The composition may be subject to variations, so we advise you to always check the list on the purchased product.
COMPOSITION :
Hyaluronic Acid .............................................................23 mg
Lidocaine hydrochloride ...................................................0.3% by mass
Phosphate buffer pH 7.3 .........................................qsp 1.2 mL
TEOSVAL RHA 4 must not be used in the following cases :
- for injections into the Plus b layer of the skin (epidermis),
- for injection depths other than those described in the "Mode of action" section,
- if the patient has skin conditions, inflammation or infection near or at the treatment site. Injection procedures may lead to reactivation of latent or subclinical herpesvirus infections,
- in patients with known hypersensitivity to hyaluronic acid with a history of severe allergy or anaPhYlactic shock,
- in cases of known hypersensitivity to Moraine and/or amide-type local anaesthetics,
- in association with peeling, laser treatment or ultrasound treatment,
- in patients with autoimmune diseases,
- in patients suffering from heart disease and/or being treated for heart disease (beta-blockers),
- in patients suffering from hepatocellular insufficiency and/or being treated for liver disease,
- in patients suffering from epilepsy or porphyria,
- during pregnancy, in lactating termites and in Children.
As potential interactions with other filling implants have not been studied, TEOSYAL RI-le 4 should not be injected into the Omette or into areas which may contain other filling implants. Do not inject this product into an area containing an implant other than hyaluronic root (which may be permanent).
Do not inject into blood vessels.
Do not inject into the periorbital area (eyelid, under the eye, crow's feet).
Do not inject into the glabellar region.
Do not inject into the Lips.
Side effects
The practitioner must inform the patient of the potential side effects associated with the treatment, which may occur immediately after the injection or at a later date. These effects include but are not limited to)
- Common: injection site pain, tenderness, redness/erythema, bruising/haematoma, swelling/oedema, hardness-induration, balls/bumps, itching,
dyschromia (including Tyndall effect/discolouration).
- Less frequent effects: inflammatory reactions, infections (including localised or generalised infections and abscesses), loss of sensitivity around the injected area or temporary paraesthesia, risk of Allergy (including hypersensitivity, allergic eczema, urticaria), nodules (possibly granulomas),
migration of the implant.
Rare but serious adverse reactions may occur:
- Intravascular injection may produce embolisation, vessel occlusion, ischaemia, skin/tissue necrosis, temporary or permanent impairment of vision(including blindness), cerebral ischaemia/haemorrhage leading to stroke, infarction.
- Immediate hypersensitivity reaction which may lead to angioedema and anaphylactic shock.
The practitioner will in turn inform the distributor and/or manufacturer of the product (medical@teoxane.com) as soon as possible. The practitioner should use or prescribe appropriate treatment.
Any serious event relating to the device must be reported to medical@teoxane.com and to the health authority of the country in which the user and/or patient is established.
