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Teoxane Teosyal Rha 4 2 Syringes Prefilled With 1.2ml

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€219.00
From €79.00
Teoxane Teosyal Rha 4 2 Syringes Prefilled With 1.2ml
Teoxane Teosyal Rha 4 2 Syringes Prefilled With 1.2ml
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TEOSYAL
RHA 4
Hyaluronic Acid 23mg + lidocaine
Creates volume that corrects wrinkles, fills skin depressions and enhances or restores facial contours.
2 pre-filled syringes of TEOSYAL® RHA 3, 2 sterile 27G1/2" needles and two traceability labels

TEOSYAL RHA 4 is a sterile, transparent, non-pyrogenic, viscoelastic, cross-linked hyaluronic acid gel of non-animal origin, which contains 0.3% by weight of lidocaine hydrochloride for its anaesthetic properties. Each box contains two pre-filled syringes of TEOSYAL RHA 4. For each syringe, the box contains two sterile 27G 1/2" needles and two traceability labels (one to be given to the patient and one to be kept by the doctor in the patient's medical file) for each syringe. The Volumea of each syringe is indicated on the packaging and on the syringe itself.

Hyaluronic Acid is a major constituent of the fundamental substance of the dermal extracellular matrix. A veritable molecular sponge, its helical structure enables it to absorb up to 1,000 times its weight in Water. It is widely distributed throughout the skin's tissues and hydrates the skin, although its content decreases with age. As Skin becomes thinner and more fragile, the first lines of skin breakage appear.
TEOSYAL RHA 4 is a biodegradable implant that gradually resorbs over time.
TEOSYAL RHA 4 can be injected at variable depths depending on the area to be treated in the deep dermis, subcutaneously or supraperiosteally, depending on the indication being treated. TEOSYAL RHA 4 creates a volume that corrects wrinkles, fills skin depressions and enhances or restores the contours of the Face. Depending on the corrections to be made and the results sought, one or more treatment/retouch sessions may be necessary to achieve optimum results. This must be determined by the Professional in charge of the treatment.

Therapeutic indications for TEOSYAL products
Reconstructive surgery, filling of scar depressions, restoration of lost volumes induced by lipoatrophy in patients undergoing anti-HIV treatment.
Aesthetic indications for TEOSYAL products: Correcting the effects of skin ageing: restoring volume, filling in skin depressions and wrinkles, restoring skin hydration.
TEOSYAL RHA 4 is indicated for reshaping the contours of the Face, restoring/increasing volume and correcting minor ptosis in areas such as the cheeks and cheekbones. It is also indicated for the filling of deep wrinkles and folds in areas of thick Skin, including moderate to severe nasolabial folds. Lidocaine hydrochloride is a local anaesthetic designed to reduce the sensation of pain.

Please note that injecting Teosyal RHA 4 requires a medical procedure that can only be carried out by a doctor (a doctor specialising in Dermo aesthetics, dermatologist or plastic surgeon).

THE PRODUCTS SOLD ON OUR SITE ARE PARAPHAMACEUTICAL PRODUCTS, WHICH MEANS THAT THEY CAN BE PURCHASED OVER THE COUNTER AND DO NOT REQUIRE A PRESCRIPTION.

This is a medical device.

This product cannot be returned or exchanged.

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.

Dosage and administration
TEOSYAL RHA 4 is for use by doctors or authorised healthcare professionals only, in accordance with local regulations. To minimise the risk of potential complications, the product should only be used by well-trained practitioners who are experienced in injection techniques and have a good knowledge of the anatomy and physiology of the injection and surrounding sites. Prior to treatment, patients should be interviewed about their medical history and informed of the indications, predictable results, contraindications, precautions and potential side effects. Patients' needs for pain relief using local or regional anaesthetics should be assessed. The areas to be treated must be disinfected with a suitable Anticeptics solution. It is strongly recommended that injections are carried out using the needles supplied in the boot.
TEOSYAL RHA 4 should be injected slowly into the deep dermis, subcutaneously or supraperiosteally, depending on the indication being treated. Preclinical and/or clinical data have not revealed any problems with a volume of up to 3 mL. Consequently, a maximum volume of 3 mL per session is authorised (all indications included). The choice of injection technique will be at the discretion of the healthcare professional in charge of the treatment, depending on the area treated and the quantity of product administered.
- Avoid injecting too superficially, as the result of the correction could be irregular.
If the Colour of the needle is visible under the Skin during injection, this suggests that the injection may have been too superficial.
- Stop the injection well before removing the needle from the Skin to avoid leakage of the product from the treatment site.
The type and severity of the defect to be treated, the depth of the injection and the injection technique determine the degree and duration of the correction.
The volume injected and the number of sessions depend on the area to be treated and the correction required.
The sites treated must be carefully massaged to ensure even distribution of the product over these areas.

Assembling the needle on the syringe
For optimum handling of TEOSYAL® RHA products, it is important that the needle is fitted to the syringe in accordance with the 4 steps shown in diagrams 1 to 5.
If you feel any obstruction or depression during injection, stop the injection and change needle.

To view the instructions, click on this link

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