up in gauge to 27G ½" reflects that greater firmness.
Position within the Teosyal RHA range
| RHA 1 | HA 15 mg/ml · 1 ml · 30G ½" — superficial fine lines and skin quality · ≥ 12 months |
|---|---|
| RHA 2 | HA 23 mg/ml · 1 ml · 30G ½" — moderate wrinkles, midface and lips · 12–18 months |
| RHA 3 (this product) | HA 23 mg/ml · 1 ml · 27G ½" — deep wrinkles, midface volume and remodelling of the lower third · 12–18 months |
| RHA 4 | HA 23 mg/ml · 1.2 ml · 27G ½" — deep wrinkles in thick skin and remodelling of the facial contour · 15–18 months |
| RHA Kiss | HA 23 mg/ml · 0.7 ml · 30G ½" — perioral region and lips · 12–18 months |
All references of the RHA range share a degree of cross-linking below 5 %, determined by nuclear magnetic resonance, and 0.3 % lidocaine. Within that margin the cross-linking increases in steps: RHA 2 is the least cross-linked, RHA 3 occupies an intermediate position and RHA 4 is the most cross-linked (FDA, Summary of Safety and Effectiveness Data P170002). That progression determines the firmness of the gel, the needle gauge supplied and the injection depth.
Indications and treatment areas
Therapeutic indication: reconstructive surgery, filling of scar depressions and reconstruction of volumes lost through lipoatrophy in patients under treatment for HIV.
Aesthetic indication: correction of deep facial wrinkles and marked skin folds, and provision of volume in:
- Midface: nasolabial folds, cheekbones, nasojugal groove
- Lower third: chin and jawline
- Perioral region: lips (including the philtrum), marionette lines, oral commissures
Technique and treatment protocol
- Injection plane: at variable depth — dermis, subcutaneous plane, supraperiosteal, or subdermis and submucosa of the red lip.
- Needles included: 27G ½", two per syringe (4 per pack).
- Cannula: a valid alternative is a 25G blunt cannula; compatibility verified by the manufacturer with TSK 25G/50 mm.
- Maximum volume: 6 ml per session. In the lips a maximum of 2 ml is recommended.
- Estimated duration: between 12 and 18 months.
- Do not inject into the epidermis. Do not combine in the same session with peeling, laser or ultrasound.
Technical data
| Manufacturer | Teoxane SA (Laboratoires Teoxane), Geneva, Switzerland |
|---|---|
| Active substance | Cross-linked hyaluronic acid 23 mg/ml |
| Degree of cross-linking | < 5 % (NMR) — intermediate within the RHA range |
| Anaesthetic | Lidocaine HCl 0.3 % by mass |
| Cross-linker | BDDE, residual < 1 ppm |
| Technology | RHA — Resilient Hyaluronic Acid |
| pH | 7.3 (phosphate buffer) |
| Presentation | 2 pre-filled syringes of 1 ml |
| Needles | 4 × 27G ½" (2 per syringe) |
| Compatible cannula | 25G (TSK 25G/50 mm verified) |
| Treatment plane | Dermis, subcutaneous, supraperiosteal, subdermis or labial submucosa |
| Estimated duration | 12–18 months |
| Classification | CE-marked medical device |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: between 2 °C and 25 °C, protected from direct sunlight.
- Do not use after the expiry date stated on the pack.
- Sterile single-use product. Do not reuse or re-sterilise the syringe or the needles.
- The pack contains: 2 pre-filled syringes of 1 ml, 4 sterile 27G ½" needles, and two traceability labels per syringe — one to be given to the patient and one for the medical record.
Contraindications and warnings
Contraindications: skin disorders, inflammation or infection in or near the treatment area; allergy to hyaluronic acid and a history of severe allergy or anaphylactic shock; allergy to lidocaine or to amide-type local anaesthetics; recent peel, laser or ultrasound treatment; autoimmune diseases; heart disease or treatment with beta-blockers; hepatocellular insufficiency or treatment for liver disease; epilepsy; porphyria; pregnancy, breastfeeding and patients under 18 years of age.
Vascular warning: intravascular injection may cause vascular occlusion, ischaemia and necrosis of the treated area. In the most serious cases it may lead to visual disturbances or blindness and to cerebral ischaemia or haemorrhage. Never inject intravascularly.
Before injection: do not treat if a dental procedure has been performed in the previous 15 days; avoid aspirin, anti-inflammatory drugs, anticoagulants and vitamin E during the preceding week; avoid alcohol and intense sun exposure on the previous day and on the day itself; remove make-up completely.
After injection: during the first 12 hours, do not apply make-up or undertake intense exertion; during the following week, avoid alcohol, prolonged sun or UV exposure, temperatures below 0 °C, sauna and hammam; for 15 days, do not undergo dental procedures or other aesthetic treatments.
Always consult the instructions for use included in the pack before treatment.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official documentation of Teoxane SA (instructions for use TEOSYAL RHA® 3, ref. 230581-00, and patient product information). This information sheet does not replace the instructions for use supplied with the product.