Teosyal RHA 2 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® 2 is the entry reference of the Resilient Hyaluronic Acid range at 23 mg/ml and the least cross-linked of the four RHA products. It is formulated for moderate wrinkles and for work in areas of high mobility — lip contour, perioral lines, mildly marked nasolabial folds — where a rigid gel would be visible on movement. It incorporates 0.3 % lidocaine and is supplied with 30G ½" needles.
- HA 23 mg/ml
- Cross-linking < 5 % (NMR)
- Lidocaine 0.3 % (3 mg/ml)
- Contents 2 syringes × 1 ml
- Needles 4 × 30G 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. Within the RHA range, RHA 2 is the least cross-linked reference (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: at the same HA concentration as RHA 3 and RHA 4, RHA 2 is the softest gel of the three. It is injected with a finer needle (30G versus 27G) and works in more superficial planes.
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 (this product) | HA 23 mg/ml · 1 ml · 30G ½" — moderate wrinkles, midface and lips · 12–18 months |
| RHA 3 | 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 wrinkles and volume augmentation in:
- Upper third: forehead, glabella, temples
- Periorbital region: eyebrows, crow's feet
- Midface: nasolabial folds, smile lines
- Perioral region: lips, marionette lines
Technique and treatment protocol
- Injection plane: at variable depth — dermis, subcutaneous plane, supraperiosteal, or subdermis and submucosa of the red lip.
- Needles included: 30G ½", two per syringe (4 per pack).
- 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) — the lowest in 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 × 30G ½" (2 per syringe) |
| 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 30G 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® 2, ref. 230580-00, and patient product information). This information sheet does not replace the instructions for use supplied with the product.